Clinical–Alimentary TractEffects of Adalimumab Therapy on Incidence of Hospitalization and Surgery in Crohn's Disease: Results From the CHARM Study
Section snippets
The CHARM Trial
The CHARM was a multicenter, Phase III, double-blind, randomized, placebo-controlled trial (ClinicalTrials.gov Identifier NCT00077779). The CHARM trial assessed the long-term efficacy and safety of adalimumab every other week and weekly versus placebo in maintaining clinical remission in patients with active, moderate-to-severe CD. Primary efficacy and safety results for CHARM have been published.14 Eligible patients were between 18 and 75 years old, had CD for >4 months (diagnosis confirmed by
Sample Characteristics
Of the 778 patients randomized, 260 were assigned to adalimumab every other week, 257 to adalimumab weekly, and 261 placebo. Baseline characteristics were similar between groups (Table 1). Mean CDAI scores at randomization were 204 (standard deviation, 89) for the whole sample and 195, 209, and 209 for the adalimumab every other week, adalimumab weekly, and placebo groups, respectively. In the study sample, 35.6% were smokers, 15% had fistulizing disease, and 40.2% were receiving
Discussion
CD is a chronic condition that often requires hospitalization and surgery for management. A Norwegian study that followed a cohort of 221 CD patients prospectively for 5 years found that 28% had undergone surgery.16 The risk for patients with moderate-to-severe disease, such as those who participated in the CHARM trial, is likely to be even greater. Moreover, hospitalized CD patients are at increased risk for subsequent readmission.17 Approximately three quarters of CD patients are hospitalized
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The authors disclose the following: the CHARM study and the analysis reported in this paper were supported by research grants from Abbott Laboratories, Abbott Park, Illinois. The analysis reported in this paper is based on a Phase III trial and pertains to a commercial product (HUMIRA [adalimumab]). Dr G.Y. Zou of the Robarts Research Institute, The University of Western Ontario, London, Ontario, Canada, performed an independent review of the statistical analyses conducted for this manuscript. Dr Feagan had full access to all of the data and takes full responsibility for the veracity of the data and analyses.
Brian Feagan, Remo Panaccione, William Sandborn, Geert D'Haens, Stefan Schreiber, Paul Rutgeerts, and Edward Loftus, Jr, have served as study investigators and consultants for Abbott Laboratories and have participated in continuing medical education events supported by unrestricted educational grants from Abbott. Andrew Yu and Eric Wu are employees of Analysis Group, Inc, who conducted this analysis under contract from Abbott. Kathleen Lomax, Jingdong Chao, and Parvez Mulani are Abbott employees.