Evidence map›Paper›PMID 23303850›Full record

Trial reportNeurology2013

CNS vasculitis in a patient with MS on daclizumab monotherapy.

Joan Ohayon, Unsong Oh, Nancy Richert, Jayne Martin, Alexander Vortmeyer, Henry McFarland, Bibiana Bielekova

Open access · bronzeAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Neurology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
3.4field-weighted citation impact, top 8% 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

13 citing papers in PubMed, 27 citations in OpenAlex.

  1. Article
  2. Natural killer cells in the central nervous system.Cell communication and signaling : CCS · 2023
    Review
  3. What Have Failed, Interrupted, and Withdrawn Antibody Therapies in Multiple Sclerosis Taught Us?Neurotherapeutics : the journal of the American Society for Experimental NeuroTherapeutics · 2022
    Review
  4. Mechanism and adverse effects of multiple sclerosis drugs: a review article. Part 2.International journal of physiology, pathophysiology and pharmacology · 2019
    Review
  5. GFAPα IgG-associated encephalitis upon daclizumab treatment of MS.Neurology(R) neuroimmunology & neuroinflammation · 2018
    Article
  6. The effects of interleukin-2 on immune response regulation.Mathematical medicine and biology : a journal of the IMA · 2018
    Article
  7. Review
  8. Daclizumab.Hospital pharmacy · 2016
    Article
  9. Spotlight on daclizumab: its potential in the treatment of multiple sclerosis.Degenerative neurological and neuromuscular disease · 2016
    Review
  10. Review
  11. Review
  12. Review
  13. Review
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

7 authors at 3 institutions in 1 country.

Joan OhayonNeuroimmunology Branch, National Institutes of Neurological Disorders and Stroke (NINDS), National Institutes of Health (NIH), Bethesda, MD, USA.
Unsong Oh
Nancy Richert
Jayne Martin
Alexander Vortmeyer
Henry McFarland
Bibiana Bielekova
Virginia Commonwealth University · USBiogen (United States) · USColumbia University · US

Funding

From therapeutic mechanisms to unraveling the pathophysiology of MSZIANS003056 · NINDS · NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE · PI BIELEKOVA, BIBIANA · 2009 to 2018
$14.5M
Center for Clinical and Translational ResearchUL1TR000058 · NCATS · VIRGINIA COMMONWEALTH UNIVERSITY · PI MOELLER, FREDERICK GERARD · 2012 to 2015
$12.5M
Comprehensive multimodal analysis of patients with neuroimmunological diseasesZIANS003055 · NINDS · NATIONAL INSTITUTE OF NEUROLOGICAL DISORDERS AND STROKE · PI BIELEKOVA, BIBIANA · 2009 to 2018
$9.0M
Center for Clinical and Translational ResearchKL2TR000057 · NCATS · VIRGINIA COMMONWEALTH UNIVERSITY · PI MOELLER, FREDERICK GERARD · 2012 to 2014
$1.4M
Center for Clinical and Translational ResearchKL2RR031989 · NCRR · VIRGINIA COMMONWEALTH UNIVERSITY · PI CLORE, JOHN N. · 2010 to 2011
$995k
NCATS NIH HHS KL2 TR000057NCATS NIH HHS KL2TR000057NCATS NIH HHS UL1 TR000058NCRR NIH HHS KL2 RR031989
6 · The paper itself

Abstract

objectiveTo report the development of CNS vasculitis in a patient with multiple sclerosis (MS) treated with daclizumab.

methodsThis report includes clinical, MRI, immunologic, and pathology data and CSF analysis.

resultsAfter completing a phase II daclizumab monotherapy study with an optimal response as evidenced by significant decrease in MRI disease activity and stable clinical examinations, the patient elected to continue daclizumab therapy outside of NIH study. Daclizumab was discontinued after 21 doses due to the onset of new clinical symptoms and evidence of a vascular pattern of contrast enhancement on brain and spine MRI. Because of continued clinical deterioration, stereotactic brain biopsy was performed, showing small-vessel CNS vasculitis. Treatment was initiated with IV methylprednisolone followed by a regimen of cyclophosphamide. Immunologic studies suggest that unexpected lack of expansion of CD56(bright) NK cells and predictable decline in FoxP3+ T-regs combined with a transient interruption in daclizumab dosing may have contributed to this serious side effect.

conclusionsOnly safety data from larger phase III studies and potentially postmarketing experience will define the exact risk of daclizumab-induced immunopathologies. Nevertheless, our case provides plausible hypothesis and potential biomarker that may be used to screen susceptible patients and implement preventive safety measures during potentially vulnerable periods.

Indexed as

Antibodies, Monoclonal, HumanizedAnti-Inflammatory AgentsCD56 AntigenCyclophosphamideDaclizumabDisability EvaluationEnzyme-Linked Immunosorbent AssayFemaleHumansImmunoglobulin GImmunosuppressive AgentsKiller Cells, NaturalMagnetic Resonance ImagingMaleMethylprednisoloneMultiple SclerosisAntibodies, Monoclonal, HumanizedAnti-Inflammatory AgentsCD56 AntigenCyclophosphamideDaclizumabImmunoglobulin GImmunosuppressive AgentsMethylprednisolone

Identifiers

PMID23303850
PMCPMC3590053
OpenAlexW2078503495

What OpenQuestion holds

Textmetadata
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.