Division of Rheumatology and Clinical Immunology, The University of Hong Kong, Pok Fu Lam, Hong Kong.
Hospital for Special Surgery and Weill Cornell Medicine, New York, NY, USA.
Rheumatol Int. 2017 Nov;37(11):1789-1798. doi: 10.1007/s00296-017-3780-8. Epub 2017 Aug 29.
Biologic therapies have improved the management of rheumatoid arthritis (RA) and the treat-to-target approach has resulted in many patients achieving remission. In the current treatment landscape, clinicians have begun considering dose reduction/tapering for their patients. Rheumatology guidelines in Asia, Europe, and the United States include down-titration of biologics but admit that the level of evidence is moderate. We conducted a systematic literature review to assess the published studies that evaluate down-titration of biologics in RA. The published literature was searched for studies that down-titrated the following biologics: abatacept, adalimumab, certolizumab, etanercept, golimumab, infliximab, rituximab, and tocilizumab. Eligible studies included randomized controlled trials (RCTs), non-RCTs, observational, and pharmacoeconomic studies. The outcomes of interest were (1) efficacy and health-related quality of life, (2) disease flares, and (3) impact on cost. Eleven full-text publications were identified; only three were RCTs. Study results suggest that dosing down may be an option in many patients who have achieved remission or low disease activity. However, some patients are likely to experience a disease flare. Across the studies, the definition of disease flare and the down-titration criteria were inconsistent, making it difficult to conclude which patients may be appropriate and when to attempt down-titration. Studies have evaluated the practice of dosing down biologic therapy in patients with RA; however, a relatively small number of RCTs have been published. Although down-titration may be an option for some patients in LDA or remission, additional RCTs are needed to provide guidance on this practice.
生物制剂改善了类风湿关节炎（RA）的治疗管理，达标治疗方法使许多患者实现了缓解。在当前的治疗环境下，临床医生开始考虑为患者减少或逐渐减少药物剂量。亚洲、欧洲和美国的风湿病学指南包括降低生物制剂的剂量，但承认证据水平为中等。我们进行了系统的文献回顾，以评估评估 RA 中生物制剂降阶治疗的已发表研究。对以下生物制剂降阶治疗的已发表文献进行了检索：阿巴西普、阿达木单抗、依那西普、戈利木单抗、英夫利昔单抗、利妥昔单抗和托珠单抗。合格的研究包括随机对照试验（RCT）、非随机对照试验、观察性研究和药物经济学研究。感兴趣的结果包括（1）疗效和健康相关生活质量，（2）疾病发作，（3）对成本的影响。确定了 11 篇全文出版物，其中只有 3 篇是 RCT。研究结果表明，在许多达到缓解或低疾病活动度的患者中，减少剂量可能是一种选择。然而，一些患者可能会出现疾病发作。在这些研究中，疾病发作的定义和降阶标准不一致，难以确定哪些患者可能适合以及何时尝试降阶。研究已经评估了在 RA 患者中降低生物治疗剂量的实践；然而，已发表的 RCT 相对较少。虽然对于一些处于低疾病活动度或缓解期的患者，降阶可能是一种选择，但需要更多的 RCT 来提供关于这种治疗的指导。
