Selected Poster Abstracts from 4th Annual Elevate-Derm PA & NP Conference

J Clin Aesthet Dermatol. 2024;17(1–2 Suppl 1):S15–S30.


Acne

Early and sustained reductions in moderate-to-severe acne with fixed-dose clindamycin phosphate 1.2%, benzoyl peroxide 3.1%, and adapalene 0.15% gel

Presenters: Julie C. Harper,1 Leon H. Kircik,2 Michael Gold,3 Adelaide A. Hebert,4 Jeffrey L. Sugarman,5 Lawrence Green,6 Linda Stein Gold,7 Hilary Baldwin,8 James Q. Del Rosso,9 Eric Guenin10

Affiliations: 1Dermatology & Skin Care Center of Birmingham, Birmingham, AL; 2Icahn School of Medicine at Mount Sinai, New York, NY; 3Tennessee Clinical Research Center, Nashville, TN; 4University of Texas Health McGovern Medical School, Houston; Houston, TX; 5University of California, San Francisco, CA; 6George Washington University School of Medicine, Washington, DC; 7Henry Ford Hospital, Detroit, MI; 8The Acne Treatment and Research Center, Brooklyn, NY; 9JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; 10Ortho Dermatologics, Bridgewater, NJ*

*Ortho Dermatologics is a division of Bausch Health US, LLC.

Introduction: A delay in rapid acne improvement may negatively impact patient adherence to acne therapy. A three-pronged combination approach using once-daily application of an antibiotic, antibacterial, and retinoid may provide quicker improvement than stand alone or dual combination products. The first triple-combination, fixed-dose acne topical in development, clindamycin phosphate 1.2%/benzoyl peroxide (BPO) 3.1%/adapalene 0.15% (IDP-126) gel, was efficacious and safe in three clinical studies. As rapid and substantial acne improvements can increase patient adherence, threshold lesion reductions for IDP-126 were compared to its dyads and vehicle gel.

Methods: A Phase II (N=741, NCT03170388) and two Phase III (N=183, NCT04214639; N=180, NCT04214652), double-blind, 12-week studies enrolled participants aged nine years or older with moderate-to-severe acne. Participants were randomized to receive once-daily IDP-126 or vehicle gel; the Phase II study included three additional dyad gel randomization arms: BPO/adapalene, clindamycin phosphate/BPO, and clindamycin phosphate/adapalene. Endpoints included least squares mean percent change from baseline in inflammatory and noninflammatory lesion counts. The percentage of participants achieving 50- and 75-percent or greater thresholds in lesion reduction was evaluated.

Results: After four weeks of treatment with IDP-126 gel, 61.4 percent of participants in the Phase II study had 50-percent or greater reduction in inflammatory lesions, which was significantly greater than with the three dyads (45.8–47.4%) or vehicle (41.8%; p<0.05, all). These early reductions were sustained throughout the study, with significantly (p<0.05) more IDP-126-treated participants achieving 50-percent or greater reduction in inflammatory lesions versus the dyads and vehicle at Weeks 8 and 12. By Week 12, IDP-126 led to substantial acne reductions, with significantly more participants achieving 75-percent or greater reduction in inflammatory lesions, compared to dyads and vehicle (65.8% vs. 49.9–51.2% and 21.6%, respectively; p<0.05, all). Similar trends were observed for noninflammatory lesions in the Phase II study and for inflammatory and noninflammatory lesions in the Phase III studies.

Conclusions: Therapeutic effects of IDP-126 gel were rapid and sustained. Lesion count reductions were significantly greater with IDP-126 versus its dyads and vehicle gel as early as Week 4, with substantial reductions observed after 12 weeks of IDP-126 treatment. This fast-acting feature of IDP-126—coupled with its optimized efficacy, once-daily application, and good tolerability—may positively impact treatment adherence.

Funding/financial disclosures: Ortho Dermatologics.

Topical clindamycin for acne vulgaris: pharmacovigilance safety review and retrospective analysis of gastrointestinal events

Presenters: Natalia M. Pelet del Toro, MD;1 Andrew Strunk, MA;1 Jashin J. Wu, MD;2 Linda Stein Gold, MD;3 James Q. Del Rosso, DO;4–6 Robert T. Brodell, MD;7 George Han, MD1

Affiliations: 1Department of Dermatology, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, New Hyde Park, New York, NY; 2Department of Dermatology, University of Miami Miller School of Medicine, Miami, FL; 3Henry Ford Hospital, Detroit, MI; 4JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; 5Advanced Dermatology and Cosmetic Surgery, Maitland, FL; 6Touro University Nevada, Henderson, NV; 7University of Mississippi Medical Center, Jackson, MS

Introduction: Clindamycin, a lincosamide antibiotic, was the 125th most prescribed medicine in the United States (US) in 2020. Topical formulations that combine clindamycin with benzoyl peroxide or a retinoid are commonly used for acne vulgaris (AV) treatment. While oral and topical clindamycin carry warnings/contraindications regarding the development of gastrointestinal (GI) adverse events (AEs), the real-world incidence of these AEs with topical clindamycin is unknown. The objective of this study was to provide an overview of safety data for topical clindamycin when used for AV treatment.

Methods: Safety data from published literature on PubMed® (case reports, clinical trials data, retrospective data), previously unpublished worldwide pharmacovigilance data (from January 1, 1900–December 31, 2022), and two unpublished retrospective cohort studies of US electronic medical records (EMRs; January 1, 2011–January 31, 2019) were reviewed, with a focus on inflammatory bowel disease (IBD) and GI AEs following topical clindamycin monotherapy or combination treatment.

Results: There have been only four published case reports of topical clindamycin-associated GI AEs, which were all published between the years 1981 to 1997. In eight published pivotal Phase III clinical trials of topical clindamycin monotherapy or combination treatment for AV, GI-related AEs were reported in 1.4 percent of clindamycin-treated participants (38/2,672; safety populations). According to the pharmacovigilance data, the rate of GI-related adverse drug reactions with topical clindamycin-containing products was 0.000045 percent (64/141,084,533). In one published retrospective report, there were zero reports of colitis from the 1,124 patients estimated to have received topical clindamycin prescriptions in the years 1977 to 1980. In the first retrospective EMR study, results indicated that physicians prescribe topical clindamycin for AV treatment equally to patients with (19.0%; 98/515) or without a history of IBD (20.7%; 14,495/70,151). The second retrospective EMR study showed that among patients with AV and an initial prescription for topical clindamycin (monotherapy or combination; n=18,012), there were three (0.02%) incident cases of pseudomembranous colitis within 30 days; none of these cases had a history of IBD.

Conclusion: A review of published case reports, clinical trials safety data, worldwide pharmacovigilance data, and retrospective US prescription data demonstrates that GI events—including colitis or pseudomembranous colitis—in patients exposed to topical clindamycin are extremely low, regardless of IBD history.

Funding/financial disclosure: Ortho Dermatologics.

Triple-combination fixed-dose clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide 3.1% for moderate-to-severe acne: efficacy and safety results from a pooled Phase III analysis

Presenters: Linda Stein Gold, MD;1 Michael Gold, MD;2 Leon H. Kircik, MD;3 Julie C. Harper, MD;4 James Q. Del Rosso, DO;5 Christopher G. Bunick, MD, PhD;6 Neal Bhatia, MD;7 Hilary Baldwin, MD;8 Zoe D. Draelos, MD;9 Valerie D. Callender, MD;10 Edward Lain, MD, MBA11

Affiliations: 1Henry Ford Hospital, Detroit, MI; 2Tennessee Clinical Research Center, Nashville, TN; 3Icahn School of Medicine at Mount Sinai, New York, NY; 4Dermatology & Skin Care Center of Birmingham, Birmingham, AL; 5JDR Dermatology Research/Thomas Dermatology, Las Vegas, NV; 6Yale Department of Dermatology and Program in Translational Biomedicine, New Haven, CT; 7Therapeutics Clinical Research, San Diego, CA; 8The Acne Treatment and Research Center, Brooklyn, NY; 9Dermatology Consulting Services, PLLC, High Point, NC; 10Callender Dermatology and Cosmetic Center, Glenn Dale, MD; 11Austin Institute for Clinical Research, Austin, TX

Introduction: A three-pronged approach to acne treatment that combines an antibiotic, antimicrobial agent, and retinoid in a single formulation may be more efficacious than single/double treatments, while potentially reducing antibiotic resistance. IDP-126 polymeric mesh gel (clindamycin phosphate 1.2%/adapalene 0.15%/benzoyl peroxide [BPO] 3.1%)—the first fixed-dose triple-combination acne topical in development—demonstrated superior efficacy to vehicle and component dyads, with good safety/tolerability in a Phase II and two Phase III studies of moderate-to-severe acne. This post hoc analysis further examined the efficacy and safety of IDP-126 in data pooled from these Phase III studies.

Methods: In two identical Phase III (N=183, NCT04214639; N=180, NCT04214652), double-blind, randomized, 12-week studies, participants aged nine years or older with moderate-to-severe acne were randomized 2:1 to receive once-daily IDP-126 or vehicle gel. Endpoints included two-grade or greater reduction from baseline in Evaluator’s Global Severity Score and clear/almost clear skin (treatment success) and least squares mean percent change from baseline in inflammatory/noninflammatory lesion counts. Treatment-emergent adverse events (TEAEs) and cutaneous safety/tolerability were evaluated.

Results: A total of 363 participants were randomized; the majority were female (58.4%) and had moderate acne (91.2%). At Week 12, 50 percent of participants achieved treatment success with IDP-126 versus 22.6 percent with vehicle gel (p<0.001). IDP-126 resulted in over 70-percent reductions in inflammatory and noninflammatory lesions at Week 12, which were significantly greater than vehicle (inflammatory: 77.9% vs. 57.9%, respectively; noninflammatory: 73.0% vs. 48.2%, respectively; p<0.001, both). Most TEAEs were of mild-to-moderate severity, and less than three percent of IDP-126-treated participants discontinued study treatment due to AEs. Transient increases from baseline in investigator-assessed scaling and erythema and participant-assessed itching, burning, and stinging were observed with IDP-126, but resolved back to or near baseline values by Week 12.

Conclusion: The innovative fixed-dose triple-combination clindamycin phosphate 1.2%/adapalene 0.15%/BPO 3.1% gel was efficacious and well tolerated in children, adolescents, and adults with moderate-to-severe acne. Half of participants achieved clear or almost clear skin by 12 weeks, rates not previously seen in clinical studies of other topical acne products.

Funding/financial disclosures: Ortho Dermatologics.

Atopic Dermatitis

A Phase III study of ruxolitinib cream in children aged 2–<12 years with atopic dermatitis (TRuE-AD3): 8-week analysis

Presenters: Lawrence Eichenfield, MD;1 Linda Stein Gold, MD, PhD;2 Eric Simpson, MD, MCR;3 Andrea Zaenglein, MD;4 April Armstrong, MD, PhD, MPH;5 Megha Tollefson, MD;6 Weily Soong, MD;7 Lara Wine Lee, MD, PhD;8 Alim Devani, MD;9 Seth Forman, MD;10 Dareen Siri, MD;11 Brett Angel, MD;12 Howard Kallender, PhD;12 Qian Li, PhD;12 Amy Paller, MD13

Affiliations: 1University of California San Diego, San Diego, CA; 2Henry Ford Health System, Detroit, MI; 3Oregon Health & Science University, Portland, OR; 4Penn State/Hershey Medical Center, Hershey, PA; 5David Geffen School of Medicine at University of California Los Angeles, Los Angeles, CA; 6Mayo Clinic, Rochester, MN; 7AllerVie Health, Birmingham, AL; 8Medical University of South Carolina, Charleston, SC; 9Dermatology Research Institute, Calgary, Alberta, Canada; 10ForCare Clinical Research, Tampa, FL; 11Midwest Allergy Sinus Asthma SC, Normal, IL; 12Incyte Corporation, Wilmington, DE; 13Northwestern University Feinberg School of Medicine, Chicago, IL

Introduction: Ruxolitinib cream was well tolerated in patients aged two years and older with atopic dermatitis (AD) in a pediatric pilot pharmacokinetics (PK)/safety study (NCT03257644); efficacy was consistent with results in adolescents/adults (TRuE-AD1/TRuE-AD2 [NCT03745638/NCT03745651]). This Phase III, double-blind, pediatric study (TRuE-AD3 [NCT04921969]) evaluated efficacy, safety, and PK of ruxolitinib cream in patients aged 2 to 11 years with mild-to-moderate AD for three months or more (Investigator’s Global Assessment [IGA] 2/3; 3–20% affected body surface area [BSA]; for ages 6–11 years, mean itch Numerical Rating Scale [NRS] ≥4). Patients were randomized 2:2:1 to twice-daily 0.75%/1.5% ruxolitinib cream or vehicle for eight weeks; rescue therapy was not permitted.

Results: Overall, 330 patients were enrolled (vehicle, n=65; 0.75%/1.5% ruxolitinib cream, n=134/n=131). Median (range) age was 6 (2–11) years. Mean (standard deviation [SD]) affected BSA was 10.5 percent (5.4%). Mean (SD) Eczema Area and Severity Index (EASI) score was 8.6 (5.4); 76.4 percent of patients had IGA 3. A clinical effect was observed in patients applying 0.75%/1.5% ruxolitinib cream versus vehicle at Week 2, increasing through Week 8 for IGA treatment success (IGA 0/1 with ≥2-grade improvement from baseline; 36.6%/56.5% vs. 10.8%, respectively; p≤0.0001 for both) and 75-percent or greater improvement in EASI (51.5%/67.2% vs. 15.4%, respectively; p<0.0001 for both). In patients aged 6 to 11 years, four-point or greater improvement in itch NRS (NRS4) at Week 8 was achieved by 37.5/43.4 percent (0.75%/1.5% ruxolitinib cream) versus 29.7 percent (vehicle); median time to NRS4 was 11.0/13.0 days versus 23.0 days, respectively (hazard ratio: 1.74/1.77; p<0.05 for both). Treatment-related adverse events (AEs) through Week 8 were reported in 5.3 percent of patients treated with ruxolitinib cream (combined) and 3.1 percent treated with vehicle; 2.7 and zero percent, respectively, reported application site pain. No AEs suggestive of systemic Janus kinase inhibition or serious AEs were reported. Mean (SD) steady-state plasma concentrations of ruxolitinib at Week 8 for 0.75%/1.5% ruxolitinib cream were 15.8 (30.4)/28.4 (59.2)nM, well below that associated with myelosuppression (281nM).

Conclusion: In patients aged 2 to 11 years with mild-to-moderate AD, ruxolitinib cream achieved significant efficacy at Week 8 versus vehicle. Patients aged 6 to 11 years had improved itch at Week 8 and reduced time to NRS4 with ruxolitinib cream versus vehicle. Ruxolitinib cream was well tolerated. These results were similar to results in adolescents/adults.

Efficacy and safety of lebrikizumab is maintained to two years in patients with moderate-to-severe atopic dermatitis

Presenters: Emma Guttman-Yassky,1 Stephan Weidinger,2 Eric Simpson,3 Melinda Gooderham,4 Alan Irvine,5 Lynda Spelman,6 Jonathan Silverberg,7 Hany Elmaraghy,8 Louise DeLuca-Carter,8 Maria Lucia Buziqui Piruzeli,8 Chaoran Hu,8 Fan Emily Yang,8 Evangeline Pierce,8 Laia Bardolet,9 Diamant Thaci10

Affiliations: 1Icahn School of Medicine at Mount Sinai, New York, NY; 2University Hospital Schleswig-Holstein, Kiel, Germany; 3Oregon Health & Science University, Portland, OR; 4SKiN for Dermatology, Probity Medical Research and Queen’s University, Peterborough, Ontario, Canada; 5Children’s Health Ireland, Dublin, Ireland; 6Veracity Clinical Research, Queensland, Australia; 7George Washington University School of Medicine and Health Sciences, Washington, DC; 8Eli Lilly and Company, Indianapolis, IN; 9Almirall S.A, Barcelona, Spain; 10Institute and Comprehensive Center for Inflammatory Medicine at the University of Lübeck, Lübeck, Germany

Introduction: We report the efficacy and safety of lebrikizumab (LEB) in the long-term extension study ADjoin (NCT04392154) following 104 weeks of continuous LEB treatment with and without topical corticosteroid (TCS) use.

Methods: Patients in ADvocate1&2 (NCT04146363, NCT04178967) who achieved either 75-percent or greater improvement in Eczema Area and Severity Index (EASI75) or Investigator’s Global Assessment (IGA) 0/1 (without rescue) at Week 16 were rerandomized 2:2:1 to LEB 250mg once every two weeks (Q2W), LEB 250mg Q4W, or placebo (LEB withdrawal). Patients who completed Week 52 of ADvocate1&2 were able to enroll in ADjoin. Patients in ADhere (NCT04250337) who achieved either EASI75 or IGA 0/1 (without rescue) at Week 16 were able to enroll into ADjoin and randomized 2:1 to LEB 250mg Q2W or LEB 250mg Q4W. Data are reported for patients originating from ADvocate1&2 and ADhere who received LEB 250mg Q2W or Q4W in ADjoin. Efficacy outcomes were assessed based on all collected data (as observed analysis) up to 104 weeks of LEB treatment. Safety was reported from ADjoin enrollment up to the data cutoff April 14, 2023.

Results: At Week 104, IGA 0/1 was maintained by 38 of 44 (86.4%; Q2W) and 42 of 55 (76.4%; Q4W) patients from ADvocate1&2, respectively, and 26 of 31 (83.9%; Q2W) and 11 of 14 (78.6%; Q4W) patients from ADhere. EASI75 was maintained by 65 of 68 (95.6%; Q2W) and 77of 80 (96.3% Q4W) ADvocate1&2 patients, respectively, and 39 of 41 (95.1%; Q2W) and 24 of 25 (96.0%; Q4W) ADhere patients at Week 104. Among patients who achieved EASI75 at Week 16, EASI90 was achieved by 56 of 68 (82.4%; Q2W) and 66 of 80 (82.5%; Q4W) ADvocate1&2 patients, respectively, and 35 of 41 (85.4%; Q2W) and 18 of 25 (72.0%; Q4W) ADhere patients at Week 104. During ADjoin, 166 of 267 (62.2%) patients from the subpopulations of ADvocate1&2 and ADhere who received LEB Q2W or Q4W in ADjoin reported adverse events (AEs), most of which were mild (31.5%, n=84) or moderate (27.0%, n=72) in severity. Serious AEs were reported by 10 (3.8%) patients. There was one death in the ADhere Q2W arm. Six (2.3%) patients reported AEs leading to treatment discontinuation. The safety profile of LEB in ADjoin was consistent with that observed during ADvocate1&2 and ADhere.

Conclusion: Efficacy outcomes were maintained long-term, over two years of continuous LEB treatment, in both LEB 250mg Q2W and Q4W arms. The safety profile of LEB in ADjoin is consistent with previous LEB studies in patients with moderate-to-severe AD.

Previously presented at the Fall Clinical Dermatology Conference, 2023.

Lebrikizumab demonstrates progressive improvements in skin clearance and itch relief over one year in patients with atopic dermatitis

Presenters: April Armstrong,1 Kamran Ghoreschi,2 David Rosmarin,3 Todd Schlesinger,4 Alan Irvine,5 Anthony Bewley,6 Marta Casillas,7 Gaia Gallo,7 Yuxin Ding,7 Chenjia Xu,7 Ignasi Pau-Charles,8 and Eric Simpson9

Affiliations: 1University of California Los Angeles, Los Angeles, CA; 2Charité University Hospital, Berlin, Germany; 3Indiana University School of Medicine, Indianapolis, IN; 4Clinical Research Center of the Carolinas, Charleston, SC; 5Trinity College Dublin, Dublin, Ireland; 6Barts Health NHS Trust and Queen Mary University, London, UK; 7Eli Lilly and Company, Indianapolis, IN; 8Almirall S.A., Barcelona, Spain; 9Oregon Health & Science University, Portland, OR

Introduction: In ADvocate1 and ADvocate2, lebrikizumab (LEB) demonstrated statistically significant efficacy at Week 16 in patients with moderate-to-severe atopic dermatitis (AD), compared to placebo. Most patients who met the per protocol response at Week 16 maintained their response up to Week 52. The design of these studies did not allow for a continuous view of a single cohort of patients from Week 0 to Week 52 due to the rerandomization that occurred at Week 16. The analysis estimated the response trajectory of patients as though they had been treated continuously with LEB from baseline to Week 52. This analysis is designed to mimic LEB treatment as it may appear in the real world by including patients who, based on their responses at Week 16, either continued receiving LEB every 2 weeks (Q2W) or switched to LEB Q4W.

Methods: In this analysis algorithm, the induction period data consisted of all patients who received LEB Q2W monotherapy for the first 16 weeks. For the 36-week maintenance period, a single response rate was calculated as a weighted sum of response rates from two different treatment arms. The first treatment arm consisted of patients who met the protocol-defined response criteria at Week 16 and then received LEB Q4W for 36 weeks. The second treatment arm consisted of patients who did not meet the protocol-defined response criteria at Week 16 and then received LEB Q2W in an open-label escape arm for 36 weeks. Intermittent use of topical corticosteroids was permitted during the 36-week maintenance period. For induction and maintenance periods, data after treatment discontinuation due to lack of efficacy were handled using nonresponder imputation (NRI); data after treatment discontinuation due to other reasons and other missing data were handled using multiple imputation. For the induction period only, data after any rescue medication use were handled using NRI. Outcomes included Investigator’s Global Assessment (IGA) 0/1 with two-point or greater improvement, 75-percent or greater improvement in Eczema Area and Severity Index (EASI75), and Pruritus Numerical Rating Scale (NRS) four-point or greater improvement (in patients with baseline ≥4).

Results: The proportion of patients achieving the respective endpoints at Week 16 and Week 52 were 38 and 54 percent, respectively, for IGA 0/1 with two-point or greater improvement; 55 and 76 percent, respectively, for EASI75; and 43 and 61 percent, respectively, for Pruritus NRS four-point or greater improvement.

Conclusion: Since these trials were not designed as treat-through, caution should be used when interpreting these results. Treatment with LEB in ADvocate1 and ADvocate2 resulted in continued improvements from Weeks 0 to 52 in patients with moderate-to-severe AD.

Previously presented at the Fall Clinical Dermatology Conference, 2023.

Lebrikizumab does not impact vaccine-induced immune responses: results from a Phase III study in adult patients with moderate-to-severe atopic dermatitis

Presenter: Jennifer Soung,1 Vivian Laquer,2 Joseph F. Merola,3 Seth Forman,4 Hany Elmaraghy,5 Eric Meskimen,5 Chaoran Hu,5 Chitra R. Natalie,5 Evangeline Pierce,5 Hitoe Torisu-Itakura,5 Esther Garcia Gil,6 Abel D. Jarell7

Affiliations: 1Southern California Dermatology, Santa Ana, CA; 2First OC Dermatology Research, Fountain Valley, CA; 3Harvard University, Boston, MA; 4Forward Clinical Trials, Tampa, FL; 5Eli Lilly and Company, Indianapolis, IN; 6Almirall, Barcelona, Spain; 7Allcutis Research, Portsmouth, NH

Introduction: Lebrikizumab (LEB) is a monoclonal antibody that has shown efficacy and safety in patients with moderate-to-severe atopic dermatitis (AD) in Phase II/III trials. LEB targets interleukin (IL)-13 and inhibits signaling of the IL-4Rα/IL-13Rα1 complex. The potential immunomodulator effect of LEB necessitates investigating its impact on immune responses.

Methods: ADopt-VA was a United States (US) Phase III, 16-week, randomized, double-blind, placebo-controlled study to assess LEB impact on vaccine immune responses in adult patients with moderate-to-severe AD. The primary endpoint was the immune response to two vaccines, the diphtheria/tetanus toxoids/pertussis (Tdap) vaccine and meningococcal (Groups A, C, Y, and W-135; MCV) vaccine. LEB was given as a 500mg loading dose at baseline and Week 2, followed by 250mg LEB every two weeks (Q2W). At Week 12, both vaccines (Tdap and MCV) were administered to all patients (LEB group: n=107, placebo (PBO) group: n=81). Immune responses were determined by antibody level differences between Week 12 and Week 16. Secondary efficacy endpoints at Week 16 were Investigator’s Global Assessment (IGA) score and 75-percent or greater improvement in Eczema Area and Severity Index (EASI75).

Results: For the Tdap vaccine, 73.6 percent of LEB-treated patients had a positive antibody response, compared to 73.4 percent for PBO-treated patients (90% confidence interval [CI]: 0.3 [–10.2, 11.2]). For the MCV vaccine, LEB-treated patients had an 86.9-percent positive antibody response, compared to 75 percent for PBO-treated patients (90% CI: 12.2 [2.5, 22.0]). IGA 0/1 was achieved by 40.6 percent of LEB-treated patients versus 18.9 percent who received PBO (p≤0.001); EASI75 was achieved by 58.0 and 32.7 percent of patients, respectively (p<0.001). The safety profile was consistent with previous LEB trials.

Conclusion: These data show that LEB does not negatively impact immune responses for Tdap or MCV vaccines in adults with moderate-to-severe AD.

Previously presented at the International Society for Investigative Dermatology (ISID), 2023.

Patients with moderate-to-severe atopic dermatitis experience heterogeneous disease course phenotypes: results of a real-world study in the United States

Presenters: Lakshi Aldredge,1 Matthew Reynolds,2 Zach Dawson,3 Simran Marwaha,4 Leigh Ann Pansch,5 Eileen Cheever,6 Raj Chovatiya,7 William Malatestinic,3 Peter Anderson,4 Evangeline Pierce,3 Amber Reck Atwater,3 James Piercy,4 Jonathan I. Silverberg8

Affiliations: 1VA Portland Healthcare System, Portland, OR; 2Arkansas Dermatology, North Little Rock, AR; 3Eli Lilly and Company, Indianapolis, IN; 4Adelphi Real World, Bollington, UK; 5Dermatologists of Southwest Ohio, Cincinnati, OH; 6Clearview Dermatology, Leominster, MA; 7Northwestern University Feinberg School of Medicine, Chicago, IL; 8George Washington University School of Medicine and Health Sciences, Washington, DC

Introduction: Atopic dermatitis (AD) is a heterogenous disease characterized by fluctuating symptoms over time. Longitudinal assessments of AD symptoms are not typically evaluated but are important to personalize care. The objective of this analysis was to identify phenotypic AD patterns and assess how frequently these patterns occur in the real world.

Methods: Data were collected from the Adelphi AD Disease Specific Programme™, a cross-sectional real-world study with retrospective data collection, including nurse practitioners (NPs) and physician assistants (PAs) based in dermatology/allergy practice settings and their patients with AD (aged ≥18 years) in the United States (US) from February 2021 to February 2022. All patients had a history of moderate-to-severe AD but could be at any level of AD severity at the time of data collection. For each patient, the NP/PA completed a record form, including demographics, subjective severity, body areas affected, and characterization of the patient’s longitudinal disease course, as defined with text and images adapted from Chovatiya and Silverberg (Am J Clin Dermatol. 20223;23:459–468). The percentage of patients within seven AD phenotype categories was assessed. Within these categories, we evaluated disease severity (mild, moderate, severe), presence or absence of current flaring, and systemic treatment use. A total of 127 NP/PAs (48 NPs, 79 PAs) provided records for 914 patients.

Results: Of these patients, the percentage of patients within each AD phenotype category was 11 percent in “seasonal flare,” 13 percent in “frequent moderate flares,” 19 percent in “moderate with severe flares,” 18 percent in “moderate or severe daily symptoms,” six percent in “persistent severe daily symptoms,” 16 percent in “none of the phenotypes,” and 17 percent in “too early to tell.” Within each phenotype category, most patients had current mild-to-moderate AD. At the time of data collection, approximately 50 percent of the patients in the following phenotype categories were currently flaring: “seasonal flare,” “frequent moderate flare,” and “persistent severe daily symptoms.” A total of 446 (51%) of the 874 patients who had ever received prescribed treatment were currently taking a systemic treatment; by phenotype categories, the percentage of patients taking systemic treatment ranged from 28 percent in the “too early to tell” category to 78 percent in the “persistent severe daily symptoms” category.

Conclusion: Results suggest an unmet need among patients with severe AD. Longitudinal assessments may help counsel patients on treatment expectations.

Previously presented at the 8th Annual Fall Clinical Dermatology Conference for Physician Assistants and Nurse Practitioners.

Rapid and early onset of itch relief with tapinarof cream 1% once daily in two pivotal Phase III trials in adults and children down to two years of age with atopic dermatitis

Presenters: Eric Simpson,1 Jonathan I. Silverberg,2 Robert Bissonnette,3 Linda Stein Gold,4 April Armstrong,5 Adelaide A. Hebert,6 Rocco T. Serrao,7 Jeannette R. Jakus,8 Philip M. Brown,9 David S. Rubenstein,9 Stephen C. Piscitelli,9 Anna M. Tallman,9 Lawrence F. Eichenfield10

Affiliations: 1Oregon Health & Science University, Portland, OR; 2The George Washington University School of Medicine and Health Sciences, Washington, DC; 3Innovaderm Research Inc., Montreal, QC, Canada; 4Henry Ford Health System, Detroit, MI; 5Keck School of Medicine, University of Southern California, Los Angeles, CA; 6University of Texas Health McGovern Medical School and Children’s Memorial Hermann Hospital, Houston, TX; 7Dermatologists of Southwest Ohio, Mason, OH; 8State University of New York Downstate Health Sciences University, New York, NY; 9Dermavant Sciences, Inc., Morrisville, NC; 10University of California San Diego and Rady Children’s Hospital, San Diego, CA

Introduction: Itch is the most bothersome symptom for patients with atopic dermatitis (AD). In ADORING 1 and 2, two identical Phase III, double-blind, vehicle-controlled trials, tapinarof cream 1% (VTAMA®, Dermavant Science, Inc.) once daily (QD) demonstrated efficacy and was well tolerated in adults and children aged two years or older with moderate-to-severe AD. Here, we evaluate time to onset of itch relief.

Methods: In ADORING 1 and 2, patients with a validated Investigator’s Global Assessment (IGA) for AD score of three or greater, Eczema Area and Severity Index (EASI) score of six or greater, and body surface area (BSA) involvement of 5 to 35 percent were randomized 2:1 to tapinarof cream or vehicle QD for eight weeks. Itch relief was assessed by changes in Peak Pruritus Numerical Rating Scale (PP-NRS) score, daily and by visit, from baseline through Week 8. PP-NRS considers itch over the past 24 hours; lower scores indicate less pruritus.

Results: A total of 407 and 406 patients were randomized in ADORING 1 and 2. At baseline, mean PP-NRS scores were 6.7 and 6.8 in both trials, respectively. For daily evaluations of itch from baseline, greater reductions in mean PP-NRS scores for tapinarof cream versus vehicle were observed as early as Day 1, 24 hours after initial application, in ADORING 1 (–1.2 vs. –0.9), and Day 2 in ADORING 2 (–1.6 vs. –1.4). Daily itch improvements continued through Week 8 of both trials. Statistically significant reductions in mean weekly PP-NRS scores occurred as early as Week 1 (earliest assessment) with tapinarof cream versus vehicle (–2.0 vs. –1.2, p<0.0001; –2.0 vs. –1.3 p=0.0010) in ADORING 1 and 2, respectively. Significantly greater reductions in mean PP-NRS scores with tapinarof cream versus vehicle were seen for all visits through Week 8 (–4.1 vs. –2.6; –4.1 vs. –2.4, both p<0.0001).

Conclusion: Tapinarof cream 1% QD demonstrated rapid, significant, and clinically meaningful pruritus relief from 24 hours after initial application, with improvements increasing through Week 8 in both trials in adults and children aged two years or older with moderate-to-severe AD.

Systemic therapy for patients with moderate atopic dermatitis results in increased disease control satisfaction, best disease control, and decreased frequency of flare: a real-world study

Presenters: Joe Gorelick,1 T.J. Chao,2 Wendy Cantrell,3 Zach Dawson,4 Evangeline Pierce,4 Amber Reck Atwater,4 Peter Anderson,5 James Piercy,5 Simran Marwaha,5 Matthew Reynolds,6 Andrea Nguyen7

Affiliations: 1California Skin Institute, San Jose, CA; 2Atlanta North Dermatology, Woodstock, GA; 3Village Dermatology, Mountain-Brook, AL; 4Eli Lilly and Company, Indianapolis, IN; 5Adelphi Real World, Cheshire, UK; 6Arkansas Dermatology, North Little Rock, AR; 7First OC Dermatology, CA

Introduction: Topical medications are first-line therapy, and clinical guidelines recommend advanced systemic therapy for moderate and severe atopic dermatitis (AD) when topical therapy cannot control the disease. Here, we report nurse practitioner and physician assistant (NP/PA) perception of disease control and disease burden for patients with moderate AD.

Methods: NP/PAs were surveyed as part of the Adelphi AD Disease Specific Programme™, a cross-sectional, real-world study with retrospective data collection in the United States from February 2021 to February 2022. NP/PAs provided patient information on treatment, AD severity, flare status, clinician satisfaction with current treatment, and reasons for dissatisfaction with treatment. Patients with moderate AD were summarized by treatment (no treatment/other treatment, topicals only, systemics±topicals, and systemics only). Here, we report NP/PA perception of current control of AD, reason for dissatisfaction with current control, and disease flare in patients with moderate AD.

Results: Among patients with moderate AD, 52 had other/no treatment, 150 had topicals only, 166 had systemics±topicals, and 18 had systemics only. NP/PAs reported that they were satisfied, very satisfied, or extremely satisfied with current control in 26.9 percent of patients (n=14) with other/no treatment, 51.3 percent (n=77) with topicals only, 65.7 percent (n=109) with systemics±topicals, and 77.8 percent (n=14) with systemics only. NP/PAs that reported that they were dissatisfied, very dissatisfied, or extremely dissatisfied with current control in 50 percent of patients (n=26) with other/no treatment, 18.7 percent (n=28) with topicals only, 13.9 percent (n=23) with systemics±topicals, and 5.6 percent (n=1) with systemics only. The most frequent reason for dissatisfaction with disease control was the sustained impact of AD on quality of life (QoL). NP/PAs reported that best control was achieved in 50 percent of patients (n=9) treated with only systemics, followed by 40 percent of patients (n=67) with any systemics±topicals, 34 percent (n=51) with only topicals, and 23 percent (n=12) with other/no treatment. Current disease flare was reported in 73 percent of patients (n=19) with other/no treatment, 62 percent (n=66) with only topicals, 51 percent (n=65) with any systemics±topicals, and 30 percent (n=3) with only systemics.

Conclusion: Among patients with moderate AD, NP/PAs were most satisfied with disease control, felt that best disease control was achieved, and reported fewer flares when patients were taking systemics alone or systemics±topicals. In conclusion, systemic therapy increased provider disease control satisfaction, achieved best disease control, and decreased frequency of AD flares.

Previously presented at the Maui Derm NP+PA Fall, 2023.

Tapinarof cream 1% once daily: significant efficacy in atopic dermatitis in two Phase III trials in adults and children down to 2 years of age

Presenters: Jonathan I. Silverberg,1 Lawrence F. Eichenfield,2 Adelaide A. Hebert,3 Eric Simpson,4 Linda Stein Gold,5 Robert Bissonnette,6 Kim A. Papp,7,8 John Browning,9 Pearl Kwong,10 Neil J. Korman,11 Philip M. Brown,12 David S. Rubenstein,12 Stephen C. Piscitelli,12 Matthew C. Somerville,12 Anna M. Tallman,12 Leon Kircik13

Affiliations: 1The George Washington University School of Medicine and Health Sciences, Washington, DC; 2University of California San Diego and Rady Children’s Hospital, San Diego, CA; 3University of Texas Health McGovern Medical School and Children’s Memorial Hermann Hospital, Houston, TX; 4Oregon Health & Science University, Portland, OR; 5Henry Ford Health System, Detroit, MI; 6Innovaderm Research Inc., Montreal, QC, Canada; 7Probity Medical Research Inc. and Alliance Clinical Trials, Waterloo, ON, Canada; 8University of Toronto, Toronto, ON, Canada; 9University of Texas Health San Antonio, TX; 10Solutions through Advanced Research, Jacksonville, FL; 11University Hospitals Cleveland Medical Center, Cleveland, OH; 12Dermavant Sciences, Inc., Morrisville, NC; 13Icahn School of Medicine at Mount Sinai, New York, NY

Introduction: ADORING 1 and 2 were two identical Phase III, randomized, double-blind, vehicle-controlled trials of tapinarof cream 1% (VTAMA®, Dermavant Science, Inc.) once daily (QD) in adults and children aged two years or older with moderate-to-severe atopic dermatitis (AD). We report pivotal Phase III efficacy and safety.

Methods: Patients with a validated Investigator’s Global Assessment for Atopic Dermatitis (vIGA-AD) score of three or greater, Eczema Area and Severity Index (EASI) score of six or greater, and body surface area (BSA) involvement of 5 to 35 percent were randomized to tapinarof cream or vehicle QD for eight weeks. Primary efficacy endpoint was vIGA-AD response (score of clear [0] or almost clear [1] and ≥2-grade improvement from baseline at Week 8). Secondary efficacy endpoints included 75-percent or greater improvement in EASI score (EASI75) and proportion (aged ≥12 years) with baseline Peak Pruritus Numerical Rating Scale (PP-NRS) score of four or greater achieving a four-point or greater reduction at Week 8. Safety assessments included incidence of adverse events (AEs).

Results: A total of 407 and 406 patients were randomized in ADORING 1 and 2, respectively. At baseline, 84.0 to 89.9 percent of patients had a vIGA-AD score of three (moderate), mean EASI score of 12.5 to 13.3, and mean BSA affected of 16.7 to 16.9 percent across trials. At Week 8, primary and secondary efficacy endpoints were met with statistical significance with tapinarof cream, compared to vehicle, with vIGA-AD response in 45.4 versus 13.9 percent, respectively, and 46.4 versus 18.0 percent, respectively (both p<0.0001); EASI75 response in 55.8 versus 22.9 percent, respectively, and 59.1 versus 21.2 percent, respectively (both p<0.0001); and four-point or greater reduction in PP-NRS in 55.8 versus 34.2 percent, respectively (p=0.0366), and 52.8 versus 24.1 percent, respectively (p=0.0015), in ADORING 1 and 2. AEs were mostly mild or moderate; the most frequent (≥5% any group) were folliculitis, headache, and nasopharyngitis. Trial discontinuations due to AEs were lower with tapinarof cream versus vehicle.

Conclusion: Tapinarof cream 1% QD demonstrated statistically significant efficacy compared to vehicle for primary and secondary endpoints in adults and children aged two years or older with moderate-to-severe AD. Tapinarof cream 1% was well tolerated with no new safety signals.

Melanoma

The i31-gene expression profile test for cutaneous melanoma identifies patients with head and neck tumors who could forego sentinel lymph node biopsy

Presenters: Teo Soleymani, MD;1 Brian Martin, PhD;2 Michael Tassavor, MD3

Affiliations: 1Mohs Micrographic and Dermatologic Surgery, Cutaneous Oncology, Division of Dermatology, David Geffen School of Medicine, University of California, Los Angeles, CA; 2Castle Biosciences, Inc., Friendswood, TX; 3Skin Cancer Center, Cincinnati, OH

Introduction: Patients with cutaneous melanoma (CM) lesions located on the head and neck (HN) have a worse prognosis than those with tumors at other locations. Moreover, HN tumors can present additional complexities for sentinel lymph node biopsy (SLNB) procedures. Current guidelines recommend that patients with a less than five-percent risk of SLN positivity forego the procedure, those with a 5 to 10 percent risk of positivity discuss and consider SLNB, and those with a greater than 10-percent risk of positivity undergo the procedure. An algorithm integrating the 31-gene expression profile (31-GEP) molecular risk stratification test with clinical and pathological features (i31-GEP) provides a precise risk prediction for SLNB positivity, which can help patients and clinicians make risk-aligned decisions about undergoing SLNB among a high-risk population.

Methods: Patients from a previously published multicenter cohort study with tumors located in the HN region and who had undergone SLNB were included in the analysis (n=245). Patients with less than five-percent and five-percent or greater risk predicted by the i31-GEP were considered low- or high-risk, respectively. A low-risk prediction was considered a negative test result and a high-risk prediction was considered a positive test result for i31-GEP accuracy calculations. Chi-squared analysis was performed to compare positivity rates.

Results: Among patients with CM classified as having a less than five-percent risk of SLN positivity by the i31-GEP, zero percent (n=0/61) had a positive SLN. Incorporating the i31-GEP into decision-making could have increased the yield of SLNB from 8 (n=19/245) to 10.3 percent (m=19/184; p=0.009), a 29-percent improvement over staging alone. The i31-GEP had a 100-percent sensitivity, 27-percent specificity, 10.3-percent positive predictive value, and 100-percent negative predictive value.

Conclusions: These results demonstrate that the i31-GEP identified patients at low risk of SLNB positivity in a clinically challenging subset of patients with HN tumors. Better risk prediction can improve patient care by guiding appropriate clinical management, allowing low-risk patients to avoid unnecessary procedures and associated costs.

Psoriasis

A Phase IIIb study evaluating safety and efficacy of risankizumab in adult patients with moderate-to-severe plaque psoriasis with palmoplantar (nonpustular) involvement

Presenters: Mark Lebwohl,1 Michael Bukhalo,2 Linda Stein Gold,3 Michelle Pelle,4 Bradley Glick,5 Mar Llamas-Velasco,6 Samuel Sanchez-Rivera,7 Tianyu Zhan,8 Leonidas Drogaris,8 Kevin Douglas,8 Greg St. John,8 Ramon Espaillat,8 Robert Bissonnette9

Affiliations: 1Icahn School of Medicine at Mount Sinai, New York, NY; 2Arlington Dermatology, Ascension St. Alexius Medical Center, Hoffman Estates, IL; 3Dermatology Clinical Research, Henry Ford Health System, Detroit, MI; 4MedDerm Associates, San Diego, CA; 5GSI Clinical Research, LLC, Miami, FL; 6Dermatology Department, Hospital Universitario de La Princesa, Madrid, Spain; 7Dr. Samuel Sanchez PSC, University of Puerto Rico School of Medicine, San Juan, Puerto Rico; 8AbbVie, North Chicago, IL; 9Innovaderm Research Inc., QC, Canada

Introduction: This study aimed to evaluate safety and efficacy of risankizumab (RZB) versus placebo (PBO) in adult patients with moderate-to-severe nonpustular palmoplantar psoriasis (PPPsO).

Method: IMMprint, a Phase IIIb study evaluated safety and efficacy of RZB versus PBO in patients with moderate-to-severe PPPsO with a static Physician’s Global Assessment (sPGA) of moderate or severe (≥3), Palmoplantar Psoriasis Area and Severity Index (PPASI) score of eight or greater, and at least one additional PsO plaque. The 52-week treatment was split into Period A, patients randomized (1:1) to RZB 150mg or PBO, and Period B, patients continuing RZB or switching from PBO to RZB (PBO/RZB). Primary endpoint was achievement of palmoplantar Investigator’s Global Assessment (ppIGA) 0/1 with an at least two-point reduction from baseline at Week 16. Ranked secondary endpoints included 75- and 90-percent improvement in PPASI (PPASI75, PPASI90), sPGA 0/1, and PPASI100 at Week 16.

Results: Of 174 enrolled patients, 87 (mean [standard deviation; SD] age: 56.9 [12.9] years) were randomized to RZB and 87 (mean [SD] age: 53.9 [14.3] years) were randomized to PBO. Baseline characteristics were similar, except for a numerical difference in psoriatic arthritis (RZB vs. PBO: 11.5% vs. 4.6%, respectively). At Week 16, a higher proportion of patients receiving RZB achieved ppIGA 0/1, compared to PBO (33.3% vs.16.1%, respectively; p=0.006). Patients receiving RZB also demonstrated significantly higher responses than patients receiving PBO in all ranked secondary endpoints (PPASI75: 42.5% vs. 14.9%, p<0.001; PPASI90: 27.6% vs. 5.7%, p<0.001; sPGA 0/1: 32.2% vs. 11.5%, p<0.001; PPASI100: 17.2% vs. 1.1%, p<0.001). Four patients (3 RZB, 1 PBO) discontinued the drug in Period A. At Week 52, ppIGA 0/1 was achieved by 50.6 percent of RZB-treated patients and 61.7 percent of the PBO/RZB group. The proportion of patients achieving PPASI75 at Week 52 was 57.5 percent (RZB) and 65.4 percent (PBO/RZB). Achievement of sPGA 0/1 (RZB vs. PBO/RZB) was 43.7 percent versus 66.7 percent. PPASI100 was achieved by 26.4 (RZB) and 37.0 percent (PBO/RZB) of patients at Week 52. The proportions of patients with adverse events (AEs) were 29.1 percent (RZB) and 23.0 percent (PBO) in Period A and 49.4 percent (RZB) and 35.8 percent (PBO/RZB) in Period B. One RZB-treated patient with prior cardiovascular risk factors had an adjudicated myocardial infarction and subsequently died after 140-day follow-up period. The number of patients with COVID-19 were three (RZB; 1 serious infection) and two (PBO) in Period A and 11 (RZB) and seven (PBO/RZB) in Period B.

Conclusion: This study demonstrates RZB can provide effective improvement compared to PBO by Week 16 with continuous improvement until Week 52 with no new safety signals in patients with moderate-to-severe PPPsO involvement.

Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, in moderate-to-severe plaque psoriasis: evaluation of lipid parameters in the Phase III POETYK PSO-1 and PSO-2 trials

Presenters: Mark Lebwohl,1 Bruce Strober,2 Misti Linaberry,3 Kim Hoyt,3 Subhashis Banerjee,3 Renata M. Kisa,3 Nehal N. Mehta4

Affiliations: 1Icahn School of Medicine at Mount Sinai, New York, NY; 2Yale University School of Medicine, New Haven, and Central Connecticut Dermatology, Cromwell, CT; 3Bristol Myers Squibb, Princeton, NJ; 4The George Washington University School of Medicine, Washington, DC

Introduction: Tyrosine kinase 2 (TYK2) is an intracellular enzyme that mediates signaling of cytokines (e.g., interleukin [IL]-23, Type I interferons) that are involved in psoriasis pathogenesis. Deucravacitinib, an oral, selective, allosteric TYK2 inhibitor, is approved in the United States (US), European Union (EU), and other countries for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. In the Phase III POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) trials, deucravacitinib was significantly more efficacious than placebo or apremilast and was well tolerated. Here, changes in lipid parameters in these trials are reported.

Methods: In PSO-1 and PSO-2, patients with moderate-to-severe plaque psoriasis (Psorasis Area and Severity Index [PASI] ≥12, static Physician’s Global Assessment [sPGA] ≥3, body surface area [BSA] involvement ≥10%) were randomized 1:2:1 to oral placebo, deucravacitinib 6mg once daily, or apremilast 30mg twice daily. This analysis evaluated serum lipids in patients taking placebo, deucravacitinib, or apremilast during Weeks 0 to 16 and those taking deucravacitinib continuously during Weeks 0 to 52 in PSO-1 and PSO-2. Mean changes in total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides are reported, as are shifts from baseline in Common Terminology Criteria for Adverse Events version 5 (CTCAE v5) severity grade of hypercholesterolemia and hypertriglyceridemia.

Results: A total of 666 and 1,020 patients were randomized in PSO-1 and PSO-2, respectively. Mean baseline levels of total cholesterol, HDL cholesterol, and LDL cholesterol were comparable between treatment groups. Mean changes from baseline to Week 16 were small, and none were clinically meaningful. Worsening of hypercholesterolemia grade from baseline was observed with similar frequencies among patients receiving placebo, deucravacitinib, and apremilast (10.6%, 11.7%, and 8.4%, respectively); nearly all shifts were one grade, and there was no Grade 3 or higher event. Baseline triglyceride levels were near the upper limit of normal (150mg/dL) across treatment groups. A 10.3mg/dL increase in mean triglycerides from baseline to Week 16 was observed with deucravacitinib, but worsening in hypertriglyceridemia greater than one grade from baseline was rare (1.2%) and comparable to placebo (1.4%). Most deucravacitinib-treated patients maintained the same or shifted to a lower grade of hypertriglyceridemia from baseline to Week 16. Among patients treated with deucravacitinib continuously for 52 weeks, mean changes in total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides were small. Shifts greater than one grade from baseline for hypercholesterolemia and hypertriglyceridemia were uncommon (0.2% and 1.9%, respectively). No patient discontinued deucravacitinib due to a lipid-related adverse event.

Conclusion: There were no meaningful changes in cholesterol, HDL cholesterol, and LDL cholesterol levels with deucravacitinib treatment. Minimal increases in mean triglyceride levels from baseline to Weeks 16 and 52 were accompanied by very few worsening shifts greater than one grade.

Funding/financial disclosures: This study was sponsored by Bristol Myers Squibb. Writing and editorial assistance was provided by Jieming Fang, MD, of Peloton Advantage, LLC, an OPEN Health company, funded by Bristol Myers Squibb.

ML: Research funds on behalf of Mount Sinai: AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, Dermavant, Eli Lilly, Incyte, Janssen, Ortho Dermatologics, Regeneron, and UCB; consultant: Almirall, AltruBio, AnaptysBio, Arcutis, Avotres, Boehringer Ingelheim, Brickell Biotech, Bristol Myers Squibb, Castle Biosciences, Celltrion, CorEvitas Psoriasis Registry, Dermavant, EPI Health, Evommune, Forte Biosciences, Galderma, Genentech, Incyte, LEO Pharma, Meiji Seika Pharma, Mindera Health, Pfizer, Seanergy, Strata, Trevi, and Verrica. BS: Consultant (honoraria): AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Connect Biopharma, Dermavant, Eli Lilly, Equillium, GlaxoSmithKline, Immunic Therapeutics, Janssen, LEO Pharma, Maruho, Meiji Seika Pharma, Mindera Health, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, UCB, Ventyx Biosciences, and vTv Therapeutics; speaker: AbbVie, Eli Lilly, Janssen, and Sanofi Genzyme; co-scientific director (consulting fee): CorEvitas Psoriasis Registry; investigator: AbbVie, Cara Therapeutics, CorEvitas Psoriasis Registry, Dermavant, Dermira, and Novartis. ML, SB, and RMK: Employees and shareholders: Bristol Myers Squibb. KH: Consultant: Bristol Myers Squibb via Syneos Health. NNM: Consultant: Abcentra, Amgen, and Novartis.

Deucravacitinib in plaque psoriasis: maintenance of response over 3 years in the Phase III POETYK PSO-1 and PSO-2 trials

Presenters: Bruce Strober,1 Howard Sofen,2 Shinichi Imafuku,3 Carle Paul,4 Melinda Gooderham,5 Lynda Spelman,6 Seong Jun Seo,7 Thierry Passeron,8 Renata M. Kisa,9 Victoria Berger,9 Eleni Vritzali,9 Kim Hoyt,9 Matthew J. Colombo,9 Subhashis Banerjee,9 Matthias Augustin,10 Linda Stein Gold,11 Andrew Alexis,12 Diamant Thaçi,13 Andrew Blauvelt,14 Mark Lebwohl15

Affiliations: 1Yale University School of Medicine, New Haven, Cromwell, CT; 2University of California, Los Angeles  School of Medicine, Los Angeles, CA; 3Fukuoka University Hospital, Fukuoka, Japan; 4Toulouse University, Toulouse, France; 5SKiN Centre for Dermatology, Peterborough, ON, Canada; 6Veracity Clinical Research, Brisbane, QLD, Australia; 7Chung-Ang University Hospital, Seoul, Korea; 8University Hospital of Nice, Nice, France; 9Bristol Myers Squibb, Princeton, NJ; 10University Medical Center Hamburg-Eppendorf, Hamburg, Germany; 11Henry Ford Health System, West Bloomfield, MI; 12Weill Cornell Medicine, New York, NY; 13University of Lübeck, Lübeck, Germany; 14Oregon Medical Research Center, Portland, OR; 15Icahn School of Medicine at Mount Sinai, New York, NY

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor for moderate-to-severe plaque psoriasis, was superior to placebo and apremilast in two global, 52-week, Phase III trials and maintained long-term efficacy through two years with no new safety signals in an ongoing long-term extension (LTE) trial. We report clinical efficacy for up to three years (148 weeks) in a subset of patients from these trials.

Methods: POETYK PSO-1 and PSO-2 randomized patients 1:2:1 to oral placebo, deucravacitinib 6mg once daily (QD), or apremilast 30mg twice daily. At Week 52, patients could enter the LTE and receive open-label deucravacitinib 6mg QD. Deucravacitinib efficacy, as of June 15, 2022, was evaluated through Week 148 in patients from the pooled PSO-1/PSO-2 populations who received continuous deucravacitinib from Day 1, achieved 75-percent or greater reduction from baseline in Psoriasis Area and Severity Index (PASI75) at Week 16 (primary endpoint) or Week 24 (peak response), and entered the LTE. Maintenance of response assessments included PASI75, PASI90, and static Physician’s Global Assessment (sPGA) of 0 (clear) or 1 (almost clear) with a two-point or greater improvement from baseline, which were reported using modified nonresponder imputation.

Results: Of the patients (N=513) who completed 52 weeks in the parent trials and received continuous deucravacitinib treatment from Day 1, 313 (61.4%) achieved PASI75 at Week 16 and 336 (66.5%) achieved PASI75 at Week 24. Among Week 16 PASI75 responders, PASI75, PASI90, and sPGA 0/1 response rates were maintained from Week 52 (87.0%, 60.6%, and 70.8%, respectively) to Week 148 (84.5%, 60.0%, and 62.8%, respectively). Among Week 24 PASI75 responders, PASI75, PASI90, and sPGA 0/1 response rates were maintained from Week 52 (90.2%, 61.6%, and 74.1%, respectively) to Week 148 (86.0%, 60.4%, and 64.5%, respectively).

Conclusion: Clinical efficacy was maintained with continuous deucravacitinib treatment in most Week 16 and Week 24 PASI75 responders from the parent trials through 148 weeks, supporting long-term effectiveness of once-daily oral deucravacitinib for moderate-to-severe plaque psoriasis.

Funding/financial disclosures: This study was sponsored by Bristol Myers Squibb. Writing and editorial assistance was provided by Regina Kelly, MA, of Peloton Advantage, LLC, an OPEN Health company, funded by Bristol Myers Squibb.

BS: Consultant (honoraria): AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Connect Biopharma, Dermavant, Eli Lilly, Equillium, GlaxoSmithKline, Immunic Therapeutics, Janssen, LEO Pharma, Maruho, Meiji Seika Pharma, Mindera Health, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, UCB, Ventyx Biosciences, and vTv Therapeutics; speaker: AbbVie, Eli Lilly, Janssen, and Sanofi Genzyme; co-scientific director (consulting fee): CorEvitas Psoriasis Registry; investigator: AbbVie, Cara Therapeutics, CorEvitas Psoriasis Registry, Dermavant, Dermira, and Novartis. HS: Clinical investigator: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Janssen, LEO Pharma, Novartis, and Sun Pharma. SI: Grants and personal fees: AbbVie, Eisai, Janssen, Kyowa Kirin, LEO Pharma, Maruho, Sun Pharma, Taiho Yakuhin, Tanabe Mitsubishi, and Torii Yakuhin; personal fees: Amgen (Celgene), Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Eli Lilly, GlaxoSmithKline, Novartis, and UCB. CP: Grants and consultant: AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Janssen, LEO Pharma, Merck, Mylan, Novartis, Pfizer, Sandoz, and UCB. MG: Advisory board, principal investigator, consulting and lecture fees: AbbVie, Amgen, Arcutis, Bausch Health, Boehringer Ingelheim International GmbH, Celgene, Eli Lilly, Janssen, Novartis, Sanofi Genzyme, Sun Pharma, and UCB; advisory board, primary investigator, and lecture fees: Galderma SA, LEO Pharma, Pfizer, and Regeneron; advisory board, primary investigator and consultant fees: Aslan Pharmaceuticals; primary investigator and consultant fees: Akros Pharma and Kyowa Kirin; primary investigator: Aristea, AnaptysBio, Bristol Myers Squibb, Coherus Biosciences, GlaxoSmithKline, Incyte, Dermira, Immunotherapeutics, MedImmune, Meiji Seika, Merck, MoonLake, and Nimbus Therapeutics; advisory board: Asana Biosciences. LS: Consultant, paid investigator, and/or speaker: AbbVie, Amgen, Anacor, Ascend, Astellas, AstraZeneca, Blaze Bioscience, Boehringer Ingelheim, Botanix, Bristol Myers Squibb, Celgene, Dermira, Eli Lilly, Galderma, Genentech, GlaxoSmithKline, Hexima, Janssen, LEO Pharma, Mayne Pharma, MedImmune, Merck, Merck-Serono, Novartis, Otsuka, Pfizer, Phosphagenics, Photon MD, Regeneron, Roche, Samumed, Sanofi Genzyme, SHR Pharmacy, Sun Pharma ANZ, Trius, UCB, and Zai Lab. SJS: Nothing to disclose. TP: Advisory board and consulting fees: AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eli Lilly, Galderma, Incyte, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi Genzyme, Sun Pharma, and UCB. RMK, VB, EV, MJC, and SB: Employees and shareholders: Bristol Myers Squibb. KH: Consultant: Bristol Myers Squibb via Syneos Health. MA: Advisory boards: AbbVie, Amgen, Boehringer Ingelheim, Janssen Biotech, and LEO Pharma; consulting fees: AbbVie, Amgen, Eli Lilly, Janssen Biotech, LEO Pharma, Novartis, Sun Pharma, and UCB; honoraria: AbbVie, Amgen, Boehringer Ingelheim, Eli Lilly, Janssen Biotech, LEO Pharma, Novartis, Sun Pharma, and UCB; investigator: AbbVie, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen Biotech, LEO Pharma, Merck, Novartis, Sun Pharma, and UCB; research grants: AbbVie, Amgen, Boehringer Ingelheim, Celgene, Janssen Biotech, Leo Pharma, Merck, and Sun Pharma; speaker: AbbVie, Amgen, Janssen Biotech, LEO Pharma, Sun Pharma, and UCB. LSG: Consultant, advisory board member, and/or speaker: AbbVie, Amgen, Arcutis, Aslan, Bausch Health, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Dermira, Eli Lilly, Galderma, Incyte, Janssen, Leo Pharma, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB. AA: Grants (funds to institution): AbbVie, Almirall, Amgen, Arcutis, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Dermavant, Galderma, LEO Pharma, Novartis, Valeant (Bausch Health), and Vyne; advisory board/consulting: AbbVie, Allergan, Almirall, Amgen, Arcutis, Bausch Health, Beiersdorf, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Cutera, Dermavant, Eli Lilly, EPI Health, Galderma, Incyte, Janssen, LEO Pharma, L’Oréal, Ortho, Pfizer, Sanofi-Regeneron, Swiss American, UCB, VisualDx, and Vyne; speaker: Bristol Myers Squibb, Pfizer, Regeneron, and Sanofi Genzyme; royalties: Springer, Wiley-Blackwell, Wolters Kluwer Health. DT: Research support and principal investigator (clinical trial funds to institution): AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galderma, Janssen-Cilag, LEO Pharma, Novartis, Pfizer, Regeneron, Roche, Sandoz-Hexal, Sanofi, and UCB; consultant: AbbVie, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Galapagos, LEO Pharma, Novartis, Pfizer, and UCB; lecturer: AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Eli Lilly, LEO Pharma, Novartis, Pfizer, Roche-Posay, Sanofi, Target RWE, and UCB; scientific advisory board: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Janssen-Cilag, LEO Pharma, Novartis, Pfizer, Sanofi, and UCB. AB: Speaker (with honoraria): AbbVie, Bristol Myers Squibb, Eli Lilly, Pfizer, Regeneron, and Sanofi; scientific adviser (with honoraria): AbbVie, Abcentra, Aclaris, Affibody, Aligos, Almirall, Alumis, Amgen, AnaptysBio, Apogee, Arcutis, Arena, Aslan Pharmaceuticals, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, CTI BioPharma, Dermavant, EcoR1, Eli Lilly, Escient, Evelo Biosciences, Evommune, Forte Biosciences, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, LEO Pharma, Lipidio, Merck, Nektar, Novartis, Pfizer, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB, Union, Ventyx Biosciences, Vibliome, and Xencor; clinical study investigator (institution has received clinical study funds): AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Concert, Dermavant, Eli Lilly, Evelo Biosciences, Evommune, Galderma, Incyte, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, UCB, and Ventyx Biosciences. ML: Research funds on behalf of Mount Sinai: AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, Dermavant, Eli Lilly, Incyte, Janssen, Ortho Dermatologics, Regeneron, and UCB; consultant: Aditum Bio, Almirall, AltruBio, AnaptysBio, Arcutis, Aristea, Avotres, Boehringer Ingelheim, Brickell Biotech, Bristol Myers Squibb, Cara Therapeutics, Castle Biosciences, Celltrion, CorEvitas Psoriasis Registry, Dermavant, Dr. Reddy’s Laboratories, EPI Health, Evommune, Forte Bioscience, Helsinn Therapeutics, Hexima, Incyte, LEO Pharma, Meiji Seika Pharma, Mindera Health, Pfizer, Seanergy, Strata, Trevi, and Verrica.

Deucravacitinib in plaque psoriasis: 3-year safety and efficacy results from the Phase III POETYK PSO-1 and PSO-2 trials

Presenters: April W. Armstrong,1 Mark Lebwohl,2 Richard B. Warren,3 Howard Sofen,1,4 Shinichi Imafuku,5 Mamitaro Ohtsuki,6 Lynda Spelman,7 Thierry Passeron,8 Kim A. Papp,9 Renata M. Kisa,10 Victoria Berger,10 Eleni Vritzali,10 Kim Hoyt,10 Matthew J. Colombo,10 Subhashis Banerjee,10 Bruce Strober,11 Diamant Thaçi,12 Andrew Blauvelt13

Affiliations: 1University of California, Los Angeles, Los Angeles, CA; 2Icahn School of Medicine at Mount Sinai, New York, NY; 3NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester, UK; 4Dermatology Research Associates, Los Angeles, CA; 5Fukuoka University Hospital, Fukuoka, Japan; 6Jichi Medical University, Tochigi, Japan; 7Veracity Clinical Research, Brisbane, QLD, Australia; 8Université Côte d’Azur, University Hospital of Nice, Nice, France; 9Alliance Clinical Trials and Probity Medical Research, Waterloo, and University of Toronto, Toronto, ON, Canada; 10Bristol Myers Squibb, Princeton, NJ; 11Yale University School of Medicine, New Haven, and Central Connecticut Dermatology Research, Cromwell, CT; 12University of Lübeck, Lübeck, Germany; 13Oregon Medical Research Center, Portland, OR

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the United States (US), European Union (EU), and other countries for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. Deucravacitinib was superior to placebo and apremilast in the global, 52-week, Phase III POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) trials in moderate-to-severe plaque psoriasis. Upon completing the parent trials, patients could enroll in the ongoing POETYK long-term extension (LTE; NCT04036435) trial. Deucravacitinib-treated patients maintained long-term safety profiles and efficacy responses through two years with no new safety signals. Here, we report safety and efficacy of deucravacitinib for up to three years (Week 148).

Methods: PSO-1/PSO-2 randomized patients 1:2:1 to oral placebo, deucravacitinib, or apremilast. At Week 52, patients in the LTE received open-label deucravacitinib. Safety was evaluated in patients who received one or more deucravacitinib doses. Exposure-adjusted incidence rate (EAIR) per 100 person-years (PY) is calculated as 100*(# of patients with an adverse event [AE])/(total exposure time for all patients at risk [time to initial AE occurrence for patients with AE + total exposure time for patients without AE]). Efficacy outcomes included 75-percent or greater reduction from baseline in Psoriasis Area and Severity Index (PASI75), PASI90, and static Physician’s Global Assessment (sPGA) 0/1. Efficacy was reported using modified nonresponder imputation (mNRI) in patients who received continuous deucravacitinib from Day 1 in PSO-1/PSO-2.

Results: A total of 1,519 patients received one or more deucravacitinib doses; 513 received continuous deucravacitinib from Day 1 in PSO-1/PSO-2 and enrolled in the LTE. Cumulative exposure was 3,294.3 PY. EAIRs/100 PY were similar or decreased from the two- to three-year cumulative period, respectively, for AEs (154.4, 144.8), serious AEs (6.1, 5.5), discontinuation due to AEs (2.8, 2.4), herpes zoster (0.7, 0.6), malignancies (0.9, 0.9), major adverse cardiovascular event (MACE; 0.4, 0.3), venous thromboembolism (VTE; 0.1, 0.1), and deaths (0.4, 0.3). Clinical response rates were maintained at Week 148 by mNRI (PASI75: 73.2% [95% confidence interval; CI: 68.7, 77.8]; PASI90: 48.1% [43.2, 53.1]; sPGA 0/1: 54.1% [49.1, 59.1]).

Conclusion: Deucravacitinib demonstrated sustained clinical response with continuous treatment and a consistent safety profile through three years.

Funding/financial disclosures: This study was sponsored by Bristol Myers Squibb. Writing and editorial assistance was provided by Julianne Hatfield, PhD, of Peloton Advantage, LLC, an OPEN Health company, funded by Bristol Myers Squibb.

AWA: Research investigator, scientific advisor, and/or speaker: AbbVie, Almirall, Arcutis, ASLAN, Beiersdorf, Boehringer Ingelheim, Bristol Myers Squibb, Dermavant, Dermira, EPI Health, Incyte, Janssen, LEO Pharma, Lilly, Mindera Health, Nimbus, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi, Sun Pharma, and UCB. ML: Research funds on behalf of Mount Sinai: AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, Dermavant, Incyte, Janssen, Lilly, Ortho Dermatologics, Regeneron, and UCB; consultant: Almirall, AltruBio, AnaptysBio, Arcutis, Avotres, Boehringer Ingelheim, Brickell Biotech, Bristol Myers Squibb, Castle Biosciences, Celltrion, CorEvitas Psoriasis Registry, Dermavant, EPI Health, Evommune, Forte Biosciences, Galderma, Genentech, Incyte, LEO Pharma, Meiji Seika Pharma, Mindera Health, Pfizer, Seanergy, Strata, Trevi, and Verrica. RBW: Research grants: AbbVie, Almirall, Amgen, Celgene, Janssen, LEO Pharma, Lilly, Novartis, Pfizer, and UCB; Consulting fees: AbbVie, Almirall, Amgen, Astellas, Boehringer Ingelheim, Celgene, DICE Therapeutics, GSK, Janssen, LEO Pharma, Lilly, Novartis, Pfizer, Sanofi, UCB, and UNION Therapeutics. HS: Clinical investigator: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, LEO Pharma, Lilly, Novartis, and Sun Pharma. SI: Grants and personal fees: AbbVie, Eisai, Janssen, Kyowa Kirin, LEO Pharma, Maruho, Sun Pharma, Taiho Yakuhin, Tanabe Mitsubishi, and Torii Yakuhin; personal fees: Amgen (Celgene), Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, GSK, Lilly, Novartis, and UCB. MO: Honoraria and/or research grants: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Eisai, Janssen, Kyowa Kirin, LEO Pharma, Lilly, Maruho, Mitsubishi Tanabe Pharma, Nichi-Iko, Nippon Kayaku, Novartis, Pfizer, Sanofi, Sun Pharma, Taiho Pharmaceutical, Torii Pharmaceutical, and UCB. LS: Consultant, paid investigator, and/or speaker: AbbVie, Amgen, Anacor, Ascend, Astellas, AstraZeneca, Blaze Bioscience, Boehringer Ingelheim, Botanix, Bristol Myers Squibb, Celgene, Dermira, Galderma, Genentech, GSK, Hexima, Janssen, LEO Pharma, Lilly, Mayne Pharma, MedImmune, Merck, Merck-Serono, Novartis, Otsuka, Pfizer, Phosphagenics, Photon MD, Regeneron, Roche, Samumed, Sanofi Genzyme, SHR Pharmacy, Sun Pharma ANZ, Trius, UCB, and Zai Lab. TP: Advisory board and consulting fees: AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, Galderma, Incyte, Janssen, LEO Pharma, Lilly, Novartis, Pfizer, Sanofi Genzyme, Sun Pharma, and UCB. KAP: Consultant: AbbVie, Acelyrin, Akros, Amgen, Aralez, Arcutis, Avillion, Bausch Health/Valeant, Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite Biopharma, Celgene, Celltrion, Coherus, Dermavant, Dermira, DICE Therapeutics, Dow Pharma, Evelo Biosciences, Forbion, Galderma, Incyte, Janssen, Kyowa Kirin, LEO Pharma, Lilly, Meiji Seika Pharma, Merck, Mitsubishi Pharma, Novartis, Pfizer, Regeneron, Reistone, Roche, Sanofi Aventis/Genzyme, Sandoz, Sun Pharma, Takeda, UCB, vTv Therapeutics, and Xencor; speakers bureau: AbbVie, Amgen, Bausch Health/Valeant, Celgene, Galderma, Incyte, Janssen, Kyowa Kirin, LEO Pharma, Lilly, Merck, Novartis, Pfizer, and Sanofi Genzyme; clinical research grants: AbbVie, Akros, Amgen, Anacor, Arcutis, Avillion, Bausch Health/Valeant, Boehringer Ingelheim, Bristol Myers Squibb, Can-Fite Biopharma, Celgene, Coherus BioSciences, Dermavant, Dermira, DICE Therapeutics, Dow Pharma, Evelo Biosciences, Galderma, Gilead, GSK, Incyte, Janssen, Kyowa Kirin, LEO Pharma, Lilly, Merck, Novartis, Pfizer, Regeneron, Roche, Sanofi Genzyme, Sun Pharma, Takeda, and UCB; honoraria: AbbVie, Acelyrin, Akros, Amgen, Aralez, Bausch Health/Valeant, Boehringer Ingelheim, Celgene, Celltrion, Coherus BioSciences, Dermavant, DICE Therapeutics, Forbion, Galderma, Janssen, Kyowa Kirin, LEO Pharma, Lilly, Meiji Seika Pharma, Merck, Mitsubishi Pharma, Novartis, Pfizer, Reistone, Sanofi Genzyme, Sandoz, Sun Pharma, Takeda, UCB, vTv Therapeutics, and Xencor; scientific officer: Akros, Anacor, Arcutis, DICE Therapeutics, and Kyowa Kirin; steering committees: AbbVie, Amgen, Bausch Health/Valeant, Boehringer Ingelheim, Celgene, Janssen, Kyowa Kirin, Lilly, Merck, Novartis, Pfizer, Regeneron, Reistone, and Sanofi Genzyme; advisory boards: AbbVie, Amgen, Bausch Health/Valeant, Boehringer Ingelheim, Bristol Myers Squibb, Celgene, DICE Therapeutics, Dow Pharma, Galderma, Janssen, Lilly, Merck, Novartis, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, and UCB. RMK, VB, EV, MJC, and SB: Employees and shareholders: Bristol Myers Squibb. KH: Consultant: Bristol Myers Squibb via Syneos Health. BS: Consultant (honoraria): AbbVie, Almirall, Amgen, Arcutis, Arena, Aristea, Asana, Boehringer Ingelheim, Bristol Myers Squibb, Connect Biopharma, Dermavant, Equillium, GSK, Immunic Therapeutics, Janssen, LEO Pharma, Lilly, Maruho, Meiji Seika Pharma, Mindera Health, Novartis, Ortho Dermatologics, Pfizer, Regeneron, Sanofi Genzyme, Sun Pharma, UCB, Ventyx Biosciences, and vTv Therapeutics; speaker: AbbVie, Janssen, Lilly, and Sanofi Genzyme; co-scientific director (consulting fee): CorEvitas Psoriasis Registry; Investigator: AbbVie, Cara Therapeutics, CorEvitas Psoriasis Registry, Dermavant, Dermira, and Novartis. DT: Research support and principal investigator (clinical trials funds to institution): AbbVie, Almirall, Amgen, Biogen Idec, Bristol Myers Squibb , Boehringer Ingelheim, Eli Lilly, Galderma, GlaxoSmithKline, Janssen-Cilag, LEO Pharma, Merck Sharp & Dohme, Novartis, Pfizer, Regeneron, Roche, Sandoz-Hexal, Sanofi, and UCB; consultant: AbbVie, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Galapagos, LEO Pharma, Novartis, Pfizer, and UCB; lecturer: AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, LEO Pharma, Lilly, Merck Sharp & Dohme, Novartis, Pfizer, La Roche-Posay, Sandoz-Hexal, Sanofi, Target RWE, and UCB; scientific advisory board: AbbVie, Amgen, Bristol Myers Squibb, Boehringer Ingelheim, Janssen-Cilag, LEO Pharma, Lilly, Morphosis, Merck Sharp & Dohme, Novartis, Pfizer, Sanofi, and UCB. AB: Speaker (with honoraria): AbbVie, Bristol Myers Squibb, Lilly, Pfizer, Regeneron, and Sanofi; scientific adviser (with honoraria): AbbVie, Abcentra, Aclaris, Affibody, Aligos, Almirall, Alumis, Amgen, AnaptysBio, Apogee, Arcutis, Arena, Aslan, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, CTI BioPharma, Dermavant, EcoR1, Escient, Evelo Biosciences, Evommune, Forte Biosciences, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, LEO Pharma, Lilly, Lipidio, Merck, Nektar, Novartis, Pfizer, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB, UNION Therapeutics, Ventyx Biosciences, Vibliome, and Xencor; clinical study investigator (clinical study funds received by institution): AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Concert, Dermavant, Evelo Biosciences, Evommune, Galderma, Incyte, Janssen, LEO Pharma, Lilly, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, UCB, and Ventyx Biosciences.

Deucravacitinib long-term efficacy with continuous treatment in plaque psoriasis: 2-year results from the Phase III POETYK PSO-1 and POETYK LTE trials

Presenters: Mark Lebwohl,1 Richard B. Warren,2 Leon Kircik,1 Elizabeth Colston,3 Lauren Hippeli,3 Andrew Napoli,3 Renata M. Kisa,3 Subhashis Banerjee,3 Alan Menter,4 Diamant Thaçi,5 Andrew Blauvelt6

Affiliations: 1Icahn School of Medicine at Mount Sinai, New York, NY; 2Dermatology Centre, Northern Care Alliance NHS Foundation Trust, NIHR Manchester Biomedical Research Centre, Manchester University NHS Foundation Trust, Manchester Academic Health Science Centre, Manchester, UK; 3Bristol Myers Squibb, Princeton, NJ; 4Baylor University Medical Center, Dallas, TX; 5Institute and Comprehensive Center for Inflammation Medicine, University of Lübeck, Lübeck, Germany; 6Oregon Medical Research Center, Portland, OR

Introduction: Deucravacitinib, an oral, selective, allosteric tyrosine kinase 2 inhibitor, is approved in the United States (US), European Union (EU), and other countries for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. In the Phase III POETYK PSO-1 (NCT03624127) and POETYK PSO-2 (NCT03611751) trials, deucravacitinib demonstrated superior efficacy versus placebo and apremilast in patients with psoriasis. Here, long-term efficacy after about two years of deucravacitinib exposure is reported.

Methods: In PSO-1, patients were randomized 1:2:1 to placebo, deucravacitinib 6mg once daily (QD), or apremilast 30mg twice daily; at Week 52, patients could enter the long-term extension (LTE; NCT04036435) trial where they received deucravacitinib 6mg QD. This analysis focused on patients randomized to deucravacitinib on Day 1 who continued treatment in the LTE trial. Efficacy endpoints were assessed with modified nonresponder imputation (mNRI) and included 75-percent or greater reduction from baseline in Psoriasis Area and Severity Index (PASI75), PASI90, and static Physician’s Global Assessment score of 0 (clear) or 1 (almost clear) with a two-point or greater improvement from baseline (sPGA 0/1). Maintenance of response was assessed in patients who achieved PASI75 at Week 24.

Results: In the mNRI population, 262 patients who were randomized to deucravacitinib on Day 1 of PSO-1 continued treatment in the LTE trial, including 200 who had achieved PASI75 at Week 24. At Week 112, response rates for PASI75, PASI90, and sPGA 0/1 with deucravacitinib were 82.4, 55.2, and 66.5 percent, respectively. Among Week 24 PASI75 responders, efficacy was maintained from Week 24 (PASI75: 100%; PASI 90: 64.5%; sPGA 0/1: 83.5%) to Week 112 (PASI 75: 91.4%; PASI 90: 64.5%; sPGA 0/1: 73.7%).

Conclusion: Clinical efficacy was maintained for up to 112 weeks with continuous deucravacitinib treatment.

Funding/financial disclosures: This study was sponsored by Bristol Myers Squibb. Writing and editorial assistance was provided by Stephan Lindsey, PhD, of Peloton Advantage, LLC, an OPEN Health company, funded by Bristol Myers Squibb.The authors also acknowledge Julie Scotto, BS, MPH, for her contributions to this analysis.

ML: Research funds on behalf of Mount Sinai: AbbVie, Amgen, Arcutis, Avotres, Boehringer Ingelheim, Cara Therapeutics, Dermavant, Eli Lilly, Incyte, Janssen, Ortho Dermatologics, Regeneron, and UCB; consultant: Almirall, AltruBio, AnaptysBio, Arcutis, Avotres, Boehringer Ingelheim, Brickell Biotech, Bristol Myers Squibb, Castle Biosciences, Celltrion, CorEvitas Psoriasis Registry, Dermavant, EPI Health, Evommune, Forte Biosciences, Galderma, Genentech, Incyte, LEO Pharma, Meiji Seika Pharma, Mindera Health, Pfizer, Seanergy, Strata, Trevi, and Verrica. RBW: Research grants: AbbVie, Almirall, Amgen, Celgene, Janssen, LEO Pharma, Novartis, Pfizer, and UCB; consulting fees: AbbVie, Almirall, Amgen, Astellas, Boehringer Ingelheim, Celgene, DICE Therapeutics, Eli Lilly, GlaxoSmithKline, Janssen, LEO Pharma, Novartis, Pfizer, Sanofi, UCB, and UNION Therapeutics. LK: Research grants: AbbVie, Allergan, Almirall, Amgen, Arcutis, Boehringer Ingelheim, Breckinridge Pharma, Bristol Myers Squibb, Celgene, Cellceutix, Centocor, Combinatrix, Connetics, Coria, Dermavant, Dermira, Dow Pharma, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Genentech, GlaxoSmithKline, Idera, Johnson & Johnson, LEO Pharma, Maruho, Merck, Medicis, Novartis AG, Pfizer, PharmaDerm, Promius, Stiefel, Sun Pharma, UCB, Valeant, and XenoPort; honoraria: AbbVie, Allergan, Almirall, Amgen, Arcutis, Biogen Idec, Bristol Myers Squibb, Celgene, Cipher, Connetics, Dermavant, Dermira, Dr. Reddy’s Laboratories, Eli Lilly, Galderma, Genentech, GlaxoSmithKline, Johnson & Johnson, LEO Pharma, Merck, Novartis AG, PharmaDerm, Promius, Serono (Merck Serono International SA), Stiefel, Sun Pharma, Taro, UCB, and Valeant. EC, LH, AN, RMK, and SB: Employees and shareholders: Bristol Myers Squibb. AM: Advisory board: Abbott Labs, Amgen, Boehringer Ingelheim, Janssen Biotech, and LEO Pharma; consultant: Abbott Labs, Amgen, Eli Lilly, Janssen Biotech, LEO Pharma, Novartis, Sun Pharma, and UCB; honoraria: Abbott Labs, Amgen, Boehringer Ingelheim, Eli Lilly, Janssen Biotech, LEO Pharma, Novartis, Sun Pharma, and UCB; investigator: Abbott Labs, Amgen, Boehringer Ingelheim, Celgene, Eli Lilly, Janssen Biotech, LEO Pharma, Merck, Novartis, Sun Pharma, and UCB; research grants: Abbott Labs, Amgen, Boehringer Ingelheim, Celgene, Janssen Biotech, LEO Pharma, Merck, and Sun Pharma; speaker: Abbott Labs, Amgen, Janssen Biotech, LEO Pharma, Sun Pharma, and UCB. DT: Research support and principal investigator (clinical trial funds to institution): AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Galderma, Janssen-Cilag, LEO Pharma, Novartis, Pfizer, Regeneron, Roche, Sandoz-Hexal, Sanofi, and UCB; consultant: AbbVie, Almirall, Boehringer Ingelheim, Bristol Myers Squibb, Galapagos, LEO Pharma, Novartis, Pfizer, and UCB; lecturer: AbbVie, Almirall, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Eli Lilly, LEO Pharma, Novartis, Pfizer, La Roche-Posay, Sanofi, Target RWE, and UCB; scientific advisory board: AbbVie, Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Eli Lilly, Janssen-Cilag, LEO Pharma, Novartis, Pfizer, Sanofi, and UCB. AB: Speaker (with honoraria): AbbVie, Bristol Myers Squibb, Eli Lilly, Pfizer, Regeneron, and Sanofi; scientific adviser (with honoraria): AbbVie, Abcentra, Aclaris, Affibody, Aligos, Almirall, Alumis, Amgen, AnaptysBio, Apogee, Arcutis, Arena, ASLAN, Athenex, Bluefin Biomedicine, Boehringer Ingelheim, Bristol Myers Squibb, Cara Therapeutics, CTI BioPharma, Dermavant, EcoR1, Eli Lilly, Escient, Evelo Biosciences, Evommune, Forte Biosciences, Galderma, HighlightII Pharma, Incyte, InnoventBio, Janssen, Landos, LEO Pharma, Lipidio, Merck, Nektar, Novartis, Pfizer, Rani, Rapt, Regeneron, Sanofi Genzyme, Spherix Global Insights, Sun Pharma, Takeda, TLL Pharmaceutical, TrialSpark, UCB, UNION Therapeutics, Ventyx Biosciences, Vibliome, and Xencor; clinical study investigator (clinical study funds received by institution): AbbVie, Acelyrin, Allakos, Almirall, Alumis, Amgen, Arcutis, Athenex, Boehringer Ingelheim, Bristol Myers Squibb, Concert, Dermavant, Eli Lilly, Evelo Biosciences, Evommune, Galderma, Incyte, Janssen, LEO Pharma, Merck, Novartis, Pfizer, Regeneron, Sanofi, Sun Pharma, UCB, and Ventyx Biosciences.

Durability of efficacy and safety of roflumilast cream 0.3% in adults with chronic plaque psoriasis from a 52-week, Phase II open-label safety trial

Presenter: Mark Lebwohl; on behalf of the Roflumilast Study 202 investigators and authors

Affiliation: Icahn School of Medicine at Mount Sinai, New York, NY

Introduction: Roflumilast cream is a potent phosphodiesterase 4 inhibitor recently approved in the United States (US) for the treatment of plaque psoriasis with no limitations on duration of use. An open-label trial was conducted to evaluate long-term safety (52 weeks) of once-daily roflumilast cream (NCT03764475). This abstract presents data on durability of response as measured by the percentage of patients with an Investigator’s Global Assessment (IGA) score of clear or almost clear, percentage improvement in Psoriasis Area Severity Index (PASI) score, and reduction in body surface area (BSA) affected.

Methods: Patients who completed a parent, Phase IIb, 12-week, randomized controlled trial could continue on open-label roflumilast cream 0.3% (Cohort 1, n=230), and patients naïve to roflumilast were also enrolled (Cohort 2, n=102). All psoriasis lesions (except scalp) were treated, including face and intertriginous areas, for up to 52 weeks. If affected, palms and soles were treated, but not evaluated toward any efficacy assessments. Median duration of response was determined using the Kaplan–Meier method.

Results: With cumulative treatment up to 64 weeks in Cohort 1 and 52 weeks in Cohort 2, long-term safety and tolerability were consistent with the 12-week, Phase IIb study. Overall, 73.5 percent of patients completed the study; 3.9 percent discontinued due to adverse events (AEs) and 0.9 percent discontinued due to lack of efficacy. Treatment-related AEs were reported in 2.7 percent patients; none were deemed serious. Investigator tolerability assessments at each visit demonstrated that 99 percent of patients rated “no evidence of irritation.” At Week 52, IGA success (demonstrating clear/almost clear plus ≥2-grade improvement from baseline) was achieved by 34.8 percent of patients in Cohort 1 and 39.5 percent in Cohort 2. Of the patients in Cohort 2, 40 percent achieved IGA success at Week 12. IGA clear/almost clear was achieved by 46.8 percent of patients across both cohorts at Week 12, which was consistent through Week 52 (44.8%). Similarly, a 60.5-percent mean PASI improvement and 60.1-percent mean BSA improvement from baseline were observed at Week 12 and remained consistent through Week 52 (59.4% and 63.3%, respectively). Of the 185 patients who achieved IGA clear/almost clear during the open-label trial, the median durability of IGA clear/almost clear was 10 months (40.1 weeks). Among patients who achieved IGA clear/almost clear, 50 percent maintained clear/almost clear status for at least 10 months.

Conclusion: In this long-term safety study, roflumilast cream was well tolerated, with a safety profile consistent with the parent Phase IIb trial, and effectively maintained clear/almost clear skin with no tachyphylaxis observed.

Funding/financial disclosures: Sponsored by Arcutis Biotherapeutics, Inc.

Efficacy and safety of roflumilast foam 0.3% in patients with scalp and body psoriasis in the Phase 3 ARRECTOR trial

Presenters: Melinda Gooderham,1 Jerry Bagel,2 Janet DuBois,3 Leon H. Kircik,4 Benjamin Lockshin,5 KimA. Papp,6 Jennifer Soung,7 David Krupa,8 Patrick Burnett,8 David Berk,8 David H. Chu8

Affiliations: 1SKiN Centre for Dermatology, Probity Medical Research and Queen’s University, Peterborough, ON, Canada; 2Psoriasis Treatment Center of Central New Jersey, East Windsor, NJ; 3DermResearch, Inc., Austin, TX; 4Icahn School of Medicine at Mount Sinai, New York, NY, Indiana Medical Center, Indianapolis, IN, Physicians Skin Care, PLLC, Louisville, KY, and Skin Sciences, PLLC, Louisville, KY; 5DermAssociates, LLC, Rockville, MD; 6Probity Medical Research and Alliance Clinical Research, Waterloo, ON, Canada; 7Southern California Dermatology, Santa Ana, CA; 8Arcutis Biotherapeutics, Inc., Westlake Village, CA

Introduction: Roflumilast is a selective, nonsteroidal, highly potent phosphodiesterase 4 inhibitor under investigation as a once-daily foam for the treatment of scalp and body psoriasis. This Phase III randomized controlled trial (NCT05028582) was conducted in patients aged 12 years or older with scalp and body psoriasis, minimum Scalp-Investigator’s Global Assessment (S-IGA) score of moderate (3 on a 5-point scale), and minimum Body-IGA (B-IGA) of mild (2). Overall body surface area (BSA) affected by psoriasis was 25 percent or less (including ≤20% for non-scalp areas, not including palm/soles). The purpose of the study was to assess the efficacy and safety of once-daily roflumilast foam 0.3% versus vehicle foam in patients with scalp and body psoriasis.

Methods: Patients were randomized 2:1 to apply once-daily roflumilast foam 0.3% (n=281) or vehicle (n=151) for eight weeks. The co-primary efficacy endpoints were S-IGA and B-IGA success (S-IGA/B-IGA of clear [0] or almost clear [1] plus ≥2-grade improvement from baseline) at Week 8.

Results: Significantly more roflumilast-treated than vehicle-treated patients achieved S-IGA success (66.4% vs. 27.8%; p<0.0001) and B-IGA success (45.5% vs. 20.1%; p<0.0001), with 40.0 and 27.8 percent of roflumilast-treated patients achieving S-IGA and B-IGA 0, respectively (p<0.0001; nominal for B-IGA), at Week 8. All secondary endpoints achieved statistical significance. Notably, improvement in itch was observed as early as 24 hours following first application (p=0.0164) as measured by change from baseline in Scalp Itch-Numeric Rating Score (SI-NRS). Safety and local tolerability were favorable, with at least 95 percent of patients reporting no or mild sensation. Rates of discontinuation due to adverse events were low and similar among roflumilast-treated (1.8%) and vehicle-treated (1.3%) patients.

Conclusion: Roflumilast foam 0.3% improved scalp and body psoriasis across multiple efficacy endpoints while demonstrating favorable safety and tolerability.

Funding/financial disclosures: Sponsored by Arcutis Biotherapeutics, Inc.

Efficacy of tapinarof cream 1% once daily for the treatment of mild-to-severe intertriginous plaque psoriasis

Presenters: Howard Sofen,1 Stephen Tyring,2 Sandra Marchese Johnson,3 Scott Guenthner,4 Patrick Shannon,5 Philip M. Brown,6 Katherine Tillman,6 Nancy Fitzgerald,6 Brandon Kirsch,6 Anna M. Tallman6

Affiliations: 1David Geffen University of California, Los Angeles School of Medicine, Los Angeles, CA; 2University of Texas Health Science Center, Houston, TX; 3Johnson Dermatology, Fort Smith, AR; 4The Indiana Clinical Trials Center, PC, Plainfield, IN; 5Advanced Dermatology and Skin Cancer Center, Boardman, OH; 6Dermavant Sciences, Inc., Morrisville, NC

Introduction: Tapinarof cream 1% (VTAMA®, Dermavant Science, Inc.) is a nonsteroidal, topical aryl hydrocarbon receptor agonist approved for the treatment of plaque psoriasis in adults with no restrictions on location, extent, or duration of use. Psoriasis affecting intertriginous skin is difficult to treat; topical corticosteroids have restrictions on strength and duration on use, with the risk of potentially irreversible side effects (e.g., striae). In the Phase III PSOARING trial program, tapinarof cream 1% once daily (QD) was efficacious and well tolerated for the treatment of psoriasis, including in intertriginous areas. Here, we assessed the efficacy and safety of tapinarof cream to treat adults with mild-to-severe intertriginous plaque psoriasis.

Methods: In this Phase IV, real-world, open-label trial, adults received tapinarof cream for 12 weeks. Patients had plaque psoriasis with lesions affecting intertriginous areas that were stable for three months or more before trial entry, and an intertriginous Physician’s Global Assessment (iPGA) score of two (mild), three (moderate), or four (severe). The primary endpoint was the proportion of patients who achieved an iPGA response, defined as an iPGA score of clear (0) or almost clear (1) and two-grade or greater improvement from baseline at Week 12. Additional endpoints included time to achieve an iPGA response, and achievement of complete disease clearance (iPGA score: 0) by visit. Safety and tolerability evaluations included treatment-emergent adverse events (TEAEs) and investigator-assessed Local Tolerability Scale (LTS) and LTS-external genitalia scores.

Results: Thirty-four patients with mild-to-severe psoriasis in intertriginous areas received tapinarof cream. At baseline, 29.4, 64.7, and 5.9 percent had an iPGA score of two (mild), three (moderate), and four (severe), respectively; 11.8 percent had plaque psoriasis affecting genitalia. At Week 12, 82.8 percent of patients (n=24/29) achieved an iPGA response and 65.5 percent (n=19/29) achieved complete disease clearance. There was rapid onset of efficacy with tapinarof treatment, with both iPGA response and complete disease clearance achieved as early as Week 2. Median time to iPGA response was approximately six weeks. Most TEAEs were mild or moderate, consistent with previous trials; only one patient discontinued due to a TEAE (contact dermatitis). Tapinarof was well tolerated; most patients had no irritation (LTS score: 0) at all visits for intertriginous areas or genitalia specifically.

Conclusion: Tapinarof cream 1% QD demonstrated rapid onset of clinically meaningful efficacy in patients with intertriginous psoriasis, as early as Week 2, with 82.8 percent achieving the iPGA primary endpoint. Completely clear intertriginous skin was achieved by 65.5 percent of patients. Tapinarof cream is a well-tolerated, nonsteroidal treatment option in adults with mild-to-severe plaque psoriasis in intertriginous areas.

Long-term safety of apremilast from a pooled analysis of 15 randomized, placebo-controlled studies of psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet’s syndrome

Presenters: Philip J. Mease, MD;1 Gülen Hatemi, MD;2 Maria Paris, MD;3 Sue Cheng, MD;3 Peter Maes, BA;3 Wendy Zhang, MD;3 Rebecca Shi, MS;3 Andrea Flower, MS;3 Linda Stein Gold, MD4

Affiliations: 1Swedish Medical Center/Providence St. Joseph Health and University of Washington School of Medicine, Seattle, WA; 2Istanbul University – Cerrahpaşa, School of Medicine, Istanbul, Turkey; 3Amgen, Inc., Thousand Oaks, CA; 4Henry Ford Health System, West Bloomfield, MI

Introduction: As of March 20, 2022, 706,585 patients (557,379 patient-years of exposure) have been treated with apremilast worldwide for approved indications of plaque psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet’s syndrome. This pooled analysis assessed the longer-term safety and tolerability of apremilast 30mg twice daily (BID) across three indications for up to five years. This analysis is the largest yet that focuses on long-term safety of apremilast.

Methods: Data from up to five years of exposure were pooled from 15 randomized, placebo-controlled studies across three indications and divided into placebo-controlled and all apremilast exposure groups. Long-term safety and tolerability of apremilast 30mg BID were analyzed. Treatment-emergent adverse events (TEAEs) were assessed, focusing on TEAEs of special interest. AEs of special interest included thrombotic events, malignancies, major adverse cardiac events (MACEs), serious infections, and depression.

Results: The analysis included 4,183 patients exposed to apremilast (6,788 patient-years). TEAEs were primarily mild-to-moderate in the placebo-controlled period (96.6%) and throughout all apremilast exposure (91.6%). Rates of TEAEs of special interest were similar between placebo and apremilast groups in the placebo-controlled period. For all apremilast exposure, the exposure-adjusted incident rate per 100 patient-years was 6.20 (any serious TEAE), 1.78 (depression), 1.10 (serious infections), 1.04 (malignancies; 0.48: nonmelanoma skin cancer; 0.03: lymphomas); 0.30 (MACEs), 0.21 (serious opportunistic infections), and 0.10 (venous thromboembolism events; 0.07: deep vein thrombosis; 0.03: pulmonary embolism). The most common TEAEs were diarrhea, nausea, headache, upper respiratory tract infection, and nasopharyngitis.

Conclusion: The incidence of TEAEs of special interest and serious TEAEs was low despite long-term apremilast exposure, further establishing apremilast as a safe oral option with a favorable benefit-risk profile for the long-term treatment for psoriasis, psoriatic arthritis, and oral ulcers associated with Behçet’s syndrome.

Funding/financial disclosures: The study and medical writing was sponsored by Amgen, Inc. Writing support was funded by Amgen, Inc. and provided by Christina Mulvihill, PharmD, of Peloton Advantage, LLC, an OPEN Health company, and Dawn Nicewarner, PhD, employee of and stockholder in Amgen, Inc.

PJM: Grant/research support and consultant: AbbVie, Amgen Inc., Bristol Myers Squibb, Eli Lilly, Galapagos, Gilead, Janssen, Novartis, Pfizer, Sun, and UCB; consultant: Boehringer Ingelheim, GlaxoSmithKline; speaker’s bureau: AbbVie, Amgen Inc., Eli Lilly, Janssen, Novartis, Pfizer, and UCB.GH: Grant/research support: AbbVie, Amgen Inc., and Celgene Corporation; speaker: AbbVie, Boehringer Ingelheim, Novartis, and UCB Pharma. MP, SC, PM, WZ, RS, and AF: employees and stockholders: Amgen, Inc. LSG: honoraria, grants, and/or research funding as a speaker, investigator, and advisory board member: AbbVie, Amgen, Arcutis, Celgene Corporation, Dermavant, Dermira, Eli Lilly, Galderma, LEO Pharma, Novartis, Pfizer, Regeneron, Sanofi Genzyme, UCB, and Valeant.

Tapinarof cream 1% once daily improves patient-reported outcomes in the treatment of mild-to-severe intertriginous plaque psoriasis

Presenters: Howard Sofen,1 Stephen Tyring,2 Sandra Marchese Johnson,3 Scott Guenthner,4 Patrick Shannon,5 Philip M. Brown,6 Katherine Tillman,6 Nancy Fitzgerald,6 Brandon Kirsch,6 Anna M. Tallman6

Affiliations: 1David Geffen University of California, Los Angeles School of Medicine, Los Angeles, CA; 2University of Texas Health Science Center, Houston, TX; 3Johnson Dermatology, Fort Smith, AR; 4The Indiana Clinical Trials Center, PC, Plainfield, IN; 5Advanced Dermatology and Skin Cancer Center, Boardman, OH; 6Dermavant Sciences, Inc., Morrisville, NC

Introduction: Tapinarof cream 1% (VTAMA®, Dermavant Science, Inc.) once daily (QD) is a first-in-class, nonsteroidal, topical aryl hydrocarbon receptor agonist approved for the treatment of plaque psoriasis in adults, with no restrictions on location, extent, or duration of use. In the previously reported Phase III PSOARING trials, tapinarof was efficacious and well tolerated in the treatment of plaque psoriasis, including when used on intertriginous and sensitive skin areas. Intertriginous or inverse psoriasis, especially in sensitive areas, has a high impact on patient health-related quality of life (HRQoL) through pruritus, pain, and psychological distress. This open-label, Phase IV trial assessed patient-reported outcomes (PROs) in adults with mild-to-severe plaque psoriasis in intertriginous areas treated with tapinarof cream.

Methods: Adults with plaque psoriasis affecting intertriginous areas and an intertriginous Physician’s Global Assessment (iPGA) score of two (mild), three (moderate), or four (severe) were treated with tapinarof cream 1% QD for 12 weeks. PROs included Peak Pruritus Numerical Rating Scale (PP-NRS) score for intertriginous areas, achievement of a four-point or greater reduction in PP-NRS score, Dermatology Life Quality Index (DLQI) score by visit, and responses to a Patient Satisfaction Questionnaire (PSQ) at Week 12.

Results: In total, 34 patients received tapinarof cream 1% QD. Baseline mean intertriginous PP-NRS and total DLQI scores were 5.9 and 9.0, respectively, demonstrating significant itch and burden on HRQoL. Improvement in mean PP-NRS score was demonstrated at Week 1 (–1.1), the earliest assessment, and continued through Week 12 (−3.8). At Week 12, 75 percent of patients (n=15/20) achieved a four-point or greater reduction in PP-NRS score. Improvement in mean DLQI score from baseline was observed as early as Week 1 (−2.4). By Week 2, the mean DLQI minimal clinically important difference of −4.0 was exceeded (−4.1), improving to a mean difference of −6.3 at Week 12. Most patients strongly agreed or agreed with PSQ questions assessing satisfaction with application ease (100%), cosmetic elegance (90.3%), efficacy (80.6%), confidence in tapinarof (80.6%), and application time not impacting everyday life (90.3%). Compared to other topical drugs previously used to treat plaque psoriasis, the majority of patients strongly agreed or agreed that tapinarof was more effective (85.7%) and preferred (85.7%).

Conclusion: In patients with intertriginous plaque psoriasis, tapinarof cream 1% QD demonstrated rapid and clinically meaningful improvements in patient-reported pruritus and HRQoL as early as Week 1, with continued improvement through Week 12. Patients also reported high rates of satisfaction and positive perceptions of tapinarof cream, which were consistent with previously reported Phase III trials.

Psoriatic Arthritis

Long-term efficacy and safety of risankizumab for csDMARD-IR patients with active psoriatic arthritis: 148-week results from the KEEPsAKE 1 trial

Presenters: Lars Erik Kristensen,1 Mauro Keiserman,2 Kim Papp,3 Leslie McCasland,4 Douglas White,5 Vassilis Stakias,6 Thomas Iyile,6 Kyle Carter,6 Ahmed M. Soliman,6 Leonidas Drogaris,6 Michael M. Chen,6 Byron Padilla,6 Frank Behrens7

Affiliations: 1The Parker Institute, Copenhagen University Hospital, Bispebjerg and Frederiksberg Hospital, Copenhagen, Denmark; 2Pontifical Catholic University, School of Medicine, Porto Alegre, Brazil; 3Alliance Clinical Trials, Waterloo, University of Toronto, Canada; 4Loyola University Medical Center, Maywood, IL and Department of Veterans Affairs, Hines VA Hospital, Hines, IL; 5Waikato Hospital, Hamilton, New Zealand and Waikato Clinical School, University of Auckland, Auckland, New Zealand; 6AbbVie, North Chicago, IL; 7Rheumatology & Fraunhofer ITMP, CIMD, Goethe University, Frankfurt, Germany

Objective: To report long-term efficacy and safety of risankizumab in patients with active psoriatic arthritis (PsA) through Week 148.

Methods: KEEPsAKE 1 is an ongoing Phase III clinical trial evaluating the efficacy and safety of risankizumab (RZB) versus placebo (PBO) in adult patients with active PsA who demonstrated inadequate response, intolerance, or contraindication to one or more conventional synthetic disease modifying antirheumatic drugs (csDMARD-IR). Patients were randomized 1:1 to receive RZB 150mg or placebo at Weeks 0, 4, and 16. At Week 24, patients randomized to RZB received blinded PBO, and patients randomized to PBO received first dose of blinded RZB. At Week 28, all patients received open-label RZB every 12 weeks until Week 36. At Week 36, patients classified as nonresponders were discontinued from study drug. Efficacy and safety were analyzed in all randomized patients receiving one or more doses of RZB. Safety assessments were based on treatment-emergent adverse events (TEAEs).

Results: Overall efficacy results were maintained at Week 148, compared to Weeks 52 and 100. At Week 148, 41.1 percent of RZB-treated and 41.5 percent of PBO/RZB-treated patients achieved ACR50. A total of 38.1 percent of RZB-treated and 35.5 percent of PBO/RZB-treated patients achieved minimal disease activity (MDA). A total of 69.3 percent of RZB-treated and 67.1 percent of PBO/RZB-treated patients achieved 90-percent or greater improvement in Psoriasis Area and Severity Index (PASI90) at Week 148. Modified Nail Psoriasis Severity Index (mNAPSI) and Physician’s Global Assessment of Fingernail Psoriasis (PGA-F) scores improved from baseline by 15.01 and 1.5 points, respectively, for RZB-treated patients and by 13.99 and 1.4 points, respectively, for PBO/RZB-treated patients. Among patients with enthesitis at baseline, resolution was seen in 62.6 percent of RZB-treated and 62.4 percent of PBO/RZB-treated patients. Among patients with dactylitis at baseline, resolution was seen in 77.5 percent of RZB-treated and 74.8 percent of PBO/RZB-treated patients. At Week 148, mean PsA-modified Total Sharp Score (mTSS) increased by 0.55 from baseline for RZB-treated and by 0.94 for PBO/RZB-treated patients; 88.5 percent of RZB-treated and 84.4 percent of PBO/RZB-treated patients showed no radiographic progression (PSA-mTSS ≤0 from baseline). At Week 148, Health Assessment Questionnaire-Disability Index (HAQ-DI; RZB: 0.41, PBO/RZB: 0.35), Short Form-36 physical component summary (SF-36 PCS; RZB: 8.61, PBO/RZB: 7.78) and Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue (RZB: 7.4, PBO/RZB: 6.4) scores showed increase from baseline. Overall rates of TEAEs, serious TEAEs, and AEs leading to discontinuation of study drug remained stable.

Conclusion: The 148-week results of KEEPsAKE 1 demonstrated durable efficacy of RZB 150mg in treating clinical manifestations and improving health-related quality of life. RZB was well tolerated with no new safety signals.

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