The following article is a part of conference coverage from the Digestive Disease Week 2021 Annual Meeting , held virtually from May 21 to 23, 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 DDW 2021.
For patients with ulcerative colitis, an increased likelihood of achieving corticosteroid-free remission is associated with maintenance treatment with ozanimod vs placebo. This was reported in data presented at the Digestive Disease Week 2021 annual meeting.
Investigators performed further analysis of patients in the maintenance phase of the True North phase 3 trial. Patients with a clinical response to ozanimod at week 10 of the induction phase were re-randomized to either maintenance with 1 mg of ozanimod or placebo. Corticosteroid doses were kept stable during induction then tapered as tolerated during maintenance.
Roughly 33% of patients were on concomitant systemic corticosteroids at baseline. By week 10, 18.4% and 6.0% of the ozanimod and placebo groups achieved clinical remission while on stable corticosteroids, respectively (P <.0001). In the re-randomized maintenance population, 37.0% of the 230 patients in the ozanimod group and 18.5% of the 227 patients in the placebo group achieved clinical remission at week 52 (P <.0001). There was also a higher proportion of patients in corticosteroid-free remission in the ozanimod group vs placebo at week 52 (31.7% vs 16.7%, respectively; P <.001).
Across nearly all subgroups analyzed, the proportions of patients achieving corticosteroid-free remission remained significantly higher with ozanimod compared with placebo. This included those with or without clinical remission at week 10 (yes, 44.4% vs 27.5%; P =.02; no, 24.8% vs 10.9%; P =.001), prior anti-tumor necrosis factor therapy (yes, 23.7% vs 10.1%; P =.033; no, 35.7% vs 19.6%; P <.001), or extent of colitis (extensive, 33.3% vs 15.7%; P =.002; left-sided, 30.9% vs 17.2%; P =.006, respectively). Ozanimod also favored several other baseline disease characteristics, demographics, and baseline levels of fecal calprotectin (>250 mg/kg).
According to investigators, maintenance treatment of ozanimod is associated with increased likelihood of corticosteroid-free remission vs placebo across a wide range of patient characteristics.
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Schreiber S, Armuzzi A, Dignass A, et al. Corticosteroid-free remission in patients with moderately to severely active ulcerative colitis treated with ozanimod: results from the maintenance phase of True North. Presented at: Digestive Disease Week Annual Meeting; May 21-23, 2021. Abstract 412.