Asthma and Airway Centre, University Health Network, University of Toronto, Toronto, Ontario, Canada.
Global Respiratory Medical Franchise, GSK, Research Triangle Park, North Carolina.
Allergy. 2019 Sep;74(9):1716-1726. doi: 10.1111/all.13850. Epub 2019 Jul 1.
Mepolizumab and omalizumab are treatments for distinct but overlapping severe asthma phenotypes.
To assess if patients eligible for both biologics but not optimally controlled with omalizumab experience improved asthma control when switched directly to mepolizumab.
OSMO was a multicenter, open-label, single-arm, 32-week trial in patients with ≥2 asthma exacerbations in the year prior to enrollment, despite receiving high-dose inhaled corticosteroids and other controller(s), plus omalizumab (≥4 months). At baseline, patients with blood eosinophil counts ≥150 cells/µL (or ≥300 cells/µL in the prior year) and an Asthma Control Questionnaire (ACQ)-5 score ≥1.5 discontinued omalizumab and immediately commenced mepolizumab 100 mg subcutaneously every 4 weeks. Endpoints included change from baseline in ACQ-5 score (primary), St George's Respiratory Questionnaire (SGRQ) score and the proportions of ACQ-5 and SGRQ responders, all at Week 32, and the annualized exacerbation rate over the study period.
At Week 32 (intent-to-treat population [n = 145]), the least squares (LS) mean changes (standard error [SE]) in ACQ-5 and SGRQ total scores were -1.45 (0.107) and -19.0 (1.64) points; with 77% and 79% of patients achieving the minimum clinically important differences (ACQ-5: ≥0.5 points; SGRQ: ≥4 points), respectively. The annualized rate of clinically significant exacerbations was 1.18 events/year, a 64% reduction from 3.26 events/year during the previous year. Safety and immunogenicity profiles were consistent with previous trials.
After directly switching from omalizumab to mepolizumab, patients with uncontrolled severe eosinophilic asthma experienced clinically significant improvements in asthma control, health status, and exacerbation rate, with no tolerability issues reported.
美泊利珠单抗和奥马珠单抗是两种针对不同但重叠的严重哮喘表型的治疗方法。
评估对于同时符合这两种生物制剂治疗条件但奥马珠单抗治疗控制不佳的患者，直接转换为美泊利珠单抗治疗是否能改善哮喘控制。
OSMO 是一项多中心、开放性、单臂、32 周临床试验，纳入了在入组前 1 年中有≥2 次哮喘加重病史的患者，这些患者尽管接受了高剂量吸入皮质激素和其他控制药物治疗，以及奥马珠单抗（≥4 个月）治疗，但仍未得到良好控制。在基线时，具有血嗜酸性粒细胞计数≥150 个/µL（或前 1 年中≥300 个/µL）和哮喘控制问卷（ACQ）-5 评分≥1.5 的患者停用奥马珠单抗，并立即开始接受美泊利珠单抗 100mg 皮下注射，每 4 周 1 次。主要终点为第 32 周时与基线相比的 ACQ-5 评分变化（主要终点）、圣乔治呼吸问卷（SGRQ）评分以及 ACQ-5 和 SGRQ 应答者的比例，以及研究期间的年化加重率。
在第 32 周（意向治疗人群 [n=145]），ACQ-5 和 SGRQ 总分的最小二乘（LS）均值变化（标准误 [SE]）分别为-1.45（0.107）和-19.0（1.64）分；分别有 77%和 79%的患者达到最小临床重要差异（ACQ-5：≥0.5 分；SGRQ：≥4 分）。年化临床显著加重率为 1.18 次/年，与前 1 年的 3.26 次/年相比降低了 64%。安全性和免疫原性特征与之前的试验一致。
在直接从奥马珠单抗转换为美泊利珠单抗后，未得到控制的严重嗜酸性粒细胞性哮喘患者的哮喘控制、健康状况和加重率得到了临床显著改善，且未报告出现耐受问题。
