Comparative analysis of first-year fingolimod and natalizumab drug discontinuation among Swedish patients with multiple sclerosis
| Autor: | Tomas Olsson, Johan Askling, Thomas Frisell, C Kiesel, Fredrik Piehl, Lars Alfredsson, Nina Nordin, Lars Forsberg, Jan Hillert |
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| Rok vydání: | 2015 |
| Předmět: |
Adult
Male medicine.medical_specialty Multiple Sclerosis Time Factors Drug discontinuation Treatment outcome Severity of Illness Index 03 medical and health sciences Sex Factors 0302 clinical medicine Second line Natalizumab Internal medicine Humans Immunologic Factors Medicine Registries 030212 general & internal medicine Sweden Fingolimod Hydrochloride business.industry Multiple sclerosis Health services research Middle Aged medicine.disease Fingolimod Drug survival Treatment Outcome Neurology Physical therapy Female Neurology (clinical) business 030217 neurology & neurosurgery medicine.drug |
| Zdroj: | Multiple Sclerosis Journal. 22:85-93 |
| ISSN: | 1477-0970 1352-4585 |
| Popis: | Background: Natalizumab (NTZ) and fingolimod (FGL) are mainly used second line in relapsing–remitting multiple sclerosis (MS), although pivotal trials included mainly treatment-naïve 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 (FGLafterNTZ). 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 FGLafterNTZ versus FGLNTZ-naïve patients. Proportion on drug after 1 year was high, NTZ=87%, FGLNTZ-naïve=83% and FGLafterNTZ=76%. Adverse events was the most frequent reason for discontinuing FGL (FGLNTZ-naïve=9%, FGLafterNTZ=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%, FGLNTZ-naïve=3%, FGLafterNTZ=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. |
| Databáze: | OpenAIRE |
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