{"id":26860,"date":"2024-11-15T04:15:00","date_gmt":"2024-11-14T20:15:00","guid":{"rendered":"http:\/\/csccm.org.cn\/?p=26860"},"modified":"2024-11-15T05:57:02","modified_gmt":"2024-11-14T21:57:02","slug":"nejm%e5%8f%91%e8%a1%a8%e8%ae%ba%e6%96%87%ef%bc%9a%e6%8a%97tl1a%e5%8d%95%e5%85%8b%e9%9a%86%e6%8a%97%e4%bd%93tulisokibart%e6%b2%bb%e7%96%97%e6%ba%83%e7%96%a1%e6%80%a7%e7%bb%93%e8%82%a0%e7%82%8e","status":"publish","type":"post","link":"https:\/\/csccm.org.cn\/?p=26860","title":{"rendered":"[NEJM\u53d1\u8868\u8bba\u6587]\uff1a\u6297TL1A\u5355\u514b\u9686\u6297\u4f53Tulisokibart\u6cbb\u7597\u6e83\u75a1\u6027\u7ed3\u80a0\u708e\u76842\u671f\u4e34\u5e8a\u8bd5\u9a8c"},"content":{"rendered":"\n

ORIGINAL ARTICLE<\/a><\/p>\n\n\n\n

Phase 2 Trial of Anti-TL1A Monoclonal Antibody Tulisokibart for Ulcerative Colitis<\/h1>\n\n\n\n

Bruce E.\u00a0Sands,\u00a0Brian G.\u00a0Feagan,\u00a0Laurent\u00a0Peyrin-Biroulet,\u00a0et al<\/h3>\n\n\n\n

N Engl J Med\u00a02024;391:1119-1129<\/h3>\n\n\n\n

DOI: 10.1056\/NEJMoa2314076<\/h3>\n\n\n\n

Abstract<\/h2>\n\n\n\n

BACKGROUND<\/h3>\n\n\n\n

Tulisokibart is a tumor necrosis factor\u2013like cytokine 1A (TL1A) monoclonal antibody in development for the treatment of moderately to severely active ulcerative colitis. A genetic-based diagnostic test was designed to identify patients with an increased likelihood of response.<\/p>\n\n\n\n

METHODS<\/h3>\n\n\n\n

We randomly assigned patients with glucocorticoid dependence or failure of conventional or advanced therapies for ulcerative colitis to receive intravenous tulisokibart (1000 mg on day 1 and 500 mg at weeks 2, 6, and 10) or placebo. Cohort 1 included patients regardless of status with respect to the test for likelihood of response. Cohort 2 included only patients with a positive test for likelihood of response. The primary analysis was performed in cohort 1; the primary end point was clinical remission at week 12. Patients with a positive test for likelihood of response from cohorts 1 and 2 were combined in prespecified analyses.<\/a><\/p>\n\n\n\n

RESULTS<\/h3>\n\n\n\n

In cohort 1, a total of 135 patients underwent randomization. A significantly higher percentage of patients who received tulisokibart had clinical remission than those who received placebo (26% vs. 1%; difference, 25 percentage points; 95% confidence interval [CI], 14 to 37; P<0.001). In cohort 2, a total of 43 patients underwent randomization. A total of 75 patients with a positive test for likelihood of response underwent randomization across both cohorts. Among patients with a positive test for likelihood of response (cohorts 1 and 2 combined), clinical remission occurred in a higher percentage of patients who received tulisokibart than in those who received placebo (32% vs. 11%; difference, 21 percentage points; 95% CI, 2 to 38; P=0.02). Among all the enrolled patients, the incidence of adverse events was similar in the tulisokibart and placebo groups; most adverse events were mild to moderate in severity.<\/p>\n\n\n\n

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CONCLUSIONS<\/h3>\n\n\n\n

In this short-term trial, tulisokibart was more effective than placebo in inducing clinical remission in patients with moderately to severely active ulcerative colitis. (Funded by Prometheus Biosciences, a subsidiary of Merck; ARTEMIS-UC ClinicalTrials.gov number, NCT04996797<\/a>.)<\/p>\n","protected":false},"excerpt":{"rendered":"

ORIGINAL ARTICLE Phase 2 Trial of Anti-TL1A Monoclonal […]<\/p>\n","protected":false},"author":3,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[32,23],"tags":[],"_links":{"self":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/26860"}],"collection":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/users\/3"}],"replies":[{"embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=26860"}],"version-history":[{"count":2,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/26860\/revisions"}],"predecessor-version":[{"id":27242,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=\/wp\/v2\/posts\/26860\/revisions\/27242"}],"wp:attachment":[{"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=26860"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=26860"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/csccm.org.cn\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=26860"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}