Department of Internal Medicine, Clinical Immunology, Clinical Pathology and Infectious Diseases, AOU Federico II, Via Pansini 5, Naples, 80131, Italy.
Division of ENT, Azienda Ospedaliera dei Colli, Naples, Italy.
Ther Adv Respir Dis. 2021 Jan-Dec;15:17534666211009398. doi: 10.1177/17534666211009398.
Severe eosinophilic asthma is frequently associated to chronic rhinosinusitis and nasal polyposis (CRSwNP) that contribute to poor asthma control. Mepolizumab is an anti-IL-5 monoclonal antibody, approved for the treatment of severe eosinophilic asthma. A limited number of studies have assessed the efficacy of mepolizumab on CRSwNP in severe asthmatics. We aim to evaluate the efficacy of mepolizumab on sino-nasal symptoms, polyp growth and asthma control in severe eosinophilic asthma patients with CRSwNP in real life.
In this study 44 severe eosinophilic asthma patients with CRSwNP were treated with mepolizumab (100 mg q4w) for 1 year. The following outcomes were assessed before (T0), after 6 (T6) and 12 months (T12) of treatment: sino/nasal outcome test (SNOT-22), Total Endoscopic Nasal Polyp Score (TENPS), %FEV1 (FEV1/FEV1 predicted) and Asthma control test (ACT). Blood eosinophil count, exhaled nitric oxide (FENO) and prednisone intake were measured. In a subgroup of patients, nasal cytology was performed before (T0), after 6 (T6) and after 12 months (T12) of treatment with mepolizumab.
We reported a significant reduction of SNOT-22 [from 51.5 ± 21.2 at baseline (T0) to 31.70 ± 17.36 at T6 and 29.7 ± 21.5 at T12 (T0-T12 < 0.001)] and a decrease of TENPS (from 2.88 ± 3.07 to 1.70 ± 2.37 and 1.77 ± 2.56 at T0, T6 and T12, respectively, T0-T12 = 0.99). A significant improvement of %FEV, ACT and a decrease in blood eosinophils and mean prednisone intake were also reported. No statistically significant decreasing trend was measured for FENO. Nasal cytology findings suggest a significant reduction of eosinophil percentage following mepolizumab treatment (from 16.8 ± 7.2% to 3.6 ± 6.2% and 0.8 ± 2.4% at T0, T6 and T12 respectively, T0 to T12: < 0.001).
Mepolizumab improves sino-nasal and asthma symptoms and reduces polyp growth in patients with severe eosinophilic asthma and concomitant CRSwNP in real life.
严重嗜酸粒细胞性哮喘常与慢性鼻-鼻窦炎伴鼻息肉（CRSwNP）相关，这会导致哮喘控制不佳。美泊利珠单抗是一种抗白细胞介素-5（IL-5）的单克隆抗体，已被批准用于治疗严重嗜酸粒细胞性哮喘。少数研究评估了美泊利珠单抗在严重哮喘合并 CRSwNP 患者中的疗效。我们旨在评估美泊利珠单抗在严重嗜酸粒细胞性哮喘合并 CRSwNP 患者中的疗效，包括对鼻-鼻窦症状、息肉生长和哮喘控制的影响。
本研究纳入了 44 例严重嗜酸粒细胞性哮喘合并 CRSwNP 患者，接受美泊利珠单抗（100mg，每四周一次）治疗 1 年。在治疗前（T0）、治疗后 6 个月（T6）和 12 个月（T12）评估以下结局：鼻-鼻窦结局测试（SNOT-22）、总内镜鼻息肉评分（TENPS）、FEV1%预计值（FEV1/FEV1 预计值）和哮喘控制测试（ACT）。同时还测量了血嗜酸性粒细胞计数、呼出气一氧化氮（FENO）和泼尼松的摄入量。在部分患者中，还在治疗前（T0）、治疗后 6 个月（T6）和治疗后 12 个月（T12）进行了鼻细胞学检查。
我们报告 SNOT-22 显著降低[从基线（T0）的 51.5±21.2 降至 T6 的 31.70±17.36 和 T12 的 29.7±21.5（T0-T12 < 0.001)]，TENPS 降低[从 2.88±3.07 降至 T0、T6 和 T12 时的 1.70±2.37 和 1.77±2.56，T0-T12 = 0.99]。FEV1%预计值、ACT 和血嗜酸性粒细胞计数及泼尼松平均摄入量也显著改善。FENO 未观察到统计学上的降低趋势。鼻细胞学检查结果提示，美泊利珠单抗治疗后，嗜酸性粒细胞百分比显著降低[从 16.8±7.2%降至 T0、T6 和 T12 时的 3.6±6.2%和 0.8±2.4%，T0 至 T12： < 0.001]。
美泊利珠单抗可改善严重嗜酸粒细胞性哮喘合并 CRSwNP 患者的鼻-鼻窦和哮喘症状，并减少息肉生长。
