Reinduction With Certolizumab Pegol in Patients With Relapsed Crohn's Disease: Results From the PRECiSE 4 Study

Reinduction With Certolizumab Pegol in Patients With Relapsed Crohn's Disease: Results From the PRECiSE 4 StudyWilliam J. Sandborn

Affiliations
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MinnesotaReprint requests Address requests for reprints to: William J. Sandborn, MD, Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota 55905. fax: (507) 266-0335
, Stefan Schreiber
AffiliationsInstitute for Clinical Molecular Biology, Christian Albrechts University, Kiel, Germany
, Stephen B. Hanauer
AffiliationsDepartment of Gastroenterology and Nutrition, University of Chicago Medical Center, Chicago, Illinois
, Jean–Frédéric Colombel
AffiliationsHepato-Gastroenterologie, Hôpital Claude Huriez, Lille, France
, Ralph Bloomfield
AffiliationsUCB Pharma, Slough, Berkshire, United Kingdom
, Gary R. Lichtenstein
AffiliationsUniversity of Pennsylvania School of Medicine, Philadelphia, Pennsylvania
, PRECiSE 4 Study Investigators
published online 05 April 2010.

Abstract
We sought to determine the efficacy of certolizumab pegol reinduction in patients with active Crohn's disease who respond to induction therapy with certolizumab pegol and then relapse during continuous or interrupted maintenance therapy.

Methods
In the Pegylated Antibody Fragment Evaluation in Crohn's Disease: Safety and Efficacy (PRECiSE) 2 trial, 428 patients who responded to induction therapy with certolizumab pegol at week 6 were randomized to continuous therapy with certolizumab pegol or placebo (drug interruption) during weeks 6 to 26. Patients who relapsed before week 26 could enter PRECiSE 4, an ongoing open-label extension trial in which patients on continuous therapy underwent recapture with a single extra 400-mg dose of certolizumab pegol, and patients who relapsed after drug interruption underwent reinduction with certolizumab pegol 400 mg at weeks 0, 2, and 4 followed by maintenance with certolizumab pegol 400 mg every 4 weeks. Disease activity was measured by the Harvey–Bradshaw Index.

Results
During PRECiSE 2, 124 patients had disease relapse and entered PRECiSE 4; 49 patients had received continuous therapy and 75 patients had drug interruption. At week 4 of PRECiSE 4, response rates were 63% in patients who relapsed on continuous therapy and 65% after drug interruption. Response was maintained in 55% and 59% of these responders, respectively, through week 52.

Conclusions
Administration of 1 additional dose of certolizumab pegol to patients who relapsed on continuous maintenance therapy, and certolizumab pegol reinduction to those who relapsed after drug interruption, are effective strategies for treating patients who have relapsed after successful induction therapy with certolizumab pegol.

Keywords: Anti-TNF Inhibitor, Relapsed Crohn's Disease, Certolizumab Pegol, PRECiSE 4

Abbreviations used in this paper: CDAI, Crohn's Disease Activity Index, HBI, Harvey–Bradshaw Index, PRECiSE, Pegylated Antibody Fragment Evaluation in Crohn's Disease: Safety and Efficacy, TNF, tumor necrosis factor

Conflicts of interest The authors disclose the following: William Sandborn has received research support from and served as a consultant for UCB Pharma, Centocor, and Abbott Laboratories; Stefan Schreiber has received consulting fees from Abbott Laboratories, Schering-Plough and its subsidiary Essex Pharma, and UCB Pharma, has received lecture fees from Abbott Laboratories, Essex/Schering-Plough, and UCB Pharma, and has received research grant support from Abbott and UCB Pharma; Stephen Hanauer has served as a consultant to and has been involved in clinical research with Abbot Laboratories, Bristol-Myers Squibb, Centocor, Elan Pharmaceuticals, Ferring Pharmaceuticals, Genentech, Proctor and Gamble, Prometheus, Salix, Shire, and UCB Pharma, and has served as a consultant for AstraZeneca, GlaxoSmithKline, and Millennium Pharmaceuticals; Jean-Frédéric Colombel has received consulting fees and honoraria, has been involved in clinical research, and has received research support from UCB Pharma, Schering-Plough, Centocor, and Abbott Laboratories; Ralph Bloomfield is an employee of UCB Pharma; and Gary Lichtenstein has received consulting fees from Abbott Laboratories, Centocor, Ferring, Tanabe, Schering-Plough, Elan, Genentech, Given Imaging, Millennium Pharmaceuticals, Proctor and Gamble, Prometheus, Salix, Shire, UCB Pharma, and Wyeth, has received lecture fees from Abbott, Centocor, Proctor and Gamble, Salix, and UCB Pharma, and has undertaken research with Abbott, AstraZeneca, Bristol-Myers Squibb, Proctor and Gamble, Salix, and Shire.

Funding This study was funded by UCB, Brussels. Medical writing assistance was provided by Sian Kneller, MSc, and Bill Kadish, MD, PAREXEL, and was funded by UCB, Brussels.

PII: S1542-3565(10)00302-2

doi:10.1016/j.cgh.2010.03.024

© 2010 AGA Institute. Published by Elsevier Inc. All rights reserved.

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Reinduction With Certolizumab Pegol in Patients With Relapsed Crohn's Disease: Results From the PRECiSE 4 Study