Background: Immunoglobulin (Ig) E-mediated pathophysiological mechanisms are common in allergic diseases including severe allergic asthma (SAA). The anti-IgE monoclonal antibody omalizumab may be particularly beneficial for patients with SAA and multiple allergic comorbidities (AC) including perennial/seasonal rhinitis, conjunctivitis, atopic dermatitis (AD), and food allergy.
Methods: We conducted a post-hoc analysis of the patients from the STELLAIR study (n=872, 149 minors and 723 adults). The patients were classified based on the presence of multiple AC (≥ 3 AC or < 3 AC) or AD as assessed by questionnaire. Response to omalizumab was assessed after 4– 6 months (T_{4– 6}) and after 12 months (T₁₂). Asthma response at T_{4– 6} was based on global evaluation of treatment effectiveness, reduction of ≥ 40% in annual exacerbation rate, and a combination of both. Asthma response at T₁₂ was based on change in yearly exacerbation and hospitalization rates. AC improvement at T₁₂ was based on patient perception.
Results: Patients with ≥ 3 AC demonstrated a higher combined response to omalizumab (74.7% vs 58.3%) at T_{4– 6} and had reduced yearly exacerbation and hospitalization rates (88.9% vs 77.4% and − 94.0% vs − 70.5%, respectively). Patients with ≥ 3 AC were more likely to show an improvement in their AC (85.3% vs 51.9%) at T₁₂. Results were similar in minors and adults. The presence of AD was associated with greater omalizumab effectiveness at T_{4– 6} and a greater AC improvement at T₁₂. Improvement of AD and food allergies at T₁₂ were 73.2% and 38.7%, respectively, in the population overall.
Conclusion: This post-hoc analysis of the STELLAIR study shows that omalizumab is beneficial for all SAA patients and especially for patients with multiple AC or AD. In patients with ≥ 3 AC, omalizumab also improved AC outcomes.



中文翻译：

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奥马珠单抗对伴有多种过敏合并症的严重过敏性哮喘的疗效：STELLAIR 研究的事后分析

背景：免疫球蛋白 (Ig) E 介导的病理生理机制在包括严重过敏性哮喘 (SAA) 在内的过敏性疾病中很常见。抗 IgE 单克隆抗体奥马珠单抗可能对患有 SAA 和多种过敏性合并症 (AC) 的患者特别有益，包括常年性/季节性鼻炎、结膜炎、特应性皮炎 (AD) 和食物过敏。
方法：我们对 STELLAIR 研究中的患者（n=872，149 名未成年人和 723 名成人）进行了事后分析。根据问卷评估的多重 AC（≥ 3 AC 或 < 3 AC）或 AD 对患者进行分类。_{在 4-6 个月 (T 4-6} ) 和 12 个月 (T ₁₂ ) 后评估对奥马珠单抗的反应。_{T 4-6}时的哮喘反应是基于对治疗有效性的全球评估、年恶化率降低 ≥ 40%，以及两者的结合。_{T 12}时的哮喘反应是基于每年恶化和住院率的变化。_{T 12}时的AC 改善基于患者的感知。
结果： ≥ 3 AC 的患者在 T _4-6时表现出对奥马珠单抗的更高联合反应（74.7% 对 58.3%），并且降低了年恶化率和住院率（分别为 88.9% 对 77.4% 和 - 94.0% 对 - 70.5% ）。≥ 3 AC 的患者在 T _{12时更有可能表现出 AC 的改善（85.3% vs 51.9%）}. 未成年人和成年人的结果相似。AD 的存在与 T _{4-6时更大的奥马珠单抗有效性和 T 12}时更大的 AC 改善相关。在整个人群中，AD 和食物过敏在 T ₁₂时的改善分别为 73.2% 和 38.7%。
结论：这项 STELLAIR 研究的事后分析表明，奥马珠单抗对所有 SAA 患者都有益，尤其是对多发性 AC 或 AD 患者。在≥ 3 AC 的患者中，奥马珠单抗还改善了 AC 结局。