Effects of golimumab, an anti-tumour necrosis factor-α human monoclonal antibody, on lipids and markers of inflammation.
Effects of golimumab, an anti-tumour necrosis factor-α human monoclonal antibody, on lipids and markers of inflammation.
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DOI：
10.1136/annrheumdis-2012-202089
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发表时间：
2014-01
影响因子：
27.4
通讯作者：
Rahman MU
中科院分区：
文献类型：
--
作者：
Kirkham BW;Wasko MC;Hsia EC;Fleischmann RM;Genovese MC;Matteson EL;Liu H;Rahman MU
在两项III期、随机、安慰剂对照试验（GO-BEFORE和GO-FORWARD）中评估戈利木单抗联合或不联合甲氨蝶呤（MTX）对类风湿关节炎（RA）患者血脂和心血管疾病（CVD）炎症标志物的影响。GO-BEFORE组（n=637，MTX初治）和GO-FORWARD组（n=444，MTX应答不足）的患者随机接受安慰剂+MTX、戈利木单抗100 mg+安慰剂、戈利木单抗50 mg+MTX或戈利木单抗100 mg+MTX。 每4周一次皮下注射（安慰剂和戈利木单抗）。 应答不足的患者在第16周（GO-FORWARD）或第28周（GO-BEFORE）进入早期逃逸。GO-FORWARD中所有安慰剂+MTX患者在第24周交叉至戈利木单抗50 mg+MTX组。 评估了从基线到第14周（GO-FORWARD）或第24周（GO-BEFORE）和第52周血脂水平和炎症标志物的变化。在GO-FORWARD试验的第14周，戈利木单抗+MTX患者的总胆固醇（TC）、高密度脂蛋白（HDL）和低密度脂蛋白（LDL）升高，（分别为16.00 vs 2.00（p<0.001）; 3.00 vs 0.00（p<0.05）; 8.00 vs 4.00（p<0.001））;仅在接受戈利木单抗治疗的患者中观察到LDL亚组分的有利变化。在GO-BEFORE组第24周，仅MTX组和戈利木单抗+MTX组的TC和LDL升高，LDL亚组分改善。在两项研究中，戈利木单抗+MTX与安慰剂+MTX相比，CVD风险的炎症标志物显著改善，并且通常维持至第52周。致动脉粥样硬化指数基本稳定。虽然接受戈利木单抗+MTX治疗的RA患者的TC和LDL水平轻度升高，但致动脉粥样硬化指数通常保持稳定，观察到LDL亚组分的有利变化，炎症标志物改善。
To assess the effect of golimumab, with or without methotrexate (MTX), on serum lipids and inflammatory markers of cardiovascular disease (CVD) in patients with rheumatoid arthritis (RA) in two phase 3, randomised, placebo-controlled trials (GO-BEFORE and GO-FORWARD). Patients in GO-BEFORE (n=637, MTX-naïve) and GO-FORWARD (n=444, MTX-inadequate response) were randomised to placebo+MTX, golimumab 100 mg+placebo, golimumab 50 mg+MTX, or golimumab 100 mg+MTX. Subcutaneous injections (placebo and golimumab) were given every 4 weeks. Patients with an insufficient response entered early escape at week 16 (GO-FORWARD) or 28 (GO-BEFORE). All placebo+MTX patients in GO-FORWARD crossed over to golimumab 50 mg+MTX at week 24. Changes from baseline to weeks 14 (GO-FORWARD) or 24 (GO-BEFORE), and 52 in serum lipid levels and inflammatory markers were assessed. At week 14 in the GO-FORWARD trial, total cholesterol (TC), high-density lipoprotein (HDL) and low-density lipoprotein (LDL) increased in golimumab+MTX patients versus MTX-only patients (16.00 vs 2.00 (p<0.001); 3.00 vs 0.00 (p<0.05); 8.00 vs 4.00 (p<0.001); respectively); favourable changes in LDL subfractions were only observed in golimumab-treated patients. At week 24 in GO-BEFORE, TC and LDL increased, and LDL subfractions improved in the MTX-only and golimumab+MTX groups. Inflammatory markers of CVD risk improved significantly with golimumab+MTX versus placebo+MTX in both studies and were generally maintained through week 52. Atherogenic indices were generally stable. While TC and LDL levels increased mildly in RA patients receiving golimumab+MTX, atherogenic indices generally remained stable, favourable changes in LDL subfractions were observed, and inflammatory markers improved.
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Golimumab是一种通过每月皮下注射给予的肿瘤坏死因子{alpha}的人类抗体，尽管甲氨蝶呤疗法是活跃的类风湿关节炎：Go-Fornward研究。
影响因子：
27.4
作者：
Keystone EC;Genovese MC;Klareskog L;Hsia EC;Hall ST;Miranda PC;Pazdur J;Bae SC;Palmer W;Zrubek J;Wiekowski M;Visvanathan S;Wu Z;Rahman MU;GO-FORWARD Study
通讯作者：
GO-FORWARD Study
影响因子：
3.9
作者：
Galarraga, Bernat;Belch, Jill J. F.;Khan, Faisel
通讯作者：
Khan, Faisel
DOI：
10.1196/annals.1351.039
发表时间：
2006-01-01
期刊：
BASIC AND CLINICAL ASPECTS OF NEUROENDOCRINE IMMUNOLOGY IN RHEUMATIC DISEASES
影响因子：
--
作者：
Seriolo, Bruno;Paolino, Sabrina;Cutolo, Maurizio
通讯作者：
Cutolo, Maurizio
影响因子：
37.8
作者：
Lamarche, B;Tchernof, A;Despres, JP
通讯作者：
Despres, JP
影响因子：
--
作者：
Kremer, Joel M.;Bloom, Bradley J.;Zwillich, Samuel H.
通讯作者：
Zwillich, Samuel H.