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

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

Research output: Contribution to journalArticle

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.

Original languageEnglish
JournalJournal of the Formosan Medical Association
DOIs
Publication statusAccepted/In press - 2020

All Science Journal Classification (ASJC) codes

  • Medicine(all)

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    Yang, C. C., Ro, L. S., Tsai, N. W., Lin, C. C., Huang, W. N., Tsai, C. P., Lin, T. S., Su, J. J., Huang, C. C., Lyu, R. K., Chen, H. H., Lee, W. J., Chen, P. L., & Yang, A. (Accepted/In press). Real-world evidence on the safety and effectiveness of fingolimod in patients with multiple sclerosis from Taiwan. Journal of the Formosan Medical Association. https://doi.org/10.1016/j.jfma.2020.07.002