Morsani College of Medicine, University of South Florida, Tampa, Florida.
AllerVie Health - Alabama Allergy and Asthma Center, Birmingham, Alabama.
Ann Allergy Asthma Immunol. 2023 Nov;131(5):598-605.e3. doi: 10.1016/j.anai.2023.07.017. Epub 2023 Jul 26.
Patient adherence to biologic therapies is crucial for clinical benefits. Previous assessments of US patient adherence to severe asthma (SA) biologic therapies have relied on health care insurance claims data that have limitations.
To describe real-world, specialist-reported, biologic administration and adherence among US adults with SA.
CHRONICLE (ClinicalTrials.gov identifier: NCT03373045) is an ongoing real-world, noninterventional study of patients with SA treated by US subspecialists. Sites report date and location for all biologic administrations. We evaluated biologic (benralizumab, dupilumab, mepolizumab, omalizumab, reslizumab) adherence as the proportion of days covered (PDC) during the first 52 weeks and the mean number of days until patients received the expected number of doses for 13, 26, and 52 weeks of treatment.
A total of 2117 patients received biologic administrations between February 2018 and February 2022. Most patients (84%) received biologic administrations at a subspecialist site. Over time, administrations at specialist sites decreased, whereas at-home administrations increased. The median PDC was 87%; the mean number of days to receive a 52-week (364-day) equivalent number of doses was 423 for all biologics (average delay of 58 days). Dupilumab had the lowest PDC and highest mean delays in dosing across all intervals; better adherence was observed among commercially insured patients.
Patients with SA are mostly adherent to biologic therapies. Biologics with shorter dosing intervals and at-home administration had worse adherence, likely because of greater opportunities for delays. Specialist-reported administration data provide a unique perspective on biologic adherence, which may be overestimated for at-home administrations by insurance claims data.
ClinicalTrials.gov: NCT03373045.
患者对生物疗法的依从性对于临床获益至关重要。先前对美国严重哮喘（SA）生物疗法患者依从性的评估依赖于医疗保健保险索赔数据，而这些数据存在局限性。
描述美国成年 SA 患者真实世界中专家报告的生物制剂管理和依从性。
CHRONICLE（ClinicalTrials.gov 标识符：NCT03373045）是一项正在进行的真实世界、非干预性研究，涉及由美国专家治疗的 SA 患者。各研究点报告所有生物制剂给药的日期和地点。我们评估了生物制剂（贝那鲁肽、度普利尤单抗、美泊利珠单抗、奥马珠单抗、瑞利珠单抗）的依从性，即第 1 至 52 周内的覆盖天数（PDC）比例，以及患者接受预期剂量的 13、26 和 52 周治疗的平均天数。
2018 年 2 月至 2022 年 2 月期间，共有 2117 名患者接受了生物制剂给药。大多数患者（84%）在专科门诊接受生物制剂给药。随着时间的推移，专科门诊给药减少，而家庭给药增加。PDC 的中位数为 87%；所有生物制剂接受 52 周（364 天）等效剂量的平均天数为 423 天（平均延迟 58 天）。度普利尤单抗在所有时间间隔内的 PDC 最低，剂量延迟时间最长；商业保险患者的依从性更好。
SA 患者对生物疗法的依从性较高。具有较短给药间隔和家庭给药的生物制剂依从性较差，这可能是由于延误的机会更多。专家报告的给药数据提供了对生物制剂依从性的独特视角，这可能因保险索赔数据对家庭给药的估计过高而产生偏差。
ClinicalTrials.gov：NCT03373045。
