Subcutaneous Infliximab for Perianal Crohn's Disease: The BioLap-Rem Multicenter Study From the GETAID.

Abstract

Intravenous infliximab (IFX) is the cornerstone for treating patients with perianal Crohn's disease (pCD). Data on the recently launched subcutaneous (SC) IFX for pCD are limited. The aim of our study was to evaluate the effectiveness and safety of SC IFX in pCD. We conducted a multicenter retrospective cohort study from the GETAID, including patients with either active (group 1) or inactive (group 2) pCD when they started SC IFX. Inclusion criteria were, for group 1: active pCD in the 6 months before initiation of SC IFX; for group 2: inactive pCD for >6 months at the time of IV to SC switch. The primary end points were clinical remission at 6 months in group 1 and pCD relapse in group 2. Of the 183 patients included in 24 centers, 66 were in group 1 and 117 in group 2. The median follow-up was 50.4 (27.0-64.6) and 53.4 (40.6-67) weeks, respectively. In group 1 at 6 months, clinical remission was observed in 44.6% of patients and clinical response in 87.7%. Clinical remission including seton removal occurred in 35.5% of patients. In multivariable analysis, high body mass index was the only independent predictor of remission (odds ratio 0.88, 95% confidence interval 0.77-0.99). In group 2, rates of relapse-free survival were 94.3% and 87.9% at 6 and 12 months, respectively. Sixteen cases (8.3%) of adverse events related to SC injection were observed. SC IFX was effective and safe for the treatment of active pCD and for maintaining remission after switching in this large multicenter cohort, thus supporting its use in routine practice in this indication.