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.

中文翻译：

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抗 TNFα 药物对体重相关变化的影响：使用 FDA 不良事件报告系统 (FAERS) 数据库进行的真实药物警戒研究的新见解

摘要

介绍

对免疫介导炎症性疾病 (IMID) 患者的研究不一致地表明，抗 TNFα 治疗可能与体重过度增加有关。

涵盖的领域

我们进行了嵌套病例/非病例分析，以调查美国食品和药物管理局 (FDA) 不良事件报告系统 (FAERS) 数据库中抗 TNF-α 抑制剂相关的身体变化。风险表示为使用报告优势比 (ROR) 衡量不成比例，同时调整性别、已知会导致体重增加的药物和报告类型。我们还对体重相关事件进行了发病时间 (TTO) 分析。

结果

英夫利昔单抗是体重相关变化中最常涉及的 TNF-α 抑制剂，aROR 达到 1.42 (95%CI:1. 26; 1.59)。在成人和儿童人群中，风湿性疾病患者的风险尤其增加。儿童和成人开始抗 TNFα 治疗后的中位 TTO 约为 6-7 个月。

结论

鉴于这些药物对 IMIDs 患者体重过度增加的潜在影响，有必要持续关注这种副作用，并就生活方式的改变提供适当的咨询，特别是在肥胖高风险人群中。