Efficacy of certolizumab pegol is not affected by baseline anti-infliximab antibody status in patients with Crohnʼs disease with secondary infliximab failure

Abstract

The WELCOME study prospectively assessed the efficacy of certolizumab pegol (CZP) in patients with moderate to severe Crohn's disease (CD) who had lost previous response to and/or had developed hypersensitivity to infliximab (IFX). CZP is the only PEGylated Fab' anti-TNF and is proven not to cross react with antibodies to adalimumab and infliximab. The aim of this analysis was to evaluate the impact of baseline anti-IFX antibodies on the efficacy of CZP in patients enrolled in the WELCOME study. WELCOME was a 26-week, multicenter trial, consisting of 2 phases: (1) 6-week open-label induction (CZP 400 mg at Weeks 0, 2, and 4); and (2) a double-blind randomized maintenance phase (CZP 400 mg every 2 [q2w] or 4 weeks [q4w]) in patients responding to CZP by Week 6. Eligible patients (≥ 18 y) had a CD Activity Index (CDAI) score of 220-450 and a history of IFX failure (loss of response and/or hypersensitivity). Clinical response was defined as a decrease of ≥ 100 points in the CDAI score (CDAI-100) from baseline and remission as a CDAI score of ≤150 points. Serum samples were collected from eligible patients at screening and evaluated for the presence of anti-IFX antibodies by ELISA. A total of 539 patients were enrolled and 329 Week-6 responders were randomized to double-blind maintenance therapy. Of the 465 patients who were evaluated for the presence of anti-IFX antibodies at baseline, 212 (45.6%) were positive and 253 (54.4%) were negative. At Week 6, response and remission rates were not affected by baseline anti-IFX antibody status (Table). Similarly, baseline anti-IFX antibody status did not substantially impact response or remission rates at Week 26. No Caption available. No Caption available. CZP was efficacious as induction and maintenance therapy in patients with moderate to severe CD who had previously lost response and/or developed hypersensitivity to IFX. Induction and maintenance of response and remission following treatment with CZP were not affected by baseline anti-IFX antibody status.