Teriflunomide in pediatric patients with relapsing multiple sclerosis: Open-label extension of TERIKIDS.
Teriflunomide
adolescent
child
clinical trial
relapsing multiple sclerosis
safety analysis
Journal
Multiple sclerosis (Houndmills, Basingstoke, England)
ISSN: 1477-0970
Titre abrégé: Mult Scler
Pays: England
ID NLM: 9509185
Informations de publication
Date de publication:
15 Apr 2024
15 Apr 2024
Historique:
medline:
15
4
2024
pubmed:
15
4
2024
entrez:
15
4
2024
Statut:
aheadofprint
Résumé
The double-blind TERIKIDS study demonstrated the efficacy and safety of teriflunomide. To evaluate the efficacy, safety, and tolerability of continuous teriflunomide treatment in the TERIKIDS open-label extension. In the double-blind period, children with relapsing MS were randomized to placebo or teriflunomide (14 mg adult-equivalent dose) for ⩽ 96 weeks. Participants received teriflunomide for ⩽ 192 weeks post-randomization in the open-label extension. The mean age at screening was 14.6 years. For teriflunomide/teriflunomide versus placebo/teriflunomide, estimated clinical relapse risk was reduced by 38% (hazard ratio (HR) 0.62; 95% confidence interval (CI) 0.39-0.98; Teriflunomide reduced the long-term risk of focal inflammatory activity, with generally manageable tolerability and no new safety signals. Further evidence would strengthen clinical efficacy findings.ClinicalTrials.gov: NCT02201108.
Sections du résumé
BACKGROUND
UNASSIGNED
The double-blind TERIKIDS study demonstrated the efficacy and safety of teriflunomide.
OBJECTIVE
UNASSIGNED
To evaluate the efficacy, safety, and tolerability of continuous teriflunomide treatment in the TERIKIDS open-label extension.
METHODS
UNASSIGNED
In the double-blind period, children with relapsing MS were randomized to placebo or teriflunomide (14 mg adult-equivalent dose) for ⩽ 96 weeks. Participants received teriflunomide for ⩽ 192 weeks post-randomization in the open-label extension.
RESULTS
UNASSIGNED
The mean age at screening was 14.6 years. For teriflunomide/teriflunomide versus placebo/teriflunomide, estimated clinical relapse risk was reduced by 38% (hazard ratio (HR) 0.62; 95% confidence interval (CI) 0.39-0.98;
CONCLUSION
UNASSIGNED
Teriflunomide reduced the long-term risk of focal inflammatory activity, with generally manageable tolerability and no new safety signals. Further evidence would strengthen clinical efficacy findings.ClinicalTrials.gov: NCT02201108.
Identifiants
pubmed: 38619037
doi: 10.1177/13524585241242050
doi:
Banques de données
ClinicalTrials.gov
['NCT02201108']
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
13524585241242050Déclaration de conflit d'intérêts
Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: