Improvements in moderate-to-severe hidradenitis suppurativa with upadacitinib: Results from a phase 2, randomized, placebo-controlled study.

Abstract

Hidradenitis suppurativa is a disabling inflammatory skin disease. To investigate the efficacy and safety of upadacitinib, a selective Janus kinase inhibitor. In this phase 2, randomized, placebo-controlled, double-blind clinical trial (NCT04430855), adults with moderate-to-severe hidradenitis suppurativa were randomized 2:1 to once-daily upadacitinib 30 mg or placebo. At 12 weeks, placebo patients switched to blinded upadacitinib 15 mg, and patients receiving upadacitinib 30 mg continued assigned treatment through week 48. The primary endpoint was ≥50% reduction in total abscess and inflammatory nodule count with no increase in abscess or draining fistula count relative to baseline (Hidradenitis Suppurativa Clinical Response [HiSCR50]) at week 12. Forty-seven patients received upadacitinib; 21 patients received placebo. At week 12, a significantly greater proportion of patients receiving upadacitinib achieved HiSCR50 vs a prespecified historical placebo rate (38.3% vs 25.0%; 1-sided P = .018). Comparison with the in-trial placebo group showed an adjusted difference of 14.7% (nominal P = .087). HiSCR50 achievement with upadacitinib was consistent across baseline Hurley stage and prior tumor necrosis factor inhibitor exposure and maintained through week 40. Upadacitinib's safety profile was consistent with previous reports on dermatologic conditions. Sample size was small. Findings support further investigation of upadacitinib for moderate-to-severe hidradenitis suppurativa.