Esophagus to Small Intestine
Aliment Pharmacol Ther. 2023;57(4):426–34
Effectiveness and safety of risankizumab induction therapy for 100 patients with Crohn’s disease: A GETAID multicenter cohort study
Background: Phase 3 trials have demonstrated the efficacy of risankizumab in moderate-to-severe Crohn’s disease (CD), but no real-world data are currently available. The authors aimed to assess the short-term effectiveness and safety of risankizumab in patients with CD.
Methods: From May 2021 to May 2022, all patients with refractory luminal CD treated with risankizumab in 22 French GETAID centers were retrospectively included. The primary end point was steroid-free clinical remission at week 12 (Harvey-Bradshaw [HB] score < 5). Secondary end points included clinical response (≥ 3-point decrease of HB score and/or (HB) score < 5), biochemical remission (C-reactive protein ≤ 5 mg/l), need for CD-related surgery and adverse events (AEs).
Results: Among the 100 patients included, all have been previously exposed to anti-tumor necrosis factor agents, 94 to vedolizumab, 98 to ustekinumab (all exposed to at least 3 biologics) and 61 had a previous intestinal resection. All but 3 (97%) received a 600 mg risankizumab intravenous induction at weeks 0-4-8. At week 12, steroid-free clinical remission was observed in 45.8% of patients, clinical remission in 58% and clinical response in 78.5%. In subgroup analysis restricted to patients with objective signs of inflammation at baseline (n = 79), steroid-free clinical remission at week 12 was observed in 39.2% of patients. Biochemical remission was observed in 50% of patients. Six patients discontinued risankizumab before the week 12 visit due to lack of efficacy. CD-related hospitalization was needed in 6 patients, and 3 underwent intestinal resection. In multivariable analysis, only a history of ustekinumab loss of response (vs. primary failure) (odds ratio = 2.80; 95% confidence interval: 1.07–7.82; p = 0.041) was significantly associated with clinical remission at week 12. 20 AEs occurred in 20 patients including 7 serious AEs corresponding to 6 CD exacerbation and 1 severe hypertension.
Conclusion: In a cohort of highly refractory patients with luminal Crohn’s disease and multiple prior drug failures including ustekinumab, risankizumab induction provided a clinical response in about 3 out of 4 patients and steroid-free clinical remission in about half of patients.