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Multicenter Study
. 2023 Feb;57(4):426-434.
doi: 10.1111/apt.17358. Epub 2022 Dec 19.

Effectiveness and safety of risankizumab induction therapy for 100 patients with Crohn's disease: A GETAID multicentre cohort study

Mathurin Fumery  1 , Antoine Defrance  2 , Xavier Roblin  3 , Romain Altwegg  4 , Benedicte Caron  5 , Xavier Hébuterne  6 , Carmen Stefanescu  7 , Antoine Meyer  8 , Maria Nachury  9 , David Laharie  10 , Stephane Nancey  11 , Catherine Le Berre  12 , Melanie Serrero  13 , Sophie Geyl  14 , Cyrielle Giletta  15 , Philippe Ah-Soune  16 , Nicolas Duveau  17 , Mathieu Uzzan  18 , Vered Abitbol  19 , Amelie Biron  20 , My-Linh Tran-Minh  21 , Thierry Paupard  22 , Lucine Vuitton  23 , Yasmine Elgharabawy  2 , Laurent Peyrin-Biroulet  5
Affiliations
Multicenter Study

Effectiveness and safety of risankizumab induction therapy for 100 patients with Crohn's disease: A GETAID multicentre cohort study

Mathurin Fumery et al. Aliment Pharmacol Ther. 2023 Feb.

Abstract

Background: Phase III trials have demonstrated the efficacy of risankizumab in moderate-to-severe Crohn's disease (CD), but no real-world data are currently available. We 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 centres were retrospectively included. The primary endpoint was steroid-free clinical remission at week 12 (Harvey-Bradshaw [HB] score <5). Secondary endpoints included clinical response (≥3-point decrease of HB score and/or (HB) score <5), biochemical remission (CRP ≤ 5 mg/L), need for CD-related surgery and adverse events.

Results: Among the 100 patients included, all have been previously exposed to anti-TNF agents, 94 to vedolizumab, 98 to ustekinumab (all exposed to at least three biologics) and 61 had a previous intestinal resection. All but three (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 hospitalisation was needed in six patients, and three underwent intestinal resection. In multivariable analysis, only a history of ustekinumab loss of response (vs primary failure) (odds ratio (OR), 2.80; 95% CI: 1.07-7.82; p = 0.041) was significantly associated with clinical remission at week 12. Twenty adverse events (AE) occurred in 20 patients including 7 serious AE corresponding to 6 CD exacerbation and one severe hypertension.

Conclusion: In a cohort of highly refractory patients with luminal CD 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.

Keywords: Crohn’s disease; effectiveness; induction therapy; risankizumab.

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References

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