Original article—alimentary tractCertolizumab Pegol in Patients With Moderate to Severe Crohn's Disease and Secondary Failure to Infliximab
Section snippets
Materials and Methods
This multicenter open-label induction and randomized, double-blind, maintenance-phase, active control study was conducted globally at 121 centers in 14 countries (Austria, Belgium, Canada, Denmark, France, Germany, Italy, Norway, The Netherlands, Spain, Sweden, Switzerland, the United Kingdom, and the United States) between April 2006 and August 2008 (Appendix). The protocol was approved by the Institutional Review Board or ethics committee at each center. All patients provided written informed
Patient Characteristics and Disposition
Patient disposition is shown in Supplementary Figure 1. Of 539 patients who entered the trial, 334 (62.0%) had a CDAI-100 clinical response at week 6. In total, 329 patients who responded at week 6 received at least 1 dose of the allocated randomized, double-blind, maintenance therapy (n = 168 and n = 161 randomized to treatment every 4 weeks or every 2 weeks, respectively). Of these, 79 (47.0%) patients in the every-4-weeks group and 71 (44.1%) patients in the every-2-weeks group completed 26
Discussion
Certolizumab pegol 400 mg at 0, 2, and 4 weeks induced response and remission in patients with moderate to severe Crohn's disease who had prior loss of response and/or hypersensitivity to infliximab. Among patients who responded to induction therapy, maintenance therapy with certolizumab pegol 400 mg every 4 weeks and every 2 weeks resulted in similar rates of response and remission at week 26. Subgroup analyses showed a generally consistent benefit when the results were stratified for
Acknowledgments
This study was conceived and designed by scientists at UCB Pharma (including Krassimir Mitchev and Corinne Jamoul) and the co-principal investigators (William Sandborn and Paul Rutgeerts). The statistical analysis of the entire data sets pertaining to efficacy (specifically primary and major secondary efficacy end points) and safety (specifically serious adverse events as defined in federal guidelines) have been confirmed by a UCB-employed statistician according to stringent and validated
References (24)
- et al.
Maintenance infliximab for Crohn's disease: the ACCENT I randomised trial
Lancet
(2002) - et al.
A randomized, placebo-controlled trial of certolizumab pegol (CDP870) for treatment of Crohn's disease
Gastroenterology
(2005) - et al.
Human anti-tumor necrosis factor monoclonal antibody (adalimumab) in Crohn's disease: the CLASSIC-I trial
Gastroenterology
(2006) - et al.
Adalimumab for maintenance of clinical response and remission in patients with Crohn's disease: the CHARM trial
Gastroenterology
(2007) - et al.
Development of a Crohn's disease activity indexNational Cooperative Crohn's Disease Study
Gastroenterology
(1976) - et al.
Quality of life: a valid and reliable measure of therapeutic efficacy in the treatment of inflammatory bowel diseaseCanadian Crohn's Relapse Prevention Trial Study Group
Gastroenterology
(1994) - et al.
A review of activity indices and efficacy endpoints for clinical trials of medical therapy in adults with Crohn's disease
Gastroenterology
(2002) Maintenance infliximab for Crohn's disease (author reply)
Lancet
(2002)- et al.
Comparison of scheduled and episodic treatment strategies of infliximab in Crohn's disease
Gastroenterology
(2004) - et al.
Serious infections and mortality in association with therapies for Crohn's disease: TREAT registry
Clin Gastroenterol Hepatol
(2006)
A short-term study of chimeric monoclonal antibody cA2 to tumor necrosis factor alpha for Crohn's diseaseCrohn's Disease cA2 Study Group
N Engl J Med
Certolizumab pegol for the treatment of Crohn's disease
N Engl J Med
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ClinicalTrials.gov number: NCT00308581.
Conflicts of interest These authors disclose the following: William Sandborn received grants/research support, was a consultant, and was on the advisory committee for UCB; Maria Abreu was a consultant for UCB; Geert D'Haens was a consultant, and was on the speakers bureau and advisory committee for UCB; Jean-Frédéric Colombel was a consultant, was on the advisory committee, and received lecture fees from UCB; Severine Vermeire received grants/research support, and was on the speakers bureau for UCB; Krassimir Mitchev and Corinne Jamoul are employees of UCB; Richard Fedorak was a consultant, and was on the speakers bureau and advisory committee for UCB; Douglas Wolf received grants/research support, was a consultant, and was on the speakers bureau and advisory committee for UCB; Scott Lee received grants/research support, was a consultant, and was on the speakers bureau for UCB; Paul Rutgeerts received grant/research support, was a consultant, and was on the advisory committee for UCB. Martina Spehlmann discloses no conflicts.