Friday, August 03, 2007
Landmark Study in The Lancet: Patients Treated With Betaseron(R) After First MS Attack Experienced Significant Delay in MS Progression
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."
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 years.
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.