戈利木单抗对类风湿关节炎影像学进展的影响：甲氨蝶呤治疗前使用戈利木单抗与甲氨蝶呤治疗后使用戈利木单抗的随机对照研究结果

The effects of golimumab on radiographic progression in rheumatoid arthritis: results of randomized controlled studies of golimumab before methotrexate therapy and golimumab after methotrexate therapy.

作者信息

Emery Paul, Fleischmann Roy, van der Heijde Désirée, Keystone Edward C, Genovese Mark C, Conaghan Philip G, Hsia Elizabeth C, Xu Weichun, Baratelle Anna, Beutler Anna, Rahman Mahboob U

机构信息

University of Leeds and NIHR Leeds Musculoskeletal Biomedical Research Unit, Leeds, UK.

出版信息

Arthritis Rheum. 2011 May;63(5):1200-10. doi: 10.1002/art.30263.

DOI:10.1002/art.30263

PMID:21305524

Abstract

OBJECTIVE

To evaluate the effects of golimumab on radiographic progression in patients with rheumatoid arthritis (RA).

METHODS

Methotrexate (MTX)-naive patients (in the Golimumab Before Employing Methotrexate as theFirst-Line Option in the Treatment of Rheumatoid Arthritis of Early Onset [GO-BEFORE] study; n = 637)and patients with active RA despite MTX therapy (in the Golimumab in Active Rheumatoid Arthritis Despite Methotrexate Therapy [GO-FORWARD] study; n =444) were randomly assigned to receive placebo plus MTX (group 1), golimumab 100 mg plus placebo (group 2), golimumab 50 mg plus MTX (group 3), or golimumab 100 mg plus MTX (group 4). Golimumab orplacebo was administered subcutaneously every 4 weeks. Radiographs of the hands and feet were taken at baseline, week 28, and week 52 in the GO-BEFORE study and at baseline, week 24 (week 16 for patients who entered early escape), and week 52 in the GO-FORWARD study. Radiographs were scored by 2 independent readers in each study using the van der Heijde modification of the Sharp score.

RESULTS

In the GO-BEFORE study, the mean ± SD changes in the modified Sharp score from base line to week 52 (control period) were 1.4 ± 4.6 in group 1, 1.3 ± 6.2 in group 2 (P = 0.266), 0.7 ± 5.2 in group 3 (P = 0.015), and 0.1 ± 1.8 in group 4 (P = 0.025). In the GO-FORWARD study, changes from baseline to week 24 (control period) were 0.6 ± 2.4 in group 1, 0.3 ± 1.6 in group 2 (P = 0.361), 0.6 ± 2.7 in group 3 (P = 0.953), and 0.2 ± 1.3 in group 4 (P = 0.293).

CONCLUSION

Golimumab in combination with MTX inhibited radiographic progression significantly better than did MTX alone in the GO-BEFORE study. Radiographic progression in the GO-FORWARD study was minimal in all treatment arms, precluding an adequate assessment of the effect of golimumab on radiographic progression in this study.

摘要

目的

评估戈利木单抗对类风湿关节炎（RA）患者影像学进展的影响。

方法

未使用过甲氨蝶呤（MTX）的患者（在“戈利木单抗在早发型类风湿关节炎治疗中作为一线选择前使用[GO-BEFORE]”研究中；n = 637）以及尽管接受MTX治疗但仍患有活动性RA的患者（在“尽管接受甲氨蝶呤治疗仍患有活动性类风湿关节炎的患者中使用戈利木单抗[GO-FORWARD]”研究中；n = 444）被随机分配接受安慰剂加MTX（第1组）、戈利木单抗100 mg加安慰剂（第2组）、戈利木单抗50 mg加MTX（第3组）或戈利木单抗100 mg加MTX（第4组）。每4周皮下注射戈利木单抗或安慰剂。在GO-BEFORE研究的基线、第28周和第52周以及在GO-FORWARD研究的基线、第24周（提前退出的患者为第16周）和第52周拍摄手和脚的X线片。在每项研究中，由2名独立的阅片者使用改良的Sharp评分（van der Heijde改良版）对X线片进行评分。

结果

在GO-BEFORE研究中，从基线到第52周（对照期），改良Sharp评分的均值±标准差变化在第1组为1.4±4.6，第2组为1.3±6.2（P = 0.266），第3组为0.7±5.2（P = 0.015），第4组为0.1±1.8（P = 0.025）。在GO-FORWARD研究中，从基线到第24周（对照期），第1组的变化为0.6±2.4，第2组为0.3±1.6（P = 0.361），第3组为0.6±2.7（P = 0.953），第4组为0.2±1.3（P = 0.293）。