Masayoshi Kanbori1, Hiroshi Suzuka2, Tsutomu Yajima3, Emika Kishino1, Ryuji Morishige4, Shigeki Momohara5, Atsushi Kawakami6, Miyo Ota4. 1. a Japan Safety and Surveillance Division, Research and Development Division , Janssen Pharmaceutical K.K. , Tokyo , Japan. 2. b Data Management Department, Research and Development Division , Janssen Pharmaceutical K.K. , Tokyo , Japan. 3. c Biostatistics Department, Research and Development Division , Janssen Pharmaceutical K.K. , Tokyo , Japan. 4. d Medical Affairs Division , Janssen Pharmaceutical K.K. , Tokyo , Japan. 5. e Hakkeikai Incorporated Medical Institution/Department of Orthopaedic Surgery , Keio University , Shizuoka , Japan. 6. f Department of Immunology and Rheumatology, Unit of Advanced Preventive Medical Sciences, Division of Advanced Preventive Medical Sciences , Nagasaki University Graduate School of Biomedical Sciences , Nagasaki , Japan.
Abstract
OBJECTIVES: The purpose of this study was to evaluate the real-world safety and effectiveness of golimumab (GLM) in Japanese patients with rheumatoid arthritis. METHODS: A postmarketing surveillance of 5154 patients was conducted with a follow-up duration of at least 24 weeks. Patients were divided into four groups based on the initial treatment: 50 mg or 100 mg of GLM with concomitant use of methotrexate (MTX) and 50 mg or 100 mg of GLM monotherapy. Patient characteristics at baseline, safety and effectiveness were assessed for each group. RESULTS: Over 70% of patients received 50 mg of GLM with concomitant MTX, and approximately, 20% received monotherapy. The incidence rate of adverse events was 45.40 per 100 patient-years. The incidence of adverse events including serious adverse events was comparable across all groups. The proportion of patients showing remission or low disease activity increased from 13.69% to 46.21% at the final evaluation, and no differences were observed in the percentage of remission across the four groups. Concomitant MTX use was associated with higher probability of continuing therapy. CONCLUSIONS: GLM showed effectiveness in Japanese rheumatoid arthritis patients with an acceptable safety profile.
OBJECTIVES: The purpose of this study was to evaluate the real-world safety and effectiveness of golimumab (GLM) in Japanese patients with rheumatoid arthritis. METHODS: A postmarketing surveillance of 5154 patients was conducted with a follow-up duration of at least 24 weeks. Patients were divided into four groups based on the initial treatment: 50 mg or 100 mg of GLM with concomitant use of methotrexate (MTX) and 50 mg or 100 mg of GLM monotherapy. Patient characteristics at baseline, safety and effectiveness were assessed for each group. RESULTS: Over 70% of patients received 50 mg of GLM with concomitant MTX, and approximately, 20% received monotherapy. The incidence rate of adverse events was 45.40 per 100 patient-years. The incidence of adverse events including serious adverse events was comparable across all groups. The proportion of patients showing remission or low disease activity increased from 13.69% to 46.21% at the final evaluation, and no differences were observed in the percentage of remission across the four groups. Concomitant MTX use was associated with higher probability of continuing therapy. CONCLUSIONS:GLM showed effectiveness in Japanese rheumatoid arthritispatients with an acceptable safety profile.