Omalizumab ameliorates extrarespiratory symptoms in patients with aspirin-exacerbated respiratory disease

Abstract

Omalizumab, an anti-immunoglobulin E antibody, has clinical efficacy against respiratory symptoms of aspirin-exacerbated respiratory disease (AERD). However, some patients with AERD also present with extra-respiratory (chest, gastrointestinal, and/or cutaneous) symptoms, which are resistant to conventional treatment but can be alleviated by systemic corticosteroids. To evaluate the efficacy of omalizumab on extra-respiratory symptoms related to AERD. In Study 1, 27 consecutive patients with AERD initially prescribed omalizumab at Sagamihara National Hospital between July 2009 and March 2019 were studied retrospectively. The frequency of exacerbations of AERD-related extra-respiratory symptoms was compared before and after the initiation of omalizumab treatment. In Study 2, we reported three AERD cases with aspirin challenge-induced extra-respiratory symptoms among patients studied in our previous randomized trial (registration number: UMIN000018777), which evaluated the effects of omalizumab on hypersensitivity reactions during aspirin challenge to AERD patients. The extra-respiratory symptoms induced during the aspirin challenge were compared between the placebo and omalizumab phases. In Study 1, omalizumab treatment was associated with a decrease in the frequency of exacerbation of chest pain (n [%] of patients with exacerbation frequency ≥1 time per year, 6 [22.2%] vs. 0 [0%]; P<0.001), gastrointestinal symptoms (9 [33.3%] vs. 2 [7.4%]; P=0.016), and cutaneous symptoms (16 [59.3%] vs. 2 [7.4%]; P<0.001), even under conditions of a treatment-related reduction in systemic corticosteroid dose. Omalizumab also attenuated all the extra-respiratory symptoms during the aspirin challenge in Study 2. Omalizumab ameliorated the extra-respiratory symptoms at baseline (without aspirin exposure) and during aspirin challenge.