Plasma neurofilament light chain in children with relapsing MS receiving teriflunomide or placebo: A post hoc analysis of the randomized TERIKIDS trial.


Journal

Multiple sclerosis (Houndmills, Basingstoke, England)
ISSN: 1477-0970
Titre abrégé: Mult Scler
Pays: England
ID NLM: 9509185

Informations de publication

Date de publication:
03 2023
Historique:
pubmed: 13 1 2023
medline: 3 3 2023
entrez: 12 1 2023
Statut: ppublish

Résumé

The phase 3 TERIKIDS study demonstrated efficacy and manageable safety for teriflunomide versus placebo in children with relapsing multiple sclerosis (RMS). Evaluate plasma neurofilament light chain (pNfL) concentrations in TERIKIDS. Patients received placebo or teriflunomide (14 mg adult equivalent) for up to 96 weeks in the double-blind (DB) period. In the open-label extension (OLE), all patients received teriflunomide until up to 192 weeks after randomization. pNfL was measured using single-molecule array assay (Simoa Baseline mean age was 14.5 years; 69.4% were female. Baseline geometric least square mean pNfL levels were similar for teriflunomide ( Teriflunomide treatment was associated with significantly reduced pNfL levels in children with RMS. NCT02201108.

Sections du résumé

BACKGROUND
The phase 3 TERIKIDS study demonstrated efficacy and manageable safety for teriflunomide versus placebo in children with relapsing multiple sclerosis (RMS).
OBJECTIVE
Evaluate plasma neurofilament light chain (pNfL) concentrations in TERIKIDS.
METHODS
Patients received placebo or teriflunomide (14 mg adult equivalent) for up to 96 weeks in the double-blind (DB) period. In the open-label extension (OLE), all patients received teriflunomide until up to 192 weeks after randomization. pNfL was measured using single-molecule array assay (Simoa
RESULTS
Baseline mean age was 14.5 years; 69.4% were female. Baseline geometric least square mean pNfL levels were similar for teriflunomide (
CONCLUSION
Teriflunomide treatment was associated with significantly reduced pNfL levels in children with RMS.
CLINICALTRIALS.GOV IDENTIFIER
NCT02201108.

Identifiants

pubmed: 36632983
doi: 10.1177/13524585221144742
pmc: PMC9972233
doi:

Substances chimiques

teriflunomide 1C058IKG3B
Crotonates 0
Toluidines 0

Banques de données

ClinicalTrials.gov
['NCT02201108']

Types de publication

Randomized Controlled Trial Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

385-394

Commentaires et corrections

Type : CommentIn

Références

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Auteurs

Jens Kuhle (J)

MS Center, Neurology and Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Departments of Head, Spine and Neuromedicine, Biomedicine and Clinical Research, University Hospital Basel and University Basel, Basel, Switzerland.

Tanuja Chitnis (T)

Massachusetts General Hospital for Children, Boston, MA, USA.

Brenda Banwell (B)

Children's Hospital of Philadelphia, University of Pennsylvania, Philadelphia, PA, USA.

Marc Tardieu (M)

Hôpitaux Universitaires Paris-Sud, Paris, France.

Douglas L Arnold (DL)

McGill University, Montréal, QC, Canada NeuroRx Research, Montréal, QC, Canada.

Andreea M Rawlings (AM)

Sanofi, Cambridge, MA, USA.

Svend S Geertsen (SS)

Sanofi, Cambridge, MA, USA.

Alex L Lublin (AL)

Sanofi, Cambridge, MA, USA.

Stephane Saubadu (S)

Sanofi, Cambridge, MA, USA.

Philippe Truffinet (P)

Sanofi, Cambridge, MA, USA.

Ludwig Kappos (L)

MS Center, Neurology and Research Center for Clinical Neuroimmunology and Neuroscience Basel (RC2NB), Departments of Head, Spine and Neuromedicine, Biomedicine and Clinical Research, University Hospital Basel and University Basel, Basel, Switzerland.

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Classifications MeSH