Efficacy and Safety of Ustekinumab in Asian Patients with Moderately to Severely Active Ulcerative Colitis: A Subpopulation Analysis of UNIFI Long-Term Extension through 4 Years.

Introduction: This final long-term extension (LTE) analysis assessed long-term efficacy and safety of ustekinumab (UST) in the Asian patient subpopulation with ulcerative colitis (UC) in the UNIFI study. Methods: Patients who completed 44 weeks of subcutaneous (SC) UST maintenance and agreed to enter the LTE continued maintenance therapy (UST 90 mg SC every 8 weeks [q8w] or 12 weeks [q12w] or placebo). The LTE lasted from week (WK) 44 through WK 220 (final safety visit), with the final efficacy visit at WK 200. At WK 56, randomized patients could receive a dose adjustment. Descriptive outcomes, such as symptomatic remission, full Mayo score outcomes, endoscopic improvement, and safety, were assessed. Results: Forty-one randomized patients entered the LTE at WK 44 and continued UST treatment (UST 90 mg SC q12w, 46.3% [19/41] or q8w, 53.7% [22/41]) through WK 188. Symptomatic remission was maintained through WK 200 (62.5% and 37.9% of patients in the UST 90 mg SC q12w and q8w groups, respectively). At WK 200, 78.9% and 50.0% of patients in the UST 90 mg SC q12w and q8w groups, respectively, were in corticosteroid-free symptomatic remission. Full Mayo clinical remission/response rates at WK 200 were 58.8%/94.1% and 75.0%/100.0% in UST 90 mg SC q12w and q8w groups, respectively (observed). Endoscopic healing rates at WK 200 in the UST 90 mg SC q12w and q8w groups were 70.6% and 91.7%, respectively (observed). No unexpected safety concerns were observed. Conclusions: Despite the small sample size which limited data interpretation, long-term UST 90 mg SC treatment is safe and efficacious in Asian patients with moderately to severely active UC demonstrating clinical benefit, consistent with the global population. In addition, Asian patients with relatively stable clinical condition may benefit from UST 90 mg SC when administered in a q12w treatment regimen given its sustained efficacy and low discontinuation rates.