Priovant Therapeutics on Wednesday published skin-specific outcomes from its Phase 3 VALOR trial of brepocitinib in JAMA Dermatology, detailing efficacy and safety signals in patients with dermatomyositis.
The study, conducted across 90 sites with 241 subjects, evaluated two doses of brepocitinib—30 mg and 15 mg—against placebo. Primary efficacy and safety results from the trial were previously reported in the New England Journal of Medicine.
Brepocitinib, an oral TYK2 and JAK1 inhibitor, demonstrated statistically significant improvements in itch and skin disease severity. Among patients with at least moderate itch at baseline, 54% of those receiving the 30 mg dose showed clinically meaningful improvement by Week 4, rising to 74% by Week 52, compared with 10% and 33% in the placebo group, respectively.
For patients with moderate-to-severe skin disease at baseline, 46% of the 30 mg cohort achieved “Clear or Almost Clear” skin on the Investigator’s Global Assessment by Week 52, versus 22% on placebo. Functional skin remission, measured by the Cutaneous Dermatomyositis Activity and Severity Index, was achieved by 44% of the 30 mg group, compared with 21% in the placebo arm. Overall, 61.7% of patients on the 30 mg dose showed clinically meaningful improvement in skin disease activity at Week 52, versus 44.3% on placebo.
Corticosteroid use also declined in the 30 mg cohort. Among those receiving oral corticosteroids at baseline, 61.7% tapered to 2.5 mg/day or less by Week 52, compared with 34.4% on placebo, while 41.7% discontinued corticosteroids entirely, versus 23.4% in the placebo group.
Safety data indicated a higher rate of serious infections in the 30 mg brepocitinib group compared to placebo. Conversely, new or recurrent malignancies, cardiovascular events, and thromboembolic events occurred more frequently in the placebo arm than in the 30 mg cohort.
Priovant, a subsidiary of Roivant Sciences (NASDAQ: ROIV), plans to use the findings to support regulatory submissions for brepocitinib in dermatomyositis.
