Efficacy of synthetic and biological DMARDs: a systematic literature review informing the 2025 update of the EULAR recommendations for the management of rheumatoid arthritis.

Methods

Medline (PubMed), Embase (OVID), Cochrane Central Register of Controlled Trials, and Web of Science were searched for randomised controlled trials (RCTs) of conventional-synthetic, biological, and targeted-synthetic DMARDs (csDMARDs, bDMARDs, tsDMARDs), as well as GCs and biosimilars, published from 14 January 2022 to 22 January 2025.

检索了Medline (PubMed)、Embase (OVID)、Cochrane中央控制试验注册处和Web of Science，以寻找从2022年1月14日至2025年1月22日发表的常规合成、生物制剂和靶向合成疾病修饰性抗风湿药物（csDMARDs、bDMARDs、tsDMARDs）以及糖皮质激素（GCs）和生物类似物的随机对照试验（RCTs）。

Additional searches on DMARDs, GCs, and antifibrotics for RA-associated interstitial lung disease (RA ILD), and on DMARDs and GCs for preventing RA in at-risk individuals, were conducted from database inception to 22 January 2025.

对RA相关间质性肺病(RA ILD)的DMARDs、GCs和抗纤维化药物，以及对高风险个体预防RA的DMARDs和GCs进行了额外的搜索，从数据库建立之初到2025年1月22日。

Results

A total of 12,567 references were identified; 390 full-texts were reviewed, and 72 studies were included.

共识别出12,567篇参考文献；审查了390篇全文，并包括了72项研究。

Phase 3-4 RCTs evaluated csDMARDs (hydroxychloroquine, iguratimod, leflunomide, and methotrexate), bDMARDs (abatacept, otilimab, and ozoralizumab), and tsDMARDs (ivarmacitinib, peficitinib, and tofacitinib).

III-IV期随机对照试验评估了传统合成疾病修饰性抗风湿药物（羟氯喹、依曲替莫德、来氟米特和甲氨蝶呤）、生物制剂疾病修饰性抗风湿药物（阿巴西普、奥替利单抗和奥佐拉利单抗）以及靶向合成疾病修饰性抗风湿药物（依维莫司、佩非替尼和托法替尼）。

Twelve novel compounds were assessed in phase 2 RCTs, and 3 articles investigated GCs.

12种新化合物在II期随机对照试验中被评估，3篇文章研究了糖皮质激素。

Strategic trials compared conventional therapies with bDMARD- or tsDMARD-based strategies and explored precision-medicine approaches such as synovial biopsy-guided treatment and therapeutic drug monitoring.

战略试验比较了传统治疗与基于bDMARD或tsDMARD的策略，并探索了精准医学方法，如滑膜活检指导治疗和治疗药物监测。

Additional evidence addressed DMARD tapering.

额外的证据涉及DMARD减量。

Two RCTs assessed antifibrotics (nintedanib and pirfenidone) for RA ILD, and 7 studies evaluated DMARDs for RA prevention in at-risk populations.

两项随机对照试验评估了抗纤维化药物（尼替达尼和吡非尼酮）用于类风湿性关节炎间质性肺病的治疗，另外7项研究评估了疾病修饰性抗风湿药物用于类风湿性关节炎高风险人群的预防。

Conclusions

This SLR, together with the safety review, informed the 2025 update of the EULAR RA management recommendations.

这项系统综述以及安全性审查，为2025年欧洲抗风湿病联盟类风湿性关节炎管理建议的更新提供了信息。

Although few phase 3 trials on novel agents were available, strategic and head-to-head studies provided important insights that enabled further refinement of the established treatment algorithm.

尽管关于新型药物的III期试验较少，但战略性和直接比较研究提供了重要的见解，使已建立的治疗方案得到进一步完善。