Original Investigation

Lutikizumab in Adults With Moderate to Severe Hidradenitis Suppurativa After Anti-TNF Therapy Failure

JAMA Dermatology 10.1001/jamadermatol.2026.0155

March 18, 2026 at 11:00 AM EDT

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What is the efficacy and safety of lutikizumab, a dual-variable domain interleukin (IL) 1α/1β antagonist, for adults with moderate to severe hidradenitis suppurativa (HS) who experienced anti–tumor necrosis factor therapy failure?In this phase 2, double-blind, placebo-controlled randomized clinical trial of 153 patients with HS, participants who received lutikizumab, 300 mg, every week or every other week showed improvements vs placebo across key assessed outcomes. Serious adverse events were reported for 2 of 39 participants treated with lutikizumab, 300 mg, every week (5.1%); 2 of 37 participants treated with lutikizumab, 300 mg, every other week (5.4%); and 1 of 40 placebo-treated participants (2.5%).These initial data from this phase 2 randomized clinical trial suggest that dual inhibition of IL-1α and IL-1β by lutikizumab improved the signs and symptoms associated with HS and support further clinical development of lutikizumab in HS.

Corresponding Author: Alexa B. Kimball, MD, MPH, 330 Brookline Ave, Boston, MA 02215 (clears@bidmc.harvard.edu).

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