US Value Evidence & Outcomes, US Medical Affairs, GlaxoSmithKline, Research Triangle Park, North Carolina.
Life Sciences, IBM Watson Health, Bethesda, Maryland.
Clin Ther. 2021 Dec;43(12):2064-2073. doi: 10.1016/j.clinthera.2021.10.010. Epub 2021 Dec 7.
Patients with life-threatening asthma typically experience recurrent exacerbations, are dependent on oral corticosteroids (OCSs), and have considerable asthma-related health care costs. Data on the impact of mepolizumab on exacerbations and OCS use in patients with life-threatening asthma in real-world clinical practice are limited. This study assessed the impact of mepolizumab on exacerbation rates and OCS use in patients with life-threatening asthma in a real-word setting.
This retrospective study utilized data from US administrative claims from patients with life-threatening asthma. Eligible patients were treated between November 1, 2015, and December 31, 2017; were ≥12 years of age upon mepolizumab initiation (index date); and had undergone at least two mepolizumab administrations during the 6 months postindex. Data from the 12 months before (baseline) and after (follow-up) index were collected, with each patient serving as his or her own control. Life-threatening asthma was defined as at least three exacerbations and/or at least one asthma-related hospitalization during baseline, and/or a history of endotracheal intubation. Asthma exacerbation frequency and OCS use were assessed.
The analysis included 327 patients who received a mean (SD) of 10.6 (4.3) mepolizumab doses during follow-up. The percentage of patients experiencing at least one exacerbation and the mean exacerbation rate were significantly reduced from baseline to follow-up with mepolizumab, from 94.5% to 67.9% (P < 0.001), and from 3.2 to 1.5 events per patient per year, corresponding to a 53.1% relative reduction (P < 0.001). The percentage of patients with OCS claims was reduced by 12.6%, from 99.1% to 86.5% (P < 0.001). Of the patients who had a reduction in mean daily OCS use, most (57.9%, 140/242) had a reduction in mean daily OCS use of at least 50%.
These data from patients with life-threatening asthma in clinical practice demonstrated that asthma exacerbation and OCS use were significantly reduced with mepolizumab treatment.
有生命威胁的哮喘患者通常会经历反复发作，依赖口服皮质类固醇（OCS），并且有相当大的哮喘相关医疗保健费用。关于美泊利珠单抗对现实世界临床实践中生命威胁性哮喘患者的发作和 OCS 使用的影响的数据有限。本研究评估了美泊利珠单抗对现实环境中生命威胁性哮喘患者发作率和 OCS 使用的影响。
这项回顾性研究利用了来自有生命威胁的哮喘患者的美国行政索赔数据。符合条件的患者在 2015 年 11 月 1 日至 2017 年 12 月 31 日之间接受治疗；在开始美泊利珠单抗治疗时（索引日期）年龄≥12 岁；并且在索引后 6 个月内至少接受了两次美泊利珠单抗治疗。收集了索引前（基线）和后（随访）12 个月的数据，每位患者作为自己的对照。有生命威胁的哮喘的定义是至少有三次发作和/或至少有一次哮喘相关住院治疗在基线期间，和/或有气管插管的病史。评估哮喘发作频率和 OCS 使用情况。
该分析包括 327 名接受平均（标准差）10.6（4.3）美泊利珠单抗剂量的患者，在接受美泊利珠单抗治疗后，至少有一次发作的患者比例和平均发作率从基线显著降低到随访，从 94.5%降至 67.9%（P<0.001），从每位患者每年 3.2 次发作降至 1.5 次，相对减少 53.1%（P<0.001）。有 OCS 索赔的患者比例降低了 12.6%，从 99.1%降至 86.5%（P<0.001）。在平均每日 OCS 使用量减少的患者中，大多数（57.9%，140/242）的平均每日 OCS 使用量减少了至少 50%。
来自临床实践中有生命威胁的哮喘患者的数据表明，美泊利珠单抗治疗可显著减少哮喘发作和 OCS 使用。
