Background: We aimed to evaluate the real-world effectiveness and safety of ustekinumab for the treatment of both bio-naïve and bio-exposed ulcerative colitis (UC) patients in a real-world setting.
Methods: Retrospective, Canadian multicenter cohort study. Primary outcomes were clinical remission and endoscopic remission. Key secondary outcomes included composite clinical and endoscopic response, safety, and persistence. Univariable logistic regression was conducted to examine associations between baseline factors and 12 month clinical and endoscopic response and remission. The primary focus was on the association between these outcomes and bio-exposure status.
Results: A total of 198 patients were included, of whom 47.5% were female and 85.9% under 65 years. The majority had severe endoscopic activity at baseline (47.5%, n=87) and were bio-exposed (88.8%, n=176; 33%, n=66 prior failure of 3 or more biologics). Patients were followed for a median of 12.8 (IQR 8.2 to 22.1) months after induction. The overall clinical remission rates were 41.3% (69/167), 38.1% (56/147), and 43.6% (58/133) at 3, 6 and 12 months, respectively. Endoscopic remission rates (MES=0) were 8.0% (7/88), 18.7% (23/123), and 12.5% (11/88) at 3, 6, and 12 months, respectively, and consistently higher in bio-naïve patients compared to bio-exposed patients through 12 months (p<0.05 at all time points). Bio-naive patients were more likely to achieve endoscopic remission compared to bio-exposed (HR=5.40, 95% CI: 1.08-26.93). Adverse events were reported in 14.1% (18/198).
Discussion: In a highly refractory and largely bio-exposed population, a substantial proportion of patients with UC treated with ustekinumab can achieve clinical and endoscopic outcomes of importance after 12 months. Prior biologic exposure is associated with lower rates of endoscopic remission.
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