Efficacy and safety of tofacitinib for treatment of alopecia areata in children: A systematic review and meta-analysis.

BACKGROUND: Tofacitinib, a potent JAK inhibitor, has gained increasing interest, in recent years, among dermatologists for the management of refractory alopecia areata. Despite a growing number of studies on its safety and efficacy, there is still a lack of clarity, especially in the pediatric population, in treatment considerations such as proper dosage, treatment duration, side-effect profile, and therapeutic strategies to guide clinicians. METHODS: Multiple databases were systematically searched. Following the PRISMA diagram, of a pool of 601 papers, seven met a checklist of inclusion criteria. These were observational studies including a total of 59 patients from four to 19 years of age. RESULTS: In the evaluated studies, tofacitinib was administered either orally at a 2.5 to 15 mg daily (mostly 5 mg twice a day) dosage for 2 to 38 months or in the form of a 2% topical solution for 3-17 months. Metanalysis showed that 49% (95% CI: 29%-69%, I2  = 59.94%) of patients experienced a reversal of alopecia after a minimum of 3 to 9 months of therapy. Fifty-five percent (95% CI: 23%-86%, I2  = 75.07%) and 41% (95% CI: 23%-59%, I2  = 0.00%) showed Good/complete and partial response rates, respectively. Oral administration was significantly more efficacious than topical application (73% vs 23%, p-Value = 0.04). Few side effects such as diarrhea and mild liver transaminases abnormalities were noted in several patients. CONCLUSION: Results of this review suggest that tofacitinib at 2.5-15 mg daily (especially 5 mg twice daily) oral formulation or 2% topical solution can be regarded as a viable alternative or adjunct to the conventional treatment options for moderate to severe forms of alopecia areata in children owing to its acceptable efficacy and side-effect profile. However, uncertainties continue to exist around treatment strategies including initial and maintenance dosages, route of administration, dose adjustments, the timing of tapering or discontinuation, and associated treatment modalities.