Jin Ran, Haughton James M, Goddard Emily J, Courmier Delphine, Radziszewski Waldemar, Meadows Rachael H, Piercy James, Cohen Stanley
Amgen Inc., Thousand Oaks, CA, USA.
Center for Observational Research, Amgen Inc., Thousand Oaks, CA, USA.
Rheumatol Ther. 2025 Jun;12(3):469-492. doi: 10.1007/s40744-025-00755-9. Epub 2025 Mar 11.
Biosimilars have provided additional treatment options for patients with immune-mediated inflammatory diseases. This study evaluated the real-world use of adalimumab biosimilar ABP 501 in European patients with rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), or psoriasis (PsO).
Data were drawn from the RA, spondyloarthritis, and PsO Adelphi Disease Specific Programmes (DSP)™, cross-sectional surveys conducted in France, Germany, Italy, Spain, and the UK between January 2020 and February 2022. Physicians completed patient record forms which collected data on demographics, treatment history, and clinical outcomes. Patients voluntarily completed questionnaires self-reporting health-related quality of life. Outcome measures were assessed for patients who initiated ABP 501 as the first advanced therapy (AT, "ABP 501 initiators") and patients who switched to ABP 501 from the first-line AT with reference product (RP) ("RP-ABP 501 switchers") in each indication.
Across disease cohorts, 868 initiators and 428 switchers were analyzed. At time of consultation, physicians reported that 77.1%, 63.2%, 67.8%, and 83.0% of initiators with RA, AS, PsA, and PsO, respectively, presented with mild disease after receiving ABP 501 for a median of 10.4-12.3 months. Among switchers, the most common reasons for switching were related to formulary or financial reasons and insurance restrictions. Most switching patients were assessed by physicians to have mild disease (75.0-87.5% across indications) at time of consultation having received ABP 501 for a median of 11.2-15.3 months. Patients' self-assessment, including EQ-5D and work productivity scores, indicated an overall good state of health while using ABP 501, regardless of indication and prior RP exposure. Overall, more than 89% of physicians and more than 86% patients reported being satisfied with the disease control provided by ABP 501.
Across indications, both physicians and patients reported positive clinical outcomes and high levels of satisfaction with ABP 501 treatment, regardless of prior use of RP.
生物类似药为免疫介导的炎症性疾病患者提供了更多治疗选择。本研究评估了阿达木单抗生物类似药ABP 501在欧洲类风湿关节炎（RA）、强直性脊柱炎（AS）、银屑病关节炎（PsA）或银屑病（PsO）患者中的实际使用情况。
数据来自2020年1月至2022年2月在法国、德国、意大利、西班牙和英国进行的RA、脊柱关节炎和PsO阿德尔菲疾病特定项目（DSP）™横断面调查。医生填写患者记录表，收集人口统计学、治疗史和临床结果数据。患者自愿填写问卷，自我报告与健康相关的生活质量。对各适应症中开始使用ABP 501作为首个高级疗法的患者（“ABP 501启动者”）和从一线高级疗法转换为使用参考产品（RP）的ABP 501的患者（“RP-ABP 501转换者”）的结局指标进行评估。
在所有疾病队列中，共分析了868名启动者和428名转换者。在会诊时，医生报告称，接受ABP 501治疗中位数为10.4 - 12.3个月后，分别有77.1%、63.2%、67.8%和83.0%的RA、AS、PsA和PsO启动者病情为轻度。在转换者中，转换的最常见原因与处方集或财务原因以及保险限制有关。大多数转换患者在会诊时被医生评估为病情轻度（各适应症中为75.0 - 87.5%），接受ABP 501治疗中位数为11.2 - 15.3个月。患者的自我评估，包括EQ-5D和工作生产力得分，表明在使用ABP 501期间总体健康状况良好，无论适应症和之前是否接触过RP。总体而言，超过89%的医生和超过86%的患者报告对ABP 501提供的疾病控制感到满意。
在所有适应症中，无论之前是否使用过RP，医生和患者均报告ABP 501治疗具有积极的临床结果和高度满意度。
