Golimumab, a human antibody to tumour necrosis factor {alpha} given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study.
Golimumab, a human antibody to tumour necrosis factor {alpha} given by monthly subcutaneous injections, in active rheumatoid arthritis despite methotrexate therapy: the GO-FORWARD Study.
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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。
DOI：
10.1136/ard.2008.099010
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发表时间：
2009-06
影响因子：
27.4
通讯作者：
GO-FORWARD Study
中科院分区：
文献类型：
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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
III期GO-FORWARD研究检查了戈利木单抗在接受甲氨蝶呤治疗的活动性类风湿关节炎（RA）患者中的疗效和安全性。患者以3：3：2：2的比例随机分配接受安慰剂注射剂+甲氨蝶呤胶囊（第1组，n = 133）、戈利木单抗100 mg注射剂+安慰剂胶囊（第2组，n = 133）、戈利木单抗50 mg注射剂+甲氨蝶呤胶囊（第3组，n = 89）或戈利木单抗100 mg注射剂+甲氨蝶呤胶囊（第4组，n = 89）。 每4周皮下注射一次。联合主要终点是第14周美国风湿病学会标准（ACR 20）改善20%或以上的患者比例以及第24周健康评估问卷残疾指数（HAQ-DI）评分较基线的变化。安慰剂+甲氨蝶呤组、戈利木单抗100 mg+安慰剂组、戈利木单抗50 mg+甲氨蝶呤组和戈利木单抗100 mg+甲氨蝶呤组第14周达到ACR 20缓解的患者比例分别为33.1%、44.4%（p=0.059）、55.1%（p=0.001）和56.2%（p<0.001）。 在第24周，HAQ-DI评分较基线的中位改善分别为0.13、0.13（p = 0.240）、0.38（p<0.001）和0.50（p<0.001）。 在研究的安慰剂对照部分（至第16周），分别有2.3%、3.8%、5.6%和9.0%的患者发生严重不良事件，分别有0.8%、0.8%、2.2%和5.6%的患者发生严重感染。在接受甲氨蝶呤治疗的活动性RA患者中，戈利木单抗联合甲氨蝶呤治疗可显著减轻RA的体征和症状，并改善身体功能。
The phase III GO-FORWARD study examined the efficacy and safety of golimumab in patients with active rheumatoid arthritis (RA) despite methotrexate therapy. Patients were randomly assigned in a 3 : 3 : 2 : 2 ratio to receive placebo injections plus methotrexate capsules (group 1, n = 133), golimumab 100 mg injections plus placebo capsules (group 2, n = 133), golimumab 50 mg injections plus methotrexate capsules (group 3, n = 89), or golimumab 100 mg injections plus methotrexate capsules (group 4, n = 89). Injections were administered subcutaneously every 4 weeks. The co-primary endpoints were the proportion of patients with 20% or greater improvement in the American College of Rheumatology criteria (ACR20) at week 14 and the change from baseline in the health assessment questionnaire-disability index (HAQ-DI) score at week 24. The proportion of patients who achieved an ACR20 response at week 14 was 33.1% in the placebo plus methotrexate group, 44.4% (p = 0.059) in the golimumab 100 mg plus placebo group, 55.1% (p = 0.001) in the golimumab 50 mg plus methotrexate group and 56.2% (p<0.001) in the golimumab 100 mg plus methotrexate group. At week 24, median improvements from baseline in HAQ-DI scores were 0.13, 0.13 (p = 0.240), 0.38 (p<0.001) and 0.50 (p<0.001), respectively. During the placebo-controlled portion of the study (to week 16), serious adverse events occurred in 2.3%, 3.8%, 5.6% and 9.0% of patients and serious infections occurred in 0.8%, 0.8%, 2.2% and 5.6%, respectively. The addition of golimumab to methotrexate in patients with active RA despite methotrexate therapy significantly reduced the signs and symptoms of RA and improved physical function.
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影响因子：
--
作者：
Keystone, EC;Kavanaugh, AF;Chartash, EK
通讯作者：
Chartash, EK
影响因子：
27.4
作者：
Bartelds, Geertje M.;Wijbrandts, Carla A.;Wolbink, Gerrit Jan
通讯作者：
Wolbink, Gerrit Jan
影响因子：
27.4
作者：
Kievit, W.;Fransen, J.;van Riel, P. L. C. M.
通讯作者：
van Riel, P. L. C. M.
影响因子：
--
作者：
Zink, Angela;Strangfeld, Anja;Listing, Joachim
通讯作者：
Listing, Joachim
影响因子：
168.9
作者：
Klareskog, L;van der Heijde, D;Sanda, M
通讯作者：
Sanda, M