Clinical–alimentary tractNatalizumab for the Treatment of Active Crohn’s Disease: Results of the ENCORE Trial
Section snippets
Patients and Methods
Selected investigators and employees of Elan Pharmaceuticals, Inc (San Diego, CA), and Biogen Idec (Cambridge, MA) designed the ENCORE study. The investigator authors had access to all data, participated in the analysis and interpretation of these data, and were members of the publication committee. The manuscript was written by a publication committee (with the assistance of a medical writer), which included authors from the group of investigators. The authors verified the completeness and
Patient Characteristics
A total of 832 patients were screened; of these, 509 were eligible for randomization at Week 0 (Figure 2). The most common reason for a patient to fail screening was a CRP concentration below the ULN, which occurred in 171 patients (21% of the entire population screened for the trial). Patients were randomly assigned to receive placebo (250 patients) or natalizumab (259 patients). Data for all patients receiving study drug were included in the safety analysis (N = 510). One patient received a
Discussion
The ENCORE trial met all prespecified primary, secondary, and tertiary end points. Results of the trial demonstrated that treatment with 3 infusions of natalizumab (300 mg) over 8 Weeks was effective for inducing response and remission in patients with moderately to severely active Crohn’s disease and objective evidence of inflammation. The ENCORE trial required patients to be in response at 2 consecutive monthly assessments to meet the primary end point criteria. Response was achieved by Week
References (22)
A structural view of integrin activation and signaling
Dev Cell
(2003)- et al.
A randomized placebo-controlled trial of a humanized monoclonal antibody to alpha4 integrin in active Crohn’s disease
Gastroenterology
(2001) - 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 disease
Gastroenterology
(1994) - et al.
A meta-analysis of the placebo rates of remission and response in clinical trials of active Crohn’s disease
Gastroenterology
(2004) - et al.
Mean platelet volume: a useful marker of inflammatory bowel disease activity
Am J Gastroenterol
(2001) C-reactive protein: anti-placebo or predictor of response
Gastroenterology
(2005)- et al.
The pathophysiologic role of alpha 4 integrins in vivo
J Clin Invest
(1994) - et al.
a4 Integrins as therapeutic targets in autoimmune disease
N Engl J Med
(2003) - et al.
Natalizumab for active Crohn’s disease
N Engl J Med
(2003)
Natalizumab induction and maintenance therapy for Crohn’s disease
N Engl J Med
Cited by (0)
Supported by a research grant from Elan Pharmaceuticals, Inc (San Diego, CA), and Biogen Idec (Cambridge, MA).
- 1
P.R., B.F., S.T., R.P., D.P., and W.S. have served as consultants for Elan Pharmaceuticals.
- 2
P.R., S.T., B.L., R.P., and W.S. have participated in continuing medical education events supported by unrestricted educational grants from Elan Pharmaceuticals, Inc, and Biogen Idec.
- 3
C.H. and J.B. are employees of Elan Pharmaceuticals, Inc, and report owning stock options.