Efficacy and safety of Ustekinumab as maintenance therapy in ulcerative colitis: Week 44 results from UNIFI

Background: Study objective was to evaluate safety and efficacy of SC ustekinumab (UST) as maintenance therapy in UC patients who were in clinical response to a single IV induction dose of UST. Methods: This was a Phase3, double-blind, randomized withdrawal study in patients with moderate-severe UC who failed conventional or biologic therapy (including anti-TNF and/or vedolizumab) and were in clinical response 8 wks after receiving a single UST IV induction dose. Study population included 523 patients randomized 1: 1: 1 to PBO SC, UST90 mg SC q8w or q12w. Primary endpoint was clinical remission at Wk44; key secondary endpoints were maintenance of clinical response, endoscopic healing, corticosteroid-free clinical remission, and maintenance of clinical remission among patients who achieved clinical remission at baseline. Results: Baseline demographics, disease characteristics, concomitant UC medications & medication history were similar among treatments. Significantly greater proportions of UST q8w and q12w patients were in clinical remission at Wk44 (43.8% and 38.4%, respectively) vs. PBO patients (24.0%). Significantly greater proportions of USTq8w and q12w patients maintained clinical response through Wk44 and achieved endoscopic healing and corticosteroid-free clinical remission vs. PBO patients. Clinical remission through Wk44 was maintained for a significantly greater proportion of q12w patients and a numerically greater proportion of q8w vs. PBO patients (Tab. 1). The proportions of patients with AEs, serious AEs, infections, and serious infections with UST were generally comparable to PBO (Tab. 2). (Table Presented) Conclusion: Both UST90 mg q8w and q12w SC achieved clinical remission and maintained clinical response and were effective in achieving endoscopic healing and corticosteroid-free remission among patients with moderate-to-severe UC induced into clinical response with single IV dose of UST. The safety for UST in UC patients was consistent with the known safety profile of UST.