BIOGEN IDEC : CORRECTING and REPLACING Biogen Idec Reports Positive Data from AVONEX Dose Titration Study at 2011 Annual Meeting of the Consortium of Multiple Sclerosis Centers
06/06/2011| 07:35am US/Eastern
The headline should read: ...AVONEX Dose Titration Study... (sted:
...AVONEX Dose Titraion Study...)
The corrected release reads:
BIOGEN IDEC REPORTS POSITIVE DATA FROM AVONEX DOSE TITRATION STUDY AT
2011 ANNUAL MEETING OF THE CONSORTIUM OF MULTIPLE SCLEROSIS CENTERS
-Data Show that Titrating AVONEX at Initiation of Treatment Reduced
Severity of Flu-like Symptoms-
Idec (NASDAQ: BIIB) today announced the findings from a randomized,
multicenter, dose-blinded clinical trial that evaluated the effect of AVONEX®
(interferon beta-1a) dose titration, or gradual dose escalation, on
flu-like symptoms associated with the therapy. The data demonstrated
that dose titration with AVONEX over three weeks at the initiation of
treatment resulted in a 76 percent reduction in flu-like symptom
severity between pre-injection and the four-six-hour post-injection time
point versus no titration (p<0.001). The study also showed that
titration over six weeks at the initiation of treatment led to a 50
percent reduction in flu-like symptom severity between the same pre- and
post-injection time point versus no titration (p<0.001). These
data were presented at the 2011 Consortium of Multiple Sclerosis Centers
(CMSC) Annual Meeting in Montreal.
"Some physicians have practiced titration in the past based on
experience of improved tolerability at initiation of interferon
treatment; however, there has been limited clinical evidence on the
benefits of dose titration," said Elliot Frohman, M.D., Ph.D., Professor
of Neurology and Neurotherapeutics and of Ophthalmology at UT
Southwestern Medical Center in Dallas, and member of the AVONEX U.S.
advisory board. "We now have robust data showing that people who
initially received titrated doses of AVONEX experienced a reduction in
severity and incidence of flu-like symptoms."
Flu-like symptoms (e.g., fever, chills, headache, muscle aches and
pains, and fatigue) have been shown to occur with interferon treatment,
and physicians currently may employ several different strategies to
alleviate these symptoms. Biogen Idec conducted the AVONEX dose
titration study to help characterize the impact of titration on severity
and incidence of flu-like symptoms.
"AVONEX has been a leading prescribed treatment for multiple sclerosis
for 15 years and continues to provide hope for patients suffering from
this disease," said Aaron Deykin, M.D., Director of Late Stage Neurology
Development at Biogen Idec. "Findings from the dose titration study add
to the real-world efficacy and safety data we have acquired for AVONEX,
and can potentially provide the medical community with additional
knowledge they can use to augment their own clinical experience to guide
their approach to the initiation of AVONEX treatment."
About the Study
An eight-week, randomized, multicenter, dose-blinded study (n=234) was
conducted to evaluate the effect of dose titration on the severity and
incidence of AVONEX-related flu-like symptoms, with a subsequent
two-week follow-up. The primary endpoint of the study was the change in
total flu-like symptoms severity score from pre-injection to the
four-six-hour post-injection time point. Healthy volunteers were
randomized to one of three treatment arms:
Three-week titration, in which AVONEX was started at one-quarter of
the full dose and increased in quarter-dose increments at weekly
intervals over three weeks to full-dose (30 µg); then was administered
at full-dose for the remaining five weeks.
Six-week titration, in which AVONEX was started at one-quarter of the
full dose and increased in quarter-dose increments at biweekly
intervals over six weeks to full-dose (30 µg); then was administered
at full-dose for the remaining two weeks.
No titration, in which the full 30-µg dose was administered weekly for
All subjects received 650 mg of oral acetaminophen within one hour prior
to each AVONEX injection, and then at four-six hours, eight-ten hours
and 12-15 hours post-injection. A total flu-like symptoms score was
calculated based on a 12-point scale, which was the summation of scores
for four individual symptoms: fever, chills, muscle aches and pains, and
fatigue. Secondary endpoints included change in total flu-like symptoms
severity score from pre-injection to the 12-15-hour post-injection time
point over the eight-week treatment period, and incidence (defined as
the percentage of subjects with a ?two-point increase in score between
pre-injection and post-injection) of flu-like symptoms at the four-six-
and 12-15-hour time points.
Results showed that over the treatment period, change in flu-like
symptom severity between pre-injection and the four-six-hour
post-injection time point was reduced by 76 percent with AVONEX
titration over three weeks versus no titration, and by 50 percent with
AVONEX titration over six weeks versus no titration. Over the same
treatment period, change in flu-like symptom severity between
pre-injection and the 12-15-hour post-injection time point was reduced
by 37 percent with AVONEX titration over three weeks versus no titration
and by 32 percent with AVONEX titration over six weeks versus no
The study results also showed that dose titration reduced the incidence
of post-injection flu-like symptoms. Participants in both titration arms
had lower incidence of flu-like symptoms at the four-six-hour
post-injection time point than subjects in the no-titration arm, with a
numerically greater benefit observed with three-week titration (odds
ratio [OR] 0.179; 95% confidence interval [CI] 0.075-0.429; P<0.001)
than six-week titration (OR 0.414; 95% CI 0.194-0.884; P=0.023).
Participants in both titration arms also had lower incidence of flu-like
symptoms at the 12-15-hour post-injection time point than subjects in
the no-titration arm, with a numerically greater benefit observed with
three-week titration (OR 0.469; 95% CI 0.272-0.807; P=0.006) than
six-week titration (OR 0.562; 95% CI 0.338-0.936; P=0.027).
The safety profiles for both titration regimens were similar to the
safety profile for the no titration AVONEX regimen. Side effects
observed in the study were consistent with those outlined in the
existing AVONEX product labeling.
About Biogen Idec
Biogen Idec uses cutting-edge science to discover, develop, manufacture
and market therapies for serious diseases with a focus on neurology,
immunology and hemophilia. Founded in 1978, Biogen Idec is the world's
oldest independent biotechnology company. Patients worldwide benefit
from its leading multiple sclerosis therapies, and the company generates
more than $4 billion in annual revenues. For product labeling, press
releases and additional information about the company, please visit www.biogenidec.com.
AVONEX is one of the most prescribed treatments for relapsing forms of
MS worldwide and has been approved for use in the United States for 15
years. It is used worldwide as a treatment for relapsing forms of MS to
slow the progression of physical disability and reduce relapses. AVONEX
is also approved for patients who have their first clinical episode and
have a brain MRI scan consistent with MS.
The most common side effects associated with AVONEX MS 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.
For information regarding the European Summary of Product
Characteristics visit http://www.ema.europa.eu/ema.
For the complete United States prescribing information, please visit http://www.AVONEX.com.
Kate Weiss, 781-464-3260
Kia Khaleghpour, 781-464-2442
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