DOP42 Efficacy and safety of deucravacitinib, an oral, selective tyrosine kinase 2 inhibitor, in patients with moderately-to-severely active Ulcerative Colitis: 12-week results from the Phase 2 LATTICE-UC study

作者：Silvio Danese, Remo Panaccione, Geert D’Haens, Laurent Peyrin‐Biroulet, Stefan Schreiber, Taku Kobayashi, Beata Gawdis-Wojnarska, Patryk Korga, H.Anido.J.Navas Aguilar, Brian J. Sharkey, Antoine G. Sreih, Courtney Radosti, Aditya Patel, James B. Canavan, David T. Rubin · 发表于：Journal of Crohn s and Colitis · 年份：2022 · DOI：10.1093/ecco-jcc/jjab232.081 · 被引用次数：21 · 研究领域：Inflammatory Bowel Disease、Colorectal Cancer Treatments and Studies、Pharmacological Effects of Natural Compounds

Abstract Background Tyrosine kinase 2 (TYK2) is an intracellular kinase that mediates the signalling of key cytokines involved in ulcerative colitis (UC) pathophysiology. Deucravacitinib (DEUC) is a novel, oral, selective TYK2 inhibitor that binds to the TYK2 regulatory domain. The safety and efficacy of DEUC were evaluated in patients (pts) with moderately-to-severely active UC. Methods LATTICE-UC (NCT03934216), a randomised, double-blind, placebo (PBO)-controlled, multicentre, Phase 2 trial, enrolled pts with moderately-to-severely active UC (modified Mayo score of 5 to 9 [endoscopic {ES} subscore ≥2, rectal bleeding {RB} subscore ≥1, stool frequency {SF} subscore ≥2) with inadequate response, loss of response, or intolerance to ≥1 conventional or biologic therapy. Pts were randomised 2:1 to oral DEUC 6 mg or PBO twice daily (BID) and stratified by baseline (BL) corticosteroid use and prior exposure to biologics. The primary endpoint was clinical remission (modified Mayo score with subscores of SF ≤1 with ≥1-point decrease from BL, RB=0, and ES ≤1 [modified, excludes friability]) at Week (Wk) 12; endoscopic response (ES ≤1) at Wk 12 was a secondary endpoint. Results Demographic and BL characteristics were generally similar across groups, except for BL disease activity as measured by the modified Mayo score and ES subscore. Most pts (63.4%) were biologic naïve, and 40.5% were receiving concomitant oral corticosteroids (Table 1). Of 131 pts randomised, 104 (79.4%) completed 1...