Is TYSABRI your best option to start treatment for Multiple Sclerosis (MS)?
TYSABRI PML STATS FOR 2011 As of July 5 2011, there have been 145 reported cases of progressive multifocal leukoencephalopathy (PML) linked to Tysabri (natalizumab). 29 people have died as a result of PML. The drug is generally regarded as highly effective, but is mostly used for patients that have stopped responding to other drugs or have aggressive cases of the disease. Part of the increase in PML is attributed to the fact that more people are passing the 2-year mark for infusions. The risk of PML appears to increase from approximately .01 per 1000 in people receiving 12 infusions or less to more than 2.05 per 1000 in people who have received more than 24 infusions. Biogen is developing a blood test that may better determine the chances of patients contracting PML. The test recently received CE Mark approval in Europe and the companies are conducting large studies of its effectiveness.
WHAT IS TYSABRI? Tysabri (Natalizumab) is a monoclonal antibody, which are antibodies made to target and destroy only certain cells in the body that affect the actions of the body's immune system. This drug is used to treat Multiple Sclerosis (MS) and Crohn’s Disease. This medication was previously named Antegren This drug is thought to restrain white blood cells from getting into the brain and attacking nerves which is believed to result in fewer brain lesions that cause MS symptoms. This drug is for folks who have tried other Disease-Modifying Therapies (DMTs) but did not have a good response, as well as those who are unable to tolerate the other treatments (by this I mean MSers that have side effects which affect their quality of life or have experienced problems with:
A very important note: Tysabri is also indicated for those folks with relapsing forms of MS. What this means is that it’s not indicated specifically for Relapsing & Remitting MS, but for relapsing forms of MS meaning that some folks with progressive forms of MS who still experience relapses may be candidates for this med. Again, only you and your doctor can make these decisions.
HOW IS THIS DRUG ADMINISTERED AND HOW OFTEN Unlike the CRAB (COPAXONE, REBIF, AVONEX, BETASERON) drugs, Tysabri is infused in a doctor’s office or infusion center once a month – every 28 days – to be exact, so there is no injection at home, no storage considerations and you only have to remember to get to the facility once a month. Tysabri can only be given at an infusion center that is registered through the "TOUCH" program. You will be examined by a doctor or nurse and get an MRI before starting the medication and then examined every 3 to 6 months for neurologic changes. You will be asked to review patient safety information and fill out a short survey before each infusion.
MORE ON EFFECTIVENSS AND HISTORY OF THE DRUG Basically, Tysabri is twice as effective as the CRAB (COPAXONE, REBIF, AVONEX, BETASERON) MS drugs in reducing relapses. Studies showed a 68% reduction over two years, as opposed to one-third reduction from the Interferon’s based drugs and Glatiramer Acetate (COPAXONE) The drug has had a rocky history. It was approved fairly quickly in December 2004 and then Biogen Idec and Elan voluntarily pulled it from the market in late February 2005 (Just 3 months after its Food and Drug Administration (FDA) approval). The medication was taken off the market after it was discovered in clinical trials that three patients had developed Progressive Multifocal Leukencephalopathy (PML) - a serious viral infection of the brain that can lead to disability or death. One of the three patients died and the other two cases were non-fatal. The problem was attributed to the patient’s using Tysabri in combination with AVONEX over a 2-year period. In Fall 2005, the drug was resubmitted to the Food and Drug Administration (FDA) for "Priority Status" review. On June 2006, the FDA reapproved Tysabri for use in MS under the condition that all prescribers and infusion centers, as well as patients themselves, be enrolled in the TOUCH Prescribing Program. TOUCH stands for "Tysabri Outreach: Unified Commitment to Health", which involves extensive education of all parties and monitoring of the patients. The bottom line is that the drug is available only to select patients through a restricted-use program (TOUCH Prescribing Program). To receive the medication you must first enroll in this program and meet all requirements. You will be interviewed before receiving each dose to make sure you still meet these requirements.
When considering this treatment for Multiple Sclerosis, you should know that the estimated risk of PML is 1/1000, but is probably lower than that, as the patients who had PML were also taking other immunosuppressants or modulators. Also you should know that this risk is higher if you have a weak immune system or are receiving certain medicines. As of July 5, 2011 the total number of PML cases has increased to 145. You should talk with your doctor if you have:
If you are using any steroid medicines If you have any of these conditions, you may need a dose adjustment or special tests to safely receive this drug to treat your MS. Also you should know that this risk is higher if you have a weak immune system or are receiving certain medicines. It is extremely important that your doctor check you every 3 to 6 months to make sure you are not developing any signs of serious infection. Do not miss any scheduled visits to your doctor.
REPORTED SIDE EFFECTS There is no association in the use of this drug with flu-like symptoms or depression (side effects which are linked to interferon drugs). The side effects associated with Tysabri are:
PROGRESSIVE MULTIFOCAL LEUKOENCEPHALOPATHY (PML) Is the most serious (but rarest) risk for patients taking this medication. It can happen in folks with weakened immune systems. It can cause death or severe disability, but is rare – estimated at 1/1,000 patients.
COMMON SIDE EFFECTS
Around 4% of patients have reported some type of allergic reactions requiring treatment (even hospitalization). The symptoms of this include: hives/itching, chills, dizziness, chest pain, flushing, trouble breathing and low blood pressure. If you’re using Tysabri, you may be more susceptible to infections. You should call your doctor if you show any signs of infection such as fever, chills, sore throat, cough, stuffy nose, redness, pain, swelling, or painful urination. in addition, you should take measures to avoid infections, including good hand washing habits and avoiding people who are sick, when possible. Call your doctor immediately if you develop any symptoms of:
Also if you start experiencing
These symptoms may start gradually and get worse quickly.
ADDITIONAL PRECAUTIONS YOU SHOULD BE AWARE OF Before starting to use this MS treatment, you will be required to stop any disease modifying treatment being used as well as to wait some time after receiving high dose solu-medrol. The time required to wait should be determined by your neurologist but here are some rough guidelines:
It is extremely important that your doctor knows exactly what you are taking before you start using this drug, including all over-the-counter medications and supplements. Do not start taking any medications during your treatment with Tysabri before asking your doctor.
The safety of Tysabri beyond 2 years is unknown.
PREGNANCY AND BREASTFEEDING RECOMMENDATIONS This drug is considered to be in category C which means that it caused some harm to fetuses in animal studies but the effect in humans is unknown. It should not be used by women who are pregnant and should be stopped for some time before trying to conceive (usually one to three months; discuss this with your doctor). Also, this drug should not be used by women who are breastfeeding.
YOUR COST The costs of this drug is about US$ 32,000 dollars a year (check exact prices at DestinationRx plus fees from the infusion center or doctor’s office. According to Elan's website, "Elan and Biogen Idec are committed to making Tysabri accessible to appropriate patients who may benefit from therapy. To achieve this goal, programs have been developed to assist patients who are uninsured or who require financial assistance. Patients who require financial assistance can receive more information by calling MS ActiveSource at 1-800-456-2255 or for more information visit the Tysabri website LATEST NEWS ABOUT TYSABRI Biogen Idec announced at the end of last year (2010), that clinical trials started on a diagnostic test for the JC virus that causes PML. A total of 42 Tysabri patients have been struck with PML, the potentially deadly brain infection. A survey conducted by RBC Capital Markets revealed that around 61% of neurologists surveyed “said the drug would be their first choice if they knew in advance about an individual's PML risk." Keep a close eye on news and developments on Tysabri by subscribing to my blog page
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