NEW YORK: Pfizer said two Litfulo vitiligo trials met their Phase 3 endpoints after 52 weeks, supporting planned global regulatory filings for adults with nonsegmental vitiligo.
Significantly more patients receiving Litfulo (ritlecitinib) achieved at least 75% improvement in facial repigmentation and 50% improvement across the body compared with placebo, Pfizer said Thursday.
The TRANQUILLO and TRANQUILLO 2 trials enrolled 2,174 patients at 271 sites worldwide. Researchers evaluated once-daily doses of 50 milligrams and 100 milligrams.
TRANQUILLO included 607 adults and adolescents aged 12 or older. TRANQUILLO 2 enrolled 1,567 adults. Participants had active or stable nonsegmental vitiligo across a broad range of disease severity.
Pfizer said treatment-related adverse-event rates were similar across the study groups. The drug’s safety profile remained consistent with its established profile in alopecia areata, and investigators identified no new safety signals.
The company disclosed only topline findings and did not provide the groups’ absolute response rates. Pfizer said it would present detailed results at a future medical meeting.
Litfulo inhibits JAK3 and TEC-family kinases involved in immune signalling. Pfizer said this mechanism may limit the immune-cell activity that destroys pigment-producing melanocytes.
The US Food and Drug Administration approved Litfulo in 2023 for severe alopecia areata in adults and adolescents aged 12 or older. The drug is not currently approved for vitiligo.
Its prescribing information carries warnings covering serious infections, cancers, major cardiovascular events and blood clots. Regulatory authorities must assess the vitiligo trial data before approving any expanded use.
