Tsuneyo Mimori1, Masayoshi Harigai2, Tatsuya Atsumi3, Takao Fujii4, Masataka Kuwana5, Hiroaki Matsuno6, Shigeki Momohara7,8, Syuji Takei9, Naoto Tamura10, Yoshinari Takasaki11, Satoshi Ikeuchi12, Satoru Kushimoto13, Takao Koike14. 1. a Department of Rheumatology and Clinical Immunology , Graduate School of Medicine, Kyoto University , Kyoto , Japan. 2. b Institute of Rheumatology, Tokyo Women's Medical University , Tokyo , Japan. 3. c Division of Rheumatology, Endocrinology and Nephrology , 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 Department of Pediatric Rheumatology, Faculty of Medicine , School of Health Sciences, Medical Center for Children, Kagoshima University , Kagoshima , Japan. 10. j Department of Internal Medicine and Rheumatology, Faculty of Medicine , Juntendo University , Tokyo , Japan. 11. k Faculty of Medicine , Juntendo University Koshigaya Hospital, Juntendo University , Saitama , Japan. 12. l Frontier PMS Section, Neurology Medical Department , Medical Division, Eisai Co, Ltd , Tokyo , Japan. 13. m Post-Marketing Surveillance Group, Data Science and Administration Department , Toyama Chemical Co, Ltd , Tokyo , Japan , and. 14. n Sapporo Medical Center NTT EC , Hokkaido , Japan.
Abstract
OBJECTIVE: To determine the real-world safety and effectiveness of iguratimod (IGU) for rheumatoid arthritis (RA), a 52-week, Japanese, post-marketing surveillance study was conducted. An interim analysis at week 24 was performed. METHODS: This study included all RA patients who received IGU following its introduction to the market. All adverse events (AEs) and adverse drug reactions (ADRs) were collected. Effectiveness was evaluated by the change in Disease Activity Score 28-C-reactive protein (DAS28-CRP) from baseline to week 24. RESULTS: Safety was analyzed in 2679 patients. The overall incidences of AEs, ADRs, and serious ADRs were 38.41, 31.65, and 3.21%, respectively; the most commonly reported serious ADRs were pneumonia/bacterial pneumonia, interstitial lung disease, and Pneumocystis jiroveci pneumonia. Concomitant glucocorticoid use and comorbid conditions associated with respiratory disease were identified as risk factors for serious infections. Pulmonary alveolar hemorrhage and increased international normalized ratio of prothrombin time were observed with concomitant use of IGU and warfarin. The DAS28-CRP decreased from baseline to week 24. CONCLUSION: Although a safety concern was identified with concomitant use of IGU and warfarin, this real-world study showed no other new safety concerns and similar effectiveness to clinical trials. IGU is a new therapeutic option for RA patients.
OBJECTIVE: To determine the real-world safety and effectiveness of iguratimod (IGU) for rheumatoid arthritis (RA), a 52-week, Japanese, post-marketing surveillance study was conducted. An interim analysis at week 24 was performed. METHODS: This study included all RApatients who received IGU following its introduction to the market. All adverse events (AEs) and adverse drug reactions (ADRs) were collected. Effectiveness was evaluated by the change in Disease Activity Score 28-C-reactive protein (DAS28-CRP) from baseline to week 24. RESULTS: Safety was analyzed in 2679 patients. The overall incidences of AEs, ADRs, and serious ADRs were 38.41, 31.65, and 3.21%, respectively; the most commonly reported serious ADRs were pneumonia/bacterial pneumonia, interstitial lung disease, and Pneumocystis jiroveci pneumonia. Concomitant glucocorticoid use and comorbid conditions associated with respiratory disease were identified as risk factors for serious infections. Pulmonary alveolar hemorrhage and increased international normalized ratio of prothrombin time were observed with concomitant use of IGU and warfarin. The DAS28-CRP decreased from baseline to week 24. CONCLUSION: Although a safety concern was identified with concomitant use of IGU and warfarin, this real-world study showed no other new safety concerns and similar effectiveness to clinical trials. IGU is a new therapeutic option for RApatients.