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Phase 2 trial examines the effectiveness of lutikizumab in treating patients with hidradenitis suppurativa who did not respond to TNF blockers.

The IL1 pathway exhibited potential as a target for hard-to-treat hidradenitis suppurativa (HS). In a phase 2 trial, the IL1α/1β antagonist lutikizumab showed numeric superiority in achieving HS clinical response by 50% (HiSCR50) versus placebo in 2 of 3 investigated regimens.

“We see more and more HS patients that fail TNF blockers,” Falk Bechara, MD, stated in a presentation at the AAD 2024 Annual Meeting. This phenomenon contributed to the design of a phase 2 trial (NCT05139602) that examined lutikizumab for patients with HS with prior unsuccessful anti-TNF therapy. The study included 153 participants randomized to weekly placebo or IL1α/1β antagonist at dosages of 300 mg bi-weekly, 100 mg bi-weekly, or 300 mg weekly over 16 weeks.

At baseline, the mean age in the 4 groups varied between 37.0 and 39.5 years, and the rate of women ranged from 53.8% to 67.6%. The highly affected study population included 64.9% to 74.4% of participants with severe HS (ie, Hurley stage 3).

Compared with placebo, participants on the 2 higher-dosed study drug arms demonstrated greater rates in reaching the primary endpoint of HiSCR50: placebo 35%, 300 mg bi-weekly 59.5% (nominal P=0.027), and 300 mg weekly 48.7% (nominal P=0.197). HiSCR75 was seen in 17.5%, 45.9% (P=0.005), and 38.5% (P=0.031), respectively.

The proportions of skin pain improvement measured by numerical rating scale (NRS)30 led to a response in 12.9% of participants on placebo, in contrast to 22.2% (100 mg bi-weekly), 34.5% (300 mg bi-weekly), and 34.8% (300 mg weekly) on lutikizumab. Dr. Bechara also described that the improvement in draining fistula count was greater on both 300 mg regimens than on placebo.

The observed adverse events in this study generally supported the assessment of lutikizumab as safe and well-tolerated. There were two serious adverse events in each of the study drug arms and 1 in the placebo group.

Medical writing support was provided by Karin Drooff, MPH.