Efficacy and Safety of Ruxolitinib Cream in Vitiligo by Patient Characteristic Subgroups: Descriptive Pooled Analysis...

Area of Science:

• Dermatology
• Immunology
• Pharmacology

Background:

• Vitiligo is a chronic autoimmune condition causing skin depigmentation.
• Topical Janus kinase (JAK) inhibitors offer a potential treatment avenue.
• Previous trials demonstrated ruxolitinib's efficacy in vitiligo repigmentation.

Purpose of the Study:

• To analyze the efficacy and safety of topical ruxolitinib cream in vitiligo patients.
• To evaluate treatment outcomes based on baseline demographics and clinical characteristics.
• To assess long-term repigmentation and tolerability over 52 weeks.

Main Methods:

• Pooled data from two Phase 3 trials (TRuE-V1, TRuE-V2) were analyzed.
• Patients aged ≥12 years with nonsegmental vitiligo received ruxolitinib cream or vehicle.
• Efficacy measured by ≥75% facial Vitiligo Area Scoring Index improvement (F-VASI75) at Week 52; safety assessed via adverse events.

Main Results:

• 50.3% of patients on continuous ruxolitinib achieved F-VASI75 at Week 52.
• 28.2% of patients who switched to ruxolitinib after 24 weeks also achieved F-VASI75.
• Consistent efficacy observed across age, sex, skin type, disease duration, and stability subgroups.
• Treatment-emergent adverse events occurred in 52.1% and were similar across subgroups.

Conclusions:

• Topical ruxolitinib cream provides clinically meaningful repigmentation in vitiligo patients at one year.
• Treatment benefits are independent of baseline patient demographics and clinical characteristics.
• Ruxolitinib cream demonstrated good tolerability with a consistent safety profile across diverse patient groups.