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Comparison of two dosing frequencies of subcutaneous interferon beta-1a in patients with a first clinical demyelinating event suggestive of multiple sclerosis (REFLEX): a phase 3 randomised controlled trial by Giancarlo Comi; Nicola De Stefano; Mark S Freedman; Frederik Barkhof; Chris H Polman; Bernard MJ Uitdehaag; Florence Casset-Semanaz; Brian Hennessy; Margaretha Stam Moraga; Sanda Rocak; Bettina Stubinski; Ludwig Kappos is a Medicine article available to read on EtoBox.

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## Background: In patients presenting with a first clinical demyelinating event that is suggestive of multiple sclerosis (ms), treatment with interferon beta can delay the occurrence of further attacks and the onset of ms. we investigated the effects of two dosing frequencies of subcutaneous interferon beta-1a in patients with a first clinical demyelinating event. ## Methods: We undertook a multicentre phase 3 study (rebif flexible dosing in early ms [reflex]) that included patients (aged 18-50 years) with a single clinical event suggestive of ms, and at least two clinically silent t2 lesions on brain mri. participants were randomly assigned in a 1:1:1 ratio by use of a centralised interactive voice response system to receive the serum-free formulation of subcutaneous interferon beta-1a 44 μg three times a week or once a week (plus placebo twice a week for masking), or placebo three times a week for up to 24 months. patients and physicians were masked to group allocation. the primary endpoint was time to a diagnosis of ms as defined by the 2005 mcdonald criteria and the main secondary endpoint was time to clinically definite ms (cdms) as defined by the poser criteria. analysis was

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Author

Giancarlo Comi; Nicola De Stefano; Mark S Freedman; Frederik Barkhof; Chris H Polman; Bernard MJ Uitdehaag; Florence Casset-Semanaz; Brian Hennessy; Margaretha Stam Moraga; Sanda Rocak; Bettina Stubinski; Ludwig Kappos

Publisher

Elsevier BV

Published

2011

Language

EN

Field

Medicine (Health Sciences)