Weight Gain on Infliximab Tied to Sex, Crohn Disease, and Disease Severity

weight, standing on scale
Results provide meaningful information for clinicians to appropriately council patients on expected weight gain after starting infliximab therapy.

Among those initiating infliximab, weight gain is more likely among those with Crohn disease and markers of severe disease, according to a study recently published in Inflammatory Bowel Diseases. Women are also less likely than men to gain weight a year after starting infliximab.

This randomized, placebo-controlled trial included 1273 participants (50% women, 91% white) with moderate-to-acute Crohn disease (81%) and ulcerative colitis, all of whom were treated to induce and maintain remission. The ACCENT I and ACCENT II studies focused on the efficacy of antitumor necrosis factor-alpha chimeric monoclonal antibody infliximab (Remicade®, Janssen Biotech, Inc.) in long-term treatment of active and fistulizing Crohn disease, respectively. The SONIC study focused on individuals with Crohn disease who were naive to immunomodulator and biologic treatments, while the ACT 1 trial focused on infliximab as a treatment for ulcerative colitis.

Data from all of these studies were extracted for analysis. The intervention group received infliximab 5 mg/kg (n=789) or 10 mg/kg (n=314), and the control group from the SONIC study received azathioprine as placebo. The relationship between weight gain and sex was explored using mixed effects models, with adjustments made for clinical and demographic characteristics.

Weight gain was more likely among those who were African American (P =.0005), had a Crohn disease diagnosis (P <.001), received infliximab of any dosage (P <.001), had elevated levels of C-reactive protein (P <.001), and had low albumin and hematocrit (P <.001 for both) with univariate analysis. After adjustments, a significant association was identified between weight gain and men, wherein men experienced a higher weight increase from baseline than women (4.3% vs 3.9%; P =.009).

Limitations to this study included the use of data from randomized clinical trials, which are prone to excluding those prescribed biologic therapy; a limited number of participants with ulcerative colitis; a lack of data on parameters affecting weight gain; a potential lack of generalizability due to data from multinational studies; and a short follow-up period.

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Study researchers concluded that “women gain significantly less weight than men when starting treatment for moderate to severe [inflammatory bowel disease]. Weight gain after starting anti-[tumor necrosis factor] is likely due to combating the [tumor necrosis factor-alpha]–associated anorexia and restoration of a positive energy balance, potentially mediated by leptin. Patients with [Crohn disease] and those who receive any dose of [infliximab] are more likely to experience increased weight gain. When starting treatment, those with more severe disease, as indicated by lower albumin and hematocrit and higher [C-reactive protein], are likely to gain more weight. Potentially, [African American] race is associated with increased weight gain, although these results should be interpreted with caution given low sample size.”

Disclosure: Raymond K. Cross, MD, reports financial associations with Abbvie, Janssen, Pfizer, UCB, and Takeda. 


Christian KE, Russman KM, Rajan DP, Barr EA, Cross RK. Gender differences and other factors associated with weight gain following initiation of infliximab: a post hoc analysis of clinical trials [published online July 2, 2019]. Inflamm Bowel Dis. doi:10.1093/ibd/izz133