Effectiveness and safety of risankizumab induction therapy for 100 patients with Crohn's disease: A GETAID multicentre cohort study - Archive ouverte HAL Accéder directement au contenu
Article Dans Une Revue Alimentary Pharmacology & Therapeutics (Suppl) Année : 2022

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

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Antoine Defrance
  • Fonction : Auteur
Xavier Roblin
Romain Altwegg
David Laharie
Cyrielle Giletta
  • Fonction : Auteur
Philippe Ah-Soune
  • Fonction : Auteur
Nicolas Duveau
  • Fonction : Auteur
Mathieu Uzzan
My‐linh Tran-Minh
Thierry Paupard
  • Fonction : Auteur
Lucine Vuitton
Yasmine Elgharabawy
  • Fonction : Auteur
Laurent Peyrin-Biroulet

Résumé

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.
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hal-03911091 , version 1 (22-12-2022)

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Citer

Mathurin Fumery, Antoine Defrance, Xavier Roblin, Romain Altwegg, Benedicte Caron, et al.. Effectiveness and safety of risankizumab induction therapy for 100 patients with Crohn's disease: A GETAID multicentre cohort study. Alimentary Pharmacology & Therapeutics (Suppl), 2022, ⟨10.1111/apt.17358⟩. ⟨hal-03911091⟩
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