早期类风湿关节炎患者在基于甲氨蝶呤的达标治疗策略中加用或不加用阿达木单抗时手部骨质流失情况——早期类风湿关节炎优化治疗算法（OPERA）试验的一项子研究
Hand bone loss in early rheumatoid arthritis during a methotrexate-based treat-to-target strategy with or without adalimumab-a substudy of the optimized treatment algorithm in early RA (OPERA) trial.
作者信息
Ørnbjerg L M, Østergaard M, Jensen T, Hørslev-Petersen K, Stengaard-Pedersen K, Junker P, Ellingsen T, Ahlquist P, Lindegaard H, Linauskas A, Schlemmer A, Dam M Y, Hansen I, Lottenburger T, Ammitzbøll C G, Jørgensen A, Krintel S B, Raun J, Hetland M L, Slot Ole, Nielsen Lars Kjær, Skjødt Henrik, Majgaard Ole, Lorenzen Tove, Horn Hans Christian, Kowalski Marcin, Johansen Inger Lauge, Pedersen Peter Mosborg, Manilo Natalia, Bliddal Henning
机构信息
Copenhagen Center for Arthritis Research and the DANBIO registry, Center for Rheumatology and Spine Diseases, Rigshospitalet, Copenhagen, Denmark.
Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
出版信息
Clin Rheumatol. 2017 Apr;36(4):781-789. doi: 10.1007/s10067-016-3489-1. Epub 2016 Dec 5.
This study aims to investigate 1-year hand bone loss (HBL) in early rheumatoid arthritis (RA) patients treated with a methotrexate (MTX) and intra-articular triamcinolone treat-to-target strategy +/- adalimumab and to determine if HBL is associated with radiographic progression after 2 years. In a clinical trial (OPERA) of 180 treatment-naive early RA patients, bone mineral density (BMD) was estimated from hand radiographs with digital X-ray radiogrammetry (DXR) at baseline, after 6 (n = 90) and 12 months (n = 70) of follow-up. Baseline and 2-year radiographs were scored according to the Sharp/van der Heijde method. Baseline characteristics and HBL (0-6 months changes in DXR-BMD) were investigated as predictors of structural damage by univariate linear (∆ total Sharp/van der Heijde score (TSS) as dependent variable) and logistic (+/-radiographic progression (∆TSS >0) as dependent variable) regression analyses. Variables with p < 0.10 were included in multivariable models. In 70 patients with available HBL data, HBL was median (interquartile range (IQR)) -1.9 (-3.3; -0.26 mg/cm) in the MTX + placebo group and -1.8 (-3.6; 0.06) mg/cm in the MTX + adalimumab group, p = 0.98, Wilcoxon signed-rank. Increased HBL (compared to general population reference values) was found in 26/37 and 23/33 patients in the MTX + placebo and MTX + adalimumab groups, chi-squared = 0.99. In 90 patients with HBL data and 2-year radiographic data, HBL was independently associated with ∆TSS after 2 years (β = -0.086 (95% confidence interval = -0.15; -0.025) TSS unit/mg/cm increase, p = 0.006) but not with presence of radiographic progression (∆TSS >0) (OR 0.96 (0.92-1.0), p = 0.10). In early RA patients treated with a methotrexate-based treat-to-target strategy, the majority of patients had increased HBL, irrespective of adalimumab; HBL was independently associated with ∆TSS after 2 years.
本研究旨在调查采用甲氨蝶呤（MTX）和关节腔内注射曲安奈德达标治疗策略±阿达木单抗治疗的早期类风湿关节炎（RA）患者1年的手部骨质流失（HBL）情况，并确定HBL是否与2年后的影像学进展相关。在一项针对180例初治早期RA患者的临床试验（OPERA）中，在基线、随访6个月（n = 90）和12个月（n = 70）时，采用数字X线摄影测量法（DXR）从手部X线片估算骨密度（BMD）。根据Sharp/van der Heijde方法对基线和2年时的X线片进行评分。通过单变量线性回归分析（以∆总Sharp/van der Heijde评分（TSS）为因变量）和逻辑回归分析（以±影像学进展（∆TSS>0）为因变量），研究基线特征和HBL（DXR-BMD在0 - 6个月的变化）作为结构损伤的预测因素。p < 0.10的变量纳入多变量模型。在70例有可用HBL数据的患者中，MTX + 安慰剂组的HBL中位数（四分位间距（IQR））为-1.9（-3.3；-0.26mg/cm），MTX + 阿达木单抗组为-1.8（-3.6；0.06）mg/cm，Wilcoxon符号秩检验，p = 0.98。MTX + 安慰剂组和MTX + 阿达木单抗组分别有26/37和23/33例患者的HBL增加（与一般人群参考值相比），卡方检验 = 0.99。在90例有HBL数据和2年影像学数据的患者中，HBL与2年后的∆TSS独立相关（β = -0.086（95%置信区间 = -0.15；-0.025）TSS单位/mg/cm增加，p = 0.006），但与影像学进展的存在（∆TSS>0）无关（比值比0.96（0.92 - 1.0），p = 0.10）。在采用以甲氨蝶呤为基础的达标治疗策略治疗的早期RA患者中，无论是否使用阿达木单抗，大多数患者的HBL都增加；HBL与2年后的∆TSS独立相关。
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