美泊利单抗在嗜酸性粒细胞型重度哮喘及重叠性重度过敏性哮喘中的真实世界疗效
Mepolizumab real-world effectiveness in severe asthma with an eosinophilic phenotype and overlapping severe allergic asthma.
作者信息
Lee Jason K, Pollard Stephen J, Liu Mark C, Schleich Florence, Pelaia Girolamo, Almonacid Carlos, Heaney Liam G, Chaudhuri Rekha, Alfonso-Cristancho Rafael, Zhang Lingjiao, Maxwell Aoife, Howarth Peter
机构信息
Toronto Allergists, Evidence Based Medical Educator, Toronto, Ontario, Canada.
Family Allergy and Asthma Research Institute, Louisville, Kentucky, USA.
出版信息
Ann Allergy Asthma Immunol. 2025 Jan 11. doi: 10.1016/j.anai.2025.01.002.
BACKGROUND
Some patients with severe asthma have overlapping allergic and eosinophilic phenotypes and may be eligible for anti-eosinophilic or anti-immunoglobin E (IgE) biologics.
OBJECTIVE
This post hoc sub-analysis assessed real-world mepolizumab effectiveness in patients with overlapping allergic and eosinophilic phenotypes, using 1-year data from the international, prospective REALITI-A (REAL world effectiveness of mepolizumab In paTIent care - Asthma) study.
METHODS
The clinically significant asthma exacerbations (CSE) rate was assessed 1 year before (pretreatment) and after (follow-up) mepolizumab treatment, stratified by baseline total IgE (tIgE) levels (<60, 60 to <190, 190 to <550, and ≥550 kilounits per litre [kU/L]), atopic status (yes/no/unknown), previous omalizumab use (yes/no), geographic baseline omalizumab eligibility (eligible/non-eligible), and baseline tIgE level and blood eosinophil count threshold combinations (<81 or ≥81 kU/L and <300 or ≥300 cells per microliter [cells/μL]).
RESULTS
Overall, 822 patients were included. CSEs occurred in 760 patients (93%) pretreatment and 398 patients (49%) during follow-up. CSE rate (rate ratio [95% CI]) was reduced in follow-up across all tIgE subgroups (<60 [n = 173]: 0.31 [0.25-0.37]; 60 to <190 [n = 176]: 0.30 [0.25-0.36]; 190 to <550 [n = 170]: 0.26 [0.20-0.33]; ≥550 kU/L [n = 155]: 0.28 [0.23-0.35]) and irrespective of atopic status (yes [n = 422]: 0.29 [0.26-0.33]; no [n = 52]: 0.33 [0.23-0.47]; unknown [n = 348]: 0.28 [0.24-0.32]), previous omalizumab use (yes [n = 151]: 0.37 [0.30-0.45]; no [n = 671]: 0.27 [0.24-0.30]), or eligibility (eligible [n = 349]: 0.29 [0.25-0.34]; non-eligible [n = 191]: 0.32 [0.27-0.38]). Furthermore, the CSE rate was reduced across all tIgE (kU/L) and blood eosinophil count (cells/μL) combinations (<81/<300 [n = 53]: 0.34 [0.24-0.47]; <81/≥300 [n = 103]: 0.33 [0.26-0.41]; ≥81/<300 [n = 98]: 0.36 [0.28-0.47]; ≥81/≥300 [n = 249]: 0.26 [0.22-0.31]).
CONCLUSION
Mepolizumab demonstrates real-world effectiveness in reducing exacerbations in patients with severe asthma and an eosinophilic phenotype, regardless of any overlapping allergic phenotype.
背景
一些重度哮喘患者具有重叠的过敏和嗜酸性粒细胞表型，可能适合使用抗嗜酸性粒细胞或抗免疫球蛋白E（IgE）生物制剂。
目的
这项事后亚组分析使用来自国际前瞻性REALITI-A（美泊利珠单抗在患者护理中的真实世界疗效 - 哮喘）研究的1年数据，评估美泊利珠单抗在具有重叠过敏和嗜酸性粒细胞表型患者中的真实世界疗效。
方法
在美泊利珠单抗治疗前（预处理）和治疗后（随访）1年评估临床显著哮喘加重（CSE）率，按基线总IgE（tIgE）水平（<60、60至<190、190至<550以及≥550千单位每升[kU/L]）、特应性状态（是/否/未知）、既往奥马珠单抗使用情况（是/否）、地理基线奥马珠单抗适用性（适用/不适用）以及基线tIgE水平和血液嗜酸性粒细胞计数阈值组合（<81或≥81 kU/L以及<300或≥300细胞每微升[细胞/μL]）进行分层。
结果
总体而言，纳入了822例患者。760例患者（93%）在预处理时有CSE发生，398例患者（49%）在随访期间发生CSE。在所有tIgE亚组中，随访期间CSE率（率比[95%CI]）均降低（<60 [n = 173]：0.31 [0.25 - 0.37]；60至<190 [n = 176]：0.30 [0.25 - 0.36]；190至<550 [n = 170]：0.26 [0.20 - 0.33]；≥550 kU/L [n = 155]：0.28 [0.23 - 0.35]），且与特应性状态（是[n = 422]：0.29 [0.26 - 0.33]；否[n = 52]：0.33 [0.23 - 0.47]；未知[n = 348]：0.28 [0.24 - 0.32]）、既往奥马珠单抗使用情况（是[n = 151]：0.37 [0.30 - 0.45]；否[n = 671]：0.27 [0.24 - 0.30]）或适用性（适用[n = 349]：0.29 [0.25 - 0.34]；不适用[n = 191]：0.32 [0.27 - 0.38]）无关。此外，在所有tIgE（kU/L）和血液嗜酸性粒细胞计数（细胞/μL）组合中CSE率均降低（<81/<300 [n = 53]：0.34 [0.24 - 0.47]；<81/≥300 [n = 103]：0.33 [0.26 - 0.41]；≥81/<300 [n = 98]：0.36 [0.28 - 0.47]；≥81/≥300 [n = 249]：0.26 [0.22 - 0.31]）。
结论
无论是否存在任何重叠的过敏表型，美泊利珠单抗在降低重度哮喘和嗜酸性粒细胞表型患者的加重发作方面均显示出真实世界疗效。
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