Borrás-Blasco Joaquín, Valcuende-Rosique Alejandro, Cornejo Silvia, Aparicio-Rubio Celia, Aguilar-Zamora Marta, Garijo-Bufort Marta, Arévalo-Ruales Karla Romelia
Pharmacy Department, Hospital de Sagunto, Port de Sagunt, Spain.
Pharmacy Department, Hospital de Alzira, Alzira, Spain.
J Pharm Technol. 2024 Dec 23:87551225241306675. doi: 10.1177/87551225241306675.
Provide real-world data on switching from adalimumab biosimilar MSB11022 to GP2017 related to persistence, adherence, and safety in adult patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA). Retrospective cohort study that used registries and medical records from a single hospital (June 2022 to April 2024). Adult patients with RA, PsA, and axSpA treated with adalimumab biosimilar MSB11022 who switched to biosimilar GP2017 were identified and followed up until April 2024, or disenrollment. Baseline demographic and clinical characteristics studied included sex, age, diagnosis, and previous treatment. Adherence was measured using medication possession ratio (MPR); patients with MPR ≥85% were considered adherent. Persistence, cause of discontinuation, safety, and dosage regimen were collected. A total of 63 patients with chronic inflammatory rheumatic diseases, of whom 36 (57.1%) were women, with an average age of 53.9 years were included. In total, 24 had axSpA, 21 had RA, and 18 had PsA. A total of 58 patients (92.1%) were biologic-naïve, and 27 (42.3%) received methotrexate. A total of 63 patients switched from adalimumab biosimilar MSB11022 to GP2017. After 12 months, 53 (84.1%) continued; 9 (14.3%) discontinued due to lack of effectiveness, side effects, or change of health department. The total persistence of patients who switched from MSB11022 to GP2017 was 12.4 ± 3.1 months. Non-naïve patients had a persistence of 13.7 ± 0.5 months, and naïve patients had 9.5 ± 3.0 months, with no significant differences. The retention rate at 12 months was 84%, with an adherence rate of 88.2%. Switching from adalimumab biosimilar MSB11022 to biosimilar GP2017 in patients with chronic inflammatory rheumatic diseases did not lead to signs of safety or loss of efficacy over 12 months other than those already known in the literature for the class of drugs.
提供关于成年类风湿关节炎(RA)、银屑病关节炎(PsA)和轴性脊柱关节炎(axSpA)患者从阿达木单抗生物类似药MSB11022转换为GP2017后,与持续用药、依从性和安全性相关的真实世界数据。采用回顾性队列研究,使用了一家医院(2022年6月至2024年4月)的登记资料和医疗记录。识别出接受阿达木单抗生物类似药MSB11022治疗且转换为生物类似药GP2017的成年RA、PsA和axSpA患者,并随访至2024年4月或退出研究。研究的基线人口统计学和临床特征包括性别、年龄、诊断和既往治疗情况。使用药物持有率(MPR)来衡量依从性;MPR≥85%的患者被视为依从。收集持续用药情况、停药原因、安全性和剂量方案。共纳入63例慢性炎症性风湿病患者,其中36例(57.1%)为女性,平均年龄53.9岁。其中,24例患有axSpA,21例患有RA,18例患有PsA。共有58例患者(92.1%)之前未使用过生物制剂,27例(42.3%)接受过甲氨蝶呤治疗。共有63例患者从阿达木单抗生物类似药MSB11022转换为GP2017。12个月后,53例(84.1%)继续用药;9例(14.3%)因疗效不佳、出现副作用或卫生部门变更而停药。从MSB11022转换为GP2017的患者总持续用药时间为12.4±3.1个月。非初治患者的持续用药时间为13.7±0.5个月,初治患者为9.5±3.0个月,差异无统计学意义。12个月时的保留率为84%,依从率为88.2%。在慢性炎症性风湿病患者中,从阿达木单抗生物类似药MSB11022转换为生物类似药GP2017,在12个月内除了该类药物文献中已知的情况外,未导致安全性问题或疗效丧失。