Real-world evidence on the safety and effectiveness of fingolimod in patients with multiple sclerosis from Taiwan

Autor: Chih-Chao Yang, Long-Sun Ro, Nai-Wen Tsai, Chou-Ching Lin, Wen-Nan Huang, Ching-Piao Tsai, Thy-Sheng Lin, Jen-Jen Su, Chin-Chang Huang, Rong-Kuo Lyu, Hsin-Hua Chen, Wei-Ju Lee, Po-Lin Chen, Audrey Yang
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Zdroj: Journal of the Formosan Medical Association, Vol 120, Iss 1, Pp 542-550 (2021)
Druh dokumentu: article
ISSN: 0929-6646
DOI: 10.1016/j.jfma.2020.07.002
Popis: 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
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