Pfizer presented detailed Phase III data for ritlecitinib (Litfulo) in nonsegmental vitiligo (NSV) at the 2026 European Academy of Dermatology and Venereology Congress, showing statistically significant improvements in facial and total-body repigmentation versus placebo at Week 52 in the TRANQUILLO 2 and TRANQUILLO trials. The findings expand on positive topline results first disclosed in July 2026.
In TRANQUILLO 2, which evaluated Litfulo 100 mg once daily in 1,567 adults, 21.86% of treated patients achieved at least 75% improvement in the Facial Vitiligo Area Scoring Index (F-VASI75) versus 2.40% on placebo, while 13.02% achieved at least 50% improvement in the Total Vitiligo Area Scoring Index (T-VASI50) versus 2.40%.
In TRANQUILLO, which evaluated 50 mg once daily in 607 patients aged 12 years and older, 12.47% achieved F-VASI75 versus 2.48% on placebo, while T-VASI50 was achieved by 8.98% versus 1.98%, respectively.
Ritlecitinib irreversibly inhibits JAK3 and the TEC family of kinases and is already approved as Litfulo in the US for severe alopecia areata in adults and adolescents aged 12 years and older. Pfizer said the safety profile in vitiligo was consistent with its established profile in alopecia areata, with no new safety signals identified.
Treatment-emergent serious adverse events occurred in 3.4% of patients receiving 100 mg in TRANQUILLO 2 versus 3.4% on placebo, and in 2.0% of patients receiving 50 mg in TRANQUILLO versus 2.5% on placebo. Decreased lymphocyte count was reported in 6.3% of patients receiving 50 mg versus 1.5% on placebo.