Abstract
OBJECTIVES: To assess whether obesity may affect response to infliximab, we conducted an individual participant data pooled analysis using data from clinical trials of infliximab in inflammatory bowel diseases (IBD), using the Yale Open Data Access (YODA) Project. METHODS: We analyzed individual participant data from four clinical trials of infliximab in adults with IBD (ACCENT-I, SONIC, ACT-1, and -2). Patients were categorized as obese (body mass index [BMI] ≥ 30 kg/m(2)) vs. non-obese, and by quartiles based on BMI or weight at time of trial entry. Primary outcome was clinical remission (Crohn's disease activity index [CDAI] < 150 or pediatric CDAI <10, Mayo Clinic Score <3); secondary outcomes were clinical response and mucosal healing. Multivariable logistic regression analysis was performed, after adjusting for sex, smoking, disease activity, and concomitant prednisone and/or immunomodulators. RESULTS: We included 1205 infliximab-treated patients (mean age 37 years, 51.6% males, 14% obese). Obesity was not associated with odds of achieving clinical remission (obese vs. non-obese: adjusted OR, 0.93 [95% CI, 0.47-1.46]; Q4 vs. Q1: aOR, 0.94 [0.61-1.47], p-value for trend = 0.97), clinical response (Q4 vs. Q1: aOR, 0.84 [0.52-1.35], p = 0.45) or mucosal healing (Q4 vs. Q1: aOR, 1.13 [0.55-2.34], p = 0.95). These results were consistent across strata based on disease type (Crohn's disease and ulcerative colitis) and trial design (induction and maintenance therapy). CONCLUSIONS: Based on individual participant data pooled analysis, obesity is not associated with inferior response to infliximab in patients with IBD. Future studies examining the association between obesity and fixed-dose therapies are warranted.