Rebif & Influenza Vaccine
"Immune Response to Influenza Vaccine is Maintained in MS Patients Treated With Rebif (interferon beta-1a)"
The Data present show that treatment with Rebif® in patients with multiple sclerosis (MS) does not alter the immune response to influenza vaccination.
Immune response to influenza vaccine was prospectively assessed in an open-label study over a four-week period in a total of 163 patients with MS.
One group of MS patients (n=86) received Rebif® (interferon beta-1a) 44 mcg subcutaneously three times weekly for at least six months before administration of the flu vaccine and continued their Rebif® treatment after the vaccination.
The control group of MS patients (n=77) did not receive interferon treatment within six months prior to study entry and during the study.
Patients of both groups received a single dose of the same influenza vaccine. The data from the two groups were similar on the primary endpoint, defined by the proportion of patients achieving a hemagglutination inhibition (HI) titer >40 four weeks after vaccination, which indicates the ability of patients to mount a positive vaccine response.
More than 90% of the patients in both groups (93% in the Rebif®-treated patients group and 91% in the group of patients receiving no interferon treatment) were able to mount an appropriate immune response.
No new safety concerns regarding the treatment of MS patients with Rebif® were identified. The proportion of patients experiencing a vaccine-related adverse event was similar for both the Rebif®-treated group and the control group. "These results demonstrate that treatment with Rebif® does not alter the immune response to influenza vaccination, and that this vaccination can be performed safely in MS patients who are treated with Rebif®," said Dr. Paul Lammers, Chief Medical Officer of Serono, Inc.
"This news is important for patients treated with Rebif® as vaccination may provide medical benefits to people with MS by preventing an influenza virus infection, and also by possibly avoiding MS exacerbations or worsening of neurologic symptoms due to concurrent viral infection."
The importance of MS patients avoiding viral infections was previously outlined by the Immunization Panel of the MS Council for Clinical Practice Guidelines. The meta-analysis performed by the Panel demonstrated that MS subjects were at increased risk of MS exacerbation during concurrent viral infections. Rebif® is the only approved MS therapy proven in a four-year clinical study in the following three key measures of treatment effectiveness: reducing MRI lesion area and activity[1], reducing relapses and delaying the progression of disability. Rebif® is also supported by eight years of safety and efficacy data.
About Rebif®
Rebif® (interferon beta-1a) is a disease-modifying drug used to treat relapsing forms of multiple sclerosis and is similar to the interferon beta protein produced by the human body. Interferon helps modulate the body's immune system, fight disease and reduce inflammation. Rebif®, which was approved in Europe in 1998 and in the US in 2002, is registered in more than 80 countries worldwide. In the United States, Rebif® is co-marketed by Serono, Inc. and Pfizer Inc. Rebif® has been proven to reduce MRI lesion activity and area[1], reduce the frequency of relapses, and delay the progression of disability.
Rebif® is available in a 22 mcg and 44 mcg ready-to-use pre-filled syringe and can be stored at room temperature for up to 30 days if a refrigerator is not available. Most commonly reported side effects are injection site disorders, flu-like symptoms, 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. The exact relationship of antibody titers to vaccine efficacy was not studied and is not known in patients receiving Rebif®.
About Multiple Sclerosis
Multiple sclerosis is a chronic, inflammatory condition of the nervous system and is the most common, non-traumatic, neurological disease in young adults. Multiple sclerosis may affect approximately two million people worldwide. While symptoms can vary, the most common symptoms of multiple sclerosis include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of multiple sclerosis are the most common.
About Influenza
Influenza is caused by a virus that attacks mainly the upper respiratory tract - the nose, throat and bronchi and rarely also the lungs. The infection usually lasts for about a week. It is characterized by sudden onset of high fever, myalgia, headache, and severe malaise, non-productive cough, sore throat, and rhinitis. Most people recover within one to two weeks without requiring any medical treatment. In the very young, the elderly and people suffering from medical conditions such as lung diseases, diabetes, cancer, kidney, or heart problems, influenza poses a serious risk. In these people, the infection may lead to severe complications of underlying diseases, pneumonia, and death. [1] The exact relationship between MRI findings and the clinical status of patients is unknown.
SOURCE: Serono