PMID- 32669233 OWN - NLM STAT- MEDLINE DCOM- 20210223 LR - 20210223 IS - 0929-6646 (Print) IS - 0929-6646 (Linking) VI - 120 IP - 1 Pt 2 DP - 2021 Jan TI - Real-world evidence on the safety and effectiveness of fingolimod in patients with multiple sclerosis from Taiwan. PG - 542-550 LID - S0929-6646(20)30291-6 [pii] LID - 10.1016/j.jfma.2020.07.002 [doi] AB - 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 x 10(3)/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. CI - Copyright (c) 2020 Formosan Medical Association. Published by Elsevier B.V. All rights reserved. FAU - Yang, Chih-Chao AU - Yang CC AD - Department of Neurology, National Taiwan University Hospital, Taipei, Taiwan. Electronic address: jesse6627@gmail.com. FAU - Ro, Long-Sun AU - Ro LS AD - Chang Gung Memorial Foundation-Linkou, Taiwan. Electronic address: cgrols@adm.cgmh.org.tw. FAU - Tsai, Nai-Wen AU - Tsai NW AD - Chang Gung Memorial Hospital-Kaohsiung, Taiwan. Electronic address: naiwen@adm.cgmh.org.tw. FAU - Lin, Chou-Ching AU - Lin CC AD - National Cheng Kung University Hospital, Taiwan. Electronic address: cxl45@mail.ncku.edu.tw. FAU - Huang, Wen-Nan AU - Huang WN AD - Neurological Institute, Taichung Veterans General Hospital, Taiwan. Electronic address: gtim5555@yahoo.com. FAU - Tsai, Ching-Piao AU - Tsai CP AD - Taipei Veterans General Hospital, Taiwan. Electronic address: cptsai@vghtpe.gov.tw. FAU - Lin, Thy-Sheng AU - Lin TS AD - National Cheng Kung University Hospital, Taiwan. Electronic address: tslin@mail.ncku.edu.tw. FAU - Su, Jen-Jen AU - Su JJ AD - Department of Neurology, National Taiwan University Hospital, Taipei, Taiwan. Electronic address: ntuhneuro@hotmail.com. FAU - Huang, Chin-Chang AU - Huang CC AD - Chang Gung Memorial Foundation-Linkou, Taiwan. Electronic address: cch0537@adm.cgmh.org.tw. FAU - Lyu, Rong-Kuo AU - Lyu RK AD - Chang Gung Memorial Foundation-Linkou, Taiwan. Electronic address: lyu5172@adm.cgmh.org.tw. FAU - Chen, Hsin-Hua AU - Chen HH AD - Neurological Institute, Taichung Veterans General Hospital, Taiwan. Electronic address: shc5555@hotmail.com. FAU - Lee, Wei-Ju AU - Lee WJ AD - 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. FAU - Chen, Po-Lin AU - Chen PL AD - Neurological Institute, Taichung Veterans General Hospital, Taiwan. Electronic address: boring@mail2000.com.tw. FAU - Yang, Audrey AU - Yang A AD - Novartis (Taiwan) Co., Ltd., Taiwan. Electronic address: audrey.yang@novartis.com. LA - eng PT - Journal Article PT - Multicenter Study PT - Observational Study DEP - 20200712 PL - Singapore TA - J Formos Med Assoc JT - Journal of the Formosan Medical Association = Taiwan yi zhi JID - 9214933 RN - 0 (Immunosuppressive Agents) RN - G926EC510T (Fingolimod Hydrochloride) SB - IM MH - Adult MH - Fingolimod Hydrochloride/adverse effects/*therapeutic use MH - Humans MH - Immunosuppressive Agents/adverse effects MH - Middle Aged MH - *Multiple Sclerosis/drug therapy MH - Neoplasm Recurrence, Local MH - Retrospective Studies MH - Taiwan OTO - NOTNLM OT - Effectiveness and safety OT - Fingolimod OT - Multiple sclerosis OT - Real-world OT - Taiwan EDAT- 2020/07/17 06:00 MHDA- 2021/02/24 06:00 CRDT- 2020/07/17 06:00 PHST- 2020/03/12 00:00 [received] PHST- 2020/06/10 00:00 [revised] PHST- 2020/07/01 00:00 [accepted] PHST- 2020/07/17 06:00 [pubmed] PHST- 2021/02/24 06:00 [medline] PHST- 2020/07/17 06:00 [entrez] AID - S0929-6646(20)30291-6 [pii] AID - 10.1016/j.jfma.2020.07.002 [doi] PST - ppublish SO - J Formos Med Assoc. 2021 Jan;120(1 Pt 2):542-550. doi: 10.1016/j.jfma.2020.07.002. Epub 2020 Jul 12.