Gastroenterology

Gastroenterology

Volume 135, Issue 5, November 2008, Pages 1493-1499
Gastroenterology

Clinical–Alimentary Tract
Effects of Adalimumab Therapy on Incidence of Hospitalization and Surgery in Crohn's Disease: Results From the CHARM Study

https://doi.org/10.1053/j.gastro.2008.07.069Get rights and content

Background & Aims

We determined the effects of adalimumab maintenance treatment on the risks of hospitalization and surgery in Crohn's disease (CD).

Methods

A total of 778 patients with CD were randomized to placebo, adalimumab 40 mg every other week or adalimumab 40 mg weekly, all after an 80-mg/40-mg adalimumab induction regimen. All-cause and CD-related hospitalizations and major CD-related surgeries were compared between the placebo and adalimumab groups (every other week, weekly, and both combined) using Kaplan–Meier analysis and Cox proportional hazard models.

Results

Both 3- and 12-month hospitalization risks were significantly lower for patients who received adalimumab. Hazard ratios for all-cause hospitalization were 0.45, 0.36, and 0.40 for the adalimumab every other week, weekly, and combined groups, respectively (all P < .01 vs placebo). Hazard ratios for CD-related hospitalization were 0.50, 0.34, and 0.42, respectively (all P < .05). Cox model estimates demonstrated adalimumab every other week and weekly maintenance therapies were associated with 52% and 60% relative reductions in 12-month, all-cause hospitalization risk, and 48% and 64% reductions in 12-month risk of CD-related hospitalization. The combined adalimumab group was associated with 56% reductions in both all-cause and CD-related hospitalization risks. Fewer CD-related surgeries occurred in the adalimumab every other week, weekly, and combined groups compared with placebo (0.4, 0.8, and 0.6 vs 3.8 per 100 patients; all P < .05).

Conclusions

Patients with moderate-to-severe CD treated with adalimumab had lower 1-year risks of hospitalization and surgery than placebo patients.

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.

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