GENEVA, SWITZERLAND -- February 29, 2000 -- New data from the largest and most comprehensive controlled long-term study in patients with relapsing-remitting multiple sclerosis (RRMS) has shown continued benefit of Rebif(R)(interferon beta-1a) 22 mcg and Rebif(R) 44 mcg administered three times weekly for four years. The PRISMS(1) four year data demonstrate a dose-effect relationship on clinical as well as MRI parameters with high dose Rebif(R) 3 x 44 mcg being superior to 3x22 mcg. In addition, the data also demonstrated that early treatment is better than delayed treatment and that the benefit of Rebif(R) on relapse rate may be greater than previously thought. Together, the data provide strong support to the concept of treating with the highest tolerated dose in order to gain maximum benefit and prevent disease progression, and to treat early (as issued by the guidelines of the US National MS Society(2)).
The PRISMS study began in 1994, involving 560 patients at 22 centers in nine countries. Two year data were published(3) in 1998 demonstrating that both Rebif(R) 3 x 22 mcg and Rebif(R) 3 x 44 mcg per week significantly reduced the number and severity of relapses, delayed disability progression and reduced disease activity and burden of disease as measured in magnetic resonance imaging (MRI). The new data are from the extension phase of this study up to four years. Over 90 percent (506) of the originally enrolled patients entered the extension phase and the vast majority of these completed the full four years. The objectives of the extension phase included the assessment of long-term benefits on the frequency of relapses, delay of disability progression, changes in MRI activity and burden of disease, dose-response and the benefit of early versus late therapy onset.
"This is very important data and good news for the multiple sclerosis community. The study was the best designed of any of the trials conducted with interferon in relapsing-remitting multiple sclerosis to date and importantly with the longest controlled follow-up," comments Mark Freedman, MD, Director of the Multiple Sclerosis Clinic at Ottawa Hospital, General Campus, and Associate Professor of Medicine (Neurology) at the University of Ottawa, an investigator in the PRISMS trial. "It clearly indicates that beta-interferons can dramatically modify the natural course of the disease over four years, an effect that will hopefully continue for even longer. It also reinforces the need to treat as early as possible with the highest tolerable dose. We now have additional scientific evidence that through the continued use of Interferon beta-1a we are able to provide our patients with optimal care."
The full data will be released to the public at a major neurological congress shortly. Ares-Serono plans to use this data to further enhance the existing label for Rebif(R). Rebif(R) is produced and marketed by Ares-Serono and is available in 50 countries worldwide, including Canada, Switzerland, the countries of the European Union, and many in Latin America.
An estimated one to two million people worldwide are living with multiple sclerosis, which is a chronic, debilitating disease of the central nervous system that affects mainly young adults. At present, most patients with MS will become increasingly disabled, but data from trials such as PRISMS suggest that therapies such as Rebif(R) may beneficially affect the progression of MS.
Ares-Serono, headquartered in Geneva, Switzerland, is a leading biotechnology company with four recombinant products on the market, Rebif(R), Gonal F(R), Serostim(R), and Saizen(R). In addition to being the world leader in reproductive health, Ares-Serono has strong market positions in multiple sclerosis, AIDS wasting, and growth. The company's research programs are focused on growing these businesses and on establishing new therapeutic areas. Currently, there are six recombinant products in development. In 1999, Ares-Serono achieved worldwide sales of US$1.054 billion. The company operates in 45 countries, and its products are sold in over 100 countries.
1 PRISMS - Prevention of Relapses and Disability by Interferon Beta-1a Subcutaneously in Multiple Sclerosis.
2 Clinical Bulletin, The National Multiple Sclerosis Society, October 1998.
3 PRISMS Study Group, Randomized Double-Blind Placebo-Controlled Study of Interferon Beta-1a in Relapsing- Remitting Multiple Sclerosis. The Lancet. Vol. 352. Nov 7, 1998. 1498-1504.
Related Links: Rebif (interferon beta-1a) and Ares-Serono.