Treatment with adalimumab in patients with chronic inflammatory rheumatic diseases: a study of treatment trajectories on a patient level in routine care.

IF 3.4 2区 医学 Q2 RHEUMATOLOGY
Imke Redeker, Stefan Moustakis, Styliani Tsiami, Xenofon Baraliakos, Ioana Andreica, Bjoern Buehring, Jürgen Braun, Uta Kiltz
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引用次数: 0

Abstract

Background: Previous experiences with non-medical switching of adalimumab (ADA) in patients with chronic inflammatory rheumatic diseases (CIRD) come mainly from phase III extension of randomised clinical trials and little from routine care.

Objectives: To analyse treatment trajectories over 2 years in patients with CIRD conducting a non-medical switch from originator to biosimilar ADA.

Design: A retrospective observational cohort study was conducted with data from a third-level rheumatology centre in Germany. CIRD patients on originator ADA who switched to ADA biosimilar from October 2018 onwards were identified and followed until September 2020.

Methods: Patients' characteristics were compared between the four a priori defined treatment trajectories 'continued biosimilar ADA therapy', 'back-switch to originator ADA therapy', 'switch to another biological disease-modifying anti-rheumatic drug (bDMARD) therapy' and 'stopped bDMARD therapy/death/drop out'. Factors associated with continuing biosimilar ADA therapy were analysed using Cox proportional hazards regression analyses.

Results: A total of 121 CIRD patients were included. Most patients (66.9%) continued therapy with biosimilar ADA over 2 years, with a treatment retention rate of 73.1%. Whereas 21 patients (17.4%) switched back to originator ADA, mainly due to adverse events, and 8 patients (6.6%) switched to a different bDMARD, mainly due to lack of effect. The estimated risk of withdrawal was lower for longer prior duration on originator ADA [hazard ratio (HR): 0.82; 95% CI: 0.69-0.97] and higher for higher C-reactive protein levels at baseline (HR: 1.18; 95% CI: 1.00-1.39). Male patients, older patients and those for whom originator ADA was their first bDMARD tended to have a lower risk of withdrawal.

Conclusion: Our results indicated that three of four patients continue biosimilar ADA over 2 years with lower risks of withdrawal for male sex, older age, longer prior duration on originator ADA and originator ADA as first bDMARD.

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慢性炎症性风湿病患者的阿达木单抗治疗:常规护理中患者水平治疗轨迹的研究
背景:以往慢性炎症性风湿病(CIRD)患者阿达木单抗(ADA)非医学转换的经验主要来自随机临床试验的III期扩展,很少来自常规护理。目的:分析CIRD患者从原研药物到生物仿制药ADA进行非医疗转换的2年治疗轨迹。设计:采用来自德国三级风湿病中心的数据进行回顾性观察队列研究。从2018年10月起转为ADA生物仿制药的CIRD患者被确定并随访至2020年9月。方法:将患者的特征在四种先验定义的治疗轨迹中进行比较:“继续生物类似药ADA治疗”、“回转到原药ADA治疗”、“切换到另一种生物疾病修饰抗风湿药物(bDMARD)治疗”和“停止bDMARD治疗/死亡/退出”。使用Cox比例风险回归分析与持续生物类似药ADA治疗相关的因素。结果:共纳入121例CIRD患者。大多数患者(66.9%)继续使用ADA生物仿制药治疗2年以上,治疗保留率为73.1%。然而,21名患者(17.4%)切换回原药ADA,主要是由于不良事件,8名患者(6.6%)切换到不同的bDMARD,主要是由于缺乏效果。原用药时间越长,预估停药风险越低[风险比(HR): 0.82;95% CI: 0.69-0.97],基线时c反应蛋白水平越高越高(HR: 1.18;95% ci: 1.00-1.39)。男性患者、老年患者和最初ADA为bDMARD的患者往往有较低的停药风险。结论:我们的研究结果表明,4例患者中有3例持续使用生物仿制药ADA超过2年,男性、年龄较大、原研药物ADA和原研药物ADA作为首发bDMARD的持续时间较长,停药风险较低。
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来源期刊
CiteScore
6.80
自引率
4.80%
发文量
132
审稿时长
18 weeks
期刊介绍: Therapeutic Advances in Musculoskeletal Disease delivers the highest quality peer-reviewed articles, reviews, and scholarly comment on pioneering efforts and innovative studies across all areas of musculoskeletal disease.
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