Interferon beta-1b 250 mcg(1) treatment delayed the onset of clinically definite multiple sclerosis (CDMS) by one year (363 days) in patients with first clinical signs of multiple sclerosis (MS) compared to placebo, according to new findings from the BENEFIT (Betaferon/Betaseron in Newly Emerging MS For Initial Treatment) study presented at today's joint 21st Congress of the European Committee for the Treatment and Research in Multiple Sclerosis/10th Annual Meeting of the Americas Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS/ACTRIMS), Thessaloniki, Greece, by Professor Ludwig Kappos, Professor of Neurology and Clinical Neuroimmunology at the University of Basel, Switzerland.

The multi-centre, double-blind, randomized, phase III BENEFIT study was conducted in 98 centres in 20 countries and included a total of 487 patients presenting with a single clinical episode suggestive of MS, for a period of up to 24 months. Two primary endpoints were evaluated:

- Time to CDMS based on a relapse or EDSS progression 1.5 points

- Time to MS according to the criteria by McDonald et al. (2001)

Results from the study showed that treatment may significantly delay the development of CDMS. Patients in the treatment group experienced an additional 363 days delay in development of CDMS compared to the placebo group. At day 255 of the study, one-quarter of patients in the placebo group had developed CDMS, while it took 618 days for a comparable number of patients to develop CDMS in the treatment group. At the end of the two-year period, 45 percent of the placebo group compared with 28 percent in the interferon beta-1b group (p< 0.0001) had developed CDMS, a relative risk reduction of 50 percent in the group treated with interferon beta-1b.

"Treatment with interferon beta-1b appears to delay patient progression to CDMS when they have been identified as being at risk of developing the disease," said Ludwig Kappos, Professor of Neurology and Clinical Neuroimmunology at the University of Basel, Switzerland and lead investigator of the BENEFIT study. "The BENEFIT study was rigorously controlled and will lend support to making early treatment decisions in patients with the first clinical signs of MS."

In assessing MS progression against the McDonald criteria, patients in the interferon beta-1b group were two times less likely to develop MS: fifty-one percent of the placebo group had already progressed to MS after six months, and 85 percent within two years compared with 28 percent and 69 percent of the interferon beta-1b treated group, respectively (p<0.00001).

The study also demonstrated that people who have symptoms suggestive of MS are willing to accept and comply with this treatment regimen that asks for every other day subcutaneous (s.c.) injections. Ninety-four percent and 93 percent of the placebo and interferon beta-1b patients, respectively, completed the two-year study period. Additionally, 95 percent of all eligible patients chose to enter the BENEFIT follow-up study taking open-label interferon beta-1b every other day treatment. The high patient acceptance to therapy in the study was facilitated through the implementation of a series of steps designed to improve a patient's tolerability to therapy, including a dose titration regimen at the initiation of therapy, the use of auto-injectors and co-medication with an analgesic.

About BENEFIT

The BENEFIT study is the first randomized multi-centre study designed to explore the impact of a high-dose, high-frequency beta interferon therapy on the progression of disease in patients with first clinical signs of MS.

A randomised, double blind, placebo controlled, parallel-group, multi-centre clinical trial, the BENEFIT study was carried out among 487 patients presenting with the first clinical event suggestive of MS within the last 60 days. These patients presented with either "monofocal" (clinical symptoms explained by one single CNS lesion) or "multifocal" (clinical symptoms explained by at least two underlying CNS lesions) symptoms and with a magnetic resonance imaging (MRI) screening scan suggestive of MS. Patients were randomized to one of two groups receiving interferon beta-1b 250 mcg or placebo s.c. every other day for up to 24 months continuously. All study participants completing the double blind study were then invited to participate in a separate open-label follow-up study with interferon beta-1b. The open label study will prospectively assess the impact of early treatment as compared to delayed treatment with interferon beta-1b on the long-term course of the disease for a total observation time of five years, as well as on the formation of new brain lesions as measured by MRI.

(1) Interferon beta-1b is marketed by Schering AG as Betaferon in Europe and by Berlex Laboratories as Betaseron in the U.S. and Canada. In the US, Europe and Japan, interferon beta-1b has been approved for all relapsing forms of MS. It is given on alternate days as a subcutaneous injection of 250 mcg.

The BENEFIT (Betaferon/Betaseron in Newly Emerging MS For Initial Treatment) study is sponsored by Schering AG Germany. {CLICK FOR MORE}