Fautrel Bruno, Kirkham Bruce, Pope Janet E, Takeuchi Tsutomu, Gaich Carol, Quebe Amanda, Zhu Baojin, de la Torre Inmaculada, De Leonardis Francesco, Taylor Peter C
Institut Pierre Louis d'Epidémiologie et de Santé Publique, Sorbonne Universités, GRC 08, 75646 Paris, France.
Department of Rheumatology, Pitié-Salpêtrière Hospital, Assistance Publique-Hôpitaux de Paris, 83 bd de l'hôpital, 75013 Paris, France.
J Clin Med. 2019 Sep 5;8(9):1394. doi: 10.3390/jcm8091394.
Patients with rheumatoid arthritis (RA) may experience residual pain and functional impairment despite good control of disease activity. This study compared improvements in pain and physical function in patients with well-controlled RA after 24 weeks' treatment with baricitinib, adalimumab or placebo in the 52-week RA-BEAM phase III study. Adults with active RA and inadequate response to methotrexate received baricitinib 4 mg once daily, adalimumab 40 mg every two weeks or placebo, with background methotrexate. Patients ( = 1010) were categorised as in remission, in remission or low disease activity, or not in remission or low disease activity at week 24. For patients in remission or low disease activity ( = 310), improvements in mean pain and physical function scores at week 24 were significantly greater with baricitinib than placebo ( < 0.001 and < 0.01, respectively) and adalimumab ( < 0.05 for both). For both outcomes, differences between adalimumab and placebo were not significant. The proportions of patients in remission or low disease activity with minimal or no pain and with normalised physical function were numerically greater with baricitinib than placebo. Baricitinib 4 mg once daily provided enhanced improvement in pain and physical function in patients with well-controlled RA, suggesting it may produce effects beyond immunomodulation.
尽管类风湿性关节炎（RA）患者的疾病活动得到了良好控制，但仍可能经历残留疼痛和功能障碍。在为期52周的RA - BEAM III期研究中，本研究比较了接受巴瑞替尼、阿达木单抗或安慰剂治疗24周后，病情得到良好控制的RA患者在疼痛和身体功能方面的改善情况。对甲氨蝶呤反应不足的活动性RA成年患者接受每日一次4 mg巴瑞替尼、每两周一次40 mg阿达木单抗或安慰剂治疗，并联合使用背景甲氨蝶呤。在第24周时，1010名患者被分类为处于缓解期、缓解或低疾病活动度，或未处于缓解期或低疾病活动度。对于处于缓解期或低疾病活动度的310名患者，在第24周时，巴瑞替尼组的平均疼痛和身体功能评分改善显著大于安慰剂组（分别为P < 0.001和P < 0.01）以及阿达木单抗组（两者均为P < 0.05）。对于这两个结果，阿达木单抗组和安慰剂组之间的差异不显著。与安慰剂相比，接受巴瑞替尼治疗的处于缓解期或低疾病活动度、疼痛极小或无疼痛且身体功能正常化的患者比例在数值上更高。每日一次4 mg巴瑞替尼在病情得到良好控制的RA患者中能增强疼痛和身体功能的改善，表明其可能产生超出免疫调节的作用。
