Tsuneyo Mimori1, Masayoshi Harigai2, Tatsuya Atsumi3, Takao Fujii4, Masataka Kuwana5, Hiroaki Matsuno6, Shigeki Momohara7,8, Syuji Takei9, Naoto Tamura10, Yoshinari Takasaki11, Kazuhiko Yamamoto12, Satoshi Ikeuchi13, Satoru Kushimoto14, Takao Koike15. 1. a Department of Rheumatology and Clinical Immunology, Graduate School of Medicine , Kyoto University , Kyoto , Japan. 2. b Division of Epidemiology and Pharmacoepidemiology of Rheumatic Diseases , Institute of Rheumatology, Tokyo Women's Medical University , Tokyo , Japan. 3. c Department of Rheumatology, Endocrinology and Nephrology, Faculty of Medicine , Hokkaido University Graduate School of Medicine , Hokkaido , Japan. 4. d Department of Rheumatology and Clinical Immunology , Wakayama Medical University , Wakayama , Japan. 5. e Department of Allergy and Rheumatology , Nippon Medical School Graduate School of Medicine , Tokyo , Japan. 6. f Matsuno Clinic for Rheumatic Diseases , Toyama , Japan. 7. g Hakkeikai Incorporated Medical Institution , Shizuoka , Japan. 8. h Department of Orthopaedic Surgery , Keio University , Tokyo , Japan. 9. i Graduate School of Medical and Dental Sciences, Comprehensive Child Health and Development Medicine , Kagoshima University , Kagoshima , Japan. 10. j Department of Internal Medicine and Rheumatology , Juntendo University Faculty of Medicine , Tokyo , Japan. 11. k Juntendo University Koshigaya Hospital, Juntendo University Faculty of Medicine , Saitama , Japan. 12. l Laboratory for Autoimmune Diseases , RIKEN Center for Integrative Medical Sciences , Kanagawa , Japan. 13. m Frontier PMS Section, Neurology Medical Department , Medical HQs, Eisai Co., Ltd. , Tokyo , Japan. 14. n Post-Marketing Surveillance Group, Data Science and Administration Department , Toyama Chemical Co., Ltd. , Tokyo , Japan. 15. o Sapporo Medical Center NTT EC , Hokkaido , Japan.
Abstract
OBJECTIVES: We evaluated the long-term (52 weeks) safety and effectiveness of iguratimod (IGU) in patients with rheumatoid arthritis (RA). METHODS: This multicenter, prospective, observational study included all evaluable RA patients who received IGU since its market launch in 2012. We evaluated adverse events (AEs); adverse drug reactions (ADRs); ADRs of special interest, including liver and renal dysfunctions, interstitial lung disease, gastrointestinal and blood disorders, and infection; and change in Disease Activity Score 28-C-reactive protein (DAS28-CRP) at week 52. RESULTS: Safety and effectiveness were analyzed in 2666 and 1614 patients, respectively. The incidences of AEs, serious AEs, ADRs, and serious ADRs were 46.92, 7.35, 38.26, and 4.58%, respectively. The incidence of ADRs peaked at approximately 4 weeks of treatment. Subsequently, the ADR incidence did not increase over time. Improvement of RA activity was shown up to week 52. CONCLUSION: Long-term treatment with IGU in patients with RA resulted in a tolerable safety profile and an improvement in RA activity. IGU could be considered a useful treatment option for patients with RA.
OBJECTIVES: We evaluated the long-term (52 weeks) safety and effectiveness of iguratimod (IGU) in patients with rheumatoid arthritis (RA). METHODS: This multicenter, prospective, observational study included all evaluable RApatients who received IGU since its market launch in 2012. We evaluated adverse events (AEs); adverse drug reactions (ADRs); ADRs of special interest, including liver and renal dysfunctions, interstitial lung disease, gastrointestinal and blood disorders, and infection; and change in Disease Activity Score 28-C-reactive protein (DAS28-CRP) at week 52. RESULTS: Safety and effectiveness were analyzed in 2666 and 1614 patients, respectively. The incidences of AEs, serious AEs, ADRs, and serious ADRs were 46.92, 7.35, 38.26, and 4.58%, respectively. The incidence of ADRs peaked at approximately 4 weeks of treatment. Subsequently, the ADR incidence did not increase over time. Improvement of RA activity was shown up to week 52. CONCLUSION: Long-term treatment with IGU in patients with RA resulted in a tolerable safety profile and an improvement in RA activity. IGU could be considered a useful treatment option for patients with RA.