Merck Serono, the biopharmaceutical division of Merck, recognizes World MS Day, announcing the launch of its updated electronic injection device, RebiSmart®, for the self-administration of Rebif®(interferon beta-1a), the company's disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS).
The new RebiSmart will allow patients to self-inject. It will collect and store data such as injection times, dates and doses and send the information wirelessly to the secure MSdialog server. It is just a matter of placing the new RebiSmart in its transmitter and pressing a button.
Together with the new RebiSmart, Merck Serono is also launching a new first-of-its-kind web-based software system, MSdialog, which allows patients with MS to engage in the management of their disease by asking them to complete periodic health report questionnaires based on short forms of published instruments and standard scales, such as the Multiple Sclerosis Quality of Life Inventory (MSQLI) and the Multiple Sclerosis International Quality of Life (MusiQoL) questionnaires. In addition, MSdialog will allow physicians and nurses to monitor patients' adherence to treatment and trends of their health status through the periodic health report questionnaires.
"Engaging and empowering patients through knowledge and technology may have the potential to improve outcomes by allowing patients to help monitor their own disease," said Dr. Gavin Giovannoni, professor of Neurology at Barts and The London School of Medicine and Dentistry. "The new RebiSmart and the MSdialog platform can provide physicians with access to certain treatment information as it happens, allowing for time during visits to discuss relevant, patient-specific issues. And patients using these technologies may be more in touch with their own disease."
Patients who use MSdialog can choose to receive email or SMS reminders to take their medication, and along with their nurses they can use MSdialog in between visits to their doctor to track the adherence and patient-reported outcomes. This information can save time for more patient-physician interaction during visits.
"Over the years, Merck Serono has continuously worked on enhancing our product profile, taking advantage of the latest medical and technological advances to ultimately meet patient needs," said Belen Garijo, President and CEO of Merck Serono. "With the introduction of MSdialog, we are now leveraging digital technology to offer patients with MS a management system that can help them engage in the treatment of their disease and create a more open dialogue with their healthcare team."
RebiSmart was the first injection device in MS that records the date, time and dosage of each injection so that an accurate dosing history can be discussed with a patient, allowing physicians to monitor and improve patient adherence to therapy. The new RebiSmart offers updates to the original device, including a larger screen, new on-screen guide, graphical display of treatment adherence and a transmitter for wireless data transfer.
The new RebiSmart is used with Rebif multidose cartridges, each of which contains one week's worth of medicine. Interactive, on-screen instructions and signals guide patients through the injection process. Individually adjustable comfort settings give patients more flexibility with injection duration and depth, helping minimize discomfort and pain.
The new RebiSmart and MSdialog will be available in May 2014 in the United Kingdom, Ireland, France, Italy, Switzerland, Austria, Finland, Portugal, Germany, Belgium, Canada, Denmark, Luxembourg, Netherlands and Sweden. Further launches will follow. Two strengths of the multidose cartridge - 132 mcg (three doses of 44 mcg) and 66 mcg (three doses of 22 mcg) - were approved by the European Medicines Agency (EMA) in January 2009.
Rebif (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis (MS) and is similar to the interferon beta protein produced by the human body. The efficacy of Rebif in chronic progressive MS has not been established. Interferon beta is thought to help reduce inflammation. The exact mechanism is unknown.
Rebif, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 90 countries worldwide. Rebif has been proven to delay the progression of disability, reduce the frequency of relapses and reduce MRI lesion activity and area*.
Rebif can be administrated with the RebiSmart electronic auto-injection device, or with the RebiDose single-use disposable pen, or the manual multidose injection pen RebiSlide. Rebif can also be administered with the autoinjector Rebiject II or by manual injection using ready-to-use pre-filled syringes. These injection devices are not available in all countries.
In January 2012, the European commission approved the extension of the indication of Rebif in early multiple sclerosis. The extension of the indication of Rebif has not been submitted in the United States.
Rebif should be used with caution in patients with a history of depression, liver disease and seizures. Most commonly reported side effects are flu-like symptoms, injection site disorders, elevation of liver enzymes and blood cell abnormalities. Patients, especially those with depression, seizure disorders, or liver problems, should discuss treatment with Rebif with their doctors.
About multiple sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately two million patients have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.
About Merck Serono
Merck Serono is the biopharmaceutical division of Merck. With headquarters in Darmstadt, Germany, Merck Serono offers leading brands in 150 countries to help patients with cancer, multiple sclerosis, infertility, endocrine and metabolic disorders as well as cardiovascular diseases. In the United States and Canada, EMD Serono operates as a separately incorporated subsidiary of Merck Serono.
Merck Serono discovers, develops, manufactures and markets prescription medicines of both chemical and biological origin in specialist indications. We have an enduring commitment to deliver novel therapies in our core focus areas of neurology, oncology, immuno-oncology and immunology.
For more information, please visit www.merckserono.com.
[*] The exact correlation between MRI findings and the current or future clinical status of patients, including disability progression, is unknown.