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Safety and Efficacy of Delayed-Release Dimethyl Fumarate in Pediatric Patients With Relapsing Multiple Sclerosis (FOCUS) by Raed Alroughani; Rajiv Das; Natasha Penner; Joe Pultz; Catherine Taylor; Satish Eraly is a Medicine article available to read on EtoBox.

What is Safety and Efficacy of Delayed-Release Dimethyl Fumarate in Pediatric Patients With Relapsing Multiple Sclerosis (FOCUS) about?

## Background: No therapies have been formally approved by the food and drug administration for use in pediatric multiple sclerosis, a rare disease. ## Objective: We evaluated the safety, efficacy, and pharmacokinetics of dimethyl fumarate in pediatric patients with multiple sclerosis. ## Methods: Focus, a phase 2, multicenter study of patients aged 10 to 17 years with relapsing-remitting multiple sclerosis, comprised an eight-week baseline and 24-week treatment period; during treatment, patients received dimethyl fumarate (120 mg twice daily on days one to seven; 240 mg twice a day thereafter). magnetic resonance imaging scans were obtained at week -8, day 0, week 16, and week 24. the primary end point was the change in t2 hyperintense lesion incidence from the baseline period to the final 8 weeks of treatment. secondary end points were pharmacokinetic parameters and adverse event incidence. ## Results: Twenty of 22 enrolled patients completed the study. there was a significant reduction in t2 hyperintense lesion incidence from baseline to the final eight weeks of treatment (p = 0.009). adverse events (most commonly gastrointestinal events and flushing) and pharmacokinetic paramet

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Author

Raed Alroughani; Rajiv Das; Natasha Penner; Joe Pultz; Catherine Taylor; Satish Eraly

Published

2018

Language

EN

Field

Medicine (Health Sciences)