Department of Social Medicine, Ribeirão Preto Medical School, University of São Paulo, Ribeirão Preto, Brazil.
GSK, Rio de Janeiro, Brazil.
J Asthma. 2021 Jul;58(7):958-966. doi: 10.1080/02770903.2020.1748049. Epub 2020 Apr 9.
This study aims to describe the eligibility for biologic therapies for severe asthma (SA) in a cohort of patients attending the Program for Control of Asthma (ProAR) in Bahia, Brazil.
Data from SA patients (≥18 years old) attending the ProAR, that were included in a case-control study conducted from 2013 to 2015, were used to reassess patients according to a modified ERS/ATS 2014 SA criteria. Patients were then classified according to the eligibility for SA biological therapy based on current prescription labels.
From 544 patients in the cohort, 531 (97.6%) were included and 172 (32.4%) were identified as SA patients according to the ERS/ATS 2014 modified criteria. Of these 172 patients, 69 (40.1%) were ineligible for any of the biologicals approved for asthma (omalizumab, mepolizumab, reslizumab and benralizumab), 60 (34.9%) patients were eligible for one of the biological therapies, and 10 (5.8%) patients were eligible for all biological therapies.
More than half of patients with SA were eligible for biologic therapy in our study, but none of them received this form of treatment. Almost half of them were not eligible to any of the approved biologics, however. The variability and overlap in patients' eligibility highlight the importance of evaluating each patient individually for a more personalized treatment approach. While there is a need to increase access for some of those eligible that may really need a biologic treatment, continuous efforts are required to develop alternatives to those who are not eligible.
本研究旨在描述巴西巴伊亚控制哮喘计划（ProAR）中接受生物疗法治疗严重哮喘（SA）的患者队列的资格标准。
本研究使用了来自 2013 年至 2015 年进行的病例对照研究中参加 ProAR 的 SA 患者（≥18 岁）的数据，重新评估了患者，并根据改良的 ERS/ATS 2014 年 SA 标准进行分类。然后根据当前处方标签将患者分为 SA 生物治疗的资格标准。
从队列中的 544 名患者中，有 531 名（97.6%）患者被纳入，根据 ERS/ATS 2014 年的改良标准，有 172 名（32.4%）患者被诊断为 SA 患者。在这 172 名患者中，有 69 名（40.1%）患者不符合任何一种批准用于哮喘的生物制剂（奥马珠单抗、美泊利单抗、瑞利珠单抗和贝那利珠单抗）的使用标准，有 60 名（34.9%）患者符合一种生物制剂的使用标准，有 10 名（5.8%）患者符合所有生物制剂的使用标准。
在我们的研究中，超过一半的 SA 患者有资格接受生物治疗，但他们都没有接受这种治疗。然而，几乎一半的患者不符合任何一种批准的生物制剂的使用标准。患者的资格标准存在差异和重叠，这突出了为每位患者进行个体化评估以制定更个性化治疗方案的重要性。虽然需要增加一些确实需要生物治疗的合格患者的治疗机会，但需要不断努力开发不适合的替代方案。
