The introduction of new medications in pediatric multiple sclerosis: Open issues and challenges

Research output: Contribution to journalJournal articleResearchpeer-review

  • Angelo Ghezzi
  • Maria Pia Amato
  • Gilles Edan
  • Hans Peter Hartung
  • Eva Kubala Havrdová
  • Ludwig Kappos
  • Xavier Montalban
  • Carlo Pozzilli
  • Sørensen, Per Soelberg
  • Maria Trojano
  • Patrich Vermersch
  • Giancarlo Comi

Disease-modifying drugs (DMDs) for multiple sclerosis (MS) have been evaluated in pediatric patients in observational studies demonstrating a similar, even better clinical effect compared to adults, with a similar safety. Only fingolimod has been tested in a randomized controlled trial (RCT) and is approved for pediatric multiple sclerosis (ped-MS). Numerous methodological, practical, and ethical issues underline that RCTs are difficult to conduct in ped-MS. This also creates a lack of safety information. To facilitate the availability of new agents in ped-MS, we encourage to develop a different approach based on pharmacokinetic/pharmacodynamic studies to yield information on optimal doses and implementation of obligatory registries to obtain information on safety as primary endpoint.

Original languageEnglish
JournalMultiple Sclerosis Journal
Volume27
Issue number3
Pages (from-to)479-482
Number of pages4
ISSN1352-4585
DOIs
Publication statusPublished - 2021

Bibliographical note

Publisher Copyright:
© The Author(s), 2020.

    Research areas

  • clinical trials, disease-modifying drugs, observational studies, Pediatric multiple sclerosis, randomized controlled trials

ID: 303772425