Pulmonary Research Institute of Southeast Michigan, Farmington Hills, MI, USA.
Boehringer Ingelheim Pharmaceuticals, Inc, Ridgefield, CT, USA.
Int J Chron Obstruct Pulmon Dis. 2020 Nov 11;15:2879-2888. doi: 10.2147/COPD.S237408. eCollection 2020.
In the Withdrawal of Inhaled Steroids during Optimized Bronchodilator Management (WISDOM) trial, inhaled corticosteroid (ICS) withdrawal in patients with chronic obstructive pulmonary disease receiving triple therapy (long-acting β-agonist+long-acting muscarinic antagonist+ICS) did not change moderate/severe exacerbation risk. However, many patients were not taking triple therapy before study participation. This analysis was conducted to eliminate the impact of non-ICS users on WISDOM results by re-analyzing the data using only the subset of patients who were taking triple therapy at screening.
The effect of ICS withdrawal on moderate/severe exacerbation risk in the subgroup of WISDOM patients taking triple therapy before enrolling in the study was evaluated in this post hoc analysis. Additionally, the effect of ICS withdrawal in patients with a history of ≥2 exacerbations in the previous year and various blood eosinophil counts was assessed.
Overall, 39.0% (n=970: ICS continuation, 479; ICS withdrawal, 491) of the WISDOM trial population were taking triple therapy at screening. Baseline characteristics were generally similar between groups. Moderate/severe exacerbation risk between the ICS withdrawal and continuation groups (hazard ratio [HR], 1.05; 95% confidence interval [CI]: 0.89-1.25) was not increased in patients taking triple therapy at screening versus the overall trial population (HR [95% CI]: 1.06 [0.94-1.19]). However, in patients with a history of ≥2 exacerbations, exacerbation risk (HR [95% CI]) increased nominally with blood eosinophil count from 1.07 [0.81-1.41] (≥100 cells/μL) to 1.45 [0.58-3.60] (≥400 cells/μL).
Consistent with results from the overall WISDOM trial population, ICS withdrawal did not increase exacerbation risk in patients taking triple therapy at screening. Patients with a history of frequent exacerbations and higher blood eosinophil counts could benefit from continuation of ICS-based therapy.
在优化支气管扩张剂管理期间停用吸入性皮质类固醇（WISDOM）试验中，慢性阻塞性肺疾病患者在接受三联疗法（长效β激动剂+长效毒蕈碱拮抗剂+吸入皮质类固醇）治疗时停用吸入皮质类固醇（ICS）并未改变中重度恶化的风险。然而，许多患者在研究参与前并未接受三联疗法。本分析通过仅对参加研究前接受三联疗法的患者亚组重新分析数据，以消除非 ICS 使用者对 WISDOM 结果的影响。
本事后分析评估了在研究入组前接受三联疗法的 WISDOM 患者亚组中 ICS 停药对中重度恶化风险的影响。此外，还评估了 ICS 停药在过去 1 年中恶化次数≥2 次和各种血液嗜酸性粒细胞计数的患者中的作用。
总体而言，WISDOM 试验人群中有 39.0%（n=970：ICS 继续治疗，479；ICS 停药，491）在筛查时接受三联疗法。两组的基线特征总体相似。与整体试验人群相比，在筛查时接受三联疗法的患者中，ICS 停药组与继续治疗组之间的中重度恶化风险（风险比[HR]，1.05；95%置信区间[CI]：0.89-1.25）并未增加（HR [95%CI]：1.06 [0.94-1.19]）。然而，在有≥2 次恶化史的患者中，恶化风险（HR [95%CI]）随着血液嗜酸性粒细胞计数的增加而略有增加，从 1.07 [0.81-1.41]（≥100 个细胞/μL）增加至 1.45 [0.58-3.60]（≥400 个细胞/μL）。
与整体 WISDOM 试验人群的结果一致，在筛查时接受三联疗法的患者中，ICS 停药并未增加恶化风险。有频繁恶化史和更高血液嗜酸性粒细胞计数的患者可能受益于继续接受基于 ICS 的治疗。
