Clinical trial: impact of prior infliximab therapy on the clinical response to certolizumab pegol maintenance therapy for Crohn’s disease

Authors

Errata

This article is corrected by:

  1. Errata: Corrigenda Volume 34, Issue 11-12, 1356, Article first published online: 16 November 2011

Dr S. B. Hanauer, University of Chicago, 5841 S. Maryland Avenue, MC 4076, Chicago, IL 60637, USA.
E-mail: shanauer@medicine.bsd.uchicago.edu

Abstract

Aliment Pharmacol Ther 2010; 32: 384–393

Summary

Background  Certolizumab pegol (CZP) is an effective therapy for Crohn’s disease refractory to aminosalicylates, corticosteroids and immunosuppressants. In PRECiSE 2, patients were also eligible for enrolment if prior infliximab therapy was terminated due to loss of response.

Aim  To evaluate prior infliximab therapy on sustained response and remission to CZP for Crohn’s disease.

Methods  PRECiSE 2 were was analysed for predictors of sustained response and remission. Covariates included prior infliximab therapy, and baseline Crohn’s Disease Activity Index (CDAI).

Results  Week 26 response (≥100-point decrease from baseline CDAI) and remission (CDAI ≤ 150) were greater with CZP vs. placebo in patients previously receiving infliximab (response: 44.2% vs. 25.5%, = 0.018; remission: 32.7% vs. 13.7, = 0.008) and infliximab-naïve patients (response: 68.7% vs. 39.6%, < 0.001; remission: 52.8% vs. 33.3%, < 0.001). Prior infliximab use was the only independent predictor of week 26 response and remission in both groups [response ORCZP vs. placebo = 3.06 (95% CI: 1.21–7.77); remission ORCZP vs. placebo = 4.22 (95% CI: 1.45–12.28)]. Adverse events were similar for both groups.

Conclusions  Certolizumab pegol is an effective maintenance therapy in Crohn’s disease regardless of prior infliximab use. Efficacy is higher in patients receiving CZP therapy as a first-line biologic, but ∼50% of infliximab-experienced patients benefited from second-line CZP therapy.

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