Researchers at the University of Nebraska Medical Center were part of
whats being called a landmark international, 23-center study that tested
the safety of the drug natalizumab also known as Antegren. The drug may
benefit those with multiple sclerosis, a neurological disease and Crohns
disease, an intestinal disease.
Its a very promising medication that appears to slow down the disease
more than any of the other medications we have now, said Eliad Culcea,
M.D., UNMC assistant professor of neurology, who was part of the UNMC team.
It showed a significant decrease in the reduction of new lesions in the
brain, which means patients can be functional a longer period of time without
disease symptoms.
Results of the phase II, six-month preliminary study were published
in the Jan. 2 issue of the New England Journal of Medicine. UNMC enrolled
and evaluated some of its multiple sclerosis patients for the study, according
to Kathy Healey, nurse practitioner and coordinator of the study. UNMC
health professionals see 800 to 900 MS patients in its University Medical
Associates clinic.
Multiple sclerosis is a disease of the white matter of the brain and
spinal cord that affects the central nervous system. Symptoms of the disease,
such as weakness, tremors, loss of vision, cognitive changes, depression
and motor problems are episodic, meaning they come and go.
Frequency of symptoms vary patient-to-patient, anywhere from one short
episode a year, up to six-months long. With each flare of symptoms, the
number of brain lesions increase and the disease advances, according to
Mary Filipi, UNMC nurse practitioner who was involved in the study. If
left untreated, half of MS patients become wheelchair dependent within
15 years of disease onset.
Medication manages symptoms and acute attacks. However, the use of current
medications prescribed slow the disease by only 30 to 60 percent, according
to one of the UNMC study group members.
In Crohn’s patients, the study drug increased the rate of remission
and improved the patients’ quality of life.
In the randomized, double-blind trial, researchers studied 213 patients
with whats called relapsingremitting or relapsing secondary progressive
multiple sclerosis. At every 28 days over a six-month period, about one-third
of the patients received 3 mg of intravenous natalizumab per kilogram of
body weight, another third received 6 mg per kilogram and about a third
received placebo every 28 days for 6 months.
Currently, MS patients may receive injections anywhere from once a week
to every day. If this drug turns out to be effective, it would be very,
very helpful for patients to only receive one injection every 28 days,
said Ekaterini Markopoulou, M.D., assistant professor of neurology. If
it turns out that this drug can decrease the disease burden and resulting
disability in the long-term, it would be an important development in the
treatment of MS.
Researchers found marked reductions in the number of new lesions in
both groups receiving the drug: 9.6 per patient in the placebo group, as
compared with 0.7 in the group given 3 mg of the drug and 1.1 in the group
given 6 mg of the drug. Twenty-seven of 71 patients in the placebo
group had relapses, as compared with 13 in the group given 3 mg of natalizumab
and 14 in the group given 6 mg of natalizumab.
The drug, a monoclonal antibody, works by blocking the adhesion of immune
cells to blood vessels and by inhibiting movement of immune cells from
the bloodstream into the brain. The drug is a new class of medication that
prevents inflammation.
The improvement of quality of life is one of the reasons why patients
take their medications, said Mary Filipi, UNMC nurse practitioner, who
also was part of the UNMC team. Wouldnt it be wonderful if patients could,
say, only receive an injection once a month or longer. People tell me they
want to forget they have this disease in between medications.
This is a difficult disease for patients to handle. You dont know
when episodes will hit you, what part of the body it will affect, how hard
it will hit, how long it will stay and how much deficit you will have when
it goes away. A teenaged athlete ended up having to periodically use crutches
because of the debilitating effects of MS. He told me hed rather have
had a stroke because he would then know how he would be from day-to-day.
The uncertainty he felt was heart-wrenching, Filipi said.
The drug companies that funded the study, Elan Pharmaceuticals and Biogen,
expect to seek approval for the drug at the end of 2003 in the United States
and Europe.
In Nebraska, about 110 to 140 cases per 100,000 people will occur, according
to the National Multiple Sclerosis Society. An estimated 1,600 to 1,800
Nebraskans have MS.
Life expectancy for people with MS has steadily improved. In 1890, the
disease was treated with herbs and bedrest, and life expectancy was five
years, according to the NMSS. By 1970, life expectancy rose to about 32
years, and today, people have a normal life expectancy.
Nationwide, it is estimated 250,000 to 350,000 people have multiple
sclerosis, which is often diagnosed between age 20 and 40. It is more common
among caucasians, particularly those of northern European ancestry, and
is more common in women than in men. Some of the potential causes of the
disease are believed to be viruses, as well as environmental, genetic,
and immune system factors.
Researchers say although the study found no major side effects to the
drug, a more extensive phase III study is now underway to study it effectiveness.
Our research team should be congratulated for contributing to such
a high quality international study that brings potentially unique, well-tolerated
and very effective therapy for multiple sclerosis, said Pierre Fayad,
M.D., Reynolds Centennial Professor and chairman of the UNMC Department
of Neurological Sciences.
Besides Drs. Culcea and Markopoulou, Healey and Filipi, other members
of the UNMC research team were: Agapito Lorenzo, M.D., and Sandy Roberts,
nurse. The late Jinan Al-Omaishi, M.D., led the UNMC study.