Quarato Carla Maria Irene, Tondo Pasquale, Lacedonia Donato, Soccio Piera, Pescatore Dalila, Baccellieri Maria Lisa, Lepore Giorgia, Foschino Barbaro Maria Pia, Scioscia Giulia
Institute of Respiratory Diseases, Policlinico Riuniti of Foggia, 71122 Foggia, Italy.
Department of Medical and Surgical Sciences, University of Foggia, 71122 Foggia, Italy.
J Clin Med. 2025 Mar 18;14(6):2075. doi: 10.3390/jcm14062075.
The current availability of monoclonal antibodies against key mediators of type-2 (T2) inflammation has led to a redefinition of the ultimate objectives of severe asthma treatment to a more composite concept of disease remission. The aim of this real-life study was to estimate the percentage of patients who achieved clinical remission over 4 years of treatment with benralizumab, and to identify baseline predictors for the achievement of such a composite outcome in the long term. Data from a 4-year follow-up of 23 patients who were prescribed benralizumab as an add-on therapy because of uncontrolled severe eosinophilic asthma were retrospectively analyzed and compared. Clinical remission was considered to be "complete" if oral corticosteroid (OCS) use was not required, there were no exacerbations, an asthma control test (ACT) score ≥ 20 was achieved and a pre-bronchodilation percent predicted a forced expiratory volume in 1 s (FEV%) ≥ 80%. Clinical remission was considered to be "partial" if OCS use was not required, plus at least two of the other three aforementioned criteria. The overall percentage of patients who achieved clinical remission was 86.9% after 12 months, and 91.3% after 24 and 48 months of treatment. The rate of complete remission over partial remission increased over time. After 12 months of treatment, 65% of patients fulfilled the criteria for complete remission and 35.0% for partial remission. After 48 months of treatment, 71.4% of patients were in a status of complete remission and 28.6% in a status of partial remission. A long-term composite outcome of complete clinical remission was more likely to be achieved by severe eosinophilic asthma patients with comorbid nasal polyposis, bronchiectasis and osteoporosis, and with OCS dependency, a predicted pre-bronchodilation FEV% ≥ 80% and a predicted FEF < 65% at baseline. Our real-life experience suggests that treatment with benralizumab may allow the achievement and long-term maintenance of clinical remission in a high percentage of severe eosinophilic asthma patients, up to 4 years of follow-up.
目前针对2型（T2）炎症关键介质的单克隆抗体的出现，已导致对重度哮喘治疗的最终目标重新定义为一个更综合的疾病缓解概念。这项真实世界研究的目的是评估接受贝那利珠单抗治疗4年实现临床缓解的患者百分比，并确定长期实现这种综合结局的基线预测因素。对23例因重度嗜酸性粒细胞性哮喘控制不佳而被处方贝那利珠单抗作为附加治疗的患者进行了4年随访数据的回顾性分析和比较。如果不需要使用口服糖皮质激素（OCS）、没有发作、哮喘控制测试（ACT）评分≥20且支气管扩张前预测1秒用力呼气容积（FEV%）≥80%，则临床缓解被认为是“完全”的。如果不需要使用OCS，加上上述其他三个标准中的至少两个，则临床缓解被认为是“部分”的。治疗12个月后实现临床缓解的患者总体百分比为86.9%，治疗24个月和48个月后为91.3%。完全缓解率与部分缓解率随时间增加。治疗12个月后，65%的患者符合完全缓解标准，35.0%符合部分缓解标准。治疗48个月后，71.4%的患者处于完全缓解状态，28.6%处于部分缓解状态。合并鼻息肉、支气管扩张和骨质疏松且有OCS依赖、基线支气管扩张前预测FEV%≥80%和预测FEF<65%的重度嗜酸性粒细胞性哮喘患者更有可能实现完全临床缓解的长期综合结局。我们的真实世界经验表明，使用贝那利珠单抗治疗可能使高比例的重度嗜酸性粒细胞性哮喘患者实现并长期维持临床缓解，随访长达4年。
