Biogen, Bayer Drugs Don’t Slow MS Progress, Study Finds

By Meg Tirrell - 2012-07-17T20:07:56Z

The most commonly prescribed multiple sclerosis drugs, including those made by Biogen Idec Inc. (BIIB), Bayer AG (BAYN) and Merck KGaA, failed to slow disability progression in a long-term study that raises new questions on whether the treatments can achieve that goal.

Researchers compared historical outcomes for MS patients in British Columbia to assess the use of interferon beta drugs. The results, published online today in the Journal of the American Medical Association, found the medicines didnt delay progress of the patients disability.

It dampens somewhat the enthusiasm for so-called first- line therapies, said Ludwig Kappos of University Hospital in Basel, Switzerland, and author of an editorial that accompanied the study, in an e-mail today.

MS is an autoimmune disease that affects about 2.1 million people worldwide and can lead to limb numbness, loss of vision and paralysis, according to the National Multiple Sclerosis Society. The most common form, relapsing-remitting, is characterized by sporadic flare-ups followed by periods of inactivity.

Avonex, made by Biogen, Bayers Betaseron and Merck KGaA (MRK)s Rebif generated $6.6 billion in 2011 revenue, according to data compiled by Bloomberg. Called disease-modifying drugs, they have been shown to slow the frequency of relapses and reduce the development of brain lesions. Their ability to slow disability progression has been less clear, wrote the researchers, led by Afsaneh Shirani of the University of British Columbia, in the paper reported today.

A key feature of MS is clinical progression of the disease over time manifested by the accumulation of disability, the researchers wrote. There is a lack of well- controlled longitudinal studies investigating the effect of interferon beta on disability progression.

The study used data from the British Columbia Multiple Sclerosis database from 1985 to 2008. It compared three groups: 868 patients with relapsing-remitting MS who were treated with interferon beta therapy from July 1995 to December 2004; 829 patients who met the criteria to receive interferon beta therapy in that time period yet were untreated with it; and 959 patients who met the same criteria before interferon beta therapies became available in 1995 in Canada.

The use of two control groups sought to eliminate the chance of bias based on patients choosing not to receive therapy for reasons such as less severe disease, the researchers wrote.

The analysis considered advancement to a score of 6 on the Expanded Disability Status Scale, or EDSS, a commonly used metric to measure disability progression in MS. That score means a patient requires help from a cane or crutch to walk about 100 meters.

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Biogen, Bayer Drugs Don’t Slow MS Progress, Study Finds