{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,12]],"date-time":"2026-10-12T10:46:46Z","timestamp":1791802006583,"version":"4.3.4"},"reference-count":27,"publisher":"Oxford University Press (OUP)","license":[{"start":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T00:00:00Z","timestamp":1788393600000},"content-version":"am","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"name":"Shanghai Huaota Biopharmaceutical Co., Ltd."}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":[],"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>Generalized pustular psoriasis (GPP) is a rare, severe inflammatory skin disease characterized by acute flares. Recibokibart is a humanized IgG1 monoclonal antibody targeting the interleukin (IL)-36 receptor. In a phase Ib open-label study, a single intravenous dose of recibokibart was associated with an acceptable safety profile and rapid improvements in pustulation, overall skin disease severity and systemic inflammatory markers through 12 weeks.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Objectives<\/jats:title>\n                    <jats:p>To evaluate the efficacy and safety of recibokibart in patients with acute flares of GPP.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>In this multicentre, randomized, double-blind, placebo-controlled phase II trial conducted in China, patients with moderate-to-severe acute GPP were randomly assigned in a 2 : 1 ratio to receive a single intravenous dose of recibokibart (1050\u2005mg) or placebo at day 1. Patients with persistent disease activity at day 8 were eligible to receive open-label recibokibart, and patients with recurrent flares after achieving a Generalized Pustular Psoriasis Physician Global Assessment (GPPGA) total score of 0 or 1 could receive an additional open-label dose. The primary efficacy endpoint was the proportion of patients who achieved a GPPGA pustulation subscore of 0 or 1 at week 1 (day 8).<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>A total of 33 patients were randomized (recibokibart, n = 22; placebo, n = 11). At week 1 (day 8), the primary endpoint of achieving a GPPGA pustulation subscore of 0 or 1 was met by 86% of patients in the recibokibart group vs. 9% in the placebo group (between-group difference 77.3%, 95% confidence interval 42.5\u201388.9; P &amp;lt; 0. 001). At week 1 (day 8), greater improvements were observed with recibokibart vs. placebo across key secondary endpoints, including achievement of a GPPGA total score of 0 or 1 (64% vs. 0%), complete pustule clearance (55% vs. 0%), and mean percentage change from baseline in GPPASI (\u221259.3% vs. 0%). By week 4, 73% of patients treated with recibokibart achieved \u2265 75% improvement from baseline in Generalized Pustular Psoriasis Area and Severity Index (GPPASI). Clinical improvements were observed as early as 24\u2005h after treatment and were maintained through week 12, although assessments after day 8 included patients who received open-label treatment. The most frequently reported adverse events with recibokibart included hypoproteinaemia, hypertriglyceridaemia, hyperlipidaemia and pruritus.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>A single intravenous dose of recibokibart resulted in rapid improvement in pustular and overall skin disease severity in patients with acute GPP flares, with an acceptable safety profile.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1093\/bjd\/ljag369","type":"journal-article","created":{"date-parts":[[2026,9,3]],"date-time":"2026-09-03T08:20:19Z","timestamp":1788423619000},"source":"Crossref","is-referenced-by-count":1,"title":["Efficacy and safety of recibokibart, an interleukin-36 receptor antibody, in generalized pustular psoriasis: a\u00a0phase II randomized controlled trial"],"prefix":"10.1093","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-3521-7130","authenticated-orcid":false,"given":"Baoqi","family":"Yang","sequence":"first","affiliation":[{"name":"Department of Dermatology, Dermatology Hospital of Shandong First Medical University , Jinan ,","place":["China"]},{"name":"Department of Dermatology, Shandong Provincial Institute of Dermatology and Venereology, Shandong Academy of Medical Sciences , Jinan ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuzhen","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Dermatovenereology, The 2nd Affiliated Hospital of Harbin Medical University , Harbin ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yu","family":"Wang","sequence":"additional","affiliation":[{"name":"Department of Dermatovenereology, The Affiliated Hospital of Guizhou Medical University , Guiyang ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Liuyi","family":"Yang","sequence":"additional","affiliation":[{"name":"Department of Dermatovenereology, The Affiliated Hospital of Guizhou Medical University , Guiyang ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yanyan","family":"Feng","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Chengdu Second People\u2019s Hospital , Chengdu ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yangfeng","family":"Ding","sequence":"additional","affiliation":[{"name":"Department of Dermatology, Shanghai Skin Disease Hospital , Shanghai ,","place":["China"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shanshan","family":"Li","sequence":"additional","affiliation":[{"name":"Department of Dermatovenereology, The First Hospital of Jilin University , Changchun 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