Department of Rheumatology, Case Western Reserve University, University Hospitals, Cleveland, OH, USA.
Division of Arthritis and Rheumatic Diseases, Oregon Health and Science University, Portland, OR, USA.
Curr Rheumatol Rep. 2024 May;26(5):155-163. doi: 10.1007/s11926-024-01137-w. Epub 2024 Feb 9.
Limited data is available for tapering or discontinuation of biologic therapy in patients with axSpA who are in disease remission. The current review concentrates on published studies regarding dose tapering or withdrawal of biologics in axSpA.
Recent evidence in light of randomized controlled trials suggests that tapering of b-DMARDs is a feasible strategy to maintain remission or low disease activity in axSpA patients. TNF inhibitors were the studied biologics in most of these trials. The disease flare rates were comparable to those maintained on standard dose in most of these studies, although with variable tapering strategies and follow-up. Additionally, the duration of disease in remission prior to tapering, studied primary outcome, and flare definitions were heterogeneous. Female sex, HLA-B*27 negativity, high physician global score, and high CRP were negative predictors of successful tapering, but not consistently reported in all the trials. Although designed to address efficacy, there were no safety concerns with b-DMARD tapering. Withdrawal or complete discontinuation of biologics met with increased risk of flares compared to standard dosing. Tapering of TNF inhibitors may be feasible in certain axSpA patients with an acceptable disease state; however, discontinuation is not currently recommended owing to increased risk of flare. Future studies with axSpA patients with longer remission duration prior to taper and different doses and types of b-DMARDs may provide more guidance.
对于处于缓解期的 axSpA 患者,生物制剂的减量或停药数据有限。本综述集中于 axSpA 中生物制剂减量或停药的已发表研究。
鉴于随机对照试验的新证据表明,b-DMARD 的减量是维持 axSpA 患者缓解或低疾病活动度的可行策略。这些试验中的大多数研究了 TNF 抑制剂。在大多数这些研究中,疾病复发率与维持标准剂量相当,尽管减量策略和随访有所不同。此外,减量前疾病缓解的持续时间、研究的主要结局和复发定义存在异质性。女性、HLA-B*27 阴性、高医师总体评分和高 CRP 是减量成功的负预测因素,但并非所有试验均一致报告。尽管减量设计旨在解决疗效问题,但 b-DMARD 减量没有安全性问题。与标准剂量相比,生物制剂的停药或完全停药会增加复发风险。在某些具有可接受疾病状态的 axSpA 患者中,TNF 抑制剂的减量可能是可行的;但是,由于复发风险增加,目前不建议停药。具有更长减量前缓解期和不同剂量和类型的 b-DMARDs 的 axSpA 患者的未来研究可能会提供更多指导。