O30 Risankizumab for refractory crohn’s disease: real world experience from a pre-approval access program & early access to medicines scheme

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Background Risankizumab is a new generation humanised monoclonal antibody that selectively binds to, and inhibits, interleukin-23p19 with established applications in immune-mediated inflammatory diseases outside of inflammatory bowel disease (IBD), and now indicated for the treatment of moderate-to-severe Crohn’s disease (CD). Access was granted for an eligible cohort that was defined by ongoing active disease alongside non-response to ustekinumab and vedolizumab, as well as adalimumab and/or infliximab. Our aim was to assess the real-world effectiveness of risankizumab in treatment-refractory CD population. Methods We performed a retrospective cohort analysis of prospectively obtained data for patients starting risankizumab between January 2021 and August 2022. All patients received three initial four-weekly 600mg intravenous infusions. Clinical disease activity, biochemical activity and quality of life were measured using Harvey-Bradshaw Index (HBI), CRP, and IBD-Control scores, respectively. Study evaluations were made at baseline, weeks 4, and 12. Data were analysed in ANOVA and are described as median (range). Results Of the 34 CD patients who have commenced risankizumab, 29 (85%) remain on treatment, with a median treatment duration of 10.7 months. Here, we report on 28 patients who had completed the 12-week induction period at time of submission. The cohort comprised individuals with relatively aggressive disease characteristics – the majority had stricturing phenotypes (16, 57%), nearly a fifth had penetrating disease (5, 18%), and over half had perianal involvement (16, 57%). Sixteen (68%) participants had undergone prior luminal surgery, eight of whom, still having stomas, were not included in HBI analysis. Median CRP decreased from 10 mg/L (1–63) at baseline to 5 mg/L (1–23, p=0.0072) at week 4 and 5 mg/L (1–34, p=0.015) at week 12. HBI fell from 6 (0–36) at baseline to 3 (0–21, p=0.027) at week 4 and 2 (0–12, p=0.0027) at week 12. IBD-Control improved from 4 (0–14) at baseline to 11 (3–16, p≤0.0001) at week 4 and 10 (2–16, p≤0.0001) at week 12. Of the 7 patients on corticosteroids at baseline, 4 had discontinued by the end of the 12-week induction period, a further 2 discontinued during maintenance treatment and only 1 continues at the point of last follow-up. Conclusions We present a heterogeneous, though representative, cohort of patients with refractory CD despite use of currently licensed biologic therapies. Over an induction period of 12 weeks, our data suggest a positive impact of risankizumab, with respect to inflammatory biomarker CRP, clinical disease activity by HBI, and quality of life.

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