OBJECTIVES : To evaluate the association between Tumour necrosis factor-alpha (TNF-α) inhibitors and changes in anthropometric measures using a real-world data.

METHODS : A nested case-control study was performed using the Food and Drug Administration Adverse Event Reporting System (FAERS) database. Association was quantified as reporting odds ratio (ROR) while adjusting for potential confounders. We also conduct a retrospective longitudinal survey of 16 pediatric patients diagnosed with IBD at our centre. Anthropometric data (expressed as z scores of weight and BMI ) and glycolipid measures were collected at the time of anti-TNF initiation and annually.

RESULTS : A significant weight-related event signal was found for anti-TNF in FAERS. The highest ROR was found for infliximab: 1.6 (95% CI:1.4–1.75) and lowest for golimumab 0.85 (0.7–1.2). In a retrospective survey, median age of patients was 9.5 years at the diagnosis of IBD. At baseline, mean weight was -2.88 (SD 1.7), while mean BMIz was -0.14 (1.3). Compared to baseline, there was a significant increase in body weight z score after 2 years (mean gain 2.06 ±0.38 p < 0.0001). Changes between first and second year of treatment were statistically significant (1.99 ± 0.36; p<0.001). Variations in BMIz was not statistically significant at any time point. At 1 year there was a significant increase in total cholesterol and low-density lipid. Two-year changes in body weight z scores was positively correlated with 2-year changes in LDL (r=–0.54, p = 0.02) while negatively with disease activity score (r=-0.51; p=0.04). Two- year changes LDL was positively correlated with serum glucose (r=0.51; p=0.047).

CONCLUSIONS : Anti-TNF-α treatment appears to be associated with an increase in body weight, BMI, and other anthropometric parameters. Given the different course of the IBD in children and adults, this association should be considered before initiating biologics for undernourished, overweight, and obese patients.