WAYNE, N.J., Aug. 2 /PRNewswire/ -- Patients treated with Betaseron(R)
(interferon beta-1b) shortly after their first clinical MS event or
"attack" showed a 40 percent lower risk of developing confirmed disability
progression compared to patients in whom treatment was delayed. The
results-which were fast-tracked and published in The Lancet this
week-provide the first controlled evidence that delaying Betaseron
treatment has an effect on later accumulation of disability, as observed
over the three-year study period. No other MS therapy has demonstrated this
effect in this early patient population.
The BENEFIT study (BEtaseron in Newly Emerging multiple sclerosis For
Initial Treatment), sponsored by Bayer HealthCare, compared Betaseron
treatment initiated after a first clinical event with delayed treatment.
The study was conducted at 98 sites in 20 countries and included a total of
In the study, investigators measured progression of patient disability
using a validated scale called EDSS (Expanded Disability Status Scale)(1)
Disability progression was defined as an increase in a patient's EDSS score
by at least one point that was confirmed after six months. A confirmed
increase by one point in the EDSS scale can be an important and robust
predictor of permanent and severe disability later in the disease.(2)
"This research has important implications for the way we treat MS
because, for the first time, we have controlled data that irrefutably
demonstrates the value of early intervention with effective treatment for
patients," said Dr. Ludwig Kappos, Professor of Neurology and Clinical
Neuroimmunology at the University of Basel, Switzerland and lead
investigator of the BENEFIT study. "These findings support the decision to
actively treat patients at the first clinical sign of MS to delay the
accumulation of disability."
"We now see real hope for changing the course of disease progression
for relapsing MS if people with the disease start an effective treatment
like Betaseron right away, rather than wait for further clinical signs of
MS to occur," said James Simsarian, M.D., Past President of the Consortium
of Multiple Sclerosis Centers (CMSC) and Director of the MS Program at the
Neurology Center of Fairfax in Fairfax, Virginia.
Other key findings of the BENEFIT follow-up study include:
-- Sensitivity analyses confirmed the robustness of the main findings.
-- Development of neutralizing antibodies did not have an impact on
disability-related or relapse-related outcomes in the trial.
-- Betaseron was safe and well-tolerated, with the reporting of adverse
events (AEs) similar to those previously reported for the drug.(3)
-- 90 percent of the patients who entered the follow-up study elected to
receive Betaseron treatment, indicating high patient acceptance of
treatment. In the study, methods that may have helped patients stay on
therapy included: the implementation of dose titration at the start of
treatment, the use of an auto-injector to give the injections and co-
medication with an analgesic in the first weeks of treatment.
"Bayer HealthCare revolutionized the treatment of MS when we introduced
Betaseron as the first disease-modifying treatment," said Darlene Jody,
M.D., Senior Vice President and President of Bayer HealthCare's Specialized
Therapeutics Global Business Unit. "The BENEFIT results have the potential
to again transform the MS treatment paradigm as they provide convincing
evidence that treating patients with Betaseron shortly after the first
clinical event suggestive of MS can delay disability progression."
BENEFIT is a multi-center trial conducted at 98 sites in 20 countries
and included patients presenting with a first clinical episode suggestive
of MS and typical MRI findings. The primary outcome measures were time to
diagnosis of CDMS, time to confirmed EDSS progression and patient reported
Quality of Life outcomes (FAMS-TOI). A total of 468 patients were
randomized to receive either 250 micrograms of Betaseron every other day or
placebo as a subcutaneous injection in a double-blind fashion. The
placebo-controlled treatment period lasted up to 24 months or up to the
time when patients experienced a second attack and were diagnosed with
clinically definite MS. All study participants were then invited to
participate in a follow-up study with Betaseron to prospectively assess the
impact of such early versus delayed treatment with Betaseron on the
long-term course of the disease for a total observation time of five years.
The results reported in The Lancet are from a pre-planned analysis at three
MS is a chronic, progressive disease of the central nervous system and
the likelihood of disability increases the longer someone has MS. Symptoms
of MS vary from person to person and can be unpredictable. They may
include: fatigue or tiredness, dimness of vision in one or both eyes,
weakness of one or both legs, numbness and tingling in the face, arms, legs
and trunk of the body, spasticity (muscle stiffness), dizziness, double
vision, slurred speech and loss of bladder control.
Betaseron (Interferon beta-1b) is indicated for the treatment of
relapsing forms of multiple sclerosis to reduce the frequency of clinical
exacerbations. Patients with multiple sclerosis in whom efficacy has been
demonstrated include patients who have experienced a first clinical episode
and have MRI features consistent with multiple sclerosis.
Betaseron is the only high-dose, high-frequency interferon beta FDA
approved for use in patients after the first attack suggestive MS.
The most commonly reported adverse reactions are lymphopenia,
injection- site reaction, asthenia, flu-like symptom complex, headache and
pain. Gradual dose titration and use of analgesics during treatment
initiation may help reduce flu-like symptoms. Betaseron should be used with
caution in patients with depression. Injection-site necrosis has been
reported in four percent of patients in controlled trials. Patients should
be advised of the importance of rotating injection sites. Female patients
should be warned about the potential risk to pregnancy. Cases of
anaphylaxis have been reported rarely. See "Warnings," "Precautions," and
"Adverse Reactions" sections of full Prescribing Information.
About Bayer HealthCare Pharmaceuticals
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals
unit of Bayer HealthCare LLC, a division of Bayer AG. One of the world's
leading, innovative companies in the healthcare and medical products
industry, Bayer HealthCare combines the global activities of the Animal
Health, Consumer Care, Diabetes Care, and Pharmaceuticals divisions. In the
U.S., Bayer HealthCare Pharmaceuticals comprises the following business
units: Women's Healthcare, Diagnostic Imaging, Specialized Therapeutics,
Hematology/Cardiology and Oncology. The company's aim is to discover and
manufacture products that will improve human health worldwide by
diagnosing, preventing and treating diseases.
This news release contains forward-looking statements based on current
assumptions and forecasts made by Bayer Group management. Various known and
unknown risks, uncertainties and other factors could lead to material
differences between the actual future results, financial situation,
development or performance of the company and the estimates given here.
These factors include those discussed in our public reports filed with the
Frankfurt Stock Exchange and with the U.S. Securities and Exchange
Commission (including Form 20-F). The company assumes no liability
whatsoever to update these forward-looking statements or to conform them to
future events or developments.
1 Kurtzke JF. Rating neurologic impairment in multiple sclerosis: an
expanded disability status scale (EDSS). Neurology 1983; 33: 1444-52.
2 Rio J, Nos C, Tintore M, Tellez N, Galan I, Pelayo R, Comabella M,
Montalban X. Defining the response to interferon-beta in relapsing-
remitting multiple sclerosis patients. Ann Neurol 2006; 59: 344-52.
3 AEs were within the established range as reported in the Betaseron PI.
SOURCE Bayer HealthCare Pharmaceuticals