Work

Real-World Safety of Janus Kinase Inhibitors in Alopecia Areata: A Propensity Score-Matched Cohort Study of a Global Federated Health Network

Year: 2026

Type: article

Abstract: Background/Objectives: Janus kinase inhibitors (JAKis) have transformed the treatment of alopecia areata (AA), but pivotal trials had short follow-ups and real-world long-term safety data remain scarce. We compared incident adverse outcomes between patients with AA exposed and not exposed to JAKis. Methods: In this retrospective cohort study of the TriNetX Global Collaborative Network, adults (≥18 years) with ≥2 diagnoses of AA (ICD-10-CM L63) and ≥2 medication events for baricitinib, tofacitinib, ritlecitinib, or oral ruxolitinib were matched 1:1 by propensity score on demographics and 13 comorbidities to patients with AA and no recorded exposure to these agents. Cox models estimated hazard ratios (HRs); p values for the 19 estimable outcomes were adjusted using the Benjamini–Hochberg procedure (false discovery rate 5%), and E-values assessed unmeasured confounding. Drug-specific and eight sensitivity analyses were performed. Results: Matching yielded 1771–1805 patients per cohort, depending on the outcome domain. Acne was more frequent with JAKis (HR, 2.425; 95% CI, 1.838–3.200; q < 0.001) in all analyses, including versus conventional immunosuppressants (HR, 1.688; 95% CI, 1.321–2.157), whereas upper respiratory tract infections (HR, 0.620; 95% CI, 0.476–0.808; q = 0.004) and urinary tract infections (HR, 0.458; 95% CI, 0.290–0.724; q = 0.006) were recorded less frequently. Cutaneous cancer was more frequent (HR, 2.639; 95% CI, 1.322–5.270; q = 0.024) and persisted after 30- and 180-day latency periods but was attenuated under a fixed 2-year follow-up and after exclusion of other JAKi indications. Severe infections, herpes zoster, and autoimmune and psychiatric outcomes did not differ significantly. Conclusions: In real-world AA care, JAKis were not associated with a statistically significant increase in severe infections or incident psychiatric outcomes, although power for rare serious outcomes was limited. Acne was the most consistent adverse-event signal, whereas the cutaneous cancer finding was not fully robust across specifications and requires confirmation.

Source: Journal of Clinical Medicine

DOI: 10.3390/jcm15207825

Authors: Mateusz Łysek, Beata Jastrząb-Miśkiewicz, Piotr K. Krajewski

Institutions: Wrocław University of Science and Technology, 4. Wojskowy Szpital Kliniczny z Polikliniką

Language: English

Topic: Hair Growth and Disorders

Subfield: Urology

Field: Medicine

Domain: Health Sciences

SDG: Good health and well-being

Open Access status: gold

Estimated APC paid: $3,137