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.
Rheumatology (Oxford). 2021 Dec 24;61(1):270-280. doi: 10.1093/rheumatology/keab274.
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.
The main inclusion criteria of this prospective, observational, multicentre study were confirmed RA diagnosis, treatment by MTX monotherapy and need for therapeutic management modification.
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.
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.
ClinicalTrials.gov NCT02288520.
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。
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。
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。
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。
ClinicalTrials.gov NCT02288520。
