Abstract：
An unmet clinical need exists in the management of treatment-refractory allergic bronchopulmonary aspergillosis (ABPA). Omalizumab has shown promising effects in case series and cohort studies; however, evidence to support its routine clinical use is lacking.
The aim of this systematic review and meta-analysis was to evaluate the clinical effectiveness and safety of omalizumab in patients with ABPA.
We conducted a systematic search across standard databases using specific key words until May 13, 2021. We performed a meta-analysis to compare the effectiveness (exacerbations, oral corticosteroid [OCS] use, lung function, and patient-reported asthma control) and safety of pre- and post-omalizumab treatment. Subgroup analyses were performed for treatment duration and underlying disease.
In total, 49 studies (n = 267) were included in the qualitative synthesis and 14 case series (n = 186) in the quantitative meta-analysis. Omalizumab treatment significantly reduced the annualized exacerbation rate compared with pretreatment (mean difference, -2.09 [95% CI, -3.07 to -1.11]; P < .01). There was a reduction in OCS use (risk difference, 0.65 [95% CI, 0.46-0.84]; P < .01), an increase in termination of OCS use (risk difference, 0.53 [95% CI, 0.24-0.82]; P < .01), and a reduction in OCS dose (milligrams per day) (mean difference, -14.62 [95% CI, -19.86 to -9.39]; P < .01) in ABPA patients receiving omalizumab. Omalizumab improved FEV1 % predicted by 11.9% (95% CI, 8.2-15.6; P < .01) and asthma control, and was well-tolerated.
Omalizumab treatment reduced exacerbations and OCS use, improved lung function and asthma control in patients with ABPA, and was well-tolerated. The results highlight the potential role of omalizumab in the treatment of ABPA.
The aim of this systematic review and meta-analysis was to evaluate the clinical effectiveness and safety of omalizumab in patients with ABPA.
We conducted a systematic search across standard databases using specific key words until May 13, 2021. We performed a meta-analysis to compare the effectiveness (exacerbations, oral corticosteroid [OCS] use, lung function, and patient-reported asthma control) and safety of pre- and post-omalizumab treatment. Subgroup analyses were performed for treatment duration and underlying disease.
In total, 49 studies (n = 267) were included in the qualitative synthesis and 14 case series (n = 186) in the quantitative meta-analysis. Omalizumab treatment significantly reduced the annualized exacerbation rate compared with pretreatment (mean difference, -2.09 [95% CI, -3.07 to -1.11]; P < .01). There was a reduction in OCS use (risk difference, 0.65 [95% CI, 0.46-0.84]; P < .01), an increase in termination of OCS use (risk difference, 0.53 [95% CI, 0.24-0.82]; P < .01), and a reduction in OCS dose (milligrams per day) (mean difference, -14.62 [95% CI, -19.86 to -9.39]; P < .01) in ABPA patients receiving omalizumab. Omalizumab improved FEV1 % predicted by 11.9% (95% CI, 8.2-15.6; P < .01) and asthma control, and was well-tolerated.
Omalizumab treatment reduced exacerbations and OCS use, improved lung function and asthma control in patients with ABPA, and was well-tolerated. The results highlight the potential role of omalizumab in the treatment of ABPA.
摘要：
背景：治疗难治性过敏性支气管肺曲霉病（ABPA）的治疗存在未满足的临床需求。奥马珠单抗在病例系列和队列研究中显示出有希望的效果；然而，缺乏支持其常规临床使用的证据.
目的：本系统评价和荟萃分析的目的是评估奥马珠单抗在ABPA患者中的临床有效性和安全性。
方法：使用特定关键字对标准数据库进行系统搜索，直到2021年5月13日。进行了荟萃分析以比较有效性(恶化，口服皮质类固醇[OCS]使用，肺功能,患者报告的哮喘控制）和奥马珠单抗治疗前后的安全性。对治疗持续时间和潜在疾病进行亚组分析。
结果：总计，49项研究（n=267）纳入定性综合，14项病例系列（n=186）纳入定量荟萃分析。与治疗前相比，奥马珠单抗治疗显着降低了年度加重率（平均差异[MD]：-2.09[-3.07；-1.11]，P<0.01)。OCS使用减少(风险差异[RD]：0.65[0.46；0.84]，P<0.01),OCS使用终止的增加(RD：0.53[0.24；0.82]，P<0.01),在接受奥马珠单抗的ABPA患者中，OCS剂量（mg/day）减少（MD：-14.62[-19.86;-9.39];P<0.01）。奥马珠单抗可改善1秒用力呼气量（FEV1）％，预测为11.9％（8.2;15.6，P<0.01）和哮喘控制，并被很好地容忍。
结论：奥马珠单抗治疗可减少ABPA患者的急性发作和OCS使用，改善肺功能和哮喘控制，且耐受性良好。结果强调了奥马珠单抗在ABPA治疗中的潜在作用。
目的：本系统评价和荟萃分析的目的是评估奥马珠单抗在ABPA患者中的临床有效性和安全性。
方法：使用特定关键字对标准数据库进行系统搜索，直到2021年5月13日。进行了荟萃分析以比较有效性(恶化，口服皮质类固醇[OCS]使用，肺功能,患者报告的哮喘控制）和奥马珠单抗治疗前后的安全性。对治疗持续时间和潜在疾病进行亚组分析。
结果：总计，49项研究（n=267）纳入定性综合，14项病例系列（n=186）纳入定量荟萃分析。与治疗前相比，奥马珠单抗治疗显着降低了年度加重率（平均差异[MD]：-2.09[-3.07；-1.11]，P<0.01)。OCS使用减少(风险差异[RD]：0.65[0.46；0.84]，P<0.01),OCS使用终止的增加(RD：0.53[0.24；0.82]，P<0.01),在接受奥马珠单抗的ABPA患者中，OCS剂量（mg/day）减少（MD：-14.62[-19.86;-9.39];P<0.01）。奥马珠单抗可改善1秒用力呼气量（FEV1）％，预测为11.9％（8.2;15.6，P<0.01）和哮喘控制，并被很好地容忍。
结论：奥马珠单抗治疗可减少ABPA患者的急性发作和OCS使用，改善肺功能和哮喘控制，且耐受性良好。结果强调了奥马珠单抗在ABPA治疗中的潜在作用。
