J Rheumatol:巴瑞克替尼治疗类风湿性关节炎的MRI和剂量选择

2019-05-29 xiangting MedSci原创

这组患者的MRI结果提示巴瑞克替尼4mg和8mg抑制了滑膜炎、骨炎和联合炎症。

在RA患者的巴瑞克替尼IIb期研究中,使用磁共振成像(MRI)以支持III期项目的剂量选择。

使用稳定剂量甲氨蝶呤的301名活动性RA患者按照2:1:1:1:1被随机分为安慰剂组或每日1次巴瑞克替尼(1、2、4或8mg),共24周。154名有明确影像学侵蚀的患者在基线和第12、24周进行手/腕部MRI检查。两名对治疗和随诊顺序不知情的影像学专家,对滑膜炎、骨炎、骨侵蚀和软骨消失进行评分。计算联合炎症(骨炎+ 3×滑膜炎评分)和总关节损伤评分(侵蚀+ 2.5×软骨消失评分)。使用ANCOVA调整基线评分后对治疗组进行比较。

安慰剂组、巴瑞克替尼4mg和巴瑞克替尼8mg组的患者,滑膜炎从基线到第12周的平均变化分别为-0.10、-1.50和-1.60(巴瑞克替尼4mg和8mg,p=0.003 vs安慰剂)。骨炎的平均变化分别为0.00、-3.20和-2.10(巴瑞克替尼4mg vs安慰剂,p=0.001;巴瑞克替尼8mg,p=0.037)。这些治疗组骨侵蚀的平均变化分别为0.90、0.10和0.40(4mg组,p=0.089;8mg组,p=0.275)。

这组患者的MRI结果提示巴瑞克替尼4mg和8mg抑制了滑膜炎、骨炎和联合炎症。这证实了先前已被证明的巴瑞克替尼临床疗效,并增加了III期研究中4mg巴瑞克替尼可以减少影像学进展的可信度。[临床试验注册号(www.ClinicalTrials.gov): NCT01185353 ]

原始出处:

Charles Peterfy. MRI and Dose Selection in a Phase II Trial of Baricitinib with Conventional Synthetic Disease-modifying Antirheumatic Drugs in Rheumatoid Arthritis. J Rheumatol. 15 May 2019.

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