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We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com. Back to Healio Key takeaways: Duvakitug outperformed placebo in endoscopic response and clinical remission at 14 weeks in CD and UC. Results were consistent among patients who had been previously treated or were naive to advanced therapy. An investigational anti-TL1A monoclonal antibody achieved \u201cclinically meaningful\u201d outcomes compared with placebo in patients with inflammatory bowel disease, according to results of the RELIEVE UCCD trial. Duvakitug (TEV-48574; Teva Pharmaceuticals, Sanofi) demonstrated efficacy in clinical remission at week 14 among patients with ulcerative colitis and in endoscopic response among those with Crohn\u2019s disease, with no new safety concerns identified.
Data derived from Jairath V, et al. Lancet Gastroenterol Hepatol. 2026;doi:10.1016\/S2468-1253(26)00119-6.
Existing therapies for moderately to severely active CD and UC often are associated with adverse events, and patients do not always achieve remission or may lose response over time, according to study background. Vipul Jairath \u201cWhen CD is not well controlled, ongoing inflammation and fibrosis may contribute to disease progression, cumulative bowel damage and complications over time, increasing the risk of hospitalization, surgery and added costs for patients and healthcare systems,\u201d Vipul Jairath, MBChB, DPhil, a RELIEVE UCCD investigator and John and Susan McDonald Endowed Chair in IBD Clinical Research at Western University, told Healio. \u201cThese challenges underscore the need for therapies that can deliver deeper and more durable disease control.\u201d Patients with UC also may experience relapsing inflammation, tissue damage and fibrosis, which can result in substantial disease burden and negatively affect quality of life, according to Walter Reinisch, MD, primary coinvestigator of the trial. Walter Reinisch \u201cBecause disease control can be difficult to maintain, patients may find themselves in a continual cycle of adjusting or switching therapies to address loss of response,\u201d Reinisch, director of the IBD study group at Medical University of Vienna, told Healio. \u201cThese unmet needs motivated us to investigate TL1A-inhibition, targeting a pathway that may contribute to both inflammation and fibrosis in IBD,\u201d Reinisch added. \u2018Innovative\u2019 study design Jairath, Reinisch and colleagues conducted the multicenter, phase 2b RELIEVE UCCD trial to investigate the efficacy and safety of duvakitug among adults aged 18 to 75 years with moderately to severely active CD or UC. Eligible participants were enrolled from 163 investigational sites in 19 countries from Sept. 30, 2022, through Nov. 12, 2024. \u201cThis study used an innovative basket study design to enhance operational efficiency,\u201d Jairath said. \u201cThe basket approach uses a single master protocol, facilitating shared infrastructure and resources within sites, to allow the study to be conducted in two different inflammatory bowel disease indications with distinct primary endpoints for each indication.\u201d The CD cohort included 139 patients (mean age, 39.5 years; 58% men; 95% white), of whom 57% previously had been treated with at least one advanced therapy. Participants in this cohort were randomly assigned 1:1:1 to receive an initial 2,250 mg loading dose of duvakitug subcutaneously, then biweekly duvakitug 450 mg (n = 46) or 900 mg (n = 46), or a loading dose of placebo, followed by placebo every 2 weeks (n = 46). Endoscopic response, defined as a 50% or greater reduction from baseline in Simple Endoscopic Score for Crohn\u2019s Disease, at week 14 served as the primary endpoint. The UC cohort included 137 patients (mean age, 41 years; 63% men; 96% white), of whom 31% previously had been treated with at least one advanced therapy. Participants in this cohort also were randomly assigned to loading doses, followed by 450 mg duvakitug (n = 47), 900 mg duvakitug (n = 46) or placebo (n = 44) every 2 weeks. Clinical remission, measured by modified Mayo score, at week 14 served as the primary endpoint for this cohort. \u2018Strong efficacy\u2019 In the CD cohort, 26% of patients in the 450 mg duvakitug group achieved endoscopic response at week 14, as did 48% in the 900 mg group, compared with 13% in the placebo group. \u201cThe robust endoscopic response was particularly encouraging, as endoscopic response is an important treatment goal and is associated with improved long-term outcomes for patients with Crohn\u2019s disease,\u201d Jairath said. \u201cThese findings suggest that duvakitug may help address key disease processes underlying CD.\u201d In a subgroup analysis of previously treated patients, researchers observed a 44% treatment difference between duvakitug 900 mg and placebo groups, compared with a 7% difference between duvakitug 450 mg and placebo. Among advanced therapy-naive patients, treatment differences were similar between both doses of duvakitug and placebo (25%). Treatment-emergent adverse events occurred in all groups, the most common of which were anemia, nasopharyngitis and headache. Serious adverse events were reported in 13% of patients in the 450 mg group, 2% in the 900 mg group and 11% in the placebo group. Duvakitug also outperformed placebo in the UC cohort. At 14 weeks, 36% of patients in the 450 mg group achieved clinical remission, as did 48% in the 900 mg group, vs. 20% in the placebo group. \u201cWithin the UC cohort, the clinical remission data was highly compelling,\u201d Reinisch said. As in the CD cohort, duvakitug showed \u201cstrong efficacy\u201d compared with placebo among both advanced therapy-experienced and naive patients with UC, according to Reinisch. Subgroup analyses showed treatment differences of 22% and 29%, respectively, among treatment-experienced patients in the 450 mg and 900 mg groups compared with placebo, and 12% and 26% among treatment-naive patients. \u201cThe robust rates of clinical remission are highly encouraging and suggest that duvakitug has the potential to offer a new therapeutic approach for people living with UC, including those who have already cycled through other advanced therapy,\u201d Reinisch said. Treatment-emergent adverse events were similar among UC groups, as well, and<\/p>\n","protected":false},"author":1,"featured_media":3434,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-3433","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/posts\/3433","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=3433"}],"version-history":[{"count":0,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/posts\/3433\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=\/wp\/v2\/media\/3434"}],"wp:attachment":[{"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=3433"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=3433"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/drsoniafawad.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=3433"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}
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