Background and Aims: To assess whether obesity may affect response to infliximab, we conducted an individual participant data (IPD) 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 IPD from 6 clinical trials of infliximab in adults or children with IBD (ACCENT-I and -II, SONIC, ACT-1 and -2, REACH). 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 or pediatric CDAI<10, Mayo Clinic Score <3); secondary outcomes were clinical response and mucosal healing. Using multivariable logistic regression analysis, association between quartiles of BMI (or weight) and achieving remission were analyzed, after adjusting for sex, smoking, disease activity, and concomitant prednisone and/or immunomodulators. Results: We included 1399 infliximab-treated patients (mean age 36y, 52.1% males, 14% obese). Obesity was not associated with odds of achieving clinical remission (Q4 vs. Q1: adjusted OR, 0.94 [95% CI, 0.61-1.47], p-value for trend=0.97), clinical response (Q4 vs. Q1: adjusted OR, 0.84 [0.52-1.35], p=0.45) or mucosal healing remission (Q4 vs. Q1: adjusted OR, 1.13 [0.55-2.34], p=0.95) (Figure 1). These results were consistent across strata based on disease type (CD and ulcerative colitis), trial design (induction and maintenance therapy), and in adults and pediatric studies (Table 1). Conclusions: Based on IPD 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.
