Taylor Peter C, Alten Rieke, Álvaro Gracia Jose María, Kaneko Yuko, Walls Chad, Quebe Amanda, Jia Bochao, Bello Natalia, Terres Jorge Ross, Fleischmann Roy
Botnar Research Centre, Nuffield Department of Orthopaedics, Rheumatology, and Musculoskeletal Sciences, University of Oxford, Oxford, UK
Internal Medicine II, Rheumatology, SCHLOSSPARK-KLINIK, University Medicine Berlin, Berlin, Germany.
RMD Open. 2022 Mar;8(1). doi: 10.1136/rmdopen-2021-001994.
This post hoc analysis assessed speed, magnitude and maintenance of pain improvement in patients with early rheumatoid arthritis (RA) receiving baricitinib, baricitinib and methotrexate (MTX), or MTX over 1 year. Cumulative pain and quality of life benefits were also assessed.
Randomised, double-blind, phase 3 study RA-BEGIN (NCT01711359) compared baricitinib 4 mg (N=159), baricitinib 4 mg +MTX (N=215) and MTX (N=210) in patients with RA who had no or limited prior disease-modifying antirheumatic drug treatment. Pain was assessed on a 0-100 mm Visual Analogue Scale (VAS). Proportion of patients with ≥30%, ≥50% and ≥70% pain improvement from baseline; ≤20 mm and ≤10 mm on the pain VAS; and time to achieve pain improvement thresholds were assessed over 52 weeks, as were Patient Global Assessment (PtGA) and 36-Item Short Form Health Survey Physical Component Score (SF-36 PCS) outcomes.
Baricitinib monotherapy or combination with MTX provides greater (least square mean changes (LSM) from baseline -40 mm and -43 mm, respectively) and more rapid (median 12 and 8 weeks to ≥70% improvement, respectively) pain relief than MTX alone (LSM -31 mm, median 20 weeks to ≥70% improvement) over 52 weeks. Baricitinib, alone or combination, provides 9-10 additional weeks of limited to no pain, similar gain in achievable wellness measured through PtGA, and 5-7 additional weeks with change in SF-36 PCS ≥5 vs MTX over 1 year.
Patients treated with baricitinib reported significantly greater and more rapid pain relief, more weeks with limited to no pain, and clinically meaningful improvements in physical health than patients treated with MTX alone over 1 year.
本事后分析评估了早期类风湿关节炎（RA）患者接受巴瑞替尼、巴瑞替尼与甲氨蝶呤（MTX）联合治疗或MTX单药治疗1年期间疼痛改善的速度、幅度和持续性。还评估了累积疼痛和生活质量获益情况。
随机、双盲、3期RA-BEGIN研究（NCT01711359）比较了4mg巴瑞替尼（N = 159）、4mg巴瑞替尼+MTX（N = 215）和MTX（N = 210）在既往未接受或仅接受过有限的改善病情抗风湿药物治疗的RA患者中的疗效。采用0至100mm视觉模拟量表（VAS）评估疼痛。评估了自基线起疼痛改善≥30%、≥50%和≥70%的患者比例；疼痛VAS评分≤20mm和≤10mm的患者比例；以及达到疼痛改善阈值的时间，同时还评估了患者整体评估（PtGA）和36项简明健康调查身体成分评分（SF-36 PCS）结果，为期52周。
在52周的时间里，与单独使用MTX（最小二乘均值变化（LSM）为-31mm，达到≥70%改善的中位时间为20周）相比，巴瑞替尼单药治疗或与MTX联合治疗能提供更大幅度（分别较基线的LSM为-40mm和-43mm）且更快速（达到≥70%改善的中位时间分别为12周和8周）的疼痛缓解。巴瑞替尼单药治疗或联合治疗在1年中比MTX多提供9至10周的轻度至无疼痛时间、通过PtGA测量的可实现健康状况的类似改善，以及SF-36 PCS变化≥5的额外5至7周时间。
与单独接受MTX治疗的患者相比，接受巴瑞替尼治疗的患者在1年中报告疼痛缓解显著更大且更迅速、轻度至无疼痛的周数更多，以及身体健康方面有具有临床意义的改善。
