{"id":47535,"date":"2003-01-10T00:00:00","date_gmt":"2003-01-10T06:00:00","guid":{"rendered":"https:\/\/www.unmc.edu\/newsroom\/2003\/01\/10\/unmc-researchers-participate-in-new-drug-study-formultiple-sclerosis-crohns-disease-results-published-in-prestigious-newengland-journal-of-medicine\/"},"modified":"2022-08-29T10:46:09","modified_gmt":"2022-08-29T15:46:09","slug":"unmc-researchers-participate-in-new-drug-study-formultiple-sclerosis-crohns-disease-results-published-in-prestigious-newengland-journal-of-medicine","status":"publish","type":"post","link":"https:\/\/www.unmc.edu\/newsroom\/2003\/01\/10\/unmc-researchers-participate-in-new-drug-study-formultiple-sclerosis-crohns-disease-results-published-in-prestigious-newengland-journal-of-medicine\/","title":{"rendered":"UNMC researchers participate in new drug study for\n\nmultiple sclerosis, Crohn’s disease; results published in prestigious New\n\nEngland Journal of Medicine"},"content":{"rendered":"

Researchers at the University of Nebraska Medical Center were part of<\/p>\n

whats being called a landmark international, 23-center study that tested<\/p>\n

the safety of the drug natalizumab also known as Antegren. The drug may<\/p>\n

benefit those with multiple sclerosis, a neurological disease and Crohns<\/p>\n

disease, an intestinal disease.<\/p>\n

Its a very promising medication that appears to slow down the disease<\/p>\n

more than any of the other medications we have now, said Eliad Culcea,<\/p>\n

M.D., UNMC assistant professor of neurology, who was part of the UNMC team.<\/p>\n

It showed a significant decrease in the reduction of new lesions in the<\/p>\n

brain, which means patients can be functional a longer period of time without<\/p>\n

disease symptoms.<\/p>\n

Results of the phase II, six-month preliminary study were published<\/p>\n

in the Jan. 2 issue of the New England Journal of Medicine. UNMC enrolled<\/p>\n

and evaluated some of its multiple sclerosis patients for the study, according<\/p>\n

to Kathy Healey, nurse practitioner and coordinator of the study. UNMC<\/p>\n

health professionals see 800 to 900 MS patients in its University Medical<\/p>\n

Associates clinic.<\/p>\n

Multiple sclerosis is a disease of the white matter of the brain and<\/p>\n

spinal cord that affects the central nervous system. Symptoms of the disease,<\/p>\n

such as weakness, tremors, loss of vision, cognitive changes, depression<\/p>\n

and motor problems are episodic, meaning they come and go.<\/p>\n

Frequency of symptoms vary patient-to-patient, anywhere from one short<\/p>\n

episode a year, up to six-months long. With each flare of symptoms, the<\/p>\n

number of brain lesions increase and the disease advances, according to<\/p>\n

Mary Filipi, UNMC nurse practitioner who was involved in the study. If<\/p>\n

left untreated, half of MS patients become wheelchair dependent within<\/p>\n

15 years of disease onset.<\/p>\n

Medication manages symptoms and acute attacks. However, the use of current<\/p>\n

medications prescribed slow the disease by only 30 to 60 percent, according<\/p>\n

to one of the UNMC study group members.<\/p>\n

In Crohn’s patients, the study drug increased the rate of remission<\/p>\n

and improved the patients’ quality of life.<\/p>\n

In the randomized, double-blind trial, researchers studied 213 patients<\/p>\n

with whats called relapsingremitting or relapsing secondary progressive<\/p>\n

multiple sclerosis. At every 28 days over a six-month period, about one-third<\/p>\n

of the patients received 3 mg of intravenous natalizumab per kilogram of<\/p>\n

body weight, another third received 6 mg per kilogram and about a third<\/p>\n

received placebo every 28 days for 6 months.<\/p>\n

Currently, MS patients may receive injections anywhere from once a week<\/p>\n

to every day. If this drug turns out to be effective, it would be very,<\/p>\n

very helpful for patients to only receive one injection every 28 days,<\/p>\n

said Ekaterini Markopoulou, M.D., assistant professor of neurology. If<\/p>\n

it turns out that this drug can decrease the disease burden and resulting<\/p>\n

disability in the long-term, it would be an important development in the<\/p>\n

treatment of MS.<\/p>\n

Researchers found marked reductions in the number of new lesions in<\/p>\n

both groups receiving the drug: 9.6 per patient in the placebo group, as<\/p>\n

compared with 0.7 in the group given 3 mg of the drug and 1.1 in the group<\/p>\n

given 6 mg of the drug.  Twenty-seven of 71 patients in the placebo<\/p>\n

group had relapses, as compared with 13 in the group given 3 mg of natalizumab<\/p>\n

and 14 in the group given 6 mg of natalizumab.<\/p>\n

The drug, a monoclonal antibody, works by blocking the adhesion of immune<\/p>\n

cells to blood vessels and by inhibiting movement of immune cells from<\/p>\n

the bloodstream into the brain. The drug is a new class of medication that<\/p>\n

prevents inflammation.<\/p>\n

The improvement of quality of life is one of the reasons why patients<\/p>\n

take their medications, said Mary Filipi, UNMC nurse practitioner, who<\/p>\n

also was part of the UNMC team. Wouldnt it be wonderful if patients could,<\/p>\n

say, only receive an injection once a month or longer. People tell me they<\/p>\n

want to forget they have this disease in between medications.<\/p>\n

This is a difficult disease for patients to handle. You dont know<\/p>\n

when episodes will hit you, what part of the body it will affect, how hard<\/p>\n

it will hit, how long it will stay and how much deficit you will have when<\/p>\n

it goes away. A teenaged athlete ended up having to periodically use crutches<\/p>\n

because of the debilitating effects of MS. He told me hed rather have<\/p>\n

had a stroke because he would then know how he would be from day-to-day.<\/p>\n

The uncertainty he felt was heart-wrenching, Filipi said.<\/p>\n

The drug companies that funded the study, Elan Pharmaceuticals and Biogen,<\/p>\n

expect to seek approval for the drug at the end of 2003 in the United States<\/p>\n

and Europe.<\/p>\n

In Nebraska, about 110 to 140 cases per 100,000 people will occur, according<\/p>\n

to the National Multiple Sclerosis Society. An estimated 1,600 to 1,800<\/p>\n

Nebraskans have MS.<\/p>\n

Life expectancy for people with MS has steadily improved. In 1890, the<\/p>\n

disease was treated with herbs and bedrest, and life expectancy was five<\/p>\n

years, according to the NMSS. By 1970, life expectancy rose to about 32<\/p>\n

years, and today, people have a normal life expectancy.<\/p>\n

Nationwide, it is estimated 250,000 to 350,000 people have multiple<\/p>\n

sclerosis, which is often diagnosed between age 20 and 40. It is more common<\/p>\n

among caucasians, particularly those of northern European ancestry, and<\/p>\n

is more common in women than in men. Some of the potential causes of the<\/p>\n

disease are believed to be viruses, as well as environmental, genetic,<\/p>\n

and immune system factors.<\/p>\n

Researchers say although the study found no major side effects to the<\/p>\n

drug, a more extensive phase III study is now underway to study it effectiveness.<\/p>\n

Our research team should be congratulated for contributing to such<\/p>\n

a high quality international study that brings potentially unique, well-tolerated<\/p>\n

and very effective therapy for multiple sclerosis, said Pierre Fayad,<\/p>\n

M.D., Reynolds Centennial Professor and chairman of the UNMC Department<\/p>\n

of Neurological Sciences.<\/p>\n

Besides Drs. Culcea and Markopoulou, Healey and Filipi, other members<\/p>\n

of the UNMC research team were: Agapito Lorenzo, M.D., and Sandy Roberts,<\/p>\n

nurse. The late Jinan Al-Omaishi, M.D., led the UNMC study.<\/p>\n

 <\/p>\npwa eu ZO wZlh<\/a><\/div><\/div>","protected":false},"excerpt":{"rendered":"

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 […]<\/p>\n","protected":false},"author":79,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_relevanssi_hide_post":"","_relevanssi_hide_content":"","_relevanssi_pin_for_all":"","_relevanssi_pin_keywords":"","_relevanssi_unpin_keywords":"","_relevanssi_related_keywords":"","_relevanssi_related_include_ids":"","_relevanssi_related_exclude_ids":"","_relevanssi_related_no_append":"","_relevanssi_related_not_related":"","_relevanssi_related_posts":"","_relevanssi_noindex_reason":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-47535","post","type-post","status-publish","format-standard","hentry","category-uncategorized","department-press-release"],"yoast_head":"\nUNMC researchers participate in new drug study for multiple sclerosis, Crohn's disease; results published in prestigious New England Journal of Medicine<\/title>\n<meta name=\"description\" content=\"Researchers at the University of Nebraska Medical Center were part of whats being called a landmark international, 23-center study that tested the safety\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.unmc.edu\/newsroom\/2003\/01\/10\/unmc-researchers-participate-in-new-drug-study-formultiple-sclerosis-crohns-disease-results-published-in-prestigious-newengland-journal-of-medicine\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"UNMC researchers participate in new drug study for multiple sclerosis, Crohn's disease; 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