Evidence map›Paper›PMID 29141831›Full record

Trial reportMultiple sclerosis and related disorders2017

Long-term follow-up of a randomized study of combination interferon and glatiramer acetate in multiple sclerosis: Efficacy and safety results up to 7 years.

Fred D Lublin, Stacey S Cofield, Gary R Cutter, Tarah Gustafson, Stephen Krieger, Ponnada A Narayana, Flavia Nelson, Amber R Salter, Jerry S Wolinsky

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Multiple sclerosis and related disorders, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.5field-weighted citation impact, top 18% 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. The impact of relapse definition and measures of durability on MS clinical trial outcomes.Multiple sclerosis (Houndmills, Basingstoke, England) · 2023
    Article
  4. Article
  5. Review
  6. Article
  7. Evolution of clinical trials in multiple sclerosis.Therapeutic advances in neurological disorders · 2019
    Review
  8. Review
  9. 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

9 authors at 5 institutions in 1 country.

Fred D LublinCorinne Goldsmith Dickinson Center for Multiple Sclerosis, Department of Neurology & Friedman Brain Institute, Icahn School of Medicine at Mount Sinai, 5 East 98th Street, New York, NY, United States. Electronic address: fred.lublin@mssm.edu.
Stacey S CofieldDepartment of Biostatistics, The University of Alabama at Birmingham, Birmingham, AL, United States.
Gary R CutterDepartment of Biostatistics, The University of Alabama at Birmingham, Birmingham, AL, United States.
Tarah GustafsonCorinne Goldsmith Dickinson Center for Multiple Sclerosis, Department of Neurology & Friedman Brain Institute, Icahn School of Medicine at Mount Sinai, 5 East 98th Street, New York, NY, United States.
Stephen KriegerCorinne Goldsmith Dickinson Center for Multiple Sclerosis, Department of Neurology & Friedman Brain Institute, Icahn School of Medicine at Mount Sinai, 5 East 98th Street, New York, NY, United States.
Ponnada A NarayanaMcGovern Medical School, Department of Diagnostic and Interventional Imaging, University of Texas Health Science Center at Houston, Houston, TX, United States.
Flavia NelsonMcGovern Medical School, Department of Neurology, University of Texas Health Science Center at Houston, Houston, TX, United States.
Amber R SalterDepartment of Biostatistics, Washington University School of Medicine, St. Louis, MO, United States.
Jerry S WolinskyMcGovern Medical School, Department of Neurology, University of Texas Health Science Center at Houston, Houston, TX, United States.
The University of Texas Health Science Center at Houston · USAllen Institute for Brain Science · USUniversity of Alabama at Birmingham · USIcahn School of Medicine at Mount Sinai · USWashington University in St. Louis · US

Funding

Extension of Combination Therapy for Multiple Sclerosis (eCombiRx)U01NS045719 · NINDS · MOUNT SINAI SCHOOL OF MEDICINE OF NYU · PI LUBLIN, FRED D · 2003 to 2012
$44.7M
NINDS NIH HHS U01 NS045719
6 · The paper itself

Abstract

backgroundTo report the long-term results of the blinded extension phase of the randomized, controlled study of the combined use of interferon beta-1a (IFN) 30μg IM weekly and glatiramer acetate (GA) 20mg daily compared to each agent alone in relapsing-remitting multiple sclerosis (RRMS).

methods1008 RRMS patients were followed on protocol until the last participant enrolled completed 3 years, allowing some subjects to be followed for up to 7 years. The primary endpoint was reduction in annualized relapse rate. Secondary outcomes included time to confirmed disability, Multiple Sclerosis Functional Composite (MSFC) score and MRI metrics.

resultsSimilar to the core study, combination IFN + GA was not superior to the better of the single agents (GA) in risk of relapse. Both the combination therapy and GA were significantly better than IFN in reducing the risk of relapse. The combination was not better than either agent alone in lessening confirmed EDSS worsening or change in MSFC. Also similar to the core result, the combination was superior to either agent alone in reducing new lesion activity, but the 3 year MRI result did not presage a clinical benefit over the extended observation interval.

conclusionCombining GA & IFN did not produce a significant clinical benefit over the entire study duration. The earlier effect on reducing MRI activity did not result in a later clinical advantage. The combination showed a sustained advantage in reducing disease activity free status.

Indexed as

Adjuvants, ImmunologicAdolescentAdultDouble-Blind MethodDrug Therapy, CombinationFemaleFollow-Up StudiesGlatiramer AcetateHumansInterferon beta-1aMagnetic Resonance ImagingMaleMiddle AgedMultiple Sclerosis, Relapsing-RemittingTreatment OutcomeYoung AdultAdjuvants, ImmunologicGlatiramer AcetateInterferon beta-1aClinical trialDisease activity free statusGlatiramer acetateInterferon beta-1aRRMS

Identifiers

PMID29141831
PMCPMC5726798
OpenAlexW2759598986

What OpenQuestion holds

Textmetadata
LicenceTDM
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.