Brepocitinib Improves Cutaneous Dermatomyositis Outcomes Through 52 Weeks
Key Takeaways
- In a prespecified secondary analysis of the phase 3 VALOR trial, brepocitinib 30 mg once daily improved cutaneous dermatomyositis outcomes compared with placebo, with differences evident by week 4.
- At week 52, 61.7% of patients receiving brepocitinib 30 mg achieved a clinically meaningful CDASI-A response versus 44.3% receiving placebo.
- Serious infections were more frequent with brepocitinib 30 mg than placebo, underscoring the importance of interpreting efficacy alongside the trial’s safety findings.
Once-daily oral brepocitinib 30 mg improved skin disease activity, pruritus, and skin-related quality of life in adults with dermatomyositis as early as 4 weeks, according to results from an analysis of phase data from the 3 VALOR trial.
The analysis included data from 241 adults with active skin and muscle disease (81 received brepocitinib 30 mg and 79 received placebo). Participants had a mean age of 50.6 years, and 77.6% were female.
Brepocitinib Shows Early Cutaneous Dermatomyositis Responses
According to the data, mean Cutaneous Dermatomyositis Disease Area and Severity Index–Activity (CDASI-A) scores decreased by 6.4 points with brepocitinib 30 mg vs 3.5 points with placebo (difference, −3.0; 95% CI, −4.6 to −1.4; P < 0.001). Clinically meaningful CDASI-A responses occurred in 33.3% and 17.7% of patients, respectively. By week 52, 61.7% of patients receiving brepocitinib achieved a clinically meaningful CDASI-A response compared with 44.3% receiving placebo (difference, 16.8%; 95% CI, 1.1 to 32.5; P = 0.04).
Itch and quality-of-life measures also favored brepocitinib. Serious infections occurred in 9.9% of patients receiving brepocitinib 30 mg and 1.3% receiving placebo. The authors noted that requiring stable background disease-modifying antirheumatic drug therapy during blinded treatment was a study limitation.
“In this secondary analysis of a randomized clinical trial in dermatomyositis, once-daily brepocitinib, 30 mg, resulted in rapid, durable, and remission-level control of skin disease with an acceptable safety profile,” the authors wrote.
Source
Mangold A, et al. JAMA Dermatology. Doi:10.1001/jamadermatol.2026.3199