Suk-Won Ahn1, In Soo Joo2, Byung-Jo Kim3, Jung-Joon Sung4, Sa-Yoon Kang5, Jeeyoung Oh6, Yang-Ki Minn7, Bum Chun Suh8, Sun-Young Oh9, Yoon-Ho Hong10, Tai-Seung Nam11, Jung Im Seok12, Young-Eun Park13, Ha Young Shin14, Eun Bin Cho15, Je-Young Shin4, Hung Youl Seok16, Jin-Sung Park17, Ju-Hong Min18, Jin-Myoung Seok19, Byoung-Joon Kim20. 1. Department of Neurology, Chung-Ang University Hospital, Chung-Ang University College of Medicine, Seoul, Republic of Korea. 2. Department of Neurology, Ajou University School of Medicine, Suwon, Republic of Korea. 3. Department of Neurology, Korea University Anam Hospital, Korea University College of Medicine, Seoul, Republic of Korea. 4. Department of Neurology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Republic of Korea. 5. Department of Neurology, Jeju National University Hospital, Jeju National University School of Medicine, Jeju, Republic of Korea. 6. Department of Neurology, Konkuk University Medical Center, Konkuk University College of Medicine, Seoul, Republic of Korea. 7. Department of Neurology, Kangnam sacred heart hospital, Hallym University College of Medicine, Seoul, Republic of Korea. 8. Department of Neurology, Kangbuk Samsung Hospital, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 9. Department of Neurology, Chonbuk National University Hospital, Chonbuk National University College of Medicine, Republic of Korea. 10. Department of Neurology, Boramae Medical Center, Seoul National University College of Medicine, Seoul, Republic of Korea. 11. Department of Neurology, Chonnam National University Medical School, Gwangju, Republic of Korea. 12. Department of Neurology, School of Medicine, Catholic University of Daegu, Daegu, Republic of Korea. 13. Department of Neurology, Pusan National University Hospital, Pusan National University College of Medicine, Busan, Republic of Korea. 14. Department of Neurology, Yonsei University College of Medicine, Seoul, Republic of Korea. 15. Department of Neurology, Gyeongsang National University Changwon Hospital, Gyeongsang National University School of Medicine, Changwon, Republic of Korea. 16. Department of Neurology, Keimyung University School of Medicine, Daegu, Republic of Korea. 17. Department of Neurology, Kyungpook National University School of Medicine, Daegu, Republic of Korea. 18. Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. 19. Department of Neurology, Soonchunhyang University College of Medicine, Cheonan Hospital, Cheonan, Republic of Korea. 20. Department of Neurology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea. Electronic address: bjkim@smc.samsung.co.kr.
Abstract
INTRODUCTION: Several clinical studies using tacrolimus revealed reasonable therapeutic mechanisms and efficacy in patients with myasthenia gravis (MG). However, long-period studies in a large number of patients with MG are limited; therefore, the aim of this study was to investigate the therapeutic efficacies and safety of tacrolimus in patients with MG during a 12-month follow-up period. METHODS: Tacrolimus was administered to 150 patients with MG who were recruited based on the inclusion criteria. Fifteen medical centers in Korea participated in this study. The efficacy of tacrolimus was assessed using MG composite scales (MGCS) and the prednisolone-sparing effect. And the adverse drug reactions (ADRs) of tacrolimus were monitored in each patient from the beginning of tacrolimus treatment to the end of the follow-up period. RESULTS: After starting tacrolimus, the 32 patients were affected by ADRs, and consequentially 134 patients of the enrolled patients were followed up for 12months. They showed that the mean prednisolone dosage significantly decreased (6.1±7.6mg/day), compared to that in the baseline (11.3±9.5mg/day), and MGCS significantly improved after 12months of tacrolimus treatment, compared to that at the baseline. CONCLUSIONS: Our study showed that tacrolimus would be an effective immunosuppressant as an initial therapeutic agent in patients with MG; in addition, it showed tolerable safety profiles during the 12-month follow-up evaluation.
INTRODUCTION: Several clinical studies using tacrolimus revealed reasonable therapeutic mechanisms and efficacy in patients with myasthenia gravis (MG). However, long-period studies in a large number of patients with MG are limited; therefore, the aim of this study was to investigate the therapeutic efficacies and safety of tacrolimus in patients with MG during a 12-month follow-up period. METHODS:Tacrolimus was administered to 150 patients with MG who were recruited based on the inclusion criteria. Fifteen medical centers in Korea participated in this study. The efficacy of tacrolimus was assessed using MG composite scales (MGCS) and the prednisolone-sparing effect. And the adverse drug reactions (ADRs) of tacrolimus were monitored in each patient from the beginning of tacrolimus treatment to the end of the follow-up period. RESULTS: After starting tacrolimus, the 32 patients were affected by ADRs, and consequentially 134 patients of the enrolled patients were followed up for 12months. They showed that the mean prednisolone dosage significantly decreased (6.1±7.6mg/day), compared to that in the baseline (11.3±9.5mg/day), and MGCS significantly improved after 12months of tacrolimus treatment, compared to that at the baseline. CONCLUSIONS: Our study showed that tacrolimus would be an effective immunosuppressant as an initial therapeutic agent in patients with MG; in addition, it showed tolerable safety profiles during the 12-month follow-up evaluation.