Comparative analysis of first-year fingolimod and natalizumab drug discontinuation among Swedish patients with multiple sclerosis

被引:29
作者
Frisell, T. [1 ]
Forsberg, L. [2 ]
Nordin, N. [2 ]
Kiesel, C. [2 ]
Alfredsson, L. [3 ]
Askling, J. [1 ,4 ]
Hillert, J. [2 ]
Olsson, T. [2 ]
Piehl, F. [2 ]
机构
[1] Karolinska Inst, Dept Med, Clin Epidemiol Unit, Solna, Sweden
[2] Karolinska Inst, Dept Clin Neurosci, Solna, Sweden
[3] Karolinska Inst, Inst Environm Med, Solna, Sweden
[4] Karolinska Inst, Dept Med, Rheumatol Unit, Solna, Sweden
基金
瑞典研究理事会;
关键词
Multiple sclerosis; drug survival; fingolimod; natalizumab; treatment outcome; health services research; PLACEBO-CONTROLLED TRIAL; ORAL FINGOLIMOD; INTERFERON; IMPAIRMENT; DISABILITY; RISK;
D O I
10.1177/1352458515579216
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Background: Natalizumab (NTZ) and fingolimod (FGL) are mainly used second line in relapsing-remitting multiple sclerosis (MS), although pivotal trials included mainly treatment-naive patients. Objective: This study aims to provide real-world data on safety and discontinuation rates. Methods: Using IMSE, a drug monitoring registry for all newer MS drugs in Sweden, we analysed differences in baseline characteristics and 1-year drug survival for patients registered 2011-2013, initiating treatment with NTZ (n=640) or FGL (n=876). Among FGL initiators, n=383 (44%) had previously used NTZ (FGL(afterNTZ)). Results: Compared with NTZ, the FGL cohort was older and more often male (36/38 years, 24%/33% males). Baseline Expanded Disability Status Scale was similar across groups, but MS Severity Score was higher in NTZ patients, and Symbol Digit Modalities Test and MS Impact Scale (MSIS-29) was higher in FGL(afterNTZ) versus FGL(NTZ-naive) patients. Proportion on drug after 1 year was high, NTZ=87%, FGL(NTZ-naive)=83% and FGL(afterNTZ)=76%. Adverse events was the most frequent reason for discontinuing FGL (FGL(NTZ-naive)=9%, FGL(afterNTZ)=12%), and was significantly higher than on NTZ (3%). In contrast, the proportion of patients stopping treatment due to lack of effect was more similar: NTZ=4%, FGL(NTZ-naive)=3%, FGL(afterNTZ)=8%. Conclusion: FGL and NTZ were both well tolerated, but FGL less so than NTZ, especially in patients switching to FGL from NTZ. Group differences were not explained by differences in recorded baseline characteristics.
引用
收藏
页码:85 / 93
页数:9
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