Interferon Beta-1b Confirmed As Safe And Effective Over The Long Term

Main Category: Multiple Sclerosis
Article Date: 07 Apr 2006 - 0:00 PDT

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New results document the sustained efficacy, safety, and tolerability profile of interferon beta-1b (Betaseron) treatment in multiple sclerosis (MS) patients.

"The findings, which are from the longest follow-up investigation of any disease-modifying therapy in MS, suggest a possible advantage of early and continuous long-term treatment with interferon beta-1b,"said George Ebers, MD, with the department of clinical neurology at Oxford University in Oxford, UK.

Dr. Ebers presented the data at the 58th Annual Scientific Meeting of the American Academy of Neurology (AAN).

The investigation, known as the Betaseron 16-Year Long-Term Follow-up (16-Year LTF) Study, also found a sustained reduction in the yearly relapse rate of up to 40 percent.

The research group examined the long-term safety and efficacy of interferon beta-1b in patients with relapsing-remitting MS using data from patients who had participated in the original pivotal trial.

"There is a paucity of data on the long-term benefits of interferon beta treatment (for longer than ten years)," Dr. Ebers observed. "Given that MS evolves over several decades, there is a need for longer term data on treatment outcomes."

In that trial, patients were randomly assigned to one of three treatment arms: interferon beta-1b 50 mcg, interferon beta-1b 250 mcg, or placebo, administered subcutaneously every other day, with a median 45 month observation period. An evaluation after two years revealed that significantly more patients in the active treatment arm were relapse-free, those relapses were less frequent, and MS-related hospitalizations were cut in half. These results held up at five years.

Despite the long interval, it was still possible to locate 328 ( 88.2 percent) patients from the original pivotal trial.

The 16-year follow-up found that patients on long-term treatment had a slower disease progression compared with patients who did not continue on long-term treatment. Among the patients who reached Expanded Disability Status Scale (EDSS) level 6.0, those on long-term interferon beta-1b treatment reached EDSS 6.0 after a median of 13 years compared to seven years for patients on short-term treatment. Long-term treatment was defined as use of interferon beta-1b for more than 80 percent of the time since the start of the pivotal trial (about 12 years or longer), while short-term treatment referred to use for less than ten percent of the time (about 1.6 years or less).

Finally, Dr. Ebers said that the impact of long-term treatment on disease progression is being studied further using historical control groups.

Schering AG and Berlex funded the trial.

Written by Jill Stein
Jill Stein is a Paris-based Medical Writer

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