Area of Demyelination in Cerebellum - MRI scan
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A study released online, in advance of publication in April's issue of The Lancet Neurology, shows the drug daclizumab, added to interferon beta, reduces disease activity of multiple sclerosis (MS) more than interferon beta alone.
Daclizumab is an immunosuppressant that decreases the actions of the body's immune system and is used, mostly, to prevent a body from rejecting transplanted kidneys. Brand name: Zenapax
Interferon Beta, such as what is used in shot forms with the names Avonex and Rebrif, work by preventing inflammation and demyelination in the central nervous system.
The new phase two study, that includes 51 centers in the United States, Canada, Germany, Italy and Spain, took 230 patients that had relapsing MS that were already taking one of the interferon betas. It was a randomized study (radomly selected MS patients) that either received the high-dose daclizumab, a low-dose daclizumab or an inactive placebo. Neither the MS patients, nor the researchers, knew who was receiving what until study was concluded.
The MS patients in the study underwent MRI scans of their brains every four weeks in order to see the number of new or enlarged lesions. Each patient received gadolinium contrast-enhancing injections which helps the MRI only highlight areas of damage by leaking the highlighting contrast agent into the surrounding area of the brain where damage happens.
Study results showed the number of new or enlarged lesions was 1.32 in the high-dose group (2 milligrams/kilogram every two weeks) of 75 patients, 3.58 in the low-dose group (1 milligram/kilogram every four weeks) of 78 patients and 4.75 in the placebo controlled group of 77 patients.
Researchers also found that the levels of CD56bright natural killer (NK) cells were seven to eight times higher in those who received the daclizumab than in the placebo controlled group. CD56bright NK cells are expanded or reduced in a certain number of diseases and interact with T cells during an immune response.
"This study provides confirmatory data that daclizumab treatment causes an expansion of CD56bright natural killer cells and adds support to the theory that expansion of CD56bright natural killer cells might mediate some of the effects of daclizumab on reducing multiple sclerosis lesion activity. In addition to the results of previous trials of daclizumab in multiple sclerosis, several lines of evidence have suggested a potential immunoregulatory function for CD56bright natural killer cells: they are expanded during conditions of natural immune tolerance, for example, pregnancy," the researchers from the Neurovirology Research Laboratory at the VA Medical Center in Salt Lake City which includes John W. Rose M.D., a University of Utah professor of neurology, reported in a news release.
"This randomized controlled trial indicates that daclizumab can reduce new lesion formation in relapsing multiple sclerosis compared with interferon-beta alone," the researchers concluded. "Multiple sclerosis treatments that have the potential to improve in risk-benefit ratios when compared with available treatments are needed; thus, additional studies to define the long-term clinical risks and benefits of daclizumab are warranted."
SOURCES: The Lancet Neurology, news release, Feb. 15, 2010; Heather May sltrib.com/news/ci_14413852;
For more info: For those who live in Lima, Ohio, the Northwestern Ohio MS Chapter can be reached at: Tomahawk Drive at (419) 897-7263. They are located approximately an hour and a half from Lima, Ohio and 45 minutes from Findlay, Ohio. For directions please click here at Google Maps.
Contact The University of Utah School of Medicine • 30 N. 1900 E. Salt Lake City, UT 84132 at 801.581.7201 for any questions.
Generic Name: Daclizumab (da-KLYE-zue-mab) -- Brand Name: Zenapax
Important safety information:
* Daclizumab may cause dizziness or blurred vision. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Daclizumab . Using Daclizumab alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.
* Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Daclizumab .
* Daclizumab may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills.
* Women of childbearing age should use effective birth control methods (eg, condoms, diaphragms, spermicide) before beginning treatment with Daclizumab and continue to use birth control for 4 months after completing therapy.
* Diabetes patients - Daclizumab may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
* LAB TESTS, including complete blood cell counts, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
* Use Daclizumab with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.
* PREGNANCY and BREAST-FEEDING: It is unknown if Daclizumab can cause harm to the fetus. If you become pregnant, discuss with your doctor the benefits and risks of using Daclizumab during pregnancy. It is unknown if Daclizumab is excreted in breast milk. Do not breast-feed while taking Daclizumab .
More Information about daclizumab see here: www.drugs.com/cdi/daclizumab.html
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