Naoki Ishiguro1, Tatsuya Atsumi2, Masayoshi Harigai3, Tsuneyo Mimori4, Norihiro Nishimoto5, Takayuki Sumida6, Tsutomu Takeuchi7, Yoshiya Tanaka8, Ayako Nakasone9, Nobuhiro Takagi10, Hisashi Yamanaka11. 1. a Department of Orthopedic Surgery , Nagoya University Graduate School & Faculty of Medicine , Nagoya , Japan. 2. b Hokkaido University Graduate School of Medicine , Sapporo , Japan. 3. c Department of Pharmacovigilance , Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University , Tokyo , Japan. 4. d Department of Rheumatology and Clinical Immunology , Kyoto University , Kyoto , Japan. 5. e Osaka Rheumatology Clinic, Tokyo Medical University , Osaka , Japan. 6. f Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine , University of Tsukuba , Tsukuba , Japan. 7. g Division of Rheumatology, Department of Internal Medicine , Keio University , Minato , Japan. 8. h The First Department of Internal Medicine , School of Medicine, University of Occupational and Environmental Health , Kitakyushu , Japan. 9. i Pharmacovigilance Department , Chugai Pharmaceutical Co. Ltd. , Tokyo , Japan. 10. j Medical Science Department , Chugai Pharmaceutical Co. Ltd. , Tokyo , Japan , and. 11. k Institute of Rheumatology, Tokyo Women's Medical University , Tokyo , Japan.
Abstract
OBJECTIVE: To evaluate effectiveness and safety of tocilizumab (TCZ) in biologic-naive Japanese patients with rheumatoid arthritis (RA) in real-world settings, and to analyze the relationship between disease duration and clinical outcomes. METHODS: The FIRST Bio study was a postmarketing surveillance study of intravenous TCZ in biologics-naive patients who had a prior inadequate response or were intolerant to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD). Effectiveness, safety, and concomitant csDMARD administration were assessed. RESULTS: Of the 839 patients analyzed, 72.3% completed 52 weeks of treatment. The Clinical Disease Activity Index (CDAI) remission rate at week 52 was 36.8%. Contributing factors for CDAI remission were younger age, early disease stage, and no comorbidities. Health Assessment Questionnaire Disability Index ≤0.5 was achieved in 65.1% of patients, and was significantly associated with disease duration. Discontinuation of concomitant methotrexate (MTX) and glucocorticoids (GCs) was possible in 19.3% and 34.1% of patients, respectively, without decreasing remission rate. The incidence (events/100 patient-years) of serious adverse events was 18.09, the most common being infection. CONCLUSION: These data validate the importance of TCZ treatment in the early stages of RA in biologic-naive patients to achieve increased effectiveness. The safety profile of TCZ was reconfirmed. Furthermore, TCZ therapy may allow discontinuation of concomitant MTX and GCs without affecting remission.
OBJECTIVE: To evaluate effectiveness and safety of tocilizumab (TCZ) in biologic-naive Japanese patients with rheumatoid arthritis (RA) in real-world settings, and to analyze the relationship between disease duration and clinical outcomes. METHODS: The FIRST Bio study was a postmarketing surveillance study of intravenous TCZ in biologics-naive patients who had a prior inadequate response or were intolerant to ≥1 conventional synthetic disease-modifying antirheumatic drug (csDMARD). Effectiveness, safety, and concomitant csDMARD administration were assessed. RESULTS: Of the 839 patients analyzed, 72.3% completed 52 weeks of treatment. The Clinical Disease Activity Index (CDAI) remission rate at week 52 was 36.8%. Contributing factors for CDAI remission were younger age, early disease stage, and no comorbidities. Health Assessment Questionnaire Disability Index ≤0.5 was achieved in 65.1% of patients, and was significantly associated with disease duration. Discontinuation of concomitant methotrexate (MTX) and glucocorticoids (GCs) was possible in 19.3% and 34.1% of patients, respectively, without decreasing remission rate. The incidence (events/100 patient-years) of serious adverse events was 18.09, the most common being infection. CONCLUSION: These data validate the importance of TCZ treatment in the early stages of RA in biologic-naive patients to achieve increased effectiveness. The safety profile of TCZ was reconfirmed. Furthermore, TCZ therapy may allow discontinuation of concomitant MTX and GCs without affecting remission.