Monthly Online Magazine
By and For those with
Tables of Contents
This publication is for those who have MS, those who care for that wonderful group of people who have MS and for anyone interested in helping those with MS. We welcome Msers, carers, medical professionals and anyone who has the time to share with us.
The names of those group members who are willing to accept phone contact are listed below.
Garry Starr 6342 3094
Carol Brennan 6341 3170
Delia Thomson 6367 5015
Dulcie Maybury 6341 1686
Janet Freebairn 6342 2141
June& Kevin Sheedy
Kerri Webb 6345 1926
Ross McDonald 6862 5545
Peter &Jenny Mould 63424969
NEW DRUG APPROVED IN US
(Editor’s note) Costs etc would seem to apply to the USA. It would appear this has not been released in Australia at present.
The FDA has approved natalizumab (Tysabri,® formerly known as Antegren) to reduce the frequency of clinical relapses in relapsing forms of MS, creating another new treatment option for individuals with relapsing forms of MS.
The approval was based on results from the first year of two ongoing clinical trials of the drug alone or added to Avonex.® According to the FDA, as part of this approval, the manufacturer has made a commitment to continue their trials of Tysabri for another year.
Tysabri reduced the rate of clinical relapses by up to 66% and reduced the development of new or newly enlarging MRI-detected brain lesions. A greater proportion of those on therapy remained relapse-free.
Tysabri appears to be safe and well tolerated; the most common side effects included headache, fatigue, urinary tract infection, depression, lower respiratory tract infection, joint pain, and abdominal discomfort. There is no information available about long-term safety.
The drug is given by intravenous (into the vein) infusions every 4 weeks in a doctor’s office.
The wholesale price has been announced to be $1,808 per dose ($23,504 per year). There is currently no information about coverage by health insurers, or about the relative benefits or safety of Tysabri in comparison with other currently available treatments for MS.
DETAILS: The U.S. Food and Drug Administration (FDA) has approved natalizumab (Tysabri, formerly known as Antegren) to reduce the frequency of clinical relapses in relapsing forms of multiple sclerosis, based on safety and efficacy demonstrated during the first year of two ongoing clinical trials. Tysabri (Biogen Idec and Elan Corporation) is the sixth drug approved by the FDA for MS, and one that uses a different biological approach than those previously available to fight the disease.
The FDA evaluated data from the first year of two ongoing, two-year trials of Tysabri alone compared with placebo (“AFFIRM” study) or Tysabri added to ongoing Avonex (interferon beta-1a) treatment (“SENTINEL” study) in relapsing-remitting MS. According to information from a press release from Biogen Idec and Elan Corporation, in both trials intravenous (into the vein) infusions of Tysabri every four weeks significantly reduced the rate of clinical relapses, which was the primary outcome established for both trials. Both trials met all secondary outcomes as well, including reducing the development of new or newly enlarging MRI-detected brain lesions, and a greater proportion of those on therapy remained relapse-free. Details of both trials follow.
The full, two-year trials are still collecting data on relapse rates and progression of disability, as measured with the Expanded Disability Status Scale (EDSS), as well as a host of additional outcomes. According to the companies, results of the two-year trials are expected during the first half of 2005.
The Drug: Unlike other drugs that have already been approved for treating MS, Tysabri is a monoclonal antibody that is given every four weeks by infusion into a vein. It is designed to interfere with movement of potentially damaging immune cells from the bloodstream, across the “blood-brain barrier,” and into the brain and spinal cord. Tysabri blocks this movement by attaching to alpha 4-integrin, a protein on the surface of immune T cells that normally enables them to pass through the blood-brain barrier. This approach was initially studied in animal models, including studies supported by the National MS Society, which showed that monoclonal antibodies could block such immune cell movement and ameliorate disease. These animal studies led to the human studies that are now underway.
First-Year Results from AFFIRM Study: The AFFIRM study of Tysabri alone is a placebo-controlled study involving 942 participants worldwide. Participants were randomly assigned to receive either 300 mg IV infusion of Tysabri or inactive placebo every four weeks. Those on active therapy showed a statistically significant, 66% reduction in relapse rate. The annual rate of relapses in the Tysabri group was 0.25 versus 0.74 in the placebo group.
The secondary outcomes for the study were also significantly different for the treatment versus placebo groups. Sixty percent of those on Tysabri developed either no new MRI lesions or no newly enlarging lesions (patches of disease activity), compared to 22 percent of the placebo group. MRI scans taken after the first full year of treatment showed that 96 percent of actively treated participants had no gadolinium-enhancing lesions (lesions that show active inflammation) versus 68 percent of the placebo group. The proportion of participants who remained relapse-free was 76 percent of the treatment group versus 53 percent of the placebo group, which was also statistically significant.
First-Year Results from SENTINEL Study: The SENTINEL study of Tysabri added to Avonex, compared with a placebo plus Avonex, involves 1,171 participants worldwide. For this trial, individuals using Avonex who continued to experience disease activity were randomly assigned to add Tysabri or placebo to their standard Avonex therapy.
The participants who had Tysabri added to Avonex experienced a 54 percent reduction in the rate of clinical relapses compared to those on placebo and Avonex. The annual rate of relapses in the Tysabri plus Avonex group was 0.36, versus 0.78 in the placebo plus Avonex group. MRI scans taken after the first full year of treatment showed that 96 percent of the Tysabri plus Avonex group had no gadolinium-enhancing lesions (lesions that show active inflammation) versus 76 percent of the placebo plus Avonex group. The proportion of participants who remained relapse-free was 67 percent in the Tysabri plus Avonex group, versus 46 percent in the placebo plus Avonex group.
The secondary outcomes for this study were also significantly different for the treatment versus placebo groups. Sixty-seven percent of those in the treatment group developed no new or no newly enlarging MRI lesions, compared to 40 percent of the placebo plus Avonex group. Because the companies submitted an application to the FDA about halfway through the two-year clinical trials, the one-year data are informative but incomplete; the complete set of results from these studies are not yet available.
Safety: The treatment was safe and well tolerated. The most common side effects included headache, fatigue, urinary tract infection, depression, lower respiratory tract infection, joint pain and abdominal discomfort. The overall incidence of infection was similar between those on Tysabri and those on placebo. Serious infections such as bacterial pneumonia and urinary tract infections occurred in 1.3 percent of placebo-treated patients and 2.1 percent of Tysabri-treated patients. Tysabri has been associated with hypersensitivity reactions, including serious systemic reactions, which occurred at an incidence of less than 1 percent of patients.
Availability/Cost: Individuals prescribed Tysabri will receive the drug via IV infusion at a doctor’s office or other medical facility. The wholesale cost per vial has been announced at $1,808 (taken every 4 weeks, the yearly wholesale cost would be $23,504), There is currently no information available about coverage by health plans.
Conclusion: The approval of Tysabri is important news for the MS community. It means another new treatment option for individuals with relapsing forms of MS. Clinical experience with the drug, along with further research, will help shape the decisions about which of the several available drugs will provide optimum benefit to those with relapsing forms of multiple sclerosis.
“The approval of Tysabri is very exciting,” stated National MS Society Chief Medical Officer Dr. Aaron Miller. “The clinical trial results indicate that the drug is very effective in relapsing forms of MS and appears to be well-tolerated. Although the drug appears to be quite safe based on the currently available information, it will be very important to monitor this issue closely as the neurological community gains more experience with Tysabri. People with MS who are interested in Tysabri should discuss their individual situation thoroughly with a neurologist experienced in the care of those affected by the disease.”
In recognition of the serious nature of MS, the FDA accelerated its review of data from the ongoing Tysabri studies and has determined, based on data from the first year of a two-year study, that the drug provided benefit and could be used with relative safety. Data from the clinical studies have not yet been presented publicly to the medical or scientific communities, and the outcomes of the full two-year studies are not available. There will be additional examination of the data by the FDA when they are fully available.
While Tysabri appears to be well tolerated and has a positive benefit/risk assessment from the current information, there is no available information about long-term safety, and no information about the relative benefits or safety of Tysabri in comparison with any other currently available treatments for MS. For more information about Tysabri, individuals with MS are encouraged to consult their neurologists.
The next meeting of the Cowra Support group will be on February 16th 2005 commencing at 12 noon in the Multi Purpose Room at the Cowra Library. Lunch will be $5. Please RSVP to Dulcie as soon as you can on 6341 1686
My experiment with the combination of Copaxone and Imuran would seem to have been a failure due to the side effects I experienced. Consult with your neurologist if you are interested as the side effects I experienced may not apply to you.
Allied Health services now available under Medicare
From 1 July this year, people with complex care needs and chronic conditions such as MS can have up to 5 allied health services per year through their Medicare Card. MS Australia welcomes this initiative, as it recognises that positive health maintenance for people with chronic conditions is much broader than medical intervention.
Through an Enhanced Primary Care Plan created by a GP, a range of allied health services can be obtained, including occupational therapy, dietetics, psychology, speech therapy, podiatry and chiropractic and osteopathy.
People with MS are encouraged to talk to their GP about an Enhanced Primary Care Plan, that can recommend and authorise reputable allied health services.
Reach Gaz by email to comment: firstname.lastname@example.org