Department of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
Division of Rhinology, Department of Otolaryngology-Head & Neck Surgery, University of Toronto, Toronto, Ontario, Canada.
Int Forum Allergy Rhinol. 2024 Oct;14(10):1618-1633. doi: 10.1002/alr.23453. Epub 2024 Sep 20.
Biologic therapies approved for treating chronic rhinosinusitis with nasal polyps (CRSwNP) have well-established safety profiles but reports of rheumatic adverse events (AEs) are increasing and not well defined. This review aims to assess the risk and incidence of rheumatic AEs associated with biologic therapy in CRSwNP and summarize current reported management strategies.
A protocol was registered in PROSPERO [CRD42024525663]. A search was conducted in four electronic databases: Medline (Ovid), Embase, Scopus, and Cochrane CENTRAL from inception until January 4, 2024. Two reviewers independently screened citations and extracted data. Methodological quality was assessed using the Joanna Briggs Institute's critical appraisal tool. Data were pooled using a random effects model to calculate overall incidence and relative risk.
Twenty-one studies met the final inclusion criteria, totaling 3434 patients of which 2763 (80%) received either dupilumab (n = 2257; 82%), mepolizumab (n = 372; 13%), or omalizumab (n = 134; 5%) for treatment of CRSwNP. The overall incidence rate for any on-treatment rheumatic AE was 0.05 per person-year (95% CI, 0.03-0.09, I= 75%). Biologic therapy increased the risk of developing a rheumatic AE (RR = 2.53; 95% CI, 1.29-4.94) compared with placebo. The most frequently reported rheumatic AE was arthralgia or joint pain (n = 94; 95%), followed by lupus-like syndrome or lupus erythematosus-like reaction (n = 2; 2.5%). Discontinuation of treatment was the most common intervention (n = 21, 39%).
Biologic therapy increases the risk of rheumatic AEs in CRSwNP patients by over twofold. Healthcare providers should remain vigilant in monitoring rheumatic AEs and apply appropriate management strategies on a case-by-case basis.
已批准用于治疗慢性鼻-鼻窦炎伴鼻息肉(CRSwNP)的生物疗法具有明确的安全性,但风湿不良事件(AEs)的报告正在增加且尚未明确界定。本综述旨在评估与 CRSwNP 生物治疗相关的风湿性 AE 的风险和发生率,并总结当前报告的管理策略。
本研究方案在 PROSPERO 中注册[CRD42024525663]。在四个电子数据库中进行了检索:Medline(Ovid)、Embase、Scopus 和 Cochrane CENTRAL,检索时间从建库至 2024 年 1 月 4 日。两位评审员独立筛选引文并提取数据。使用 Joanna Briggs 研究所的批判性评估工具评估方法学质量。使用随机效应模型汇总数据,以计算总体发生率和相对风险。
21 项研究符合最终纳入标准,共纳入 3434 例患者,其中 2763 例(80%)接受了度普利尤单抗(n=2257;82%)、美泊利单抗(n=372;13%)或奥马珠单抗(n=134;5%)治疗 CRSwNP。任何治疗期间发生的风湿性 AE 的总体发生率为 0.05 人-年(95%CI,0.03-0.09,I=75%)。与安慰剂相比,生物治疗增加了发生风湿性 AE 的风险(RR=2.53;95%CI,1.29-4.94)。报告最频繁的风湿性 AE 是关节痛或关节痛(n=94;95%),其次是狼疮样综合征或红斑狼疮样反应(n=2;2.5%)。最常见的干预措施是停止治疗(n=21;39%)。
生物疗法使 CRSwNP 患者发生风湿性 AE 的风险增加了两倍以上。医疗保健提供者应保持警惕,监测风湿性 AE,并根据具体情况应用适当的管理策略。