Müller-Ladner U, Flipo R M, Vincendon P, Brault Y, Kielar D
Department for Rheumatology and Clinical Immunology, Justus-Liebig University Giessen, Kerckhoff Clinic, 61231, Bad Nauheim, Germany.
Z Rheumatol. 2012 Dec;71(10):890-9. doi: 10.1007/s00393-012-1034-4.
The objective of this study was to investigate patients' perceptions of the acceptability of two devices delivering etanercept for rheumatoid arthritis (RA) treatment and to explore whether specific patients' attributes are associated with device preferences. Two similar multicenter, open-label, randomised, parallel-design studies were conducted in a total of 13 European countries. A total of 640 adult patients with RA were randomised to receive etanercept 50 mg once-weekly subcutaneously for 12 weeks in either a pre-filled syringe (PFS) or a pre-filled pen (PFP). Patient satisfaction at week 12 was measured on a 0- to 10-point Likert scale (primary endpoint). The study was powered to demonstrate non-inferiority of a PFP over PFS for the primary endpoint. At week 12, mean patient satisfaction was 8.3 (± 2.4) points in the pen group and 7.2 (± 2.6) points in the syringe group. Non-inferiority and even superiority of the pen over the syringe was demonstrated. In conclusion, this study showed higher patient satisfaction in the group of patients injecting etanercept with a PFP compared with the group of patients using a PFS.
本研究的目的是调查患者对两种用于类风湿关节炎(RA)治疗的注射用依那西普装置可接受性的看法,并探讨特定患者属性是否与装置偏好相关。在总共13个欧洲国家进行了两项类似的多中心、开放标签、随机、平行设计研究。总共640名成年RA患者被随机分配,皮下注射依那西普50mg,每周一次,持续12周,使用预填充注射器(PFS)或预填充笔(PFP)。在第12周时,使用0至10分的李克特量表测量患者满意度(主要终点)。该研究旨在证明在主要终点方面,PFP不劣于PFS。在第12周时,笔组患者的平均满意度为8.3(±2.4)分,注射器组为7.2(±2.6)分。结果证明笔相对于注射器具有非劣效性甚至优越性。总之,本研究表明,与使用PFS的患者组相比,使用PFP注射依那西普的患者组的患者满意度更高。