Greater Tolerability Achieved With New Formulation Subcutaneous Interferon-Beta-1a for Relapsing-Remitting Multiple Sclerosis: Presented at WCTRMS

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Title: Greater Tolerability Achieved With New Formulation Subcutaneous Interferon-Beta-1a for Relapsing-Remitting Multiple Sclerosis: Presented at WCTRMS
URL: http://www.pslgroup.com/dg/22D3AA.htm
Doctor's Guide
September 22, 2008

By Louise Gagnon

MONTREAL -- September 22, 2008 -- A new formulation of subcutaneous (sc) interferon (IFN)-beta-1a demonstrates greater tolerability among adults with relapsing-remitting multiple sclerosis, according to a phase 3 study presented here at the World Congress on Treatment and Research in Multiple Sclerosis (WCTRMS).

"This [study] demonstrates the short-term efficacy of the drug," said lead investigator Nicola De Stefano, MD, University of Siena, Siena, Italy, speaking in an interview at a late-breaking poster session on September 20.

Subjects in the study -- dubbed Investigating MRI Parameters With Rebif Improved Formulation (IMPROVE) -- were randomised to a new formulation of sc IFN-beta-1a at 44 mcg 3 times weekly (n = 120) or placebo (n = 60) for 16 weeks. Subjects were aged 18 to 60 years, and had an Expanded Disability Status Scale score of 5.5 or less at baseline. Magnetic resonance imaging (MRI) brain scans were performed at study entry, and then again at weeks 4, 8, 12, and 16.

The main outcome was the mean number of combined unique active (CUA) brain lesions at week 16: 0.9 in the sc IFN-beta-1a arm versus 3.0 in the placebo arm (P < .001). There were 69% fewer lesions with sc IFN-beta-1a compared with placebo at the 16-week mark.

Finally, the number of T2-W and gadolinium-enhancing lesions were significantly lower in the IFN arm during the course of the 16 weeks, as was T2-W lesion volume at week 16, compared to the placebo arm (P < .001). Given the time period of analysis, clinical differences between the 2 study arms would not emerge, although such analysis would be fruitful, noted Dr. De Stefano. "For this short time period, you cannot look at clinical differences," she added.

Dr. De Stefano stated that previous research with the new formulation demonstrated that patients on the drug develop fewer neutralising antibodies. "[Sc IFN-beta-1a] has been shown already to guarantee less immunogenicity, so there is a better immunological profile in patients," she said. "There is also a better tolerability in terms of injection-site reactions."

Flu-like symptoms are a concern in patients who undergo IFN therapy, according to Dr. De Stefano.

A total of 11 subjects from both arms did not complete the 16-week treatment period, with 3 subjects withdrawing due to adverse events, 2 withdrawing due to disease progression, 1 withdrawing due to protocol violation, and 5 withdrawing due to other reasons.

The IMPROVE study is ongoing up to 40 weeks as a single-blind investigation where all patients are administered the new formulation. The analysis of that data, including other MRI activity, clinical endpoints, and biomarkers, is expected to be available next year, according to Dr. De Stefano.

Funding for this study was provided by Merck Serono International S.A.

[Presentation title: Efficacy of a New Formulation of Subcutaneous Interferon Beta-1a in Patients With Relapsing-Remitting Multiple Sclerosis: Results at 16 Weeks From a Double-Blind, Placebo-Controlled Study. P900]

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