ABSTRACT
Introduction
Studies in patients with immune-mediated inflammatory diseases (IMIDs) have inconsistently suggested that anti-TNFα therapy may be associated with excessive weight gain.
Areas covered
We performed a nested case/non-case analysis to investigate the anti-TNF-α inhibitor-associated body-changes in the US Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) database. The risk was expressed as a measure of disproportionality using the reporting odds ratio (ROR) while adjusting for sex, drugs known to cause weight gain and reporter type. We also performed a time-to-onset (TTO) analysis of body weight-related events.
Results
Infliximab was the most commonly involved TNF-α inhibitor in body weight-related changes, reaching an aROR of 1.42 (95%CI:1. 26; 1.59). An increased risk was especially found in patients affected by rheumatic disorders, both in the adult and pediatric population. The median TTO after the start of anti- TNFα therapy was about 6–7 months for both children and adults.
Conclusions
Given the potential effect of these agents on the excess weight gain in IMIDs patients, continuous attention for this side effect with appropriate counseling regarding lifestyle modifications are warranted, especially in those at high risk for obesity.
Declaration of interest
The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: RPvM is an employee of Oracle Health Sciences. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
Author contributions
FM conceptualized and designed the study, interpreted the data drafted the manuscript, revised and approved the final manuscript as submitted. BV, M AB, A S, P M, M G, and G M, R P. van M, participated in the conceptualization and design of the study, participated in the analysis and interpretation of the data, revised the article, and approved the final article as submitted. R S and E C participated in the conceptualization and design of the study, participated in the analysis and interpretation of the data, coordinated and supervised data collection, critically reviewed the manuscript and approved the final manuscript as submitted. CC conceptualized and designed the study, interpreted the data, coordinated and supervised data collection, critically reviewed the manuscript and approved the final manuscript as submitted.
Reviewer Disclosures
Peer reviewers on this manuscript have no relevant financial relationships or otherwise to disclose.