{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,10]],"date-time":"2026-10-10T15:40:27Z","timestamp":1791646827996,"version":"4.3.4"},"reference-count":27,"publisher":"American Medical Association (AMA)","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["JAMA Dermatol"],"published-print":{"date-parts":[[2026,5,1]]},"abstract":"\n Importance<\/jats:title>\n Hidradenitis suppurativa (HS) is a debilitating inflammatory skin disease with limited therapeutic options.<\/jats:p>\n <\/jats:sec>\n \n Objective<\/jats:title>\n To assess the efficacy and safety of lutikizumab, a dual-variable domain interleukin 1\u03b1\/1\u03b2 antagonist, for adult participants with moderate to severe HS who experienced anti\u2013tumor necrosis factor (TNF) therapy failure.<\/jats:p>\n <\/jats:sec>\n \n Design, Setting, and Participants<\/jats:title>\n This phase 2, double-blind, placebo-controlled randomized clinical trial was conducted at 45 sites in 8 countries or territories (Australia, Canada, Germany, Greece, Japan, Puerto Rico, Spain, and the US) between December 28, 2021, and November 27, 2023, and included a 35-day screening period, a 16-week treatment period, and a 9-week safety follow-up. Data were analyzed in December 2023. Participants 18 years or older with a diagnosis of HS for 12 months or longer who experienced anti-TNF treatment failure were enrolled.<\/jats:p>\n <\/jats:sec>\n \n Interventions<\/jats:title>\n Eligible participants were randomized 1:1:1:1 to receive lutikizumab, 300 mg, every week; lutikizumab, 300 mg, every other week; lutikizumab, 100 mg, every other week; or placebo, every week. The trial drug was administered starting at baseline and through week 16.<\/jats:p>\n <\/jats:sec>\n \n Main Outcomes and Measures<\/jats:title>\n The primary end point was achieving a Hidradenitis Suppurativa Clinical Response (HiSCR 50) at week 16. The secondary efficacy objective was achieving at least a 30% reduction and at least 1-unit reduction from baseline in Patient's Global Assessment of skin pain (Numerical Rating Scale [NRS] 30) after 16 weeks of treatment among among patients with a baseline NRS 3 or greater. Additional end points included achieving HiSCR 75 and HiSCR 90, change and percentage change from baseline in draining tunnels, and change from baseline in Dermatology Life Quality Index total scores.<\/jats:p>\n <\/jats:sec>\n \n Results<\/jats:title>\n A total of 153 participants received at least 1 dose of the trial medication (94 female individuals [61.4%]; mean [range] age, 40.5 [19-75] years; 108 patients [70.6%] at Hurley stage III). At week 16, 19 (48.7%), 22 (59.5%), and 10 participants (27.0%) receiving lutikizumab, 300 mg, every week; lutikizumab, 300 mg, every other week; and lutikizumab, 100 mg, every other week, respectively, achieved HiSCR50 at week 16 compared with placebo (35.0%); posterior probabilities of positive treatment effect vs placebo were 89.3%, 98.5%, and 22.8%, respectively, using a bayesian analysis. Among participants with baseline NRS scores of 3 or greater, 10 (34.5%) who received lutikizumab, 300 mg, every other week and 8 (34.8%) who received lutikizumab, 300 mg, every week achieved an NRS30 response compared with 4 (12.9%) who received placebo. There were no deaths or treatment-emergent adverse events of neutropenia, serious hypersensitivity reactions, major adverse cardiovascular events, or opportunistic infections reported.<\/jats:p>\n <\/jats:sec>\n \n Conclusions and Relevance<\/jats:title>\n In this phase 2 randomized clinical trial, lutikizumab, 300 mg, every week and 300 mg every other week showed positive treatment effects vs placebo in a hard-to-treat moderate to severe HS population that experienced anti-TNF therapy failure.<\/jats:p>\n <\/jats:sec>\n \n Trial Registration<\/jats:title>\n \n ClinicalTrials.gov Identifier:\n NCT05139602<\/jats:ext-link>\n <\/jats:p>\n <\/jats:sec>","DOI":"10.1001\/jamadermatol.2026.0155","type":"journal-article","created":{"date-parts":[[2026,3,18]],"date-time":"2026-03-18T15:30:59Z","timestamp":1773847859000},"page":"469","source":"Crossref","is-referenced-by-count":4,"title":["Lutikizumab in Adults With Moderate to Severe Hidradenitis Suppurativa After Anti-TNF Therapy Failure"],"prefix":"10.1001","volume":"162","author":[{"given":"Alexa B.","family":"Kimball","sequence":"first","affiliation":[{"name":"Harvard Medical School and Clinical Laboratory for Epidemiology and Applied Research in Skin, Department of Dermatology, Beth Israel Deaconess Medical Center, Boston, Massachusetts"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Konrad T.","family":"Sawicki","sequence":"additional","affiliation":[{"name":"AbbVie Inc, North Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lindsay","family":"Ackerman","sequence":"additional","affiliation":[{"name":"Medical Dermatology Specialists, US Dermatology Partners, University of Arizona College of Medicine, Phoenix"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hermenio","family":"Lima","sequence":"additional","affiliation":[{"name":"LEADER Research, Medicine Department Division of Clinical Immunology and Allergy, Division of Dermatology, McMaster University, Hamilton, Ontario, Canada"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Evangelos J.","family":"Giamarellos-Bourboulis","sequence":"additional","affiliation":[{"name":"Fourth Department of Internal Medicine, Medical School, National and Kapodistrian University of Athens, Athens, Greece"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tianyu","family":"Zhan","sequence":"additional","affiliation":[{"name":"AbbVie Inc, North Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leonidas","family":"Drogaris","sequence":"additional","affiliation":[{"name":"AbbVie Inc, North Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yihua","family":"Gu","sequence":"additional","affiliation":[{"name":"AbbVie Inc, North Chicago, Illinois"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christine M.","family":"Lee","sequence":"additional","affiliation":[{"name":"AbbVie 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