Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression

Aug 02, 2007, 01:00 ET from Bayer HealthCare Pharmaceuticals

    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
 468 patients.
     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."
     About BENEFIT
     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
     About MS
     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.
     About Betaseron
     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