期刊
ANNALS OF THE RHEUMATIC DISEASES
卷 71, 期 6, 页码 817-824出版社
BMJ PUBLISHING GROUP
DOI: 10.1136/ard.2011.200317
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资金
- Centocor Research & Development Inc
- Janssen Pharmaceuticals KK
- Mitsubishi Tanabe Pharmaceutical Corporation
- Abbott
- Bristol Myers Squibb
- Chugai Pharmaceutical
- Eizai Pharmaceutical
- Janssen Pharmaceutical
- Mitsubishi Tanabe Pharmaceutical
- Otsuka Pharmaceutical
- Roche
- Takeda Pharmaceutical
- Wyeth
- Astellas Pharmaceutical
- Immunofuture Inc
- Santen Pharmaceutical
- Astra Zeneca
- Banyu Pharmaceutical
- Daiichi Sankyo Pharmaceutical
- GlaxoSmith Kline
- Nippon Boehringer Ingelheim
- Teijin Pharmaceutical
- Pfizer
- Novartis
- Grants-in-Aid for Scientific Research [22390198, 23249054] Funding Source: KAKEN
Objective To assess the efficacy and safety of golimumab + methotrexate (MTX) in Japanese patients with active rheumatoid arthritis (RA). Methods 269 Japanese patients with active RA despite treatment with MTX were randomised (1:1:1) to placebo + MTX (Group 1), golimumab 50 mg + MTX (Group 2) or golimumab 100 mg + MTX (Group 3). Subcutaneous golimumab/placebo was injected every 4 weeks; stable doses of oral MTX (6-8 mg/week) were continued. Patients were allowed to enter early escape (Group 1 added golimumab 50 mg, Group 2 increased golimumab to 100 mg, Group 3 continued golimumab 100 mg) based on swollen/tender joint counts at week 14. The primary study endpoint was achievement of at least 20% improvement in the American College of Rheumatology (ACR20) response criteria at week 14. To control for multiplicity of testing, treatment group comparisons were first made between combined Groups 2 and 3 versus Group 1, followed by comparisons of Group 2 and Group 3 versus Group 1. Results The proportion of patients with an ACR20 response at week 14 was significantly higher in combined Groups 2 and 3 (73.4%, 127/173) and in each of Group 2 (72.1%, 62/86) and Group 3 (74.7%, 65/87) compared with Group 1 (27.3%, 24/88; p<0.0001 for all comparisons). Golimumab + MTX also elicited a significantly better response than placebo + MTX in other efficacy parameters, including disease activity score (DAS28) response/remission and radiographic assessments. During the 16-week fixed treatment regimen study period, 72.7%, 75.6% and 78.2% of patients had adverse events and 1.1%, 1.2% and 2.3% had serious adverse events in Groups 1, 2 and 3, respectively. Conclusion In Japanese patients with active RA despite MTX therapy, golimumab + MTX was significantly more effective than MTX monotherapy in reducing RA signs/symptoms and limiting radiographic progression with no unexpected safety concerns.
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