School of Medicine, University of Colorado, Denver, CO, USA.
Rheumatology (Oxford). 2011 Mar;50(3):437-49. doi: 10.1093/rheumatology/keq287. Epub 2010 Sep 28.
Significant advances in our understanding of RA and its management have been made in the past decade, resulting in earlier intervention with biologic DMARDs, particularly in patients with evidence of aggressive, erosive disease. Here, one such biologic therapy, the T-cell co-stimulation modulator abatacept, is discussed, exploring clinical evidence published to date on its use in patients with very early arthritis/early RA who are MTX naïve, and in patients with established RA and an inadequate response to MTX or TNF antagonists. Data from relevant clinical trials are overviewed, discussing the clinical efficacy of abatacept in early disease, the clinical outcomes over long-term treatment in different patient populations and the effects of abatacept on structural damage. Findings from integrated safety analyses of abatacept clinical trial data, representing 10,366 patient-years of exposure are described, and clinically important safety events, including serious infections, malignancies and autoimmune events, are highlighted. It is concluded that abatacept represents an effective treatment option with an established safety profile across different patient populations, including patients with both early and erosive RA and those with established disease. Furthermore, efficacy data from studies in patients with early disease suggest that the risk-benefit profile of abatacept may be more favourable when introduced earlier in the treatment paradigm.
在过去的十年中,我们对 RA 及其治疗的理解取得了重大进展,导致更早地使用生物 DMARDs 进行干预,特别是在有侵袭性、侵蚀性疾病证据的患者中。在这里,讨论了一种这样的生物治疗药物,即 T 细胞共刺激调节剂阿巴西普,探讨了迄今为止在 MTX 初治的极早期关节炎/早期 RA 患者和对 MTX 或 TNF 拮抗剂反应不足的已确诊 RA 患者中使用该药的临床证据。综述了相关临床试验的数据,讨论了阿巴西普在早期疾病中的临床疗效、不同患者人群长期治疗中的临床结局以及阿巴西普对结构损伤的影响。描述了对阿巴西普临床试验数据进行的综合安全性分析的结果,这些数据代表了 10366 患者年的暴露,突出了包括有早期和侵蚀性 RA 以及已确诊疾病的患者在内的不同患者人群中,包括严重感染、恶性肿瘤和自身免疫事件在内的临床重要安全性事件。结论是,阿巴西普在不同患者人群中均具有有效的治疗选择和已确立的安全性特征,包括早期和侵蚀性 RA 患者以及已确诊疾病的患者。此外,早期疾病患者研究中的疗效数据表明,当在治疗模式中更早引入阿巴西普时,其风险效益比可能更有利。