Kayser Moritz Z, Drick Nora, Milger Katrin, Fuge Jan, Kneidinger Nikolaus, Korn Stephanie, Buhl Roland, Behr Jürgen, Welte Tobias, Suhling Hendrik
Department of Respiratory Medicine, Hannover Medical School, Hannover, Germany.
Department of Medicine V, University Hospital, LMU, Munich, Germany.
J Asthma Allergy. 2021 Jul 12;14:863-871. doi: 10.2147/JAA.S319572. eCollection 2021.
Treatment of severe eosinophilic asthma (SEA) has been revolutionized by the development of monoclonal antibodies targeting underlying immunological pathways of eosinophilic asthma. Two of the most frequently used antibodies in clinical practice are mepolizumab, targeting interleukin (IL) 5 and benralizumab, targeting the IL5 receptor alpha. The comparative treatment efficacy of these antibodies remains unclear, particularly regarding long-term outcomes.
In this multicenter, retrospective study, we included 123 patients treated with mepolizumab and 64 patients treated with benralizumab for 12 months at one of three study sites in Germany. Data were collected at baseline and after 6 and 12 months of therapy. Endpoints were changes in pulmonary function (PF), exacerbation rate, oral corticosteroid (OCS) use and dose, asthma control test (ACT) score and fractional exhaled nitric oxide (FeNO) levels.
Both mepolizumab and benralizumab led to significant improvements in PF with an increase in median forced expiratory volume (FEV1) after 12 months from 59% to 74% for mepolizumab and 63% to 72% for benralizumab. Treatment also led to significant improvements in ACT scores after 12 months (mepolizumab: 13 [interquartile range (IQR) 9-17] to 19 [IQR 15-23]; benralizumab: 12 [IQR 9-16] to 22 [IQR 16-25]) as well as a reduction of mean OCS dose (mepolizumab 8 mg [IQR 5-12.5 mg] median prednisolone equivalent at baseline to 5 mg [IQR 3-7.5 mg]; benralizumab 7.5 mg [IQR 5-15 mg] to 5 mg [IQR 2-10 mg]). The exacerbation rates were reduced significantly, irrespective of the treatment. Overall, changes were similar after 6 and 12 months of therapy.
Both mepolizumab and benralizumab are highly effective in the long-term treatment of SEA, with no clinically relevant differences in outcomes after 12 months of therapy. In both groups, improvements were similar after 6 and 12 months of therapy, underlining the feasibility of early treatment evaluation.
针对嗜酸性粒细胞性哮喘潜在免疫途径的单克隆抗体的研发，彻底改变了重度嗜酸性粒细胞性哮喘（SEA）的治疗方式。临床实践中最常用的两种抗体是靶向白细胞介素（IL）-5的美泊利单抗和靶向IL-5受体α的贝那利珠单抗。这些抗体的相对治疗效果仍不明确，尤其是在长期疗效方面。
在这项多中心回顾性研究中，我们纳入了在德国三个研究地点之一接受美泊利单抗治疗的123例患者和接受贝那利珠单抗治疗12个月的64例患者。在基线以及治疗6个月和12个月后收集数据。观察终点为肺功能（PF）变化、急性加重率、口服糖皮质激素（OCS）的使用及剂量、哮喘控制测试（ACT）评分和呼出一氧化氮分数（FeNO）水平。
美泊利单抗和贝那利珠单抗均使PF有显著改善，12个月后，美泊利单抗组的中位用力呼气量（FEV1）从59%增至74%，贝那利珠单抗组从63%增至72%。治疗12个月后，ACT评分也有显著改善（美泊利单抗：从13[四分位间距（IQR）9 - 17]增至19[IQR 15 - 23]；贝那利珠单抗：从12[IQR 9 - 16]增至22[IQR 16 - 25]），同时平均OCS剂量减少（美泊利单抗：基线时泼尼松龙等效剂量中位数为8mg[IQR 5 - 12.5mg]降至5mg[IQR 3 - 7.5mg]；贝那利珠单抗：从7.5mg[IQR 5 - 15mg]降至5mg[IQR 2 - 10mg]）。无论采用何种治疗，急性加重率均显著降低。总体而言，治疗6个月和12个月后的变化相似。
美泊利单抗和贝那利珠单抗在SEA的长期治疗中均非常有效，治疗12个月后的疗效在临床上无显著差异。在两组中，治疗6个月和12个月后的改善情况相似，这突出了早期治疗评估的可行性。
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