Lutikizumab Improves Clinical Response Rates in Moderate to Severe HS: Analysis

In a phase 2, double-blind, placebo-controlled randomized clinical trial, lutikizumab demonstrated efficacy signals in adults with moderate to severe hidradenitis suppurativa (HS) who had previously experienced anti–tumor necrosis factor (TNF) therapy failure.

Study researchers enrolled 153 participants with a predominance of severe disease (70.6% Hurley stage III) and a mean age of 40.5 years. Participants were randomized to receive lutikizumab 300 mg weekly, 300 mg every other week, 100 mg every other week, or placebo for 16 weeks.

The primary study endpoint was achievement of Hidradenitis Suppurativa Clinical Response (HiSCR50) at week 16. HiSCR50 was achieved by 48.7% and 59.5% of patients receiving 300 mg weekly and every other week, respectively (vs 35.0% for placebo). The lower-dose group showed a reduced response rate of 27.0%. Bayesian analysis suggested a higher probability of treatment effect with the 300 mg regimens. NRS30 response rates were higher in the 300 mg groups (34.5%–34.8%) compared with placebo (12.9%) in patients with baseline skin pain scores of 3 or greater,. 

Serious adverse events occurred in 5.1% and 5.4% of patients in the 300 mg weekly and every-other-week groups, respectively (2.5% with placebo). No deaths or major safety signals were reported.

"These findings suggest that inhibition of IL-1 signaling via dual neutralization of IL-1α and IL-1β is a viable therapeutic option in moderate to severe HS," the authors wrote. "A phase 3 randomized clinical trial is currently investigating lutikizumab as a treatment for adults and adolescents with moderate to severe HS."

Source: Kimball AB, et al. JAMA Dermatol. Doi:10.1001/jamadermatol.2026.0155