Yukio Yonemoto1, Koichi Okamura1, Kimihiko Takeuchi2, Keio Ayabe3, Tetsuya Kaneko4, Masatoshi Matsushita5, Yasuyuki Tamura4, Takenobu Iso6, Chisa Okura1, Keiko Otsuka5, Hiroshi Inoue4, Kenji Takagishi1. 1. a Department of Orthopaedic Surgery , Gunma University Graduate School of Medicine , Maebashi, Gunma , Japan. 2. b Department of Rheumatology , Isesaki Fukushima Hospital , Isesaki, Gunma , Japan. 3. c Department of Orthopaedic Surgery , Keiyu Orthopaedic Hospital , Tatebayashi, Gunma , Japan. 4. d Department of Orthopaedic Surgery , Inoue Hospital , Takasaki, Gunma , Japan. 5. e Department of Orthopaedic Surgery , Isesaki Fukushima Hospital , Isesaki, Gunma , Japan. 6. f Department of Rheumatology , Gunma Rheumatism Clinic , Takasaki, Gunma , Japan.
Abstract
OBJECTIVE: The aim of this study was to compare the efficacy and safety of golimumab (GLM) 50 mg + methotrexate (MTX) combination therapy and GLM 100 mg monotherapy in patients with rheumatoid arthritis (RA). METHODS: The subjects were 115 RA patients (92 females and 23 males; median (range) age, 64 (17-87) years; median (range) disease duration, 8 (0.6-48) years) started on GLM. Eighty-three patients received GLM 50 mg/4 weeks + MTX (C group; median (range) MTX dosage 8 (2-16) mg/week), and 32 patients received GLM 100 mg/4 weeks (M group). Serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), matrix metalloproteinase-3, disease activity score (DAS) 28-ESR, DAS28-CRP, simplified disease activity index, and clinical disease activity index were evaluated 4, 12, and 24 weeks after starting GLM. RESULTS: There were no significant differences in disease activity, adverse events, and drug continuation rates at 24 weeks between the groups. The DAS28-ESR remission rate was 34% in the C group and 26% in the M group. CONCLUSIONS: GLM 100 mg monotherapy improved disease activity as well as GLM 50 mg + MTX combination therapy. GLM 100 mg monotherapy appears to have a sufficient therapeutic effect in RA patients who cannot take MTX.
OBJECTIVE: The aim of this study was to compare the efficacy and safety of golimumab (GLM) 50 mg + methotrexate (MTX) combination therapy and GLM 100 mg monotherapy in patients with rheumatoid arthritis (RA). METHODS: The subjects were 115 RApatients (92 females and 23 males; median (range) age, 64 (17-87) years; median (range) disease duration, 8 (0.6-48) years) started on GLM. Eighty-three patients received GLM 50 mg/4 weeks + MTX (C group; median (range) MTX dosage 8 (2-16) mg/week), and 32 patients received GLM 100 mg/4 weeks (M group). Serum C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), matrix metalloproteinase-3, disease activity score (DAS) 28-ESR, DAS28-CRP, simplified disease activity index, and clinical disease activity index were evaluated 4, 12, and 24 weeks after starting GLM. RESULTS: There were no significant differences in disease activity, adverse events, and drug continuation rates at 24 weeks between the groups. The DAS28-ESR remission rate was 34% in the C group and 26% in the M group. CONCLUSIONS:GLM 100 mg monotherapy improved disease activity as well as GLM 50 mg + MTX combination therapy. GLM 100 mg monotherapy appears to have a sufficient therapeutic effect in RApatients who cannot take MTX.