Roivant and Priovant announced positive Phase 3 VALOR study results for brepocitinib in a 52-week placebo-controlled trial in Dermatomyositis.
Brepocitinib 30 mg showed significant improvement compared to placebo on primary and secondary endpoints, including skin and muscle disease measurements.
Results indicate a substantial potential for brepocitinib as a treatment option for dermatomyositis patients.
Clinical Improvement
Brepocitinib 30 mg demonstrated a mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo on the primary endpoint.
Dose Response
Consistent dose response observed between 30 mg and 15 mg dose arms, highlighting the 30 mg dose as optimal.
Steroid-Sparing Effect
62% of brepocitinib 30 mg patients achieved a steroid dose ≥2.5 mg/day by the end of the study, compared to 34% for placebo.
Safety Profile
The observed safety profile of brepocitinib 30 mg was consistent with previous clinical trials, with no increased frequency of adverse events compared to placebo.
- The success of the VALOR study represents a groundbreaking moment in the dermatomyositis field, offering a potential novel therapy for patients.
- Brepocitinib demonstrated rapid, deep, and lasting clinical improvement, particularly in skin disease, muscle strength, and daily living activities.
- Results suggest brepocitinib's efficacy and safety in reducing steroid dependence and providing significant benefit to dermatomyositis patients.
The positive outcomes of the Phase 3 VALOR study highlight the potential of brepocitinib as an impactful treatment option for dermatomyositis patients. The safety and efficacy demonstrated in the trial pave the way for future advancements in the treatment of this debilitating autoimmune disease.