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Impact of Obesity on Short- and Intermediate-Term Outcomes in Inflammatory Bowel Diseases: Pooled Analysis of Placebo Arms of Infliximab Clinical Trials.

Abstract：

Background and aims:To assess whether obesity may affect natural history of inflammatory bowel diseases (IBD), we conducted an individual participant data (IPD) pooled analysis of placebo arms, using data from clinical trials of infliximab in IBD and using the Yale Open Data Access (YODA) Project. Methods:We obtained IPD from 4 placebo-controlled trials of infliximab in adults with IBD (ACCENT-I and ACCENT-II; ACT-1 and ACT-2). Patients were categorized into quartiles based on body mass index (BMI) or weight at time of trial entry. Primary outcome was clinical remission (Crohn's disease activity index [CDAI]<150, Mayo Clinic Score <3); secondary outcomes were clinical response and mucosal healing. Using multivariable logistic regression analysis, we compared association between quartiles of BMI (or weight) and achieving remission, after adjusting for sex, smoking, disease activity, and concomitant prednisone or immunomodulators. Results:We included 575 placebo-treated patients (mean age 38 years, 51.6% males, 16% obese). Obesity was not associated with odds of achieving clinical remission (Q4 vs Q1: adjusted OR, 1.36; 95% CI, 0.65-2.89; P-value for trend = 0.57), clinical response (Q4 vs Q1: adjusted OR, 1.31; 95% CI, 0.61-2.81; P = 0.45), or mucosal healing remission (Q4 vs Q1: adjusted OR, 0.55; 95% CI, 0.12-2.34; P = 0.31). These results were consistent across strata based on disease type (CD and ulcerative colitis) and trial design (induction and maintenance therapy). Conclusions:Based on IPD pooled analysis of placebo arms, obesity does not significantly impact short- and intermediate-term clinical outcomes in patients with IBD. The impact of obesity on long-term patient-important outcomes like surgery and hospitalization merits evaluation.

journal_name

Inflamm Bowel Dis

journal_title

Inflammatory bowel diseases

authors

Singh S,Proudfoot J,Xu R,Sandborn WJ

doi

10.1093/ibd/izy135

subject

Has Abstract

pub_date

2018-09-15 00:00:00

pages

2278-2284

issue

eissn

1078-0998

issn

1536-4844

pii

4999331

journal_volume

pub_type

杂志文章

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Impact of Obesity on Short- and Intermediate-Term Outcomes in Inflammatory Bowel Diseases: Pooled Analysis of Placebo Arms of Infliximab Clinical Trials.