Biogen Idec, Inc. Release: The World's Largest Observational Study Of Interferon-Beta Products For Relapsing Multiple Sclerosis Advances Understanding Of Long-Term MS Management

ZUG, Switzerland, June 28 /PRNewswire-FirstCall/ -- New data from the Global QUASIMS (Quality Assessment in MS Therapy) study was presented at the 15th annual meeting of the European Neurological Society in Vienna, Austria. QUASIMS is the world's largest retrospective, observational study in multiple sclerosis (MS) to date. It involves over 7,000 patients and compares available interferon beta preparations in relapsing MS in different clinical settings throughout the world. The data collection is still ongoing in Greece, Portugal, Spain and Argentina.

QUASIMS: Worldwide Study

The original QUASIMS study was conducted in German speaking countries (Germany, Austria and Switzerland). The data presented included patients from Slovakia, Greece, Italy, Brazil, BeNeLux and Australia.

"The results of the QUASIMS study are crucial in advancing our understanding of how to best manage relapsing-remitting MS over the long-term," said Professor Volker Limmroth, neurologist at the University of Essen in Germany and primary investigator for the QUASIMS study. "These results suggest that higher doses and frequencies of interferon beta may not necessarily be better when you take into account the comparable disease progression as assessed by the Expanded Disability Status Scale (EDSS(1)) and the fact that patients treated with AVONEX(r) could have significant advantages in the long term due to this treatment's low incidence of neutralizing antibodies (NAbs) and its once-weekly dosing, which encourages better long term adherence to therapy".

The results from Italy and the BeNeLux countries were presented independently.

QUASIMS Results from Italy

Alessandra Lugaresi, Professor and Director of the MS Clinic of "Gabriele d' Annunzio" University in Chieti, presented the QUASIMS results from Italy.

32 Multiple Sclerosis Centers completed an adapted QUASIMS questionnaire from the records of 898 Italian patients with relapsing remitting multiple sclerosis. The study collected data on pre-treatment patient characteristics and examined the course of disease in patients treated with each of the four treatment options. The study showed no significant differences in pre-treatment characteristics of patients treated with any of these, be it either in the rate of MS attacks (relapses) or the development of permanent disability, as observed in the first 2 years of treatment amongst the 4 groups.

QUASIMS Results from BeNeLux

Guy Nagels, Neurologist at the University Hospital in Antwerp, and at the National MS Center in Melsbroek, Belgium presented the QUASIMS results from Belgium, Netherlands and Luxembourg.

The BeNeLux centers used the QUASIMS questionnaire to collect data on 589 patients with relapsing remitting MS. No significant differences in pre-treatment characteristics, relapse rate or the development of permanent disability were demonstrated between treatment groups in the study.

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QUASIMS: Largest investigation of the efficacy of Interferon beta preparations

Interferon beta preparations are widely used as first-line treatment for patients with relapsing remitting multiple sclerosis. In clinical studies they have been shown to reduce relapse rates and increase the time to disease progression by approximately one third. The QUASIMS study evaluated a total of 7,156 patients with relapsing remitting MS who received interferon beta treatment for at least two years without interruption. QUASIMS is an open-label, retrospective, four-arm, multi-center, observational study that originated in Germany, Austria, and Switzerland and expanded to other countries. Patients who received uninterrupted treatment with either 30 mcg 1x/wk, AVONEX (R), 250 mcg every other day Betaferon(R), 22 mcg 3x/wk Rebif (R)or 44 mcg 3x/wk Rebif(R), were included.

Patients who received one or more disease-modifying treatments for less than 2 years, who then subsequently received one of the 4 IFN betas uninterrupted for 2 years are referred to as the "follow-up group". Individual case report forms were completed for each patient and evaluated by an independent research organization. Pre-planned outcome measures included change from baseline EDSS(1) over 1 and 2 years and the proportion of relapse-free patients at 2 years.

QUASIMS - Study results

At the start of the global QUASIMS study, patients in the four different treatment arms had mean EDSS scores of 2.52 (AVONEX(R)), 2.90 (Betaferon(R)), 2.44 (Rebif (R)22), and 2.65 (Rebif(R) 44). The study found that after two years of treatment the change from baseline in the EDSS was 0.13 (AVONEX(R)), 0.26 (Betaferon(R)), 0.16 (Rebif(R) 22) and 0.22 (Rebif(R) 44). In measuring relapse, the study showed that the percentage of patients who were relapse-free after two years was 48% (AVONEX(R)), 47% (Betaferon(R)), 44% (Rebif (R)22), and 39% (Rebif(R) 44).

In the follow-up group, the percentage of relapse-free patients at 2 years was 36.4% (AVONEX(R)), 42.1% (Betaferon(R)), 36.9% (Rebif(R) 22), and 33.8% (Rebif(R) 44).

Efficacy, as measured in this study, was similar among patients treated with the 4 different IFN beta preparations in different countries, and switching between different IFN beta preparations did not appear to provide any additional benefit.

About Multiple Sclerosis (MS)

MS is a chronic disease of the central nervous system that affects approximately 2 million people worldwide. It is a disease of young adults, mostly women, with onset typically between 20 and 40 years of age. Symptoms of MS may include vision problems, loss of balance, numbness, difficulty walking and paralysis.

About Biogen Idec

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(1) Footnote

The Expanded Disability Status Scale (EDSS) is one of the most widely used rating systems for judging the clinical status of people with MS based on their daily activity/function levels. Here are some of the scores from the EDSS and what they represent:

0.0 Normal neurological exam 1.0-1.5 No disability but with some abnormal signs on the neurological exam 2.0-3.5 Minimal disability is present but able to walk unrestricted 4.0-5.5 Increased limitation in walking ability without aid or rest 6.0 Needs a single cane, crutch, or brace in order to walk 6.5 Needs two canes, two crutches, or two braces in order to walk 7.0-7.5 May be able to take a few steps but needs a wheelchair for mobility 8.0 Not able to walk; restricted to wheelchair 8.5-9.5 Restricted to bed 10.0 Death due to MS Adapted from Kurtzke J.F. Neurology 1983 331 1444-1452

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