Results from a one-year prospective, observational study conducted to determine the impact of beginning treatment with AVONEX on MS patients' overall quality of life (QoL) were announced today. The data showed that patients receiving treatment with AVONEX experienced statistically significant improvements in QoL, as measured by the EuroQol questionnaire (EQ-5D), compared to baseline. In addition, the study demonstrated the negative impact of disability progression (as measured by the expanded disability status scale (EDSS)) on employment status and QoL. These data were presented today as a poster presentation at the 60th American Academy of Neurology annual meeting in Chicago, Illinois.
Led by Dr. Norman Putzki at the University of
Duisburg-Essen, in Essen, Germany, and Professor Hans-Peter Hartung at
Heinrich-Heine University in Dusseldorf, Germany, the prospective,
observational, open label, multicenter study, analyzed 1,157 patients with RRMS,
who had received no immunomodulatory therapy within the preceding 12 months
before beginning the study. Upon commencement of the study, patients received 30
mcg AVONEX once-weekly and were examined at five data-points over a period of 12
months (at study initiation, after three, six, nine and 12 months). Apart from
relapse rate and EDSS scores, QoL was measured by means of EQ-5D, as well as the
participation in training for injection, the influence of injection training on
the therapeutic behavior and further parameters.
The study demonstrates
the importance of treatment with AVONEX in patients with relapsing remitting
multiple sclerosis (RRMS), showing the ability to slow disability progression,
reduce relapses, and improve QoL. The study results also indicated
Over 90 percent of patients felt an improvement or noticed no
reduction in their general health while on AVONEX.
Mean EDSS score remained
practically unchanged over the 12-month treatment period (2.06 at baseline and
2.14 at the 12-month visit; p=0.233).
Injection training and care through a
nurse service was found to improve handling of side effects in nearly 60 percent
"These data reinforce that AVONEX provides patients with the
ability to delay disability progression and shows that effective treatment with
AVONEX may enhance QoL," said Dr. Norman Putzki, primary study author,
Department of Neurology, University of Duisburg-Essen, Germany.
company, we are committed to providing efficacious treatment options such as
AVONEX in an effort to help improve the quality of life of MS patients," said
Thorsten Eickenhorst, MD, Vice President of Medical Affairs at Biogen
AVONEX is the number one prescribed treatment for relapsing forms
of multiple sclerosis (MS) worldwide, and is the only once-a-week MS therapy
that is proven after the first attack. AVONEX is also proven to slow the
progression of physical disability (as shown by 37 percent reduction over two
years) and reduce the number of relapses. Nearly nine out of 10 patients
remained fully functional after five years. AVONEX has been proven effective in
clinical trials for up to three years.
This observational study was
supported by Biogen Idec.
AVONEX is the number
one most prescribed treatment for relapsing forms of MS worldwide, with more
than 130,000 patients on therapy. It was launched in the U.S. in 1996 and later
in Europe for the treatment of relapsing forms of MS to slow the progression of
disability and reduce relapses. AVONEX has been proven effective in clinical
trials for up to three years. AVONEX is marketed internationally in more than 90
countries. AVONEX was the first treatment approved for patients who have their
first clinical MS attack and have a brain MRI scan consistent with MS; this use
was approved in Europe in 2002 and in the U.S. in 2003.
The most common
side effects associated with AVONEX multiple sclerosis treatment are flu-like
symptoms, including myalgia, fever, fatigue, headache, chills, nausea, vomiting,
pain and asthenia.
AVONEX should be used with caution in patients with
depression or other mood disorders and in patients with seizure disorders.
AVONEX should not be used by pregnant women. Patients with cardiac disease
should be closely monitored. Patients should also be monitored for signs of
hepatic injury. Routine periodic blood chemistry and hematology tests are
recommended during treatment with AVONEX. Rare cases of anaphylaxis have been
reported. Please see complete prescribing information available at http://www.AVONEX.com.