Effectiveness and Safety of Off-label Tofacitinib Use for Atopic Dermatitis, Alopecia Areata and Plaque Psoriasis: An Observational Study

Abstract Background: Tofacitinib is a first-generation janus kinase inhibitor approved for rheumatoid arthritis, psoriatic arthritis and ulcerative colitis. However, it is also used for several off-label dermatological disorders. Aims and Objectives: To evaluate the effectiveness and safety of off-label use of tofacitinib in alopecia areata, plaque psoriasis and atopic dermatitis. Materials and Methods: This prospective observational study was conducted at a tertiary care hospital. Patients either currently taking tofacitinib for ≤2 weeks or being prescribed the drug for atopic dermatitis (AD), alopecia areata (AA) and plaque psoriasis (PP) were included. Socio-demographic profile, tofacitinib and other drug details were noted. Disease severity scores—SALT (Severity of Alopecia Tool) for AA, PASI (Psoriasis Area and Severity Index) for PP and SCORAD (SCORing Atopic Dermatitis) for AD patients—were recorded at enrolment and at 2, 4 and 8 ± 2 weeks’ visits, respectively. Investigators’ Global Assessment (IGA) and all treatment-emergent adverse effects were also assessed. Results: Thirty patients (13-AA; 9-PP; 8-AD) were enrolled. All were on 5 mg twice daily tofacitinib during the study course. At 8 ± 2 weeks, 13 cases (100%), 9 cases (77.77%), 8 cases (62.5%) and 30 cases (30%) achieved > 50% reduction in SALT, PASI, SCORAD and IGA, respectively. There were statistically significant differences between baseline and the follow-up visits in all disease severity scores, indicating significant clinical improvement. Twelve non-serious adverse drug reactions were noted, which resolved with symptomatic treatment and did not require drug discontinuation. Conclusion: This study generated data to guide clinicians regarding the off-label use of tofacitinib, as it showed promising results with few non-serious adverse effects.