Evidence map›Paper›PMID 33769117›Full record

Trial reportMultiple sclerosis (Houndmills, Basingstoke, England)2021

Disability improvement as a clinically relevant outcome in clinical trials of relapsing forms of multiple sclerosis.

Bruce Ac Cree, Jeffrey A Cohen, Anthony T Reder, Davorka Tomic, Diego Silva, Daniela Piani Meier, Annik K Laflamme, Shannon Ritter, David Leppert, Ludwig Kappos

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Multiple sclerosis (Houndmills, Basingstoke, England), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
1.1field-weighted citation impact, top 25% of its field
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

8 citing papers in PubMed, 13 citations in OpenAlex.

  1. Article
  2. Observational
  3. Article
  4. Review
  5. Article
  6. Review
  7. Article
  8. Slowly Expanding Lesions Predict 9-Year Multiple Sclerosis Disease Progression.Neurology(R) neuroimmunology & neuroinflammation · 2022
    Article
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

10 authors at 6 institutions in 2 countries.

Bruce Ac CreeUCSF Weill Institute for Neurosciences, Department of Neurology, University of California San Francisco, San Francisco, CA, USA.ORCID 0000-0001-7689-2533
Jeffrey A CohenDepartment of Neurology, Mellen Center for Multiple Sclerosis Treatment and Research, Neurological Institute, Cleveland Clinic, Cleveland, OH, USA.ORCID 0000-0001-9245-9772
Anthony T RederDepartment of Neurology, University of Chicago, Chicago, IL, USA.
Davorka TomicNovartis Pharma AG, Basel, Switzerland.
Diego SilvaNovartis Pharma AG, Basel, Switzerland.
Daniela Piani MeierNovartis Pharma AG, Basel, Switzerland.
Annik K LaflammeNovartis Pharma AG, Basel, Switzerland.
Shannon RitterNovartis Pharmaceuticals Corporation, East Hanover, NJ, USA.
David LeppertNovartis Pharma AG, Basel, Switzerland.
Ludwig KapposResearch Center for clinical Neuroimmunology and Neuroscience Basel (RC2NB) and MS Center, Departments of Medicine, Clinical Research, Biomedicine, and Biomedical Engineering, University Hospital, University of Basel, Basel, Switzerland.ORCID 0000-0003-4175-5509
Novartis (Switzerland) · CHCleveland Clinic · USNovartis (United States) · USUniversity of Basel · CHUniversity of California, San Francisco · USUniversity of Chicago · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundDisease-modifying therapies (DMTs) can reduce the risk of disability worsening in patients with relapsing forms of multiple sclerosis (RMS). High-efficacy DMTs can lead to confirmed or sustained disability improvement (CDI and SDI). OBJECTIVE AND

methodsPost hoc analyses of data from the TRANSFORMS, FREEDOMS, and FREEDOMS II trials and their extensions assessed the effects of fingolimod (0.5-1.25 mg/day) on stabilizing or improving disability over ⩽8 years in participants with RMS. CDI and SDI rates were compared between participants initially randomized to fingolimod, interferon (IFNβ-1a), or placebo.

resultsAt 8 years' follow-up in TRANSFORMS, 35.1% (95% confidence interval [CI], 28.2%-43.1%) of assessed participants in the IFNβ-1a-fingolimod switch group and 41.9% (36.6%-47.6%) on continuous fingolimod experienced CDI; disability did not worsen in approximately 70%. Similar results were seen in the combined FREEDOMS population. Proportionally fewer TRANSFORMS participants achieved SDI in the IFNβ-1a-fingolimod switch group than on continuous fingolimod (5.4% [3.0%-9.5%] vs 14.2% [10.8%-18.4%],

conclusionCDI and SDI are outcomes of interest for clinical trials and for long-term follow-up of participants with RMS. Monitoring CDI and SDI in addition to disability worsening may facilitate understanding of the therapeutic benefit of RMS treatments.

Indexed as

Multiple SclerosisMultiple Sclerosis, Relapsing-RemittingFingolimod HydrochlorideHumansImmunosuppressive AgentsInterferon-betaFingolimod HydrochlorideImmunosuppressive AgentsInterferon-betaconfirmed disability improvementDisease-modifying therapiesfingolimodmultiple sclerosisoutcome measurementrelapsing/remitting

Identifiers

PMID33769117
PMCPMC8597182
OpenAlexW3137339880

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

None linked

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.