Mycophenolate Mofetil Versus Placebo for Systemic Sclerosis-Related Interstitial Lung Disease: An Analysis of Scleroderma Lung Studies I and II.
Mycophenolate Mofetil Versus Placebo for Systemic Sclerosis-Related Interstitial Lung Disease: An Analysis of Scleroderma Lung Studies I and II.
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DOI：
10.1002/art.40114
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发表时间：
2017-07
期刊：
影响因子：
--
通讯作者：
Elashoff RM
中科院分区：
文献类型：
--
作者：
Volkmann ER;Tashkin DP;Li N;Roth MD;Khanna D;Hoffmann-Vold AM;Kim G;Goldin J;Clements PJ;Furst DE;Elashoff RM
比较霉酚酸酯 (MMF) 与安慰剂治疗系统性硬化症相关间质性肺疾病 (SSc-ILD) 的效果。参加硬皮病肺研究 (SLS) I 的安慰剂组和 SLS II 的 MMF 组的参与者均被纳入其中。 SLS I 将参与者随机分配至口服环磷酰胺 (CYC) 与安慰剂 1 年，而 SLS II 则将参与者随机分配至 MMF 2 年与口服 CYC 1 年，然后服用 1 年安慰剂。 SLS I 和 II 的资格标准几乎相同。主要结局是 FVC% 预测，关键次要结局包括 DLCO% 预测、皮肤评分和呼吸困难。创建联合模型是为了评估两年内治疗对这些结果过程的影响。 SLS II-MMF (N=61) 和 SLS I-安慰剂 (N=61) 参与者在性别、病程、SSc 亚型、皮肤病程度和 FVC% 预测方面具有相似的基线特征。与 SLS I 安慰剂参与者相比，SLS II-MMF 患者年龄稍大（平均 [SD] 岁：52.6[9.7] vs. 48.1[12.4]；P=0.015），且 DLCO% 预测较高（平均 [SD]：54.0[11.1] vs. 46.2[13.3]；P=0.0002）。调整基线疾病严重程度后，与安慰剂相比，MMF 治疗与 2 年以上 FVC% 预测 (P<0.0001)、DLCO% 预测 (P<0.001)、皮肤评分 (P<0.0001) 和呼吸困难 (P=0.0112) 的病程改善相关。尽管比较不同试验的参与者存在固有的局限性，但与安慰剂相比，MMF 治疗与生理结果和呼吸困难的改善相关，即使在考虑了基线疾病严重程度后也是如此。这些结果进一步证实了 MMF 用于治疗 SSc-ILD 的用途。
To compare mycophenolate (MMF) with placebo for the treatment of systemic sclerosis-related interstitial lung disease (SSc-ILD). Participants enrolled in the placebo arm of Scleroderma Lung Study (SLS) I and the MMF arm of SLS II were included. SLS I randomized participants to oral cyclophosphamide (CYC) versus placebo for 1 year, while SLS II randomized participants to MMF for 2 years versus oral CYC for 1 year followed by 1 year of placebo. Eligibility criteria for SLS I and II were nearly identical. The primary outcome was FVC%-predicted and key secondary outcomes included the DLCO%-predicted, skin score, and dyspnea. Joint models were created to evaluate the treatment effect on the course of these outcomes over 2 years. SLS II-MMF (N=61) and SLS I-placebo (N=61) participants had similar baseline characteristics for gender, disease duration, SSc subtype, extent of skin disease and FVC%-predicted. SLS II-MMF patients were slightly older (mean[SD] years: 52.6[9.7] vs. 48.1[12.4]; P=0.015) and had a higher DLCO%-predicted (mean[SD]: 54.0[11.1] vs. 46.2[13.3]; P=0.0002) than SLS I-placebo participants. After adjusting for baseline disease severity, treatment with MMF in comparison with placebo was associated with an improved course of FVC%-predicted (P<0.0001), DLCO%-predicted (P<0.001), skin score (P<0.0001), and dyspnea (P=0.0112) over 2 years. Although there are inherent limitations in comparing participants from different trials, treatment with MMF was associated with improvements in physiologic outcomes and dyspnea compared with placebo, even after accounting for baseline disease severity. These results further substantiate the use of MMF for the treatment of SSc-ILD.
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影响因子：
158.5
作者：
Tashkin, Donald P.;Elashoff, Robert;Metersky, Mark
通讯作者：
Metersky, Mark
影响因子：
1.9
作者：
Elashoff, Robert M.;Li, Gang;Li, Ning
通讯作者：
Li, Ning
影响因子：
2
作者：
Li, Ning;Elashoff, Robert M.;Tseng, Chi-Hong
通讯作者：
Tseng, Chi-Hong
DOI：
10.3899/jrheum.121043
发表时间：
2013-05
期刊：
The Journal of rheumatology
影响因子：
--
作者：
Fischer A;Brown KK;Du Bois RM;Frankel SK;Cosgrove GP;Fernandez-Perez ER;Huie TJ;Krishnamoorthy M;Meehan RT;Olson AL;Solomon JJ;Swigris JJ
通讯作者：
Swigris JJ
影响因子：
3.4
作者：
Pilar Simeon-Aznar, Carmen;Fonollosa-Pla, Vicent;Vilardell-Tarres, Miquel
通讯作者：
Vilardell-Tarres, Miquel