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Background Ustekinumab is a monoclonal antibody against the p40 subunit of IL-12 and IL23 which has been proven efficacious and safe in clinical trials, yet, real-word effectiveness studies are lacking. We aimed to determine the effectiveness and safety of ustekinumab in Crohn’s disease patients in a usual care setting, as well as to identify factors that predict response to treatment. Methods This was a retrospective review of patients with Crohn’s disease who had received ustekinumab at McMaster University Medical Center between January 2017 and August 2019. The primary endpoints were 12-month rates of clinical response, clinical remission and endoscopic improvement (according to physician assessment). We also performed a multivariate logistic regression to determine independent predictors of treatment effectiveness. Key safety outcomes were rates of adverse events including infections. Results We included 123 patients with Crohn’s disease, 58.8% of which had ileocolonic disease. Of these patients, 79.5% had prior TNF-antagonist exposure and 17.1% had previously used vedolizumab. The 12-month rate of clinical response, clinical remission, and endoscopic improvement, were 88%, 35%, and 47% respectively. On univariable analyses, longer disease duration was associated with a lower likelihood of achieving endoscopic improvement (OR 0.91 per year of disease duration, 95% CI 0.84–0.99, p = 0.03). On multivariate logistic regression, concomitant steroid use (OR 0.34, 95% CI 0.12–0.99, p = 0.049) and previous vedolizumab exposure (OR 0.13, 95% 0.02–0.77) were significantly associated with less likelihood of achieving clinical response at 12 months. Adverse events occurred in 13% of patients and infections occurred in only 1% of patients. Conclusion Ustekinumab has been effective in our real-world experience at achieving clinical response, clinical remission and endoscopic improvement in patients with Crohn’s disease. We found that concomitant steroid use and prior vedolizumab exposure were associated with a lower likelihood of clinical response. Further prospective data are needed to understand whether these are truly predictors of lack of response, or represent confounding from patients with more refractory disease.

P484 Effectiveness and safety of ustekinumab in patients with Crohn’s disease: a real-world experience