Chih-Chao Yang1, Long-Sun Ro2, Nai-Wen Tsai3, Chou-Ching Lin4, Wen-Nan Huang5, Ching-Piao Tsai6, Thy-Sheng Lin7, Jen-Jen Su8, Chin-Chang Huang9, Rong-Kuo Lyu10, Hsin-Hua Chen11, Wei-Ju Lee12, Po-Lin Chen13, Audrey Yang14. 1. Department of Neurology, National Taiwan University Hospital, Taipei, Taiwan. Electronic address: jesse6627@gmail.com. 2. Chang Gung Memorial Foundation-Linkou, Taiwan. Electronic address: cgrols@adm.cgmh.org.tw. 3. Chang Gung Memorial Hospital-Kaohsiung, Taiwan. Electronic address: naiwen@adm.cgmh.org.tw. 4. National Cheng Kung University Hospital, Taiwan. Electronic address: cxl45@mail.ncku.edu.tw. 5. Neurological Institute, Taichung Veterans General Hospital, Taiwan. Electronic address: gtim5555@yahoo.com. 6. Taipei Veterans General Hospital, Taiwan. Electronic address: cptsai@vghtpe.gov.tw. 7. National Cheng Kung University Hospital, Taiwan. Electronic address: tslin@mail.ncku.edu.tw. 8. Department of Neurology, National Taiwan University Hospital, Taipei, Taiwan. Electronic address: ntuhneuro@hotmail.com. 9. Chang Gung Memorial Foundation-Linkou, Taiwan. Electronic address: cch0537@adm.cgmh.org.tw. 10. Chang Gung Memorial Foundation-Linkou, Taiwan. Electronic address: lyu5172@adm.cgmh.org.tw. 11. Neurological Institute, Taichung Veterans General Hospital, Taiwan. Electronic address: shc5555@hotmail.com. 12. Neurological Institute, Taichung Veterans General Hospital, Taiwan; Faculty of Medicine, National Yang-Ming University School of Medicine, Taipei, Taiwan. Electronic address: winster.lee@msa.hinet.net. 13. Neurological Institute, Taichung Veterans General Hospital, Taiwan. Electronic address: boring@mail2000.com.tw. 14. Novartis (Taiwan) Co., Ltd., Taiwan. Electronic address: audrey.yang@novartis.com.
Abstract
BACKGROUND/ PURPOSE: Multiple sclerosis is classified as a rare disease in Taiwan. This study evaluated the safety and effectiveness of fingolimod in patients with relapsing-remitting multiple sclerosis (RRMS) from routine clinical practice in Taiwan. METHODS: In this retrospective, multicentre, observational study, we collected clinical data of patients treated with fingolimod 0.5 mg/day in routine clinical practice between September 2012 and December 2015. Primary outcome was the overall safety of fingolimod; secondary outcome was the annualized relapse rate (ARR). RESULTS: Overall, 62/69 (86.1%) patients were on fingolimod by the end of data collection period. Mean age (±standard deviation [SD]) at inclusion was 37.7 ± 10.10 years; mean duration of MS was 5.4 ± 4.52 years and mean duration of fingolimod exposure was 135.8 patient-years. The most common adverse events (AEs) were bradycardia (21.7%; first-dose related), upper respiratory tract infection, dizziness, and hypoaesthesia (numbness) (11.6% each), followed by urinary tract infection and back pain (7.2% each). Seven patients had liver enzyme-related AEs. Eight patients had absolute lymphocyte counts <0.2 × 103/uL over the study period. One patient developed second degree AV block after first-dosing. Serious AEs were observed in 11 patients (15.9%; mild-to-moderate). No newly developed macular oedema was detected. The ARR was 0.3 ± 0.74 in fingolimod-treated patients and 66.7% of patients were relapse-free. The mean (SD) change from baseline in expanded disability status scale score was -0.30 ± 1.353. CONCLUSION: Fingolimod 0.5 mg/day treatment with an average of 2 years of exposure was associated with a manageable safety profile, and maintained/improved effectiveness in RRMS patients from Taiwan.
BACKGROUND/ PURPOSE:Multiple sclerosis is classified as a rare disease in Taiwan. This study evaluated the safety and effectiveness of fingolimod in patients with relapsing-remitting multiple sclerosis (RRMS) from routine clinical practice in Taiwan. METHODS: In this retrospective, multicentre, observational study, we collected clinical data of patients treated with fingolimod 0.5 mg/day in routine clinical practice between September 2012 and December 2015. Primary outcome was the overall safety of fingolimod; secondary outcome was the annualized relapse rate (ARR). RESULTS: Overall, 62/69 (86.1%) patients were on fingolimod by the end of data collection period. Mean age (±standard deviation [SD]) at inclusion was 37.7 ± 10.10 years; mean duration of MS was 5.4 ± 4.52 years and mean duration of fingolimod exposure was 135.8 patient-years. The most common adverse events (AEs) were bradycardia (21.7%; first-dose related), upper respiratory tract infection, dizziness, and hypoaesthesia (numbness) (11.6% each), followed by urinary tract infection and back pain (7.2% each). Seven patients had liver enzyme-related AEs. Eight patients had absolute lymphocyte counts <0.2 × 103/uL over the study period. One patient developed second degree AV block after first-dosing. Serious AEs were observed in 11 patients (15.9%; mild-to-moderate). No newly developed macular oedema was detected. The ARR was 0.3 ± 0.74 in fingolimod-treated patients and 66.7% of patients were relapse-free. The mean (SD) change from baseline in expanded disability status scale score was -0.30 ± 1.353. CONCLUSION:Fingolimod 0.5 mg/day treatment with an average of 2 years of exposure was associated with a manageable safety profile, and maintained/improved effectiveness in RRMS patients from Taiwan.