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Safety of Fingolimod in Patients with Multiple Sclerosis Switched from Natalizumab: Results from TRANSITION―A 2-Year, Multicenter, Observational, Cohort Study

Multiple sclerosis (MS) patients receiving natalizumab and who are at risk of developing progressive multifocal leukoencephalopathy (PML) often switch to other high-efficacy disease-modifying therapies including fingolimod as a risk mitigation strategy, which could impact treatment safety and effect...

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Autores principales: Butzkueven, Helmut, Giacomini, Paul S., Cohan, Stanley, Ziemssen, Tjalf, Sienkiewicz, Daniel, Zhang, Ying, Geissbühler, Yvonne, Silva, Diego, Tomic, Davorka, Kropshofer, Harald, Trojano, Maria
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8870332/
https://www.ncbi.nlm.nih.gov/pubmed/35203978
http://dx.doi.org/10.3390/brainsci12020215
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author Butzkueven, Helmut
Giacomini, Paul S.
Cohan, Stanley
Ziemssen, Tjalf
Sienkiewicz, Daniel
Zhang, Ying
Geissbühler, Yvonne
Silva, Diego
Tomic, Davorka
Kropshofer, Harald
Trojano, Maria
author_facet Butzkueven, Helmut
Giacomini, Paul S.
Cohan, Stanley
Ziemssen, Tjalf
Sienkiewicz, Daniel
Zhang, Ying
Geissbühler, Yvonne
Silva, Diego
Tomic, Davorka
Kropshofer, Harald
Trojano, Maria
author_sort Butzkueven, Helmut
collection PubMed
description Multiple sclerosis (MS) patients receiving natalizumab and who are at risk of developing progressive multifocal leukoencephalopathy (PML) often switch to other high-efficacy disease-modifying therapies including fingolimod as a risk mitigation strategy, which could impact treatment safety and effectiveness. The TRANSITION study aimed to evaluate the safety of fingolimod over two years in patients with MS after switching from natalizumab in a real-world setting. The safety and effectiveness were assessed by monitoring serious and other adverse events (SAEs, AEs). We assessed effectiveness by recording relapses, Expanded Disability Status Scale (EDSS) scores, and MRI activity. Of 637 patients enrolled, 505 completed the study (mean age, 42 years). Overall, 72.8% and 12.7% experienced AEs and SAEs respectively. The most common AEs were fatigue, headache, and urinary tract infection; no cases of PML were observed. Fingolimod treatment resulted in low disease activity. Patients with ≤8 weeks washout period had a markedly lower risk of relapses (4.5%) than those with >8 weeks (51.4%). In patients switching from natalizumab to fingolimod, no new safety signals with overall low relapse activity were observed in patients with washout latencies of ≤8 weeks before fingolimod initiation. Fingolimod was found to be safe and effective in patients transitioning from natalizumab.
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spelling pubmed-88703322022-02-25 Safety of Fingolimod in Patients with Multiple Sclerosis Switched from Natalizumab: Results from TRANSITION―A 2-Year, Multicenter, Observational, Cohort Study Butzkueven, Helmut Giacomini, Paul S. Cohan, Stanley Ziemssen, Tjalf Sienkiewicz, Daniel Zhang, Ying Geissbühler, Yvonne Silva, Diego Tomic, Davorka Kropshofer, Harald Trojano, Maria Brain Sci Article Multiple sclerosis (MS) patients receiving natalizumab and who are at risk of developing progressive multifocal leukoencephalopathy (PML) often switch to other high-efficacy disease-modifying therapies including fingolimod as a risk mitigation strategy, which could impact treatment safety and effectiveness. The TRANSITION study aimed to evaluate the safety of fingolimod over two years in patients with MS after switching from natalizumab in a real-world setting. The safety and effectiveness were assessed by monitoring serious and other adverse events (SAEs, AEs). We assessed effectiveness by recording relapses, Expanded Disability Status Scale (EDSS) scores, and MRI activity. Of 637 patients enrolled, 505 completed the study (mean age, 42 years). Overall, 72.8% and 12.7% experienced AEs and SAEs respectively. The most common AEs were fatigue, headache, and urinary tract infection; no cases of PML were observed. Fingolimod treatment resulted in low disease activity. Patients with ≤8 weeks washout period had a markedly lower risk of relapses (4.5%) than those with >8 weeks (51.4%). In patients switching from natalizumab to fingolimod, no new safety signals with overall low relapse activity were observed in patients with washout latencies of ≤8 weeks before fingolimod initiation. Fingolimod was found to be safe and effective in patients transitioning from natalizumab. MDPI 2022-02-04 /pmc/articles/PMC8870332/ /pubmed/35203978 http://dx.doi.org/10.3390/brainsci12020215 Text en © 2022 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Butzkueven, Helmut
Giacomini, Paul S.
Cohan, Stanley
Ziemssen, Tjalf
Sienkiewicz, Daniel
Zhang, Ying
Geissbühler, Yvonne
Silva, Diego
Tomic, Davorka
Kropshofer, Harald
Trojano, Maria
Safety of Fingolimod in Patients with Multiple Sclerosis Switched from Natalizumab: Results from TRANSITION―A 2-Year, Multicenter, Observational, Cohort Study
title Safety of Fingolimod in Patients with Multiple Sclerosis Switched from Natalizumab: Results from TRANSITION―A 2-Year, Multicenter, Observational, Cohort Study
title_full Safety of Fingolimod in Patients with Multiple Sclerosis Switched from Natalizumab: Results from TRANSITION―A 2-Year, Multicenter, Observational, Cohort Study
title_fullStr Safety of Fingolimod in Patients with Multiple Sclerosis Switched from Natalizumab: Results from TRANSITION―A 2-Year, Multicenter, Observational, Cohort Study
title_full_unstemmed Safety of Fingolimod in Patients with Multiple Sclerosis Switched from Natalizumab: Results from TRANSITION―A 2-Year, Multicenter, Observational, Cohort Study
title_short Safety of Fingolimod in Patients with Multiple Sclerosis Switched from Natalizumab: Results from TRANSITION―A 2-Year, Multicenter, Observational, Cohort Study
title_sort safety of fingolimod in patients with multiple sclerosis switched from natalizumab: results from transition―a 2-year, multicenter, observational, cohort study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8870332/
https://www.ncbi.nlm.nih.gov/pubmed/35203978
http://dx.doi.org/10.3390/brainsci12020215
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