P638 Effectiveness and safety of risankizumab induction therapy for 100 patients with Crohn’s disease: a GETAID multicentre cohort study
Fumery, M.(1)*;Defrance, A.(2);Roblin, X.(3);Altwegg, R.(4);Caron, B.(5);Hebuterne, X.(6);Carmen, S.(7);Meyer, A.(8);Nachury, M.(9);Laharie, D.(10);Nancey, S.(11);Le Berre, C.(12);Serrero, M.(13);Geyl, S.(14);Gilletta, C.(15);Ah Soune, P.(16);Duveau, N.(17);Uzza, M.(18);Abitbol, V.(19);Biron, A.(20);Tran Minh, M.L.(21);Paupard, T.(22);Vuitton, L.(23);Elgharabawy, Y.(2);Peyrin-biroulet, L.(5);
(1)Amiens University Hospital, Gastroenterology, Amiens Cedex 1, France;(2)GETAID, Getaid, Paris, France;(3)Saint Etienne University Hospital, Gastroenterology, Saint Etienne, France;(4)Montpellier University Hospital, Gastroenterology, Montpellier, France;(5)Nancy University Hospital, Gastroenterology, Nancy, France;(6)Nice University Hospital, Gastroenterology, Nice, France;(7)GH Ambroise Paré-Hartmann, Gastroenterology, Neuilly, France;(8)Kremlin-Bicetre, Gastroenterology, Paris, France;(9)Lille University Hospital, Gastroenterology, Lille, France;(10)Bordeaux University Hospital, Gastroenterology, Bordeaux, France;(11)Lyon University Hospital, Gastroenterology, Lyon, France;(12)Nantes University Hospital, Gastroenterology, Nantes, France;(13)Marseille University Hospital, Gastroenterology, Marseille, France;(14)Limoges University Hospital, Gastroenterology, Limoges, France;(15)Toulouse university Hospital, Gastroenterology, Toulouse, France;(16)Toulon Hospital, Gastroenterology, Toulon, France;(17)Roubaix Hospital, Gastroenterology, Roubaix, France;(18)Hopital Mondor, Gastroenterology, Creteil, France;(19)Hopital Cochin, Gastroenterology, Paris, France;(20)Reims University Hospital, Gastroenterology, Reims, France;(21)Saint Louis Hospital, Gastroenterology, Paris, France;(22)Dunkerque Hospital, Gastroenterology, Dunkerque, France;(23)Besançon University Hospital, Gastroenterology, Besançon, France; GETAID
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.
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 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), biological remission (CRP ≤ 5 mg/L), need for CD-related surgery, and adverse events.
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 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%. Absence/mild abdominal pain with normal stool frequency was noted in 50% of patients at week 12. Biological 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 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.
In a cohort of highly refractory patients with luminal CD and multiple prior drug failures including ustekinumab, risankizumab induction provided clinical response in about 3 out of 4 patients and steroid-free clinical remission in about half of patients.