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.

摘要

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.