TY - JOUR
T1 - Effects of Adalimumab Therapy on Incidence of Hospitalization and Surgery in Crohn's Disease
T2 - Results From the CHARM Study
AU - Feagan, Brian G.
AU - Panaccione, Remo
AU - Sandborn, William J.
AU - D'Haens, Geert R.
AU - Schreiber, Stefan
AU - Rutgeerts, Paul J.
AU - Loftus, Edward V.
AU - Lomax, Kathleen G.
AU - Yu, Andrew P.
AU - Wu, Eric Q.
AU - Chao, Jingdong
AU - Mulani, Parvez
N1 - Funding Information:
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.
Funding Information:
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.
PY - 2008/11
Y1 - 2008/11
N2 - 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.
AB - 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.
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U2 - 10.1053/j.gastro.2008.07.069
DO - 10.1053/j.gastro.2008.07.069
M3 - Article
C2 - 18848553
AN - SCOPUS:55449098725
SN - 0016-5085
VL - 135
SP - 1493
EP - 1499
JO - Gastroenterology
JF - Gastroenterology
IS - 5
ER -