Yoshiya Tanaka1, Masayoshi Harigai2, Tsutomu Takeuchi3, Hisashi Yamanaka4, Naoki Ishiguro5, Kazuhiko Yamamoto6, Yutaka Ishii7, Hiroshi Nakajima7, Daniel Baker8, Nobuyuki Miyasaka9, Takao Koike10. 1. a The First Department of Internal Medicine, University of Occupational and Environmental Health Japan , Kitakyushu , Fukuoka , Japan . 2. b Department of Medicine and Rheumatology, Tokyo Medical and Dental University , Bunkyo-Ku , Tokyo , Japan . 3. c Department of Internal Medicine, Keio University , Shinjuku-Ku , Tokyo , Japan . 4. d Institute of Rheumatology, Tokyo Women's Medical University , Shinjuku-Ku , Tokyo , Japan . 5. e Department of Orthopedic Surgery, Nagoya University, Graduate School and Faculty of Medicine , Nagoya , Japan . 6. f Department of Allergy and Rheumatology, The University of Tokyo , Bunkyo-Ku , Tokyo , Japan . 7. g Janssen Pharmaceutical K.K. , Chiyoda-Ku , Tokyo , Japan . 8. h Janssen Research and Development, LLC , Spring House , PA , USA . 9. i Department of Medicine and Rheumatology, Tokyo Medical and Dental University , Bunkyo-Ku , Tokyo , Japan , and. 10. j Sapporo Medical Center NTT EC , Sapporo , Japan.
Abstract
OBJECTIVES: To assess the influence of golimumab dosage and disease activity on joint destruction in patients with active rheumatoid arthritis (RA) in the GO-FORTH study. METHODS: Efficacy was compared among groups given basal methotrexate plus placebo, golimumab (50 mg), or golimumab (100 mg) with stratification by high (HDA) or moderate (MDA) baseline disease activity and by high or low baseline C-reactive protein (CRP). RESULTS: Among HDA or high CRP patients, the mean change of the total Sharp score was 3.48 and 3.41 in the placebo group, 1.94 and 2.71 in the 50 mg group, and 0.39 and 1.15 in the 100 mg group, respectively. The percentage of progression-free patients with HDA or high CRP was 40.4% and 40.0%, 43.1% and 38.2%, and 69.8% and 61.5%, respectively. Among MDA or low CRP patients, both golimumab doses showed similar prevention of joint destruction. Among HDA or high CRP patients, a shorter disease duration and higher TSS/disease duration ratio were associated with joint destruction. CONCLUSION: Both doses of golimumab (50 or 100 mg) prevented joint destruction in MDA or low CRP patients, but 100 mg was better for HDA or high CRP patients with a shorter disease duration or higher TSS/disease duration ratio.
RCT Entities:
OBJECTIVES: To assess the influence of golimumab dosage and disease activity on joint destruction in patients with active rheumatoid arthritis (RA) in the GO-FORTH study. METHODS: Efficacy was compared among groups given basal methotrexate plus placebo, golimumab (50 mg), or golimumab (100 mg) with stratification by high (HDA) or moderate (MDA) baseline disease activity and by high or low baseline C-reactive protein (CRP). RESULTS: Among HDA or high CRPpatients, the mean change of the total Sharp score was 3.48 and 3.41 in the placebo group, 1.94 and 2.71 in the 50 mg group, and 0.39 and 1.15 in the 100 mg group, respectively. The percentage of progression-free patients with HDA or high CRP was 40.4% and 40.0%, 43.1% and 38.2%, and 69.8% and 61.5%, respectively. Among MDA or low CRPpatients, both golimumab doses showed similar prevention of joint destruction. Among HDA or high CRPpatients, a shorter disease duration and higher TSS/disease duration ratio were associated with joint destruction. CONCLUSION: Both doses of golimumab (50 or 100 mg) prevented joint destruction in MDA or low CRPpatients, but 100 mg was better for HDA or high CRPpatients with a shorter disease duration or higher TSS/disease duration ratio.
Entities:
Keywords:
Golimumab; High disease activity; Japanese; Rheumatoid arthritis; Total Sharp score