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Tysabri 20mg/ml 15ml Vial

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Treatment

The FDA has approved six drugs to treat MS, all injections. They cannot reverse the damage already caused by the disease, but they can help prevent relapses and further damage. In addition, a number of oral drugs can help alleviate some of the symptoms, such as fatigue, bladder infections, constipation, pain, depression, and involuntary jerking movements (spasticity).

The most recently approved MS drug, Tysabri (natalizumab), was licensed by the FDA in November 2004 to reduce the frequency of multiple sclerosis (MS) attacks in people with relapsing forms of MS. In February 2005, the drug manufacturer, Biogen Idec Inc., voluntarily suspended marketing of Tysabri because of two serious adverse events, including one death, reported with its use. A rare brain disease, progressive multifocal leukoencephalopathy (PML), was confirmed in two people with MS who had been taking Tysabri for more than two years.

PML can occur in people whose immune systems are suppressed. It often results in irreversible neurologic deterioration and death. Although the relationship, if any, between Tysabri and PML is not clear, the FDA concurred with the manufacturer that it voluntarily withdraw the drug from the market because of the serious nature of PML. The FDA has also prohibited new clinical trials with Tysabri until more information is available.

No previous cases of PML had been reported in the roughly 3,000 people who took Tysabri in clinical trials. The two people who developed PML were taking the drug in post-marketing studies required by the FDA.

People who were being treated with Tysabri should contact their physicians to discuss other treatments that may be appropriate. The FDA is working with the manufacturer to determine the best methods for assessing those who have received Tysabri in order to assure their safety and understand the connection, if any, between Tysabri and PML.

Four other treatments for people with relapsing MS are approved for lifelong use by the FDA: Avonex, Betaseron, and Rebif (beta interferons), and Copaxone (glatiramer acetate), a synthetic drug. All of these drugs reduce the frequency of MS attacks by influencing the activity of the immune system. In addition, Avonex and Rebif may slow down the rate of physical disability.

Each of the four drugs can be injected by the patient at home and each is used at regular intervals, ranging from once a day to once a week. Common side effects of the three interferon drugs are flu-like symptoms and reactions at the area of injection. Copaxone may trigger a short-term reaction that includes flushing, chest pain, heart palpitations, anxiety, and shortness of breath.

Another drug, Novantrone (mitoxantrone), is approved for people with secondary-progressive MS or those with rapidly worsening relapsing-remitting MS. This IV cancer chemotherapy drug is given in a medical facility. By suppressing the immune system, the drug may reduce new lesions, decrease relapses, and slow down the rate of disability. Because of the serious side effect of heart damage, Novantrone is restricted to use in an individual no more than four times a year for up to three years.

When it comes to choosing a treatment, Reingold says that’s a decision for the patient to make with a physician, taking into account the patient’s goal, quality of life, lifestyle, and insurance coverage, combined with the physician’s perspective on what the best options might be.

“Each of these drugs is different,” says Reingold. “They may be different biological molecules. They are given in different doses, they are given at different frequencies, they have different side effect profiles, and they cost different amounts.

“You may or may not be responsive to one drug,” he adds, “and you may have allergic reactions or side effects to one drug or not to another drug. There’s a certain amount of trial and error. We cannot currently tell at the onset of treatment which drug is going to be best for which people.”

As yet, there are no approved treatments for primary-progressive MS. “The currently available drugs focus their actions on inflammation while the damage at this stage is caused from degeneration and not inflammation,” says Jack Burks, M.D., a clinical professor at the University of Nevada School of Medicine in Reno, and vice president and chief medical officer at the Multiple Sclerosis Association of America (MSAA). “Patients with progressive MS can often benefit from rehabilitation therapies such as exercise, nutritional guidance, and psychological support to increase coping and adapting skills plus deal better with depression. Most people learn to recognize that quality of life is more related to having good relationships and feeling productive than running a 100-yard dash.”

Doctors advise people with all forms of MS to get enough rest, eat healthily, not smoke, and to exercise regularly. “Every person with MS should be on a regular exercise program customized to their level of disability,” says Bourdette. “Several studies of people with MS have demonstrated that exercise will improve fatigue, cardiovascular health, quality of life, and doesn’t make their MS worse.”

Importance of Early Treatment

People who have frequent relapses or whose functioning is severely affected may willingly take one of the injectable drugs approved to treat MS. When symptoms are mild, however, some people are reluctant to go on medication, says Bourdette. But even if a person has just one attack and an abnormal MRI brain scan, “they are at high risk for developing MS,” he says, adding that 80 percent to 90 percent of such people will develop MS within five years. “The goal is to make a definite diagnosis as early as possible and go on therapy.”

Even without symptoms, “the disease marches on,” adds McDermott, noting that studies involving MRIs of the brain of MS patients have shown new lesions forming even when relapses are not occurring. “I’ve seen patients who say, ‘I had a mild attack five years ago and I don’t need to be on medication–I’m feeling great.’ But the MRI shows a couple new spots, indicating areas of demyelination.” It’s like hypertension, says McDermott. “You can’t feel high blood pressure, but the damage goes on every day.”

The patients taking a placebo in clinical trials in MS “never caught up to the functioning of the patients treated with immune therapies from the beginning,” says Burks. “What is lost is gone forever.”

Harriet Fridkin, 62, knows this all too well. Fridkin knew that something was wrong in 1971, at age 29, when she couldn’t hold a drinking glass and her knees buckled under her. She was diagnosed with an orthopedic problem and the symptoms went away after her doctor prescribed several anti-inflammatory drugs. Six years later, Fridkin developed optic neuritis, which cleared up with steroid treatment. It wasn’t until 1980, when she was taken by ambulance to a hospital with vomiting, vision problems, and loss of balance, that Fridkin was diagnosed with MS. Treatments at that time were limited and Fridkin was told to “forget about it–you might never get another attack.”

When the first interferon drug for MS was approved in 1993, Fridkin’s doctor didn’t recommend it for her. Looking back, Fridkin believes that earlier treatment may have changed the course of her disease, now in a progressive state. “On a good day, I can move my left arm,” says Fridkin, who is confined to a wheelchair.

“Make sure you get help early and are proactive,” Fridkin advises people with symptoms, even mild ones. “If a doctor tells you there’s nothing you can do, don’t be afraid to get a second opinion. Read about the disease, educate yourself, and ask questions.”

Fridkin also stresses the importance of exercise but cautions not to overexert. “Don’t exercise until you overheat and are tired,” she says, “because with MS, you don’t recover as fast.” Exercising for short periods, more frequently, is less fatiguing, she says.

Drawing on the experiences of people who have had the disease for a long time can also be helpful, says Fridkin. “Join a support group and listen to what others say.” Local support groups and other assistance are available through the NMSS and the MSAA.

Ferko says she is pleased with her quality of life right now. “I haven’t been that significantly affected in comparison to many other patients,” she says, adding that planning is important. Knowing that early in the day is better for her than afternoons and evenings, Ferko does her physical activities, like grocery shopping, in the mornings and does activities that she can sit down for in the afternoon. “Once you understand your symptoms and how it works in you, you have to modify things a little.

“And one of the most important things you can do is to find a doctor who specializes in MS,” Ferko advises. “It made the difference for me.”

Future of MS Treatment

Researchers continue to work toward a better understanding of MS and to find safe and effective treatments for all forms of the disease. Current drugs can curtail relapses, but they don’t stop the body’s attack on its immune system or the degenerative aspect of MS in the more advanced stages. “A major research focus on neuroprotection to stop the degeneration is underway,” says Burks.

Another area of research centers on finding agents that not only stop the damage but also repair it, says Reingold. “We need to learn how to reverse the damage that has been done, and hopefully, to improve functioning on a day-to-day basis for people with MS.” Researchers are studying the repair and regeneration of the myelin coating on nerve fibers that is destroyed by MS. “Myelin does repair itself,” says Reingold, but myelin repair is then subject to myelin damage in a person with MS whose immune system is launching an attack.

Repairing damage from MS remains a hope for the future, but in the short term, Reingold says, “The general consensus is that no single therapy is going to prove completely efficacious for MS. We need to focus on safety and efficacy of combination therapies and try to capitalize on multiple modes of action.” Reingold expects to see more studies that combine drugs with different modes of action, and is encouraged by the explosion of clinical trials. “There are more clinical trials for more new drugs to be used on MS going on right now than ever before in history.”


FDA-Approved Drugs for the Treatment of Multiple Sclerosis

Brand Name Generic Name Manufacturer/ Distributor and Year of FDA Approval Indication (From FDA-Approved Labeling) Frequency of Injection
Betaseron interferon beta-1b Berlex Laboratories Inc., 1993 Relapsing forms of MS Every other day
Avonex interferon beta-1a Biogen Idec, 1996 Relapsing forms of MS Once a week
Copaxone glatiramer acetate TEVA Neuroscience Inc., 1996 Relapsing forms of MS Every day
Novantrone mitoxantrone Serono Inc., 2000 Worsening relapsing-remitting MS and progressive-relapsing or secondary-progressive MS Four times a year; lifetime limit of 8�12 doses
Rebif interferon beta-1a Serono Inc., 2002 Relapsing forms of MS Three times a week
Tysabri natalizumab Biogen Idec and Elan, 2004; marketing suspended Feb. 28, 2005, due to reports of two serious adverse events Relapsing forms of MS Every four weeks
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