Posted on 12/27/2004 6:26:19 PM PST by Coleus
Nurse on cutting edge of treatment for MS
Saturday, December 4, 2004
A 41-year-old Dumont man on Friday became one of the first in the nation to receive a recently approved drug that is expected to offer new hope to many multiple sclerosis patients.
The medication, Tysabri, was approved by the federal Food and Drug Administration on Nov. 23, after just one year of clinical trials, because of its effectiveness in reducing the flare-ups of multiple sclerosis, while producing few side effects.
"I'm looking at this as an early Christmas present,'' said Joe Giles, a nurse and director of critical care services at Holy Name Hospital, who was diagnosed with multiple sclerosis three years ago. "We'll see what happens.''
Giles received an infusion of the drug intravenously on Friday morning at the Teaneck hospital, where the Multiple Sclerosis Comprehensive Care Center is a participant in two studies that led to the drug's approval. One has since been completed, and the other will continue, as part of the FDA's conditions for approval of the medication.
The drug is manufactured by Biogen Idec Inc. of Boston and the Elan Corp. of Ireland.
Multiple sclerosis is a chronic, often disabling disease of the brain and spinal cord that affects about 400,000 people in the United States, including nearly 5,000 in northern New Jersey.
The new medication, delivered monthly through an infusion, is expected to be popular as a first-line treatment for new patients as well as existing patients who've stopped treatment because they don't like needle sticks. The existing drugs require injections as frequently as once a day.
"We've had a couple of hundred calls about it," said June Halper, executive director of the hospital's MS center, as well as of the New Jersey Multiple Sclerosis Network. After Tysabri's approval by the FDA, the hospital set up a hot line to handle inquiries.
Halper has faxed prescriptions for 20 patients to Biogen and expects that number will double, she said. Biogen deals directly with insurance companies for pre-certification on behalf of the patients.
The annual cost of Tysabri will be $23,500, most of which will be covered by insurance, the manufacturer hopes.
"Our initial feedback from the payers is that they recognize the therapeutic value and will pay for it. We don't see copayment as a huge issue." said Amy Brockelman, a spokeswoman for Biogen.
The patient copayment should be the same for Tysabri as for the other drugs used in multiple sclerosis treatment: Avonex, Betaseron, Copaxone and Rebif. Annual costs for those medications range from $14,000 to $17,500.
Using the new drug will require monthly trips to the hospital, because it is administered through an intravenous infusion.
"At least for the first year, we'll do it here," said Dr. Mary Ann Picone, medical director of the MS Center. During the study, clinicians observed that if an adverse reaction occurred, it was more likely during the first or second infusion, she said.
The intravenous drip takes about one hour. "If you feel any itchiness, or a funny feeling, please speak up," the nurse told Giles, as she hooked up his medication on Friday. He did not, and later in the day drove to New Brunswick to pick up his oldest son at Cook College.
The father of three, Giles said he had read about the trials and was optimistic that Tysabri would help his relapsing-remitting form of multiple sclerosis. Until Friday, he had been injecting himself every other day with Betaseron.
Giles was diagnosed with MS after experiencing dizziness, visual disturbances and falls, he said. Since then, he's suffered three or four relapses a year, mostly in the form of painful inflammations of his trigeminal, or facial, nerve.
In the first study of Tysabri's effectiveness, it reduced the frequency of relapses by 66 percent, compared with a placebo. Existing drugs on the market reduce relapses by about one-third.
In the second trial, Tysabri was tried in combination with Avonex on patients who had experienced one or more relapses while on Avonex. Tysabri in combination with Avonex reduced the relapses by 54 percent, compared to a placebo with Avonex.
"That is huge," said Halper.
An additional study of Tysabri in combination with Copaxone has been completed, but the results have not yet been released, Brockelman, the Biogen spokeswoman, said. "Clinicians may make the decision to try it in combination with interferon on a patient-by-patient basis," she said.
The FDA required the manufacturer to change the name from Antegren before approval, because it was too close to the names of other drugs on the market. "Abri" is related to the French word for shelter or protection, Brockelman said.
Eight patients at the Holy Name center are participating in the second study, Halper said. Neither the patients nor their caregivers know whether they are receiving the placebo or Tysabri.
When the study is completed in March, they will be informed and provided with Tysabri until their insurance starts to cover it, said Halper. "These people are heroes as far as we're concerned."
Ping of interest to you.
Wonder if this drug has 'cross-over' benefits for those suffering from other diseases or neurological disorders.
Whatever. . .it sounds exciting and I hope it is for all those who currently are diagnosed with this disease.
Because of the nature of MS, attacks and remissions, it is extremely difficult to say a diet or something of that nature has any real effect on the disease. Changes can simply be coincidences in the timing of a remission.
It is much more comforting to say diet or something like that affected the disease because one at least feels as if one's actions are effective, but it is more likely a dream.
My first wife died with MS and my son has the mild form, so I have studied it in great depth.
I pray that this new medication is demonstrably effective.
My wife has MS and the Medication for it is high, but we have good insurance.
She has tried 3 of the 4 listed and has tried a lot of other treatments as well.
ping
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