Evidence map›Paper›PMID 31511330›Full record

Trial reportNeurology(R) neuroimmunology & neuroinflammation2019

Lymphocyte counts and infection rates: Long-term fingolimod treatment in primary progressive MS.

Edward J Fox, Fred D Lublin, Jerry S Wolinsky, Jeffrey A Cohen, Ian M Williams, Xiangyi Meng, Marina Ziehn, Scott Kolodny, Bruce A C Cree

Abstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Neurology(R) neuroimmunology & neuroinflammation, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–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

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Review
  3. Impact of Age on Switching or Stopping Disease Modifying Therapies in Multiple Sclerosis.Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2025
    Review
  4. Review
  5. Observational
  6. Article
  7. Article
  8. Review
  9. Observational
  10. Learning from adverse treatment effects.Neurology(R) neuroimmunology & neuroinflammation · 2019
    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.

Edward J FoxFrom the Central Texas Neurology Consultants (E.J.F.), Round Rock, TX; Icahn School of Medicine at Mount Sinai (F.D.L.), New York, NY; McGovern Medical School (J.S.W.), The University of Texas Health Science Center at Houston (UTHealth), TX; Mellen Center for Multiple Sclerosis Treatment and Research (J.A.C.), Neurological Institute, Cleveland Clinic Foundation, OH; Oxford PharmaGenesis Ltd (I.M.W.), UK; Novartis Pharmaceuticals Corporation (X.M., M.Z., S.K.), East Hanover, NJ; and The University of California, San Francisco (UCSF); Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), San Francisco, CA. foxtexms@gmail.com.
Fred D LublinFrom the Central Texas Neurology Consultants (E.J.F.), Round Rock, TX; Icahn School of Medicine at Mount Sinai (F.D.L.), New York, NY; McGovern Medical School (J.S.W.), The University of Texas Health Science Center at Houston (UTHealth), TX; Mellen Center for Multiple Sclerosis Treatment and Research (J.A.C.), Neurological Institute, Cleveland Clinic Foundation, OH; Oxford PharmaGenesis Ltd (I.M.W.), UK; Novartis Pharmaceuticals Corporation (X.M., M.Z., S.K.), East Hanover, NJ; and The University of California, San Francisco (UCSF); Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), San Francisco, CA.
Jerry S WolinskyFrom the Central Texas Neurology Consultants (E.J.F.), Round Rock, TX; Icahn School of Medicine at Mount Sinai (F.D.L.), New York, NY; McGovern Medical School (J.S.W.), The University of Texas Health Science Center at Houston (UTHealth), TX; Mellen Center for Multiple Sclerosis Treatment and Research (J.A.C.), Neurological Institute, Cleveland Clinic Foundation, OH; Oxford PharmaGenesis Ltd (I.M.W.), UK; Novartis Pharmaceuticals Corporation (X.M., M.Z., S.K.), East Hanover, NJ; and The University of California, San Francisco (UCSF); Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), San Francisco, CA.
Jeffrey A CohenFrom the Central Texas Neurology Consultants (E.J.F.), Round Rock, TX; Icahn School of Medicine at Mount Sinai (F.D.L.), New York, NY; McGovern Medical School (J.S.W.), The University of Texas Health Science Center at Houston (UTHealth), TX; Mellen Center for Multiple Sclerosis Treatment and Research (J.A.C.), Neurological Institute, Cleveland Clinic Foundation, OH; Oxford PharmaGenesis Ltd (I.M.W.), UK; Novartis Pharmaceuticals Corporation (X.M., M.Z., S.K.), East Hanover, NJ; and The University of California, San Francisco (UCSF); Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), San Francisco, CA.
Ian M WilliamsFrom the Central Texas Neurology Consultants (E.J.F.), Round Rock, TX; Icahn School of Medicine at Mount Sinai (F.D.L.), New York, NY; McGovern Medical School (J.S.W.), The University of Texas Health Science Center at Houston (UTHealth), TX; Mellen Center for Multiple Sclerosis Treatment and Research (J.A.C.), Neurological Institute, Cleveland Clinic Foundation, OH; Oxford PharmaGenesis Ltd (I.M.W.), UK; Novartis Pharmaceuticals Corporation (X.M., M.Z., S.K.), East Hanover, NJ; and The University of California, San Francisco (UCSF); Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), San Francisco, CA.
Xiangyi MengFrom the Central Texas Neurology Consultants (E.J.F.), Round Rock, TX; Icahn School of Medicine at Mount Sinai (F.D.L.), New York, NY; McGovern Medical School (J.S.W.), The University of Texas Health Science Center at Houston (UTHealth), TX; Mellen Center for Multiple Sclerosis Treatment and Research (J.A.C.), Neurological Institute, Cleveland Clinic Foundation, OH; Oxford PharmaGenesis Ltd (I.M.W.), UK; Novartis Pharmaceuticals Corporation (X.M., M.Z., S.K.), East Hanover, NJ; and The University of California, San Francisco (UCSF); Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), San Francisco, CA.
Marina ZiehnFrom the Central Texas Neurology Consultants (E.J.F.), Round Rock, TX; Icahn School of Medicine at Mount Sinai (F.D.L.), New York, NY; McGovern Medical School (J.S.W.), The University of Texas Health Science Center at Houston (UTHealth), TX; Mellen Center for Multiple Sclerosis Treatment and Research (J.A.C.), Neurological Institute, Cleveland Clinic Foundation, OH; Oxford PharmaGenesis Ltd (I.M.W.), UK; Novartis Pharmaceuticals Corporation (X.M., M.Z., S.K.), East Hanover, NJ; and The University of California, San Francisco (UCSF); Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), San Francisco, CA.
Scott KolodnyFrom the Central Texas Neurology Consultants (E.J.F.), Round Rock, TX; Icahn School of Medicine at Mount Sinai (F.D.L.), New York, NY; McGovern Medical School (J.S.W.), The University of Texas Health Science Center at Houston (UTHealth), TX; Mellen Center for Multiple Sclerosis Treatment and Research (J.A.C.), Neurological Institute, Cleveland Clinic Foundation, OH; Oxford PharmaGenesis Ltd (I.M.W.), UK; Novartis Pharmaceuticals Corporation (X.M., M.Z., S.K.), East Hanover, NJ; and The University of California, San Francisco (UCSF); Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), San Francisco, CA.
Bruce A C CreeFrom the Central Texas Neurology Consultants (E.J.F.), Round Rock, TX; Icahn School of Medicine at Mount Sinai (F.D.L.), New York, NY; McGovern Medical School (J.S.W.), The University of Texas Health Science Center at Houston (UTHealth), TX; Mellen Center for Multiple Sclerosis Treatment and Research (J.A.C.), Neurological Institute, Cleveland Clinic Foundation, OH; Oxford PharmaGenesis Ltd (I.M.W.), UK; Novartis Pharmaceuticals Corporation (X.M., M.Z., S.K.), East Hanover, NJ; and The University of California, San Francisco (UCSF); Weill Institute for Neurosciences, Department of Neurology (B.A.C.C.), San Francisco, CA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate lymphocyte counts and incidences of infections in patients with primary progressive MS (PPMS) receiving fingolimod 0.5 mg/d or placebo over 5 years during the INFORMS study, to assess infection rates with longer-term treatment.

methodsINFORMS was a randomized, multicenter, double-blind, placebo-controlled, parallel-group, phase 3 study of the sphingosine 1-phosphate receptor modulator fingolimod in patients with PPMS. Lymphocyte counts and incidences of infections were compared in patients receiving fingolimod or placebo. Infection rates were assessed in patients receiving fingolimod according to nadir and mean absolute lymphocyte count (ALC).

resultsOverall, 336 patients received fingolimod 0.5 mg/d (total exposure: 908.1 patient-years), and 487 received placebo (1,423.5 patient-years). In patients receiving fingolimod, mean ALC decreased by approximately 70% in the 2 weeks following treatment initiation and remained stable throughout the study. The incidences of all infections in the fingolimod and placebo groups were similar (53.6 vs 51.9 per 100 patient-years). The most common infections in patients receiving fingolimod were urinary tract infections (5.7 per 100 patient-years), upper respiratory tract infections (4.2 per 100 patient-years), and influenza (3.2 per 100 patient-years); incidences were similar in the placebo group (5.9, 4.2, and 3.1 per 100 patient-years, respectively). There was no apparent association between nadir or mean ALC and incidence of infection-related adverse events.

conclusionsIn patients with PPMS, long-term treatment with fingolimod 0.5 mg/d for up to 5 years led to an expected decrease of approximately 70% in mean ALC and did not appear to correlate with increased risk of infection. CLASSIFICATION OF EVIDENCE: Because this is a secondary analysis, this study provides Class II evidence that long-term PPMS treatment with fingolimod decreased mean ALC by approximately 70%, but did not significantly increase infection risk.

Indexed as

AdultDouble-Blind MethodFemaleFingolimod HydrochlorideFollow-Up StudiesHumansImmunosuppressive AgentsInfectionsLymphocyte CountLymphocytesMaleMiddle AgedMultiple Sclerosis, Chronic ProgressiveTime FactorsFingolimod HydrochlorideImmunosuppressive Agents

Identifiers

PMID31511330
PMCPMC6745722

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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.