P927 Long-term Outcomes of Risankizumab in Crohn’s Disease: a Multicenter GETAID Study

Abstract Background Risankizumab is approved for moderate to severe Crohn’s disease (CD). The GETAID recently reported the real-world effectiveness of risankizumab as induction therapy for refractory CD. The aim of this study was to assess the long-term effectiveness and safety of risankizumab maintenance treatment in a large real-world cohort of patients with CD. Methods From May 2021 to August 2023, all consecutive CD patients treated with risankizumab in 25 GETAID centers have been retrospectively included. Only patients who received risankizumab 600 mg IV at week 0,4 and 8 as induction and SC 360 mg every 8 weeks as maintenance treatment were included. The primary outcome measure was steroid-free clinical remission (Harvey Bradshaw Index (HBI) <5) at week 52. Secondary outcomes included clinical response (≥ 3-point decrease of HB score and/or (HB) score < 5), endoscopic (no ulcers) and/or radiologic remission (normal intestinal ultra-sound or MRI), need for CD-related surgery, and adverse events. Results All patients had received at least three biologics and 108 (62%) had previous intestinal resection. Of the 174 patients included, 172 (99%), 162 (93%), and 167 (96%) had been previously exposed to anti-TNF, vedolizumab, and ustekinumab, respectively. Respectively 66 (38%) and 24 (14%) patients were on corticosteroids and immunosuppressants at risankizumab initiation. Median follow-up was 13.7 (10.0-18.1) months. The rates of steroid-free clinical remission and clinical remission at 52 weeks were 46% (60/131) and 50% (65/131), respectively. Absence/mild abdominal pain with normal stool frequency was observed in 48% (54/112) of patients at week 52. Among the 79 (45%) patients who had an endoscopic (n=67) and/or radiological (MRI, n=56 and IUS, n=15) evaluation during follow-up, response and remission were observed in 27 (34%) and 17 (22%) patients, respectively. Risankizumab persistence rates were 94%, 89%, and 79% at weeks 12, 26, and 52, respectively. At the end of follow-up, 45 (45/174, 26%) patients had discontinued risankizumab (loss of response, 42%; primary failure, 37%; intolerance, 13%). Thirty-six patients (36/174, 20.9%) were hospitalized and 22 (22/174, 12.6%) required intestinal resection. No factors were associated with steroid-free clinical remission at week 52. Twenty-five (14%) patients had an adverse event and 26 (15%) serious adverse events (CD flare, n=17). One death (myocardial infarction) and one cancer (papillary thyroid carcinoma) were observed. Conclusion This is the first real-life study to report long-term outcomes in patients with refractory CD treated with risankizumab. Half of the patients achieved steroid-free clinical remission after one year, and the safety profile was consistent with the literature.