Real-world evidence on the safety and effectiveness of fingolimod in patients with multiple sclerosis from Taiwan
Journal
Journal of the Formosan Medical Association
Journal Volume
120
Journal Issue
1
Pages
542-550
ISSN
0929-6646
Date Issued
2021-01
Author(s)
Ro L.-S.
Tsai N.-W.
Lin C.-C.
Huang W.-N.
Tsai C.-P.
Lin T.-S.
Huang C.-C.
Lyu R.-K.
Chen H.-H.
Lee W.-J.
Chen P.-L.
Yang A.
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. ? 2020 Formosan Medical Association
Subjects
Effectiveness and safety; Fingolimod; Multiple sclerosis; Real-world; Taiwan
SDGs
Other Subjects
alanine aminotransferase; aspartate aminotransferase; fingolimod; fingolimod; immunosuppressive agent; abdominal pain; adult; anemia; anxiety disorder; Article; backache; blurred vision; bradycardia; cerebrovascular accident; clinical practice; cohort analysis; conjunctivitis; controlled study; depression; disease duration; dizziness; drug efficacy; drug exposure; drug safety; dry eye; Expanded Disability Status Scale; face pain; fatigue; female; fever; headache; hemiplegia; herpes zoster; human; hypertransaminasemia; hypesthesia; insomnia; lymphocyte count; major clinical study; male; multiple sclerosis; muscle spasm; muscle weakness; neck pain; observational study; pelvic inflammatory disease; perianal abscess; recurrence risk; retrospective study; second degree atrioventricular block; seizure; side effect; Taiwan; upper respiratory tract infection; urinary tract infection; urosepsis; viral upper respiratory tract infection; clinical trial; middle aged; multicenter study; tumor recurrence; Adult; Fingolimod Hydrochloride; Humans; Immunosuppressive Agents; Middle Aged; Multiple Sclerosis; Neoplasm Recurrence, Local; Retrospective Studies; Taiwan
Type
journal article