The impact of anti-TNFα agents on weight-related changes: new insights from a real-world pharmacovigilance study using the FDA adverse event reporting system (FAERS) database
| Autor: | Albaraa Mohammed N. Marran, Sonia Radice, Emilio Clementi, Vera Battini, Robbert P. van Manen, Faizan Mazhar, Marco Pozzi, Michele Gringeri, Giulia Mosini, Carla Carnovale, Shahzad Akram |
|---|---|
| Rok vydání: | 2021 |
| Předmět: |
Adult
0301 basic medicine Research design Databases Factual Drug-Related Side Effects and Adverse Reactions Side effect Clinical Biochemistry computer.software_genre Pharmacovigilance 03 medical and health sciences Adverse Event Reporting System 0302 clinical medicine Drug Discovery medicine Adverse Drug Reaction Reporting Systems Humans Child Pharmacology Database Tumor Necrosis Factor-alpha United States Food and Drug Administration business.industry Odds ratio medicine.disease United States Infliximab 030104 developmental biology 030220 oncology & carcinogenesis Tumor Necrosis Factor Inhibitors Immune-mediated inflammatory diseases medicine.symptom business computer Weight gain medicine.drug |
| Zdroj: | Expert Opinion on Biological Therapy. 21:1281-1290 |
| ISSN: | 1744-7682 1471-2598 |
| Popis: | Background: Studies in patients with immune-mediated inflammatory diseases (IMIDs) have inconsistently suggested that anti-TNFα therapy may be associated with excessive weight gain. Research design and methods: 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 paediatric 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 counselling regarding lifestyle modifications are warranted, especially in those at high risk for obesity. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|