Genovese Mark C, Han Chenglong, Keystone Edward C, Hsia Elizabeth C, Buchanan Jacqueline, Gathany Timothy, Murphy Frederick T, Wu Zhong, Parasuraman Shreekant, Rahman Mahboob U
Stanford University, Palo Alto, CA, USA.
J Rheumatol. 2012 Jun;39(6):1185-91. doi: 10.3899/jrheum.111195. Epub 2012 Apr 15.
To evaluate the effect of golimumab on physical function, general health, and fatigue in patients with active rheumatoid arthritis (RA) despite methotrexate (MTX) therapy.
In the multicenter, randomized, placebo-controlled GO-FORWARD study, 444 adults with active RA despite MTX received subcutaneous placebo + MTX (crossover to golimumab 50 mg at Week 24), golimumab 100 mg + placebo, golimumab 50 mg + MTX, or golimumab 100 mg + MTX every 4 weeks. Physical function and general health were assessed using the Health Assessment Questionnaire-Disability Index (HAQ-DI) and Physical and Mental Component Summary (PCS, MCS) scores of the Medical Outcomes Study Short Form-36 questionnaire (SF-36), respectively, through Week 52. Fatigue was measured through Week 24 using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) questionnaire.
Mean improvements from baseline in HAQ-DI, SF-36 PCS, and FACIT-Fatigue scores (Weeks 14 and 24) were significantly greater for golimumab 50 mg + MTX and 100 mg + MTX versus placebo + MTX. Significantly greater proportions of patients treated with golimumab + MTX achieved clinically meaningful improvements from baseline to Weeks 14 and 24 in HAQ-DI, PCS, and FACIT-Fatigue scores. Mean improvements in SF-36 PCS (Week 14), MCS (Week 24), and FACIT-Fatigue (Weeks 14 and 24) scores were significantly greater for golimumab 100 mg + placebo versus placebo + MTX. Mean improvements from baseline in HAQ-DI, SF-36 PCS, and MCS scores through Week 24 were sustained through Week 52.
Patients with active RA despite MTX had significant improvement in physical function, general health, and fatigue following golimumab + MTX therapy; improvements in physical function and general health were maintained through Week 52. (Clinical Trials Registration NCT00264550).
评估戈利木单抗对尽管接受了甲氨蝶呤（MTX）治疗但仍患有活动性类风湿关节炎（RA）患者的身体功能、总体健康状况和疲劳的影响。
在多中心、随机、安慰剂对照的GO-FORWARD研究中，444名尽管接受MTX治疗但仍患有活动性RA的成年人每4周接受皮下注射安慰剂+MTX（在第24周交叉使用50mg戈利木单抗）、100mg戈利木单抗+安慰剂、50mg戈利木单抗+MTX或100mg戈利木单抗+MTX治疗。分别通过健康评估问卷残疾指数（HAQ-DI）以及医学结局研究简表36问卷（SF-36）的身体和精神成分总结（PCS、MCS）评分评估至第52周的身体功能和总体健康状况。使用慢性病治疗功能评估-疲劳（FACIT-疲劳）问卷测量至第24周的疲劳情况。
与安慰剂+MTX相比，50mg戈利木单抗+MTX和100mg戈利木单抗+MTX组患者在HAQ-DI、SF-36 PCS和FACIT-疲劳评分（第14周和第24周）较基线的平均改善幅度显著更大。接受戈利木单抗+MTX治疗的患者中，从基线到第14周和第24周，在HAQ-DI、PCS和FACIT-疲劳评分方面实现具有临床意义改善的患者比例显著更高。与安慰剂+MTX相比，100mg戈利木单抗+安慰剂组患者在SF-36 PCS（第14周）、MCS（第24周）和FACIT-疲劳（第14周和第24周）评分方面的平均改善幅度显著更大。至第24周，HAQ-DI、SF-36 PCS和MCS评分较基线的平均改善在第52周时得以维持。
尽管接受MTX治疗但仍患有活动性RA的患者在接受戈利木单抗+MTX治疗后，身体功能、总体健康状况和疲劳有显著改善；身体功能和总体健康状况的改善在第52周时得以维持。（临床试验注册号NCT00264550）
