Interferon Beta-1b Prolongs Survival in MS Patients

Emma Hitt, PhD

June 01, 2011

June 1, 2011 (Lisbon, Portugal) — Interferon beta-1b reduces all-cause mortality in patients with multiple sclerosis (MS), according to data from the 21-Year Long-Term Follow-up Study.

Still, the same investigators report that most deaths in MS patients are nevertheless attributable either directly or indirectly to MS.

George C. Ebers, MD, with the John Radcliffe Hospital, University Department of Clinical Neurology, Oxford, United Kingdom, and colleagues reported their findings here at the 21st Meeting of the European Neurological Society.

Interferon Reduces All-Cause Mortality

The 21-Year Long-Term Follow-up Study is an extension of a pivotal randomized controlled trial of 2 doses of interferon beta-1b vs no active treatment. Patients were randomized to receive interferon beta-1b, 50 μg or 250 μg, or placebo. Of the 372 patients initially randomized, 81 were deceased a median of 21.1 years after enrollment in the trial.

Dr. George C. Ebers

Those originally randomized to interferon beta-1b, 250 μg, had a significant reduction in all-cause mortality during long-term follow-up compared with those receiving placebo.

Average age of the patients at death was 51.8 years. Of the 81 deceased patients, cause of death had been adjudicated for 61 patients (75.3%). Of these 61 deaths, 50 (82%) were considered MS related. Other causes of death included 6 cancers and 8 resulting from cardiovascular disease or stroke. A total of 8 deaths were caused by suicide.

Dr. Douglas S. Goodin

According to the researchers, the early deaths observed in MS patients are consistent with mortality data from other natural history sources.

"There is a pronounced difference in mortality between placebo and active treatment, which appears to be largely MS related,” they add. The risk for death was reduced by 46.8% when comparing patients originally randomized to interferon beta-1b with the placebo group (P = .017).

In another data set from the same study, Douglas S. Goodin, MD, with the Department of Neurology at the University of California, San Francisco, and colleagues reported that in addition to the survival benefit observed with interferon beta-1b in the study, greater disease activity and greater disease progression were associated with a lower likelihood of being alive during long-term follow-up.

The clinical relevance is clearly that treatment had a significant survival benefit to patients treated with interferon.

"Nothing is known about disease-modifying treatments and their impact on mortality, and no one until now has looked at the predictive value of short-term clinical outcomes in patients on therapy on mortality," Dr. Goodin told Medscape Medical News. "The clinical relevance is clearly that treatment had a significant survival benefit to patients treated with interferon," he said.

However, according to Dr. Goodin, several questions remain, including what are the survival benefits observed with treatments other than interferons.

Long-Term Benefit of Early Treatment

"The present study results are very valuable, supporting a long term benefit of initiating early on disease-modifying therapies and specifically interferon therapy in extending the survival rate of MS patients," said Bianca Weinstock-Guttman, MD, an associate professor of neurology at State University of New York at Buffalo and the director of the Baird MS Center at The Jacobs Neurological Institute in Buffalo, New York.

"The benefit of an early initiation of interferon beta therapy on survival was also recently provided from another long-term study, ASSURENCE, which had 15 years of follow-up of patients taking interferon beta 1a and showed a trend (P = .0584) for a longer time to death between the 2 groups (early vs late initiation of interferon therapy; 10% death rate)," she noted.

The data from this long-term study provide an important new outcome measure — survival rate — to support the value of early initiation and long-term benefit of the use of disease-modifying therapies...

Dr. Weinstock-Guttman points out that, in the current study, MS remains the primary cause of death in this young group of patients, and the study findings provide support for long-term benefit of interferon therapy in MS patients to delay disease progression and increasing survival rate.

"The data from this long-term study provide an important new outcome measure — survival rate — to support the value of early initiation and long-term benefit of the use of disease-modifying therapies, specifically interferon, for the treatment of MS patients," she concludes.

The study was funded by Bayer HealthCare Pharmaceuticals. Dr. Ebers reports that he has financial relationships with Roche, UCB, and Bayer-Schering. Dr. Gooding discloses that he has financial relationships with Novartis, Bayer-Schering, Teva, and EMD Serono. Dr. Weinstock-Guttman discloses that she has financial associations with Biogen Idec, Teva Neuroscience, EMD Serono, Pfizer, Accorda, Novartis, Aspreva, and Cognition.

21st Meeting of the European Neurological Society (ENS): Abstracts P429 and P585. Presented May 29 and May 30, 2011.

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