Sustained remission in patients with moderate to severe ulcerative colitis: Results from the phase 3 UNIFI maintenance study

Background: The UNIFI randomized-withdrawal maintenance study evaluated the safety and efficacy of subcutaneous (SC) ustekinumab in patients with moderately-to-severely active ulcerative colitis (UC) who had responded to intravenous (IV) ustekinumab during induction. In this analysis, durability of remission through maintenance Week44 is described. Methods: At Week0 of the maintenance study, 523 patients who had responded to IV ustekinumab induction were randomized 1 : 1 : 1 to placebo SC, ustekinumab SC 90 mg q12w, or ustekinumab SC 90 mg q8w. Maintenance of clinical remission at Week44 was a major secondary endpoint; partial Mayo scores, rectal bleeding and stool frequency Mayo subscores, endoscopic healing, and Inflammatory Bowel Disease Questionnaire (IBDQ) scores were also assessed. Results: At baseline of the maintenance study, proportions of patients in symptomatic remission and IBDQ remission were similar among treatment groups (Tab. 1). The proportion of patients with endoscopic healing at baseline was lower in the ustekinumab q8w group (32.4%) compared with ustekinumab q12w (39.5%) and placebo groups (40.6%). Through Week 44, the proportions of patients in partial Mayo remission were sustained in the ustekinumab treatment groups, while the proportion of patients in the placebo group decreased, with consistent numerical separation from the ustekinumab q8w group by Week 8 and the q12w group by Week 16. Significantly greater proportions of patients in both ustekinumab groups compared with placebo maintained symptomatic and IBDQ remission through Week 44 and maintained endoscopic healing at Week 44 among patients who achieved each respective endpoint at maintenance baseline. Similarly, greater proportions of ustekinumab-treated patients had durable partial Mayo remission through Week44 versus placebo. (Table Presented) Conclusion: Both doses of ustekinumab SC maintenance therapy sustained remission, measured by patient-reported symptoms and endoscopic and quality of life assessments, in patients with moderately-to-severely active UC.