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MTX 优化或联合 bDMARDs 同样改善类风湿关节炎的疾病活动度:来自前瞻性研究 STRATEGE 的结果。

MTX optimization or adding bDMARD equally improve disease activity in rheumatoid arthritis: results from the prospective study STRATEGE.

机构信息

Department of Rheumatology, CHU Nîmes, University of Montpellier, Nîmes, France.

Institut Desbrest d'Epidemiologie et de Sante Publique, IDESP UMR UA11 INSERM - Univ. Montpellier, Montpellier, France.

出版信息

Rheumatology (Oxford). 2021 Dec 24;61(1):270-280. doi: 10.1093/rheumatology/keab274.

Abstract

OBJECTIVES

The STRATEGE (Therapeutic Strategy in Patients Treated With Methotrexate for Rheumatoid Arthritis) study aimed to describe treatment strategies in current practice in RA biologic DMARD (bDMARD)-naïve patients with an inadequate response to MTX therapy, and to compare clinical efficacy of the different therapeutic strategies on disease activity after 6 months.

METHODS

The main inclusion criteria of this prospective, observational, multicentre study were confirmed RA diagnosis, treatment by MTX monotherapy and need for therapeutic management modification.

RESULTS

The 722 patients included had a mean (s.d.) RA duration of 5.3 (6.7) years, a mean DAS28 of 4.0 (1.1); they were all receiving MTX monotherapy, 68% oral, at a mean dose of 15.0 (4.1) mg/week. Two major strategies were identified: (i) MTX monotherapy dose and/or route optimization (72%) and (ii) bDMARD initiation ± MTX (16%). MTX dosing was modified for 70% of patients, maintained (dose and route) for 28% of patients and interrupted for 2%. bDMARDs were started when the MTX mean dose was 17.4 mg/week, 56% parenterally; MTX was maintained concomitantly for 96% of patients. Six-month follow-up results adjusted by propensity score showed that both options were equally successful in improving disease activity and physical function, with 63 and 68% of good-to-moderate EULAR responses, respectively.

CONCLUSION

The STRATEGE study shows the importance of initial MTX treatment optimization before initiation of a biological treatment and emphasizes the importance of treat-to-target strategy.

TRIAL REGISTRATION

ClinicalTrials.gov NCT02288520.

摘要

目的

STRATEGE(类风湿关节炎患者接受甲氨蝶呤治疗的治疗策略)研究旨在描述当前接受生物改善病情抗风湿药物(bDMARD)治疗的类风湿关节炎(RA)生物初治患者中,对甲氨蝶呤治疗反应不足的治疗策略,并比较不同治疗策略在 6 个月后对疾病活动度的临床疗效。

方法

本前瞻性、观察性、多中心研究的主要纳入标准为确诊的 RA、接受 MTX 单药治疗以及需要治疗管理调整。

结果

纳入的 722 例患者的 RA 病程平均(标准差)为 5.3(6.7)年,DAS28 平均(标准差)为 4.0(1.1);所有患者均接受 MTX 单药治疗,68%为口服,平均剂量为 15.0(4.1)mg/周。确定了两种主要策略:(i)MTX 单药剂量和/或途径优化(72%)和(ii)bDMARD 起始±MTX(16%)。70%的患者调整了 MTX 剂量,28%的患者维持(剂量和途径),2%的患者中断。当 MTX 的平均剂量为 17.4mg/周时开始使用 bDMARD,56%为静脉内给药;96%的患者同时维持 MTX。通过倾向评分调整的 6 个月随访结果表明,两种方案在改善疾病活动度和身体功能方面同样有效,分别有 63%和 68%的患者达到了良好到中度的 EULAR 缓解。

结论

STRATEGE 研究表明,在开始生物治疗之前,初始 MTX 治疗优化的重要性,并强调了靶向治疗策略的重要性。

试验注册

ClinicalTrials.gov NCT02288520。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1041/8742827/d3894846bd39/keab274f1.jpg

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