Division of Immunology and Allergy, Department of Chest Diseases, Faculty of Medicine, Erciyes University, Kayseri, Turkey
Department of Chest Diseases, Faculty of Medicine, Erciyes University, Kayseri, Turkey
Turk J Med Sci. 2020 Apr 9;50(2):433-441. doi: 10.3906/sag-1912-62.
BACKGROUND/AIM: Oral corticosteroid (OCS)-dependent severe eosinophilic asthma with chronic rhinosinusitis with nasal polyps (SEA-CRSwNP) would be a suitable phenotype for mepolizumab treatment. This study evaluated the short-term efficacy of mepolizumab treatment in OCS-dependent SEA-CRSwNP.
Baseline and 24th week results [daily OCS doses, asthma exacerbation frequency, asthma control test (ACT) scores, blood eosinophil levels, FEV1 values, and numerical analog scale (NAS) of CRSwNP symptoms] of patients who were treated for at least 24 weeks with mepolizumab were retrospectively evaluated and compared.
A total of 16 patients were enrolled in the study. Mepolizumab was discontinued in one patient due to side effects. The daily OCS dosage was reduced from baseline in all patients, and at week 24 OCS was discontinued in 40% of the patients (baseline mean steroid dose: 9.2 ± 5.2 mg, 24th week: 1.3 ± 1.4 mg; P < 0.001). The number of asthma exacerbations within 24 weeks significantly decreased after beginning mepolizumab treatment (2.1 ± 2.7 vs. 0.07 ± 0.26; P = 0.012), and a significant increase in ACT scores (baseline mean ACT: 18 ± 5.7; 24th week mean ACT: 23.3 ± 3; P = 0.006) was observed despite the decrease in daily OCS dosages. There was no significant difference in FEV1 values between baseline and week 24. Evaluation of the general symptoms of CRSwNP, as per NAS, revealed that the baseline mean NAS was 5.6 ± 4.4, and the 24th week mean NAS was 3.2 ± 3.2 (P = 0.021).
This is the first real-life study evaluating the short-term efficacy of mepolizumab treatment on OCS-dependent SEA-CRSwNP. This study demonstrates that mepolizumab is an effective and safe biologic for the treatment of this severe asthma subphenotype.
背景/目的：依赖口服皮质类固醇（OCS）的重度嗜酸性粒细胞性哮喘伴慢性鼻-鼻窦炎伴鼻息肉（SEA-CRSwNP）可能是美泊利珠单抗治疗的合适表型。本研究评估了美泊利珠单抗治疗 OCS 依赖性 SEA-CRSwNP 的短期疗效。
回顾性评估并比较了至少接受 24 周美泊利珠单抗治疗的患者的基线和第 24 周结果（每日 OCS 剂量、哮喘加重频率、哮喘控制测试（ACT）评分、血嗜酸性粒细胞水平、FEV1 值和 CRSwNP 症状的数字模拟量表（NAS））。
本研究共纳入 16 名患者。由于副作用，1 名患者停止使用美泊利珠单抗。所有患者的每日 OCS 剂量均从基线水平降低，第 24 周时 40%的患者停止使用 OCS（基线平均类固醇剂量：9.2 ± 5.2mg，第 24 周：1.3 ± 1.4mg；P<0.001）。开始使用美泊利珠单抗治疗后，24 周内哮喘加重的次数明显减少（2.1 ± 2.7 次 vs. 0.07 ± 0.26 次；P=0.012），尽管每日 OCS 剂量减少，但 ACT 评分显著升高（基线平均 ACT：18 ± 5.7；第 24 周平均 ACT：23.3 ± 3；P=0.006）。FEV1 值在基线和第 24 周之间无显著差异。根据 NAS 评估 CRSwNP 的一般症状，发现基线平均 NAS 为 5.6 ± 4.4，第 24 周平均 NAS 为 3.2 ± 3.2（P=0.021）。
这是第一项评估美泊利珠单抗治疗 OCS 依赖性 SEA-CRSwNP 短期疗效的真实世界研究。本研究表明，美泊利珠单抗是治疗这种严重哮喘亚表型的有效且安全的生物制剂。
