Efficacy and safety of ruxolitinib cream in patients with mild to moderate hidradenitis suppurativa: Results from a randomized, double-blind, vehicle-controlled phase 2 study.

Abstract

There are no approved therapies for patients with milder hidradenitis suppurativa (HS), and available treatments are often inadequate. To evaluate the efficacy and safety of ruxolitinib (Janus kinase 1 and Janus kinase 2 inhibitor) cream in adults with mild to moderate HS. This phase 2 study enrolled adults with Hurley stage I/II HS and abscess and inflammatory nodule (AN) count 3-10 with no draining tunnels. Patients were randomized 1:1 to twice-daily 1.5% ruxolitinib cream or vehicle for 16 weeks, after which all patients applied ruxolitinib cream as needed through week 32. The primary endpoint was change from baseline in AN count at week 16. Sixty-nine patients were randomized. At week 16, change from baseline in AN count was significantly reduced with 1.5% ruxolitinib cream versus vehicle (least squares mean, -3.61 vs -2.42; P = .0215) with sustained improvement through week 32 with as-needed use. Patients applying ruxolitinib cream experienced fewer flares versus vehicle. Ruxolitinib cream was well tolerated, with no grade ≥3 treatment-emergent adverse events reported. Relatively small sample size; discontinuation rates and race were imbalanced between groups. Ruxolitinib cream demonstrated greater clinical benefit versus vehicle in patients with milder HS and had a well-tolerated safety profile.