The Current State of Patient Adherence to Lab Monitoring Guidelines for Janus Kinase Inhibitors in Patients with Alopecia Areata

J Clin Aesthet Dermatol. 2025;18(6):26–28.

by Sujeeth Krishna Shanmugam, BS; Victoria Palmer, MD; and Amy McMichael, MD

All authors are with the Department of Dermatology at the Wake Forest University School of Medicine in Winston-Salem, North Carolina.

FUNDING: This study was funded by the NAAF Student Internship Award.

DISCLOSURES: The authors declare no conflicts of interest relevant to the content of this article.

Abstract: Background: While Janus kinase inhibitors (JAKi) show excellent outcomes in Phase2b/3 trials for alopecia areata (AA), they do have potential side effects due to their immunosuppressive nature and other effects on the JAK-STAT pathway. These side effects can be mitigated by adherence to lab monitoring. Objective: The authors sought to analyze patients, using JAKi, to manage symptoms of AA, to determine frequency of lab monitoring and check for adherence to the recommended rate of every three months. Methods: A retrospective chart review was conducted by first identifying all patients diagnosed with AA at a specialty hair clinic in an academic dermatology department between January 2021 and May 2024. Each patient chart was reviewed for past and current use of any known oral JAKi. Fifty-seven patients were identified to meet our inclusion criteria and all of their charts were reviewed. The primary outcome is the average time between lab monitoring dates for each patient. The hypothesis was formulated after the data collection in the form of whether patients were being adherent to lab monitoring protocol. Results: Most patients were non-adherent to the lab testing frequency standard. Significant differences were found in blood test times between adherent and non-adherent patients and between non-adherent and extremely non-adherent patients with p-values less than 0.01 for both sets. Conclusion: Patients with AA undergoing JAKi treatment are not adhering to the recommended lab monitoring frequency. New tactics to improve adherence need to be taken. Keywords: Alopecia areata, JAKi

Introduction

Alopecia areata (AA) is an autoimmune medical condition associated with nonscarring hair loss due to excess inflammation. While usually localized to the scalp, it can affect any part of the body that has hair growth and affects 2 percent of the general population.¹ The etiology of AA is also not well understood as genetic studies in mouse models have shown it is a complex polygenic disease.^2,3

In addition to the existing complexity of AA, it also often occurs concurrently with depression and other autoimmune diseases.^4,5 This inherent complexity of AA results in a range of severities ranging from mild to severe as well as complicated treatment plans. Recently, three Janus kinase inhibitors (JAKi) have been approved by the United States Food and Drug Administration (FDA) for the treatment of moderate to severe AA. Tofacitinib has been used off-label for AA but is less utilized now that baricitinib and ritlecitinib are available as FDA-approved medications.^6,7 Deuroxolitinib has been FDA-approved and will soon be available in pharmacies as well.

While JAKi are the first medications that show excellent outcomes in Phase2b/3 trials, they do have potential side effects due to their immunosuppressive nature and other effects on the JAK-STAT pathway. Studies have shown increased infection risk, reactivation of zoster, thromboembolism, cardiovascular issues, hematopoiesis disorders, and elevated liver enzyme and lipid levels.^8,9 Although these risks are rare on their own, frequent lab monitoring has been shown to be effective in preventing poor outcomes. Currently, federal regulatory organizations recommend conducting at least complete blood cell and total lymphocyte count tests every three months as well as lipid management for certain JAKi (deuroxilitinib and baricitinib).¹⁰

This study seeks to confirm the effectiveness of using JAKi in appropriate patients with AA while determining patient adherence to the frequency of lab monitoring. This will hopefully help to gain an improved understanding of the relatively new world of JAKi usage in AA.

Methods

A retrospective chart review was conducted by first identifying all patients diagnosed with AA at a specialty hair clinic in an academic dermatology department between January 2021 and May 2024. Each patient chart was reviewed for past and current use of any known oral JAKi. For all patients with oral JAKi use, demographics, including age and ethnicity, were collected. Patient total scalp hair loss percentage before and after JAKi was also collected, using the Severity of Alopecia Tool (SALT) scores to assess improvement. If the SALT score had improved, it was deemed that the patient improved under the JAKi. Any adverse reactions that were linked to JAKi usage were also noted.

All blood tests that included the recommended labs (complete blood cell count with differential [CBC with diff]), hepatic panel, and lipid panel) were collected. Baseline Quantiferon gold and hepatitis testing were also obtained. The time difference between each repeated test was noted and the average was calculated per patient. A threshold of less than 3.5 months for average time between blood tests was deemed ‘adherent’ while anything higher was considered ‘non-adherent’. Averages above five months were escalated to an ‘extremely non-adherent’ sub-classification. Statistical analysis was conducted using Microsoft Excel under the t-test model.

Results

Thirteen patients were newly put on JAKi toward the end of the chart review and therefore did not have subsequent lab monitoring or visits to determine compliance to lab monitoring or improvement status. A vast majority of patients were found to be non-adherent to the lab testing frequency standard with evidence of potential financial aspects playing a crucial role including but not limited to issues with insurance and trouble paying for expensive medications (Table 1). Significant differences were found in blood test times between adherent and non-adherent patients (p <0.01) as well as between non-adherent and extremely non-adherent patients (p<0.01). JAKi usage resulted in SALT scores equal to or below 20 for 25 patients (44%) along with a cumulative average SALT score decrease of 42 percent across all patients (Figure 1). Patients with no improvement in SALT scores were refractory to treatment with >2 JAKis and were noted to have either alopecia totalis or ophiasis patterns of alopecia on clinical examination. Four patients showed symptoms that can be traced back to usage of JAKi including high cholesterol, general intolerance, body ache, joint pain, headache, and GI issues. Lab tests for these patients had significant abnormalities while the tests for the other patients did not yield significant abnormalities.

Discussion

The holistic approach for JAKi prescription is important given the potential adverse effects of JAKi. Since JAKi acts in an immunosuppressive mechanism, side effects include increased risk of blood clots, infections, and cardiovascular issues. Appropriate and frequent lab testing is an effective tool in preventing some of these outcomes. In this study, adherent patients and non-adherent patients that had a frequency of lab monitoring less than five months [total n=27 (61%)] are not concerned with adverse outcome. While the current recommendation is to adhere to every three-month lab testing standard, results from this study are alarming in that a large portion of patients are not adhering to this standard. In this study, there was a 7 percent rate of patients having side effects to JAKi, which include relapses of hair loss, elevated cholesterol, general drug intolerance, body ache, joint pain, headache and gastrointestinal issues, of which three of the four patients were above the three-month lab testing standard. The association, however, between the occurrence of these side effects and the non-adherence to recommended lab testing needs further evaluation. The etiology of non-adherence may be due to the difficulty for many patients traveling a long distance to the clinic and returning for frequent labs, as well as the burden of remembering to get labs in their geographic area if labs must be ordered outside of the visit. Considering that no patients had major side effects, and the majority of patients [n=53 (93%)] progressed well on the medication, a recommended approach would be to change the three-month standard into a longer period between lab testings. Longer term post-trial data may help demonstrate this safety.

While none of the patients in this study had major side effects, non-adherence remains a significant concern to physicians. Since the standard is set for now, systematic change needs to occur to target non-adherence with follow-up and non-compliance with management. At the healthcare service delivery level, automatic reminder messages to patients have not been proven to be effective.¹¹ Future research can investigate alternative methods such as phone calls or AI assisted reminders. In addition, considering that 41 percent of the extremely non-adherence patients showed signs of financial burden in this study, medical institutions could also offer financial incentives to alleviate lab testing cost burdens to patients that have demonstrated the need for it.

Treatments for AA are numerous, but most are not approved by the FDA or have limited response. JAKi, while relatively newly approved for AA, are the only medications to show measurable efficacy in Phase 2 and 3 clinical trials.^12,13 In our study, efficacy was supported with an 84 percent reduction in SALT score and that translated to an improved quality of life. Patients with undetermined improvement status were not included in this measurement as their regimen was too recently started to determine if an improvement was present or not. In addition, some patients were started on JAKi with low SALT scores due to prolonged duration of AA or social factors. While JAKi are not appropriate for every patient with AA, the efficacy is exciting compared to other medications used to treat this disease, though a holistic approach should be taken before prescription.

Limitations. There are limitations to this work. Patient chart data was limited to information gathered only at one institution. Additionally, inadequate lab monitoring could have been due to patients obtaining lab work at other facilities, rendering them unavailable for chart review. Some confounding factors such as socioeconomic status and longevity of AA diagnosis were considered but other factors such as health literacy, concurrent medications, psychosocial dynamic (patient-provider trust and communication) and behavioral factors (forgetfulness and motivation) were not.

Another limitation was this study was conducted over a three-year period. While this time frame is the same period in which JAKi became approved for use in patients with AA, reassessing the data in the future would provide a more accurate representation of the state of lab monitoring amongst patients with AA undergoing long-term JAKi therapy.

Conclusion

In conclusion, there is evidence suggesting that patients with AA undergoing JAKi treatment are not adhering to the recommended lab monitoring frequency. This recommendation was placed to help prevent adverse outcomes. As more long-term safety data are shared with the available JAKi, we may see recommendations change, but in the meantime, more aggressive discussion of laboratory requirements and follow up with labs by the prescribing office will be the course of action.

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