Sublingual Tofacitinib for Alopecia Areata: A Roll-Over Pilot Clinical Trial and Analysis of Pharmacokinetics

In a pilot clinical trial involving 18 participants with moderate-to-severe alopecia areata, sublingual tofacitinib was evaluated over a 12-week period. The trial found that 37.5% of participants showed some response to the treatment, with 12.5% achieving a 50% or greater reduction in Severity of Alopecia Tool (SALT) score, and a mean improvement in SALT score of 15.57%. Pharmacokinetic analysis indicated a mean maximum plasma concentration of 43.18 ng/ml after 1 hour and a longer estimated elimination half-life of up to 11 hours compared to the oral form, suggesting the potential for once-daily dosing. However, the study concluded that larger clinical trials with at least 100 participants per group are needed to confirm these findings and to explore dose-dependent efficacy, safety, and drug interactions.