Clinical Research Center for Allergy and Rheumatology, National Hospital Organization, Sagamihara National Hospital, Sagamihara, Japan; Department of Respiratory Medicine, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Clinical Research Center for Allergy and Rheumatology, National Hospital Organization, Sagamihara National Hospital, Sagamihara, Japan.
J Allergy Clin Immunol. 2023 Jun;151(6):1667-1672.e2. doi: 10.1016/j.jaci.2023.03.014. Epub 2023 Mar 24.
Omalizumab, an anti-IgE antibody, has clinical efficacy against respiratory symptoms of aspirin-exacerbated respiratory disease (AERD). However, some patients with AERD also present with extrarespiratory (chest, gastrointestinal, and/or cutaneous) symptoms, which are resistant to conventional treatment but can be alleviated by systemic corticosteroids.
We evaluated the efficacy of omalizumab on extrarespiratory symptoms related to AERD.
In study 1, a total of 27 consecutive patients with AERD initially prescribed omalizumab at Sagamihara National Hospital between July 2009 and March 2019 were retrospectively studied. Frequency of exacerbations of AERD-related extrarespiratory symptoms was compared before and after omalizumab treatment. In study 2, we reported 3 AERD cases with aspirin challenge-induced extrarespiratory symptoms among patients studied in our previous randomized trial (registration UMIN000018777), which evaluated the effects of omalizumab on hypersensitivity reactions during aspirin challenge to AERD patients. Extrarespiratory symptoms induced during the aspirin challenge were compared between placebo and omalizumab phases.
In study 1, omalizumab treatment was associated with decrease in frequency of exacerbation of chest pain (no. [%] of patients with exacerbation frequency ≥1 time per year, 6 [22.2%] vs 0; P < .001), gastrointestinal symptoms (9 [33.3%] vs 2 [7.4%]; P = .016), and cutaneous symptoms (16 [59.3%] vs 2 [7.4%]; P < .001), even under conditions of treatment-related reduction in systemic corticosteroid dose. Omalizumab also attenuated all the extrarespiratory symptoms during aspirin challenge in study 2.
Omalizumab ameliorated extrarespiratory symptoms at baseline (without aspirin exposure) and during aspirin challenge.
奥马珠单抗是一种抗 IgE 抗体，对阿司匹林加重性呼吸道疾病（AERD）的呼吸道症状具有临床疗效。然而，一些 AERD 患者还存在非呼吸道（胸部、胃肠道和/或皮肤）症状，这些症状对常规治疗有抗药性，但可通过全身皮质类固醇缓解。
我们评估奥马珠单抗对 AERD 相关非呼吸道症状的疗效。
在研究 1 中，我们回顾性研究了 2009 年 7 月至 2019 年 3 月期间在相模原综合医院首次开处奥马珠单抗的 27 例连续 AERD 患者。比较了奥马珠单抗治疗前后 AERD 相关非呼吸道症状恶化的频率。在研究 2 中，我们报告了我们之前的随机试验（注册号 UMIN000018777）中 3 例阿司匹林激发试验引起的 AERD 患者的非呼吸道症状，该试验评估了奥马珠单抗对 AERD 患者阿司匹林激发试验中过敏反应的影响。比较了安慰剂和奥马珠单抗阶段期间阿司匹林激发试验引起的非呼吸道症状。
在研究 1 中，奥马珠单抗治疗与减少胸痛恶化的频率相关（每年恶化频率≥1 次的患者数[%]，6 [22.2%] vs 0；P <.001）、胃肠道症状（9 [33.3%] vs 2 [7.4%]；P =.016）和皮肤症状（16 [59.3%] vs 2 [7.4%]；P <.001），即使在治疗相关减少全身皮质类固醇剂量的情况下也是如此。奥马珠单抗还在研究 2 中减轻了阿司匹林激发试验期间的所有非呼吸道症状。
奥马珠单抗改善了基线（无阿司匹林暴露）和阿司匹林激发期间的非呼吸道症状。
