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疾病活动度指导的TNF抑制剂剂量减少策略治疗类风湿性关节炎长期有效

纽约(路透社健康新闻)——从DRESS研究公布的三年数据来看,根据类风湿性关节炎(RA)患者的疾病活动程度,降低肿瘤坏死因子抑制剂(TNFi)剂量可长期维持其安全性和有效性,也能大幅减少TNFi的使用量。荷兰奈梅亨市圣马丁医院Chantal Bouman医生及其同事表示,实施这一策略可以大大改善TNFi的成本效益。在荷兰这项“皮下注射TNF抑制剂减量策略”(DRESS)研究中,患者被随机分为两组,一组根据疾病活动度接受TNFi减量(DR)策略治疗,另一组接受常规治疗,常规治疗即一种旨在维持低疾病活动度的标准化达标式治疗方案。DR策略包括逐步延长注射间期,以每三个月为单位,直至疾病复发或停止用药。这份DRESS研究2015年发表于《英国医学期刊》(BMJ)(http://bit.ly/2ttrgea),该研究显示TNFi疗法(阿达木单抗或依那西普)的DR策略在疾病复发方面不输常规治疗(UC)。到第18个月时,DR组和UC组的疾病复发率分别为12%和10%。6月12日在线版风湿性疾病年鉴中,该小组报告了DRESS扩展期研究的三年数据,其中保留了原有的组群分配。根据原始研究结果,DR策略的安全性和有效性在扩展期内维持了三年,其中包括180位原有患者中的172名。在扩展期间(18-26个月),DR组和UC组的主要疾病累积复发率分别为10%和12%;而在0-36个月期间,DR组和UC组的主要疾病累积复发率分别为17%和14%。扩展期间,DR组和UC组疾病累积短暂复发率分别为43%和35%;而在0-36个月期间,DR组和UC组的疾病累积短暂复发率分别为83% 和44%。研究人员报告称:“DR组与UC组在主要的疾病复发率方面无明显差异,在疾病活动度、功能性和生活质量方面也非常相似。”他们得出结论:“以疾病活动度为指导、针对RA患者的TNFi减量策略取得了良好的研究成果,因此在RA治疗中,这也许是一个可行且长期的治疗策略。若要进一步优化该策略,则可以把有助于成功减量或停药的预测识别因素纳入考量,因为这也许能预防疾病的短暂复发。”


原文


Disease-Activity-Guided TNF Inhibitor Dose Reduction Works Long-term in RA


NEW YORK (Reuters Health) - In patients with rheumatoid arthritis (RA), disease-activity-guided dose reduction of a tumor necrosis factor inhibitor (TNFi) is safe and effective in the long-term and leads to a large reduction in TNFi use, according to three-year data from the DRESS study.Implementation of this strategy would “vastly improve the cost-effective use of TNFi,” conclude Dr. Chantal Bouman, of Sint Maartenskliniek, Nijmegen, the Netherlands, and colleagues.In the DRESS (Dutch Dose Reduction Strategy of Subcutaneous TNF Inhibitors) study, patients were randomly allocated to a disease-activity-guided TNFi dose-reduction (DR) strategy or usual care (a standardized treat-to-target protocol aimed at maintaining low disease activity). The DR strategy consisted of a stepwise increase in the injection time interval every three months until flare or discontinuation.The DRESS study, published in The BMJ in 2015 (http://bit.ly/2ttrgea), showed that DR of TNFi therapy (adalimumab or etanercept) is non-inferior to usual care (UC) regarding flares. At 18 months, a major flare had occurred in 12% of the DR group versus 10% of the UC group.In Annals of the Rheumatic Diseases, online June 12, the team reports three-year data of an extension of the DRESS study, in which the original group allocation was maintained.Mirroring the original study findings, the safety and efficacy of the DR strategy was maintained up to three years in the extension phase which included 172 of the 180 original patients.The cumulative incidence of major flare was 10% in the DR group and 12% in the UC group in the extension phase (18 to 26 months), and 17% and 14%, respectively, from 0 to 36 months.The cumulative incidences of short-lived flares were 43% and 35% in DR and UC groups in the extension phase, and 83% and 44% from 0 to 36 months.“No relevant difference in the number of major flares could be demonstrated between DR and UC group, and disease activity, functioning and quality of life were also very similar,” the researchers report.They conclude that a “disease activity-guided DR strategy of TNFi in patients with RA doing well seems a reasonable long-term approach in RA treatment. Further optimization of this strategy could consist of identification of predictors for successful DR or discontinuation, as this might prevent short-lived flaring.”The study received no commercial funding. Several authors reported ties to pharmaceutical companies.

 

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