1. Real-world evidence on the safety and effectiveness of fingolimod in patients with multiple sclerosis from Taiwan
- Author
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Thy Sheng Lin, Jen-Jen Su, Ching Piao Tsai, Nai Wen Tsai, Chou Ching K. Lin, Chih-Chao Yang, Chin Chang Huang, Audrey Yang, Rong Kuo Lyu, Long Sun Ro, Wen Nan Huang, Hsin Hua Chen, Wei Ju Lee, and Po Lin Chen more...
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Adult ,medicine.medical_specialty ,Urinary system ,Taiwan ,Multiple sclerosis ,03 medical and health sciences ,0302 clinical medicine ,Internal medicine ,Effectiveness and safety ,Back pain ,medicine ,Humans ,Adverse effect ,Retrospective Studies ,lcsh:R5-920 ,Fingolimod Hydrochloride ,business.industry ,Fingolimod ,General Medicine ,Middle Aged ,medicine.disease ,Upper respiratory tract infection ,Real-world ,030220 oncology & carcinogenesis ,030211 gastroenterology & hepatology ,Observational study ,Neoplasm Recurrence, Local ,medicine.symptom ,lcsh:Medicine (General) ,business ,Immunosuppressive Agents ,medicine.drug ,Rare disease - 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 more...
- Published
- 2021
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