Kotisalmi Emma, Hakulinen Auli, Mäkelä Mika, Toppila-Salmi Sanna, Kauppi Paula
1Respiratory Diseases and Allergology, University of Helsinki and Helsinki University Hospital, Inflammation Center, Meilahdentie 2, FI-00029 HUS, P.O. Box 160, Helsinki, Finland.
2Respiratory Diseases and Allergology, University of Helsinki and Helsinki University Hospital, Heart and Lung Center, Helsinki, Finland.
Asthma Res Pract. 2020 May 13;6:2. doi: 10.1186/s40733-020-00055-9. eCollection 2020.
Anti-IgE (omalizumab) and anti-IL5/IL5R (reslizumab, mepolizumab and benralizumab) treatments are available for severe allergic and eosinophilic asthma. In these patients, studies have shown beneficial effects in oral corticosteroid use and exacerbations. The aim of this retrospective single-center study was to evaluate the effect of biological therapy on severe asthma and to compare different therapies.
We collected and analysed results of anti-IL5/IL5R and anti-IgE therapies for asthma from January 2009 until October 2019 in specialized care. We compared number of exacerbations, asthma symptoms and use of per oral corticosteroids and antimicrobics because of asthma before and during biological therapy, and in a separate analysis need for per oral corticosteroids, antimicrobics or surgery due to upper respiratory tract diseases in asthmatics receiving biologicals. The analyses were done using the Chi square test, T-test or Mann-Whitney U -test, the Kruskall-Wallis test or the Wilcoxon test.
Of 64 patients, 40 used continuous per oral corticosteroid therapy prior to biological therapy. The mean daily dose of per oral corticosteroid was reduced in those with anti-IL5/IL5R therapy (- 3.0 mg, = 0.02). The number of annual per oral corticosteroid courses decreased in both the anti-IL5/IL5R (- 2.8 courses, < 0.05) and anti-IgE groups (- 1.3 courses, < 0.05). The number of annual antibiotic courses (- 0.7 courses, = 0.04) and total number of exacerbation events (- 4.4 events/year, < 0.05) were reduced in the anti-IL5/IL5R group. In the 55 asthma patients analysed for upper respiratory tract findings, the results suggested a reduction in need for chronic rhinosinusitis surgery during biological therapy.
Results with biological therapies in this real-life clinical setting are comparable to those reported in clinical trials. Biological therapy reduces exacerbations and per oral corticosteroid use.
NCT04158050, retrospectively registered 6.11.2019.
抗IgE（奥马珠单抗）和抗IL-5/IL-5R（瑞利珠单抗、美泊利单抗和贝那利珠单抗）疗法可用于治疗重度过敏性和嗜酸性粒细胞性哮喘。在这些患者中，研究显示这些疗法在口服糖皮质激素使用和病情加重方面具有有益效果。这项回顾性单中心研究的目的是评估生物疗法对重度哮喘的疗效，并比较不同疗法。
我们收集并分析了2009年1月至2019年10月在专科护理中针对哮喘的抗IL-5/IL-5R和抗IgE疗法的结果。我们比较了生物疗法之前和期间因哮喘导致的病情加重次数、哮喘症状以及口服糖皮质激素和抗菌药物的使用情况，并且在另一项分析中，比较了接受生物制剂治疗的哮喘患者因上呼吸道疾病而需要口服糖皮质激素、抗菌药物或进行手术的情况。分析采用卡方检验、T检验或曼-惠特尼U检验、克鲁斯卡尔-沃利斯检验或威尔科克森检验。
在64例患者中，40例在生物疗法之前使用持续口服糖皮质激素治疗。接受抗IL-5/IL-5R疗法的患者口服糖皮质激素的日均剂量降低（-3.0毫克，P = 0.02）。抗IL-5/IL-5R组（-2.8个疗程，P < 0.05）和抗IgE组（-1.3个疗程，P < 0.05）的年度口服糖皮质激素疗程数均减少。抗IL-5/IL-5R组的年度抗生素疗程数减少（-0.7个疗程，P = 0.04），病情加重事件总数减少（-4.4次/年，P < 0.05）。在对55例哮喘患者进行的上呼吸道检查结果分析中，结果表明在生物疗法期间慢性鼻窦炎手术需求减少。
在这种现实临床环境中生物疗法的结果与临床试验中报告的结果相当。生物疗法可减少病情加重次数和口服糖皮质激素的使用。
NCT04158050，于2019年11月6日进行回顾性注册。
