P404 Persistence of subcutaneous infliximab after switching from intravenous in a French national cohort of IBD patients in remission
Mathieu, N.(1)*;Riviere, P.(2); Heluwaert, F.(3); Hébuterne, X.(4);Chupin, A.(5);Bouguen, G.(6);Vuitton, L.(7);Allez, M.(8);Montuclard, C.(9);Nachury, M.(10);Nancey, S.(11);Amélie, B.(12); Gilletta, C.(13);Abitbol, V.(14);Altwegg, R.(15);de Maissin, A.(16);Plastaras , L.(17); Ah Soune, P.(18);Boureille, A.(19);Bouhnik, Y.(20);Seksik, P.(21);Chanteloup, E.(22);marion, S.(23);Uzzan, M.(24);Andrau, P.(25);Rouillon, C.(26);Arondel, Y.(27);Peyrin Biroulet, L.(28);Laharie, D.(29);
(1)CHU Grenoble Alpes, Hepato-gastroenterology and digestive oncology department- University Hospital, Grenoble, France;(2)University Hospital of Bordeaux, Department of Gastroenterology, Bordeaux, France;(3)University Hospital of Nimes- Nimes- France, Department of Gastroenterology-, Annecy, France;(4)CHU of Nice- University Côte d’Azur-, Gastroenterology and Clinical Nutrition-, Nice, France;(5)Assistance publique-Hôpitaux de Paris AP-HP, Service de Gastro-Entérologie-, Paris, France;(6)CHU Rennes- Univ Rennes- INSERM- CIC1414- Institut NUMECAN Nutrition Metabolisms and Cancer-, Department of Gastroenterology, Rennes, France;(7)University Hospital of Besançon, Department of Gastroenterology, Besançon, France;(8)Assistance publique-Hôpitaux de Paris AP-HP- Hopital St-Louis, Service de Gastro-Entérologie-, Paris, France;(9)Valence Hospital, Department of Gastroenterology, Valence, France;(10)Institute for Translational Research in Inflammation, Universitéde Lille- Inserm- CHU Lille- U1286 - INFINITE, Lille, France;(11)Inserm U1111-CIRI- Lyon-Sud University Hospital- Hospices Civils de Lyon, Department of Gastroenterology-, Lyon, France;(12)Reims University Hospital, Department of Gastroenterology, Reims, France;(13)Toulouse University Hospital, Department of Gastroenterology, Toulouse, France;(14)Assistance publique-Hôpitaux de Paris AP-HP- Cochin Hospital, Service de Gastro-Entérologie-, Paris, France;(15)University Hospital of Montpellier, Department of Gastroenterology-, Montpellier, France;(16)CHD la Roche sur Yon Hospital, Department of gastroenterology, La Roche sur Yon, France;(17)Colmar Hospital, Department of Gastroenterology- University Hospital of Nimes, Colmar, France;(18)Toulon Hospital, Department of gastroenterology, Toulon, France;(19)Nantes University Hospital, Department of Gastroenterology, Nantes, France;(20)groupe hospitalier Ambroise Paré - Hartmann, institut des MICI, Paris, France;(21)Centre de recherche Saint-Antoine- Sorbonne Université- INSERM- APHP- Hôpital Saint-Antoine, Department of Gastroenterology, Paris, France;(22)Groupe hospitalier Saint Joseph, Depatment of gastroenterology, Paris, France;(23)Institut mutualiste Montsouris IMM, department of gastroenterology, Paris, France;(24)Beaujon Hospital- APHP- Clichy, Department of Gastroenterology, Paris, France;(25)Tarbes Hospital, Department of Gastroenterology, Tarbes, France;(26)Caen University Hospital, Department of Gastroenterology-, Caen, France;(27)centre hospitalier de Haguenau, Department of gastroenterology, Haguenau, France;(28)University Hospital of Nancy- University of Lorraine, Department of Gastroenterology and INSERM NGERE U1256, Vandoeuvre-lès-Nancy, France;(29)CHU de Bordeaux- Hôpital Haut-Lévêque-, Service d’Hépato-gastroentérologie et oncologie digestive –Universitéde Bordeaux, Bordeaux, France;
Background
Subcutaneous infliximab (IFX-SC) was launched in France for the treatment of patients with inflammatory bowel disease (IBD) in 2021. Real-life and pharmacokinetic (PK) data after switching from intravenous infliximab (IFX-IV) to IFX-SC are needed. The PEREM study is a French multicenter prospective cohort aiming to describe the persistence of IFX-SC after switch from IFX-IV.
Methods
IBD patients in steroid-free clinical remission [Harvey Bradshaw Index (HBI) ≤ 4 for Crohn's disease (CD) and partial Mayo score (PMS) ≤ 2 with each subscore ≤ 1 for UC] for at least 6 months on IFX-IV therapy were proposed to switch to IFX-SC as part of routine care. Patients were included in 40 centers between Oct 2021 and May 2022. Clinical scores (HBI, PMS), biological samples (CRP and fecal calprotectin - FC), PK and anti IFX antibodies (ATI) were evaluated 3, 6, 12 and 24 months after switch. In case of IFX-SC discontinuation, time and reason for withdrawal were documented. Safety and adverse events of interest were recorded. The primary endpoint was IFX-SC persistence at 12 months. As not all patients met this primary endpoint at the time of writing this abstract, we present here the results at 6 months (M6).
Results
Among the 444 patients included [44% female, median age: 37 years (Min, Max: 18-88), 72% Crohn's], 71% were receiving IFX-IV at a dose of 5 mg/kg every 8 weeks and 84% were treated on monotherapy. Among the 417 patients analyzed, five withdrew their consent before the M6 visit and 324 were assessed at M6; 25/324 (7.7%) discontinued IFX-SC before M6 (seven for relapse, twelve for intolerance, two for pregnancy, four for unknown reasons) including one (0.3%) switch back to IFX-IV. Rate of survival without IFX-SC discontinuation at M6 was 92.6% (95% CI 89.3-95.1). Among the patients evaluated at M6, median clinical scores did not vary between inclusion and M6: HBI from 0 (IQR: 0-1) to 0 (IQR: 0-1), PMS from 0 (IQR: 0-0) to 0 (IQR: 0-0), respectively. The median CF and CRP levels were respectively 52 μg/g (IQR: 19-142) at inclusion and 37 μg/g (IQR: 14-129) at M6, and 1 mg/L (IQR: 1-4) at inclusion and 1 mg/L (IQR 0-4) at 6 months. At baseline, median infliximab levels were 6.6 μg/mL (min, max: 0-29) and 20 μg/mL (min, max: 0.3- 79.2) at M6. No major safety signals were recorded.
Conclusion
In a national real-life multicenter cohort, rate of persistence of IFX-SC after 6 months was 92.6% in IBD patients switched in remission, without significant clinical or biological changes. Treatment switch was associated with an increase in IFX levels. These data are confirming the good efficacy and safety of IFX-SC after switch.