Wells Alvin F, Jodat Nicole, Schiff Michael
Rheumatology and Immunotherapy Center, Franklin, WI, USA ; Duke University Medical Center, Durham, NC, USA.
Rheumatology and Immunotherapy Center, Franklin, WI, USA.
Biologics. 2014 Feb 17;8:41-55. doi: 10.2147/BTT.S55783. eCollection 2014.
There are now more therapeutic options for the treatment of rheumatoid arthritis (RA) than ever before, involving a range of mechanisms of action and different routes of administration. The T-cell costimulation modulator abatacept is the first biologic therapy for RA to be available in both subcutaneous (SC) and intravenous (IV) formulations. This review evaluates the utility of SC abatacept, with a particular focus on patient-reported outcomes, including physical function, pain, fatigue, and quality of life. Practical questions relating to the clinical use of SC abatacept are also addressed, including the relevance of abatacept's mechanism of action; whether IV and SC abatacept are comparable; if patients can easily switch from IV to SC abatacept; whether an IV loading dose is needed; and if temporary treatment interruptions or lack of concomitant methotrexate can affect efficacy or safety. Topics that are of particular concern to patients when using SC biologics, such as injection-site reactions, are also discussed. Observational data from registries and meta-analyses of clinical studies suggest comparable clinical efficacy between biologic disease-modifying antirheumatic drugs; however, such analyses rarely focus on key determinants of patient quality of life such as pain, fatigue, and physical function. The head-to-head AMPLE study is one of the first studies powered to directly compare two biologics in patients with RA. Patient-reported outcomes from year 1 of the ongoing study are evaluated, demonstrating comparable improvements in physical function, pain, fatigue, Short Form-36 Health Survey, and Routine Assessment of Patient Index Data 3 scores between SC abatacept and SC adalimumab when administered with concomitant methotrexate. In summary, the data presented herein show that the SC formulation of abatacept provides a valuable addition to the range of available therapy options for patients with RA, capable of significantly improving key patient considerations such as pain, disability, loss of function, fatigue, and quality of life.
目前，类风湿关节炎（RA）的治疗选择比以往任何时候都更多，涉及一系列作用机制和不同给药途径。T细胞共刺激调节剂阿巴西普是首个有皮下（SC）和静脉（IV）两种剂型的用于RA的生物疗法。本综述评估了皮下注射阿巴西普的效用，特别关注患者报告的结局，包括身体功能、疼痛、疲劳和生活质量。还讨论了与皮下注射阿巴西普临床应用相关的实际问题，包括阿巴西普作用机制的相关性；静脉注射和皮下注射阿巴西普是否具有可比性；患者能否轻松从静脉注射阿巴西普转换为皮下注射阿巴西普；是否需要静脉注射负荷剂量；以及暂时中断治疗或未同时使用甲氨蝶呤是否会影响疗效或安全性。还讨论了患者在使用皮下生物制剂时特别关注的主题，如注射部位反应。来自注册研究和临床研究荟萃分析的观察数据表明，生物性改善病情抗风湿药之间具有相当的临床疗效；然而，此类分析很少关注患者生活质量的关键决定因素，如疼痛、疲劳和身体功能。头对头的AMPLE研究是首批有足够样本量直接比较两种生物制剂对RA患者疗效的研究之一。对这项正在进行的研究第1年患者报告的结局进行了评估，结果表明，当与甲氨蝶呤联合使用时，皮下注射阿巴西普和皮下注射阿达木单抗在身体功能、疼痛、疲劳、简短健康调查问卷36项和患者指数数据3常规评估评分方面的改善相当。总之，本文提供的数据表明，阿巴西普的皮下剂型为RA患者现有的治疗选择范围增添了有价值的补充，能够显著改善患者关注的关键问题，如疼痛、残疾、功能丧失、疲劳和生活质量。
