Background: The important progress made on asthma phenotyping encouraged the development of new therapeutic strategies, such as monoclonal antibodies (mAbs) and bronchial thermoplasty (BT). The aim of this study is to compare patients diagnosed with severe refractory asthma (SRA) who are currently being treated with omalizumab, mepolizumab, benralizumab or BT and to evaluate the efficacy of these treatments over a 12-month observation period.
Methods: Overall, 199 consecutive patients with SRA were included. The cohort was selected referring to the eligibility criteria for all available biologics and BT.
Results: Among 32 patients treated with benralizumab, we found a 16.7% reduction in hospitalizations, a 66.6% reduction in exacerbations (p = 0.0001) and the greater improvement in FEV1 (+ 37.4%, p < 0.0001). Among omalizumab group (54 patients), there was a 85.7% (p = 0.012) reduction in hospitalizations and a 88.8% (p < 0.0001) reduction in exacerbations. In the mepolizumab group (83 patients), we found a 89.5% (p = 0.02) reduction in hospitalizations and a 92.1% (p < 0.0001) reduction in exacerbations. BT subgroup (30 patients) showed a 93.7% (p = 0.001) reduction in hospitalizations and a 73.5% (p < 0.0001) reduction in exacerbations. The best results in terms of OCS sparing effect were obtained by BT (- 76%, p < 0.0001) and mepolizumab (- 90.2%, p = 0.002). Omalizumab showed the highest percentage of super responder patients.
Conclusion: To our knowledge, this is the first study to compare all marketed mAbs with BT, ending in more comprehensive and applicable results to clinical practice. All biologics, to varying degrees, reduced hospitalizations, exacerbations, and OCS use. The starting point for patients in the BT group was worse regarding hospitalizations, exacerbations and OCS, but despite this, even this non-pharmacological option obtained positive results, comparable to biologics.



中文翻译：

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重度难治性哮喘 (BIOTERM) 生物制剂和支气管热成形术临床结果的真实评估

背景：哮喘表型研究取得的重要进展促进了新治疗策略的发展，例如单克隆抗体 (mAb) 和支气管热成形术 (BT)。本研究的目的是比较目前正在接受奥马珠单抗、美泊利珠单抗、贝那利珠单抗或 BT 治疗的被诊断为严重难治性哮喘 (SRA) 的患者，并在 12 个月的观察期内评估这些治疗的疗效。
方法：总体而言，纳入了 199 名连续 SRA 患者。该队列的选择参考了所有可用生物制剂和 BT 的资格标准。
结果：在接受贝那利珠单抗治疗的 32 名患者中，我们发现住院率降低了 16.7%，恶化率降低了 66.6%（p = 0.0001），FEV1 改善更大（+ 37.4%，p < 0.0001）。在奥马珠单抗组（54 名患者）中，住院率减少了 85.7%（p = 0.012），恶化减少了 88.8%（p < 0.0001）。在美泊利单抗组（83 名患者）中，我们发现住院减少了 89.5%（p = 0.02），恶化减少了 92.1%（p < 0.0001）。BT 亚组（30 名患者）的住院率降低了 93.7%（p = 0.001），恶化率降低了 73.5%（p < 0.0001）。BT (- 76%, p < 0.0001) 和美泊利单抗 (- 90.2%, p = 0.002) 获得了 OCS 保留效果方面的最佳结果。奥马珠单抗显示出最高比例的超级反应患者。
结论：据我们所知，这是第一项将所有上市单克隆抗体与 BT 进行比较的研究，最终得出了更全面和适用于临床实践的结果。所有生物制剂都在不同程度上减少了住院、恶化和 OCS 的使用。BT 组患者在住院、恶化和 OCS 方面的起点更差，但尽管如此，即使这种非药物选择也获得了与生物制剂相当的积极结果。