Evidence map›Paper›PMID 35203978›Full record

ArticleBrain sciences2022

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

Helmut Butzkueven, Paul S Giacomini, Stanley Cohan, Tjalf Ziemssen, Daniel Sienkiewicz, Ying Zhang, Yvonne Geissbühler, Diego Silva, Davorka Tomic, Harald Kropshofer and 1 more

Abstract read
In one paragraph

Article in Brain sciences, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

11 authors.

Helmut ButzkuevenDepartment of Neuroscience, Monash University, Melbourne, VIC 3004, Australia.ORCID 0000-0003-3940-8727
Paul S GiacominiDepartment of Neurology and Neurosurgery, McGill University, Montreal, QC H3A 0G4, Canada.
Stanley CohanProvidence Multiple Sclerosis Center, Portland, OR 97225, USA.
Tjalf ZiemssenCenter of Clinical Neurosciences, University Hospital Carl Gustav Carus, 01307 Dresden, Germany.ORCID 0000-0001-8799-8202
Daniel SienkiewiczNovartis Pharmaceuticals Corporation, East Hanover, NJ 07936, USA.
Ying ZhangNovartis Pharmaceuticals Corporation, East Hanover, NJ 07936, USA.
Yvonne GeissbühlerNovartis Pharma AG, 4056 Basel, Switzerland.ORCID 0000-0001-8528-6818
Diego SilvaNovartis Pharma AG, 4056 Basel, Switzerland.
Davorka TomicNovartis Pharma AG, 4056 Basel, Switzerland.
Harald KropshoferNovartis Pharma AG, 4056 Basel, Switzerland.
Maria TrojanoDepartment of Basic Medical Sciences, Neurosciences and Sense Organs, University of Bari, 70121 Bari, Italy.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

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.

Indexed as

fingolimodnatalizumabobservational studyswitchingtransition

Identifiers

PMID35203978
PMCPMC8870332

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.