Certolizumab pegol in patients with moderate to severe Crohn's disease and secondary failure to infliximab.

Abstract

BACKGROUND & AIMS:

Patients with moderate to severe Crohn's disease who receive infliximab may experience secondary failure (loss of response and/or hypersensitivity). Data on the utility of switching to certolizumab pegol in these patients are limited.

METHODS:

A total of 539 patients with active Crohn's disease and secondary failure to infliximab were enrolled in a 26-week trial. Patients received open-label induction with subcutaneous certolizumab pegol 400 mg at weeks 0, 2, and 4. Those in clinical response at week 6 were randomized to certolizumab pegol 400 mg every 2 or every 4 weeks through week 24. The primary end point was response at week 6. Secondary end points included remission at week 6 and response and remission at week 26.

RESULTS:

At week 6, 334 of 539 patients (62.0%) achieved response and 212 of 539 (39.3%) achieved remission. A total of 329 patients were randomized and received maintenance therapy. At week 26, 39.9% (67 of 168) and 36.6% (59 of 161) of patients in the every-4-weeks and every-2-weeks groups were in clinical response, respectively (P = .55). Corresponding remission rates at week 26 were 29.2% and 30.4%, respectively (P = .81). Serious infections occurred in 9 of 539 (1.7%) and 12 of 373 (3.2%) of patients during induction and maintenance, respectively. A single malignancy (skin carcinoma) occurred in a patient receiving every-4-weeks maintenance therapy.

CONCLUSIONS:

Response to open-label induction therapy with certolizumab pegol was achieved by 62% of patients with moderate to severely active Crohn's disease and secondary failure to infliximab. Among these patients, certolizumab pegol 400 mg every 4 weeks showed similar efficacy to every-2-weeks dosing for maintenance of response and remission.

• Authors: William J Sandborn, Maria T Abreu, Geert D'Haens, Jean-Frédéric Colombel, Severine Vermeire, Krassimir Mitchev, Corinne Jamoul, Richard N Fedorak, Martina E Spehlmann, Douglas C Wolf, Scott Lee, Paul Rutgeerts
• Journal: Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association (Clin Gastroenterol Hepatol) Vol. 8 Issue 8 Pg. 688-695.e2 (Aug 2010) ISSN: 1542-7714 [Electronic] United States
• PMID: 20451663 (Publication Type: Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial)
• Copyright: Copyright 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.

Chemical References

• Antibodies, Monoclonal
• Antibodies, Monoclonal, Humanized
• Immunoglobulin Fab Fragments
• Immunologic Factors
• Polyethylene Glycols
• Infliximab
• Certolizumab Pegol

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Antibodies, Monoclonal (therapeutic use)
• Antibodies, Monoclonal, Humanized
• Certolizumab Pegol
• Crohn Disease (drug therapy)
• Female
• Humans
• Immunoglobulin Fab Fragments (therapeutic use)
• Immunologic Factors (therapeutic use)
• Infliximab
• Male
• Middle Aged
• Polyethylene Glycols (therapeutic use)
• Treatment Outcome
• Young Adult