Rapid Beneficial Effects of New Interferon Formulation on MRI Outcomes in Multiple Sclerosis: Presented at ENS
By Judith Moser, MD
MILAN, Italy — June 23, 2009 — Patients with relapsing-remitting multiple sclerosis (RRMS) show early benefit from a new formulation of subcutaneous interferon (IFN) beta-1a as measured by magnetic resonance imaging (MRI), according to a study presented here at the 19th Meeting of the European Neurological Society (ENS).
Nicola De Stefano, MD, Department of Neurological and Behavioural Sciences, University of Siena, Siena, Italy, spoke on behalf of the researchers from the Study to Evaluate Rebif New Formulation (IFN-Beta-1a) in Relapsing Remitting Multiple Sclerosis (IMPROVE) here on June 22.
The phase 3b double-blind, placebo-controlled, multicentre study evaluated the efficacy, safety, and tolerability of a new formulation of IFN beta-1a compared with placebo in patients with active RRMS. This new formulation is free from serum-derived products and has been developed with the aim of improving injection tolerability and reducing immunogenicity.
In the double-blind phase, 180 patients were randomised to receive either the new formulation of IFN beta-1a 44 mcg 3 times weekly or placebo for 16 weeks.
The primary endpoint was the number of combined unique active (CUA) brain lesions at week 16. Secondary endpoints included changes in T2 load and cumulative number of new gadolinium-enhancing and T2 lesions.
“Every single MRI endpoint was significantly in favour of the active treatment,” Dr. De Stefano summarised.
At week 16, the number of CUA lesions was significantly lower with IFN beta-1a (0.9 vs 3.0 in the placebo group, P < .001).
More than half of the patients (53.3 %) in the active-treatment group had no CUA lesions at week 16, compared with 16.7% in the placebo group.
“A beneficial effect of the treatment can be seen even in a short period,” Dr. De Stefano noted. “Post hoc analyses showed a significant effect already at 4 weeks.”
From week 4 on, the mean cumulative number of CUA lesions was significantly lower in the IFN beta-1a group, with a 41% reduction compared with the placebo group.
The cumulative number of new gadolinium-enhancing and new T2 lesions was significantly reduced at 16 weeks (P <.001).
At week 16, the change in T2 burden of disease was significantly lower with IFN beta-1a than placebo (P < .001).
The most commonly reported adverse event was flulike illness (50% and 17% in the IFN and placebo groups, respectively).
As Dr. De Stefano mentioned, a 24-week, single-arm, rater-blind treatment phase was initiated after the double-blind phase and has been completed recently, and the results will be presented soon.
Funding for this study was provided by Merck Serono S.A.
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