Liu Ling, Zhou Pengxiang, Wang Zhenhuan, Zhai Suodi, Zhou Wei
Department of Pediatrics, Peking University Third Hospital, Beijing, China.
Department of Pharmacy, Peking University Third Hospital, Beijing, China.
Front Pediatr. 2022 Mar 15;10:851177. doi: 10.3389/fped.2022.851177. eCollection 2022.
To evaluate the efficacy and safety of omalizumab in the treatment of severe or uncontrolled allergic diseases in children.
We conducted a systematic search of the PubMed, Embase, CENTRAL, and clinicaltrials.gov databases up to 23rd July 2021, with no language limitations. Randomised controlled trials (RCTs) comparing omalizumab with other treatments or placebo in children with severe or inadequately controlled allergic diseases were considered. The primary outcomes of interest were asthma exacerbation rate, allergic symptom score, desensitisation achievement for food allergy (FA), and incidence of serious adverse events (SAEs). The study selection and data extraction were conducted independently by two researchers. Quality assessments were conducted using the Cochrane risk-of-bias tool, and data were pooled using a random-effects model if was 50% or greater in the Cochrane Review Manager.
Overall, 10 RCTs [six on severe asthma, one on atopic dermatitis (AD), one on seasonal allergic rhinitis [SAR], and one on FA] consisting of 2,376 participants met the inclusion criteria. For severe asthma, omalizumab may reduce exacerbations at 12 weeks [risk ratio (RR), 0.52; 95% confidence interval (CI), 0.31-0.89], 24 weeks (RR, 0.69; 95% CI, 0.55-0.85; GRADE: moderate-quality evidence), and 52 weeks (RR, 0.62; 95% CI, 0.40-0.94; GRADE: moderate-quality evidence) and reduce the dose of inhalation corticosteroid compared with placebo. For severe AD, the association between omalizumab and allergic symptom improvement [i.e., SCORing Atopic Dermatitis or Paediatric Allergic Disease Quality of Life Questionnaire (PADQLQ)] was not confirmed. For severe SAR, omalizumab showed greater improvement in symptom load scores and saved rescue medication days. For FA, omalizumab demonstrated superiority in desensitisation compared with placebo. To date, no clinically significant drug-related SAEs have been reported.
For severe or uncontrolled asthma, AD, SAR, and FA, omalizumab may be associated with improved allergic symptoms and safety in children. Future studies should focus on the benefits and pharmacoeconomic evaluation of omalizumab in multiple allergic diseases compared with other treatments.
[https://www.crd.york.ac.uk/PROSPERO], identifier [CRD42021271863].
评估奥马珠单抗治疗儿童重度或控制不佳的过敏性疾病的疗效和安全性。
我们对截至2021年7月23日的PubMed、Embase、CENTRAL和clinicaltrials.gov数据库进行了系统检索，无语言限制。纳入比较奥马珠单抗与其他治疗方法或安慰剂治疗重度或控制不佳的儿童过敏性疾病的随机对照试验（RCT）。主要观察指标为哮喘加重率、过敏症状评分、食物过敏（FA）脱敏成功率及严重不良事件（SAE）发生率。由两名研究人员独立进行研究筛选和数据提取。采用Cochrane偏倚风险工具进行质量评估，若Cochrane系统评价管理器中的I²为50%或更高，则采用随机效应模型合并数据。
总体而言，10项RCT（6项针对重度哮喘，1项针对特应性皮炎（AD），1项针对季节性变应性鼻炎[SAR]，1项针对FA）共2376名参与者符合纳入标准。对于重度哮喘，奥马珠单抗可能在12周时降低加重风险[风险比（RR），0.52；95%置信区间（CI），0.31 - 0.89]，24周时（RR，0.69；95% CI，0.55 - 0.85；证据质量等级：中等质量证据），以及52周时（RR，0.62；95% CI，0.40 - 0.94；证据质量等级：中等质量证据），且与安慰剂相比可降低吸入性糖皮质激素剂量。对于重度AD，未证实奥马珠单抗与过敏症状改善之间的关联[即特应性皮炎评分或儿童过敏性疾病生活质量问卷（PADQLQ）]。对于重度SAR，奥马珠单抗在症状负荷评分方面改善更大，且节省了急救药物使用天数。对于FA，与安慰剂相比，奥马珠单抗在脱敏方面显示出优势。迄今为止，尚未报告有临床意义的药物相关SAE。
对于重度或控制不佳的哮喘、AD、SAR和FA，奥马珠单抗可能改善儿童过敏症状并提高安全性。未来研究应聚焦于奥马珠单抗与其他治疗方法相比在多种过敏性疾病中的益处及药物经济学评估。
