Effectiveness of Switching from Intravenous to Subcutaneous Infliximab in Patients with Inflammatory Bowel Diseases: The REMSWITCH Study.

A. Buisson (1) , M. Nachury (2) , M. Reymond , Clara Yzet (3) , P. Wils (2) , L. Payen , M. Laugie , L. Manlay , N. Mathieu , B. Pereira , Mathurin Fumery (4, 3)

1 M2iSH - Microbes, Intestin, Inflammation et Susceptibilité de l'Hôte
2 INFINITE (Ex-Liric) - Institute for Translational Research in Inflammation - U 1286
3 CHU Amiens-Picardie
4 PERITOX - Périnatalité et Risques Toxiques - UMR INERIS_I 1

BACKGROUND AND AIM: We assessed the effectiveness of switching from intravenous to subcutaneous infliximab in patients with inflammatory bowel diseases (IBD) treated with or without intensified intravenous regimen. METHODS: In this multicenter observational study, IBD patients in clinical remission (partial Mayo score ≤q 2 or Harvey-Bradshaw index ≤q 4) were switched to a unique dose of subcutaneous infliximab (120 mg eow). Pharmacological and biological data were collected at baseline, visit 1 (4-8 weeks post-switch), visit 2 (8-16 weeks post-switch) and visit 3 (16-24 weeks post-switch). Relapse was defined as clinical relapse or faecal calprotectin increase ≥q 150 μg/g compared to baseline. RESULTS: Among 184 eligible patients, 72.3% (133/184) agreed to switch to subcutaneous infliximab. At visit 3, a relapse occurred in 10.2% (6/59), 7.3% (3/38), 16.7% (3/18) and 66.7% (10/15) (p < 0.001) of patients receiving 5mg/kg/8weeks, 10 mg/kg/8weeks, 10mg/kg/6weeks, and 10mg/kg/4weeks, respectively. Dose escalation to 240mg eow, led to recapture clinical remission in 93.3% (14/15). Infliximab serum levels increased after the switch (p<0.0001) except for patients receiving 10 mg/kg/4 weeks. In multivariable analysis, 10mg/kg/4 weeks regimen (OR=12.4[1.6-98.4], p=0.017) and faecal calprotectin >250 μg/g at baseline (OR=5.4[1.1-27.6],p=0.042) had a higher risk of relapse as well as reduced (41.7%) or stable (36.8%) infliximab serum levels between baseline and visit 1 compared to increased serum levels (12.7%) (p=0.020 and p=0.019, respectively). Patients' acceptability (10 points-scale) was improved by the switch (6.9±1.6 vs 8.6±1.4; p<0.0001). No severe adverse event was reported. CONCLUSIONS: Switching from intravenous to subcutaneous infliximab 120 mg eow is safe and well-accepted leading to a low risk of relapse in IBD patients except for those receiving 10mg/kg/4weeks requiring 240 mg eow.

Mots clés: Crohn’s disease; infliximab; subcutaneous; switch; trough level; ulcerative colitis

Domaines: Médecine humaine et pathologie

A. Buisson, M. Nachury, M. Reymond, Clara Yzet, P. Wils, et al.. Effectiveness of Switching from Intravenous to Subcutaneous Infliximab in Patients with Inflammatory Bowel Diseases: The REMSWITCH Study.. Clinical Gastroenterology and Hepatology, 2023, 21 (9), pp.S1542-3565(22)00776-5. ⟨10.1016/j.cgh.2022.08.011⟩. ⟨hal-03760901⟩