背景:过敏性支气管肺曲霉病(ABPA)的治疗具有挑战性。生物疗法已被报道为ABPA的辅助治疗。主要是病例系列或病例报告。这项研究旨在分析生物制剂对定性和定量管理ABPA的功效。
方法:2023年10月发表的关于APBA的所有文章都在PubMed中进行了搜索,WebofScience,ClinicalTrials.gov,和Embase数据库。感兴趣的影响是结果相对于基线的平均变化,包括恶化率,口服皮质类固醇(OCS),和总免疫球蛋白E(IgE)水平。通过常规或个体患者数据(IPD)荟萃分析定量综合报告的结果。PROSPERO注册号:CRD42022373396。
结果:系统评价共纳入86项研究,包括346例患者。16项关于奥马珠单抗的研究被汇总用于常规的荟萃分析。奥马珠单抗治疗显着降低恶化率(-2.29[95CI-3.32,-1.26]),OCS剂量(-10.91mg[95CI-18.98,-2.85]),和总IgE水平(-273.07IU/mL[95CI-379.30,-166.84]),同时改善FEV1%预测(10.09%[95CI6.62,13.55])。关于dupilumab的31项研究,美波利单抗,或贝那利珠单抗合并进行IPD荟萃分析,回顾性。dupilumab和mepolizumab均显著降低恶化率,OCS,和总IgE水平。Benralizumab显示出类似的趋势,但没有统计学意义。Tezepelumab对ABPA的影响显示出微弱的证据。所有五种生物制剂均导致较温和的临床症状(例如,咳嗽,喘息)在奥马珠单抗治疗中发生过一次严重的不良反应。
结论:这些结果表明奥马珠单抗的临床益处,dupilumab,和美泊利单抗治疗ABPA患者。进一步随机化,需要更大样本量和更长时间随访的对照研究来证实这些发现.
BACKGROUND: Treatment of allergic bronchopulmonary aspergillosis (ABPA) is challenging. Biological therapies have been reported as adjunctive treatments for ABPA, primarily in case series or case reports. This study aimed to analyze the efficacy of biologics for managing ABPA both qualitatively and quantitatively.
METHODS: All articles on APBA published in October 2023 were searched in PubMed, Web of Science, ClinicalTrials.gov, and Embase databases. The effects of interest were the mean changes from baseline for outcomes, including exacerbation rates, oral corticosteroids usage (OCS), and total immunoglobulin E (IgE) levels. Reported outcomes were quantitatively synthesized by usual or individual patient data (IPD) meta-analyses. PROSPERO registration number: CRD42022373396.
RESULTS: A total of 86 studies were included in the systematic
review including 346 patients. Sixteen studies on omalizumab were pooled for the usual meta-analysis. Omalizumab therapy significantly reduced exacerbation rates (- 2.29 [95%CI - 3.32, - 1.26]), OCS dosage (- 10.91 mg [95%CI - 18.98, - 2.85]), and total IgE levels (- 273.07 IU/mL [95%CI - 379.30, - 166.84]), meanwhile improving FEV1% predicted (10.09% [95%CI 6.62, 13.55]). Thirty-one studies on dupilumab, mepolizumab, or benralizumab were pooled to perform an IPD meta-analysis, retrospectively. Both dupilumab and mepolizumab significantly reduced exacerbation rates, OCS, and total IgE levels. Benralizumab showed a similar trend, but it was not statistically significant. Tezepelumab showed weak evidence of its effects on ABPA. All five biologics led to milder clinical symptoms (e.g., cough, wheezing) with serious adverse effects that happened once in omalizumab treatment.
CONCLUSIONS: These results indicate the clinical benefit of omalizumab, dupilumab, and mepolizumab in patients with ABPA. Further randomized, controlled studies with a larger sample size and longer follow-up are needed to confirm these findings.