Stanziola Anna Agnese, Candia Claudio, Nazzaro Gerardo, Caso Antonio, Merola Claudia, Gallotti Lorena, Maniscalco Mauro
Department of Clinical Medicine and Surgery, University of Naples "Federico II", Naples, Italy.
Istituti Clinici Scientifici Maugeri IRCCS, Pulmonary Rehabilitation Unit of Telese Terme, Telese Terme, Italy.
Front Pharmacol. 2024 Aug 8;15:1449220. doi: 10.3389/fphar.2024.1449220. eCollection 2024.
Severe eosinophilic asthma (SEA) is often linked to a dysregulation in the Interleukin-(IL)-5 axis. Mepolizumab, a humanized monoclonal antibody, reduces eosinophils by directly binging to IL-5, potentially restoring homeostatic eosinophil biology, with a significant impact on quality of life, acute exacerbations and oral corticosteroids (OCS) elimination in SEA patients. While its short- and middle-term effects are well described, no study has so far investigated its long-lasting effects in SEA patients. The aim of our study was therefore to explore the effects of a long-term, six-year continuous treatment with mepolizumab on clinical control and clinical remission in a cohort of SEA patients.
We conducted a retrospective review of clinical records of patients who were prescribed mepolizumab between June 2017 and April 2018. We collected demographical, functional, and clinical data from visits performed at baseline and then at the specified timepoints and checked if patients had reached clinical remission after 6 years. We assessed asthma control test (ACT), exacerbation rate, and OCS elimination dose at 6 years. Clinical Remission (CR) was defined on the basis of the elimination of OCS and the contemporary presence of all the following: 1) stable lung function; 2) no exacerbation in the previous 12 months; 3) acceptable symptom control (ACT ≥ 20).
Of 86 patients screened, 62 were included in the final analysis. Our study suggests that mepolizumab is effective and well tolerated after a six-year course of continuous treatment in patients with SEA. We reported a prevalence of 28 (46.8%) patients who reached complete CR at 72 months from the treatment start. 75% of patients eliminated the maintenance OCS already after 1 year of treatment; this proportion reached the 87% within the sixth year of treatment.
Mepolizumab proved to be effective in real-life after 6 years of treatment, inducing a complete clinical remission in the 46.8% of patients, with sustained improvements in quality of life, exacerbation rate, OCS intake and lung function.
重度嗜酸性粒细胞性哮喘（SEA）通常与白细胞介素-（IL）-5轴失调有关。美泊利珠单抗是一种人源化单克隆抗体，通过直接结合IL-5来减少嗜酸性粒细胞，有可能恢复嗜酸性粒细胞的稳态生物学特性，对SEA患者的生活质量、急性加重发作和停用口服糖皮质激素（OCS）有显著影响。虽然其短期和中期效果已有充分描述，但迄今为止尚无研究调查其对SEA患者的长期影响。因此，我们研究的目的是探讨美泊利珠单抗长期（六年）持续治疗对一组SEA患者临床控制和临床缓解的影响。
我们对2017年6月至2018年4月期间开具美泊利珠单抗处方的患者临床记录进行了回顾性分析。我们收集了患者在基线以及指定时间点就诊时的人口统计学、功能和临床数据，并检查患者在6年后是否达到临床缓解。我们评估了6年时的哮喘控制测试（ACT）、加重发作率和OCS停用剂量。临床缓解（CR）的定义基于停用OCS以及同时具备以下所有条件：1）肺功能稳定；2）过去12个月内无加重发作；3）症状控制良好（ACT≥20）。
在筛选的86例患者中，62例纳入最终分析。我们的研究表明，美泊利珠单抗在SEA患者中进行六年持续治疗后有效且耐受性良好。我们报告，从治疗开始72个月时，有28例（46.8%）患者达到完全CR。75%的患者在治疗1年后就停用了维持性OCS；这一比例在治疗第六年时达到87%。
美泊利珠单抗在治疗6年后在实际应用中被证明是有效的，可使46.8%的患者实现完全临床缓解，生活质量、加重发作率、OCS摄入量和肺功能持续改善。
