Effectiveness and Safety of Risankizumab Induction Therapy for 100 Patients With Crohn's Disease

A GETAID Multicentre Cohort Study

Mathurin Fumery; Antoine Defrance; Xavier Roblin; Romain Altwegg; Benedicte Caron; Xavier Hébuterne; Carmen Stefanescu; Antoine Meyer; Maria Nachury; David Laharie; Stephane Nancey; Catherine Le Berre; Melanie Serrero; Sophie Geyl; Cyrielle Giletta; Philippe Ah-Soune; Nicolas Duveau; Mathieu Uzzan; Vered Abitbol; Amelie Biron; My-Linh Tran-Minh; Thierry Paupard; Lucine Vuitton; Yasmine Elgharabawy; Laurent Peyrin-Biroulet


Aliment Pharmacol Ther. 2023;57(4):426-434. 

In This Article

Abstract and Introduction


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.


Crohn's disease (CD) is a chronic and destructive inflammatory disease of the gastrointestinal tract characterised by phases of relapse and remission.[1] Tumour necrosis factor (TNF) antagonists, anti-integrins and anti-interleukin (IL) 12/23 are the main therapeutic agents to obtain deep remission and prevent disability.[2] Although biologics are a major advance in the treatment of CD, many patients do not respond, lose response over time or have adverse events leading to drug discontinuation.[3,4] There is a growing demand for novel therapeutic agents targeting alternative disease mechanisms.

Risankizumab is a fully human IgG1 monoclonal antibody targeting selectively the IL-23 p19 subunit and inhibiting its interaction with the IL-23 receptor complex.[5] Risankizumab is currently approved for the treatment of plaque psoriasis and psoriatic arthritis.[6] In two recent phase III trials, risankizumab demonstrated its efficacy and safety as induction therapy in patients with moderate-to-severe CD, naive or previously exposed to biologics.[5] This robust data have driven the approval of risankizumab by the Food Drug Administration (FDA) for the treatment of patients with moderate-to-severe CD.

Few studies have reported the real-world effectiveness of risankizumab in CD. Real-world studies allow for bridging some data gaps by describing patient experiences that are lacking in clinical trials that tend to exclude certain groups of patients.[7] The aim of this study was therefore to evaluate the effectiveness and safety of risankizumab induction therapy in a multicentre retrospective cohort of patients with CD failing conventional treatment.