Bayer Presents New Data on BETASERON® (interferon beta-1b) at ECTRIMS 2015
WHIPPANY, N.J., Oct. 9, 2015 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. announced today that new research studying BETASERON® (interferon beta-1b) will be presented at the 31st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), October 7 – 10 in Barcelona, Spain.
Additional analyses from the BENEFIT 11 year follow-up study, which analyzed the long-term effects of early treatment with interferon beta-1b, will be presented. Specifically, these data will include magnetic resonance imaging (MRI), optical coherence tomography and cognition results. New data further evaluating the relationship between Vitamin D and irreversible brain tissue damage in patients with clinically isolated syndrome (CIS) from the BENEFIT-5 trial, will also be presented. In addition, findings from the CogniPlus study, which assessed cognitive performance with physical activity in patients with relapsing-remitting multiple sclerosis (RRMS) treated with interferon beta-1b, will be presented.
"We are continuing to add to the body of evidence supporting interferon beta-1b, and we remain steadfastly committed to uncovering new insights into relapsing-remitting multiple sclerosis," said Dario Mirski, M.D., Bayer's vice president and head of U.S. Medical Affairs.
Notable studies evaluating interferon beta-1b from Bayer at ECTRIMS 2015 are listed below:
- Impact of early treatment of MS with interferon beta-1b: Cognitive outcomes at the 11-year follow-up of BENEFIT (BENEFIT 11)
- Poster Session I
- Thursday, October 8 at 3:45-5:00PM (ET)
- MRI results in patients with CIS treated with interferon beta-1b: 11-year follow up in BENEFIT (BENEFIT 11)
- Poster Session I
- Thursday, October 8 at 3:45-5:00PM (ET)
- Optical coherence tomography and ophthalmological findings in patients with CIS treated with interferon beta-1b: 11-year follow-up in BENEFIT (BENEFIT 11)
- Poster Session I
- Thursday, October 8 at 3:45-5:00PM (ET)
- Predicting conversion to clinically definite multiple sclerosis using machine learning on the basis of cerebral grey matter segmentations (BENEFIT)
- Poster Session II
- Friday, October 9 at 3:30-5:00PM (ET)
- Vitamin D and the development and evolution of permanent black holes among patients with clinically isolated syndrome
- Poster Session II
- Friday, October 9 at 3:30-5:00PM (ET)
- Relation between Cognitive function and Physical activity in multiple sclerosis patients treated with interferon beta-1b – The CogniPlus study
- Poster Session II
- Friday, October 9 at 3:30-5:00PM (ET)
About interferon beta-1b
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.
Important Safety Information
Contraindications. Interferon beta-1b is contraindicated in patients with a history of hypersensitivity to natural or recombinant interferon beta, Albumin (Human), mannitol, or any other component of the formulation.
Hepatic Injury. Severe hepatic injury including cases of hepatic failure has been rarely reported in patients taking interferon beta-1b. Consider the potential risk of interferon beta-1b used in combination with known hepatotoxic drugs or other products (e.g., alcohol). Monitor liver function tests and monitor for signs and symptoms of hepatic injury. Consider discontinuing interferon beta-1b if serum transaminase levels significantly increase, or if they are associated with clinical symptoms such as jaundice.
Anaphylaxis and Other Allergic-Reactions. Anaphylaxis has been reported as a rare complication of interferon beta-1b use. Other allergic reactions have included dyspnea, bronchospasm, tongue edema, skin rash and urticaria. Discontinue interferon beta-1b if anaphylaxis occurs.
Depression and Suicide. Depression and suicide have been reported to occur with increased frequency in patients receiving interferon compounds, including interferon beta-1b. Patients treated with interferon beta-1b should be advised to report immediately any symptoms of depression and/or suicidal ideation. Consider discontinuation of interferon beta-1b if depression occurs.
Congestive Heart Failure. Monitor patients with pre-existing congestive heart failure (CHF) for worsening of their cardiac condition during initiation of and continued treatment with interferon beta-1b. Consider discontinuation of interferon beta-1b if worsening of CHF occurs with no other etiology.
Injection Site Necrosis and Reactions. Injection site reactions occurred in 78% of interferon beta-1b patients receiving interferon beta-1b (compared to 26% on placebo) in controlled clinical trials with injection site necrosis reported in 4% of interferon beta-1b patients (compared to 0% on placebo). For patients who continue interferon beta-1b after injection site necrosis has occurred, interferon beta-1b should not be administered into the affected area until it is fully healed. If multiple lesions occur, therapy should be discontinued until healing occurs. Patients should be advised of the importance of the use of aseptic technique and rotating injection sites.
Leukopenia. Leukopenia has been reported in 18% of patients receiving interferon beta-1b (compared to 6% on placebo) in controlled clinical trials leading to a reduction in dose in some patients. Monitoring of complete blood and differential white blood cell counts is recommended. Patients with myelosuppression may require more intensive monitoring.
Flu-like Symptom Complex. Flu-like symptom complex for patients on interferon beta-1b was 57% (versus 37% on placebo) in controlled clinical trials. Analgesics and/or antipyretics on treatment days may help ameliorate flu-like symptoms.
Seizures. Seizures have been temporally associated with the use of beta interferons.
Monitoring for Laboratory Abnormalities. In addition to those laboratory tests normally required for monitoring patients with multiple sclerosis, complete blood and differential white blood cell counts, platelet counts and blood chemistries including liver function tests are recommended at one, three and six months after introduction of interferon beta-1b therapy, and periodically thereafter in the absence of clinical symptoms.
Pregnancy. Patients should be warned of the potential hazard to the fetus. Interferon beta-1b should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Most Common Adverse Reactions. The most commonly reported adverse reactions (at least 5% more frequent on interferon beta-1b than on placebo) in controlled clinical trials were injection site reaction (78% vs 26% for placebo), lymphopenia (86% vs 66%), flu-like symptoms (57% vs 37%), myalgia (23% vs 14%), leukopenia (13% vs 4%), neutropenia (13% vs 5%), increased liver enzymes (SGPT to greater than five times baseline value [12% vs 4%], SGOT to greater than five times baseline value [4% vs 1%]), headache (50% vs 43%), hypertonia (40% vs 33%), pain (42% vs 35%), rash (21% vs 15%), insomnia (21% vs 16%), abdominal pain (16% vs 11%), and asthenia (53% vs 48%).
For full prescribing information visit: http://labeling.bayerhealthcare.com/html/products/pi/Betaseron_PI.pdf.
About RRMS
MS is a chronically inflammatory, incurable and usually intermittent disease of the central nervous system. The most common form of multiple sclerosis is relapsing-remitting MS (RRMS). The symptoms appear suddenly, last a few days, weeks or months, and then diminish to a greater or lesser extent. Out of the 400,000 people living with MS in the United States,[i] approximately 320,000 people are initially diagnosed with RRMS, which is characterized by clearly defined attacks, or exacerbations, of worsening neurologic function.
Bayer: Science For A Better Life
Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2014, the Group employed around 119,000 people and had sales of EUR 42.2 billion. Capital expenditures amounted to EUR 2.5 billion, R&D expenses to EUR 3.6 billion. These figures include those for the high-tech polymers business, which was floated on the stock market as an independent company named Covestro on October 6, 2015. For more information, go to www.bayer.com.
Bayer®, BETASERON® and the Bayer Cross® are registered trademarks of Bayer.
Forward-Looking Statement
This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup 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 Bayer's public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
[i] Multiple Sclerosis (MS). National Multiple Sclerosis Society. Available at http://www.nationalmssociety.org/What-is-MS/Types-of-MS/Relapsing-remitting-MS. Accessed September 16, 2015.
Intended for U.S. Media Only
SOURCE Bayer HealthCare Pharmaceuticals Inc.
Share this article