Respiratory Institute, Department of Allergy and Clinical Immunology, Cleveland Clinic Foundation, Cleveland, Ohio.
Respiratory Institute, Department of Allergy and Clinical Immunology, Cleveland Clinic Foundation, Cleveland, Ohio.
Ann Allergy Asthma Immunol. 2018 Jul;121(1):98-104. doi: 10.1016/j.anai.2018.05.007. Epub 2018 May 16.
Aspirin desensitization has been associated with benefit in management of aspirin-exacerbated respiratory disease (AERD). An intervention that would encourage aspirin desensitization to be performed more frequently has substantial potential for improving outcomes and quality of life in patients with AERD.
We investigated whether omalizumab administration would be associated with attenuation of aspirin-provoked bronchospasm in patients with AERD undergoing aspirin desensitization.
We carried out a randomized, double-blind, placebo-controlled study in which subjects with AERD who fulfilled label criteria for omalizumab received omalizumab or placebo for 16 weeks, and then underwent aspirin desensitization.
Eleven subjects completed aspirin desensitization. Of the 7 who were randomized to omalizumab, 5 had no respiratory reaction during aspirin desensitization. Compared with placebo, omalizumab was associated with a significantly greater likelihood for subjects with AERD to have no respiratory reaction during desensitization (P = .04, Fisher exact test). There was an overall difference in urinary leukotriene E4 (LTE4) levels in subjects who received omalizumab and did not have a respiratory reaction during desensitization compared with subjects randomized to placebo (P = .035, mixed model with interaction). Urinary LTE4 levels were significantly higher with respiratory reaction in placebo subjects compared with levels obtained after the 100-mg dose in AERD subjects who had no respiratory reaction (P < .001, mixed model with interaction).
In atopic AERD subjects, omalizumab administration for 16 weeks was associated with "clinically silent" desensitization. Further studies to investigate the therapeutic utility of omalizumab in patients with AERD who are candidates for aspirin desensitization are warranted based on these findings.
ClinicalTrials.gov Identifier NCT00555971.
阿司匹林脱敏已被证明可改善阿司匹林加重的呼吸道疾病（AERD）的治疗效果。一种能够促进阿司匹林脱敏的干预措施，对于改善 AERD 患者的预后和生活质量具有重要意义。
我们旨在研究奥马珠单抗治疗是否能减轻正在接受阿司匹林脱敏的 AERD 患者的阿司匹林诱发的支气管痉挛。
我们进行了一项随机、双盲、安慰剂对照的研究，入组的 AERD 患者符合奥马珠单抗的用药标签标准，他们接受奥马珠单抗或安慰剂治疗 16 周，然后进行阿司匹林脱敏。
11 例患者完成了阿司匹林脱敏。在随机接受奥马珠单抗的 7 例患者中，有 5 例在阿司匹林脱敏过程中没有发生呼吸道反应。与安慰剂相比，奥马珠单抗治疗的 AERD 患者在脱敏过程中无呼吸道反应的可能性显著更高（P=0.04，Fisher 确切检验）。在脱敏过程中未发生呼吸道反应的奥马珠单抗组和随机接受安慰剂的奥马珠单抗组的尿白三烯 E4（LTE4）水平存在总体差异（P=0.035，混合模型加交互作用）。与未发生呼吸道反应的 AERD 患者的 100mg 剂量后获得的 LTE4 水平相比，安慰剂组中发生呼吸道反应的患者的尿 LTE4 水平显著升高（P<0.001，混合模型加交互作用）。
在特应性 AERD 患者中，奥马珠单抗治疗 16 周与“临床无症状”脱敏相关。基于这些发现，进一步研究奥马珠单抗在有阿司匹林脱敏适应证的 AERD 患者中的治疗效果是合理的。
ClinicalTrials.gov 标识符 NCT00555971。
