The following article is a part of conference coverage from the American College of Gastroenterology 2021 Annual Meeting , held from October 22 to 27, 2021. The team at Gastroenterology Advisor will be reporting on the latest news and research conducted by leading experts in gastroenterology. Check back for more from ACG 2021.
Upadacitinib-45 mg once daily (UPA) induction treatment was associated with statistically significant improvements in clinical, endoscopic, and combined endoscopic-histologic endpoints in adults with moderate to severe ulcerative colitis (UC), according to study results presented at the American College of Gastroenterology (ACG) 2021 Annual Meeting, held from October 22 to 27, 2021, in Las Vegas, Nevada and virtually.
The phase 3, multicenter, randomized, double-blind, placebo-controlled U-ACCOMPLISH trial (ClinicalTrials.gov Identifier: NCT03653026) included patients with moderate to severe UC, which was defined as an adapted Mayo score of 5 to 9 with a centrally read endoscopic score of 2 to 3. Participants also had an inadequate response, loss of response, or intolerance to aminosalicylates, immunosuppressants, corticosteroids, and/or biologics.
The patients were randomized 2:1 to UPA or placebo for 8 weeks, at which point responders were moved into a maintenance phase and nonresponders to an extended treatment period to receive open-label UPA for 8 more weeks. The primary endpoint was clinical remission according to adapted Mayo score, and secondary endpoints included endoscopic improvement and remission and clinical response.
A total of 522 patients were randomly assigned (UPA, 345; placebo, 177). The intent-to-treat population included 341 patients (median age, 40.0 years; 37.2% women; 68.6% White) who received UPA and 174 who received placebo (median age, 42.0 years; 38.5% women; 71.3% White). The 2 groups had comparable baseline demographics and disease characteristics; 50.7% of the UPA group and 51.1% of the placebo group were biologic inadequate responders.
The researchers found that 33.5% of patients who received UPA achieved the primary endpoint compared with 4.1% of those who received placebo (adjusted treatment difference: 29.0%; P <.001). A significantly higher proportion of patients who received UPA also achieved all ranked secondary endpoints compared with those who received placebo (all P <.001).
Serious adverse events (AEs) occurred in 3.2% of patients in the UPA group and in 4.5% of those in the placebo group. Both groups had a 0.6% rate of serious infection; 2 events of herpes zoster and 2 events of opportunistic infection occurred in the UPA group. No deaths or active tuberculosis, malignancy, and adjudicated major adverse cardiovascular events were reported.
“Treatment was well tolerated, and the safety profile and AE prevalence were comparable with previous studies of UPA with no new safety signals identified,” concluded the investigators.
Disclosure: Some of the study authors declared affiliations with biotech, pharmaceutical, and/or device companies. Please see the original reference for a full list of authors’ disclosures.
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Vermeire S, Danese S, Zhou W, et al. Efficacy and safety of upadacitinib as induction therapy in patients with moderately to severely active ulcerative colitis: results from phase 3 U-ACCOMPLISH study. Presented at: ACG 2021 Annual Meeting; October 22-27, 2021; Las Vegas, NV and virtual. Abstract P0575.