Mayo Clinic Alix School of Medicine, Scottsdale, AZ, USA.
Division of Health Care Delivery Research, Robert D. and Patricia E. Kern Center for the Science of Health Care Delivery, Mayo Clinic, Rochester, MN, USA.
J Asthma. 2022 Dec;59(12):2352-2359. doi: 10.1080/02770903.2021.2010749. Epub 2021 Dec 6.
To compare the outcomes of real-world patients who would have been eligible for asthma biologics to those who would not have been eligible.
We used data from the OptumLabs Data Warehouse (OLDW) to categorize patients into eligible and ineligible groups based on clinical trials ( = 19 trials) used for Food and Drug Administration (FDA) approval. We then compared the change in the number of asthma exacerbations before and after biological initiation between the two groups.
The percentage of people who would have been eligible for asthma biologic clinical trials ranged from 0-10.2%. The eligible group had a greater reduction in number of asthma exacerbations compared to the ineligible group based on eligibility criteria from 1 omalizumab trial (1.52, 95% CI 1.25, 1.8 in eligible vs. 0.47, 95% CI 0.43, 0.52 in ineligible) and from 1 dupilumab trial (1.6, 95% CI 0.92, 2.28 in eligible vs. 0.52, 95% CI 0.38, 0.65 ineligible). Notably, 15 of the 19 trials had fewer than 11 eligible people, limiting additional comparisons.
Fewer than 1 in 10 people in the United States treated with asthma biologics would have been eligible to participate in the trial for the biologic they used. Where comparisons could be made, trial eligible people have a greater reduction in exacerbations.
Supplemental data for this article is available online at https://doi.org/10.1080/02770903.2021.2010749 .
比较符合和不符合哮喘生物制剂适应证患者的真实世界结局。
我们使用 OptumLabs 数据仓库（OLDW）的数据，根据食品和药物管理局（FDA）批准的临床试验（ = 19 项）将患者分为符合和不符合适应证的组。然后，我们比较了两组患者在开始使用生物制剂前后哮喘恶化次数的变化。
符合哮喘生物制剂临床试验的患者比例为 0-10.2%。根据 1 项奥马珠单抗试验（符合适应证组为 1.52，95%CI 1.25，1.8；不符合适应证组为 0.47，95%CI 0.43，0.52）和 1 项度普利尤单抗试验（符合适应证组为 1.6，95%CI 0.92，2.28；不符合适应证组为 0.52，95%CI 0.38，0.65）的入选标准，符合适应证组的哮喘恶化次数减少幅度大于不符合适应证组。值得注意的是，19 项试验中有 15 项的符合适应证人数少于 11 人，限制了进一步比较。
在美国接受哮喘生物制剂治疗的患者中，不到 1/10 的人有资格参加他们所使用的生物制剂的临床试验。在可以进行比较的情况下，符合适应证的患者的恶化减少幅度更大。
本文的补充数据可在 https://doi.org/10.1080/02770903.2021.2010749 在线获取。
