Neura.net: Perspectives on CNS Disease Management

New formulation of subcutaneous interferon (Rebif^�). A new formulation of subcutaneous interferon has been created to make the drug more tolerable, with fewer injection-site reactions and less risk of developing antibodies than the former version. These are considerations when choosing an MS therapy. A clinical study confirmed that patients who received this new formulation for 16 weeks had significantly less disease activity as assessed by magnetic resonance imaging (MRI) than patients who received placebo. The formulation is used in Europe and Canada, and is expected to be available in the United States in 2009.
Thinner needles for glatiramer acetate (Copaxone^�), interferon (Betaseron^�), and intramuscular interferon (Avonex^�). The use of new, thinner needles may reduce the discomfort that can occur with the injection of DMT. A survey of people with MS found that 77% preferred a new, thinner needle for their injection of glatiramer acetate to the previous, larger needle. A new needle introduced for the injection of interferon is the thinnest subcutaneous needle for use with an MS DMT. In a clinical study, a thinner needle for injecting intramuscular interferon also received favorable reviews from patients, who reported less pain and greater ease of use than with the standard needle.
Optimal doses of glatiramer acetate and interferon The current doses of glatiramer acetate and interferon have been confirmed as optimal in recent studies. Studies of glatiramer acetate found that doubling the dose from the current 20 mg to 40 mg did not offer any additional advantages in terms of benefiting clinical symptoms or findings on MRI. Similarly, a study found that the usual dose of interferon was as effective as a dose. This study also included an arm of patients who received glatiramer acetate for comparison purposes; the study results indicated that the efficacy of glatiramer acetate was equivalent to that of either dose of interferon
Longer-acting intramuscular interferon being studied. A new, longer-acting version of intramuscular interferon is being evaluated in clinical trials. This formulation is being evaluated as an injection regimen once every 2 weeks or once per month vs the current once weekly regimen. Benefits and risks of natalizumab (Tysabri�). Natalizumab was recently shown to sustain improvements in physical disability compared to placebo in patients treated for 2 years. This is the first evidence that natalizumab can improve physical function, as well as slowing or preventing the progression of disability. Of potential concern, however, is a new report of 2 people with MS who developed progressive multifocal leukoencephalopathy (PML) while taking natalizumab. PML occurs when a virus that is carried by most people becomes reactivated. The virus is usually harmless, except in people with lowered immune defenses. A total of 5 people with MS have contracted PML since natalizumab returned to the market in 2006. It was previously withdrawn from the market in 2005 after 3 patients developed PML. To date, approximately 53,000 patients have been treated with natalizumab.
Need for cardiac monitoring with mitoxantrone (Novantrone^�). The US Food and Drug Administration (FDA) has issued an alert about the importance of monitoring cardiac function in patients being treated with mitoxantrone. In 2005, the FDA began requiring that patients undergo evaluations of cardiac function before starting mitoxantrone for the first time, and then prior to receiving each subsequent dose. A new requirement states that patients should also undergo cardiac assessments on a yearly basis after completing treatment with mitoxantrone.