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

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  3. Predictors of treatment outcome in patients with paediatric onset multiple sclerosis

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  1. Dimethyl Fumarate Treatment in Patients With Primary Progressive Multiple Sclerosis: A Randomized, Controlled Trial

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  2. Exposure to passive smoking during adolescence is associated with an increased risk of developing multiple sclerosis

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  3. Using Smartphones and Wearable Devices to Monitor Behavioral Changes During COVID-19

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  4. The apparently milder course of multiple sclerosis: changes in the diagnostic criteria, therapy and natural history

    Research output: Contribution to journalReviewResearchpeer-review

  • Angelo Ghezzi
  • Maria Pia Amato
  • Gilles Edan
  • Hans-Peter Hartung
  • Eva Kubala Havrdová
  • Ludwig Kappos
  • Xavier Montalban
  • Carlo Pozzilli
  • Maria Trojano
  • Patrich Vermersch
  • Giancarlo Comi
  • Per Soelberg Sørensen
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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 - Mar 2021

    Research areas

  • Adult, Child, Fingolimod Hydrochloride/therapeutic use, Humans, Immunosuppressive Agents/therapeutic use, Multiple Sclerosis/drug therapy, Pediatric multiple sclerosis, clinical trials, observational studies, randomized controlled trials, disease-modifying drugs

ID: 68562893