Long-term Effectiveness and Safety of Risankizumab in Patients with Crohn's Disease.

Background & Aims: Risankizumab is a selective interleukin-23 inhibitor approved for the treatment of Crohn's disease (CD). We report a large long-term real-world experience with risankizumab in CD.

Methods: We performed a prospective monitoring of clinical outcomes in patients at a large tertiary center who started treatment with risankizumab. Patients with active luminal disease who had at least 12 weeks of follow-up were included in the effectiveness analysis. Harvey-Bradshaw Index, as well as C-reactive protein and fecal calprotectin, were used to monitor disease activity. Primary outcomes were clinical remission and steroid-free clinical remission rates at weeks 12, 26, and 52. Univariate analysis followed by a multivariate analysis using a logistic regression model was performed to identify predictors of steroid-free clinical remission at 1 year. All patients who started treatment with risankizumab for any indication were included in the safety analysis.

Results: A total of 134 patients were included in the effectiveness analysis. Seventy (52%) were ustekinumab-experienced. Clinical remission rates were 69%, 64%, and 54% at weeks 12, 26, and 52, respectively. Steroid-free clinical remission rates at 12, 26, and 52 weeks were 58%, 58%, and 50%, respectively. Remission rates in ustekinumab-experienced patients were not statistically lower compared with naïve patients, and in a multivariate analysis, prior ustekinumab treatment was not associated with lower odds of achieving steroid-free clinical remission at 1 year. Adverse effects were assessed in 243 patients and were consistent with previous literature.

Conclusions: This large real-world experience with risankizumab with long-term follow-up demonstrates effectiveness and safety in patients with CD; there was comparable effectiveness in ustekinumab-naïve and ustekinumab-experienced patients.