News Release
Corporate Communications
330 Brookline Avenue 617 667-443 1
Boston, Massachusetts o22 i -s USA Fax 617 667-4488

Embargoed for Release Until
May 8th, 1998,12 pm EDT
Contact: Kristin Weidenbach (617) 667-1715
Patti Jacobs (617) 667-4431

Antibiotic Minocycline Reverses Disfiguring and Debilitating

Skin Disease Scleroderma

BOSTON, MA -- Taking a twice daily, oral dose of the antibiotic minocycline may be a long-awaited new treatment for the debilitating autoimmune disease scleroderma. The findings from a one year pilot study conducted at Beth Israel Deaconess Medical Center were presented at the 6th Biennial Congress of the International Society for Rheumatic Therapies in Boston, May 6 to 9.

"These results are highly significant," said study leader David Trentham, Beth Israel Deaconess rheumatologist, associate professor of medicine at Harvard Medical School and current president of the society. "We thought the drug would lead to improvement, but to have total clearing of the skin was quite a surprise," he said.

Trentham and his colleagues treated eleven scleroderma patients who were in the early stages of skin disease, with an oral dose of Minocycline. Of the six patients who completed the study, four had complete resolution of disease. The drug was well-tolerated and did not cause any serious side effects. Trentham and his colleagues believe that the impressive results of the pilot study warrant expanded clinical trials.

Physicians do not know exactly what causes scleroderma, but drugs developed for the treatment of rheumatoid arthritis - another connective tissue disease - have been used successfully in some patients. The antibiotic minocycline emerged as a likely drug candidate when it was recently found to effectively treat rheumatoid arthritis patients, with fewer toxic side effects than current drugs such as penicillamine and methotrexate. Rheumatologists do not really know why this antibiotic works, but they do know that it has antiinflammatory properties and it may suppress other components of the mammalian immune system, said Trentham.

Scleroderma afflicts 150,000 people in the United States but there is no universally accepted treatment and physicians do not know what starts the autoimmune processes that characterize the disease. Fibroblasts - fiber-producing cells in the connective tissue - inexplicably go awry, overproducing collagen which is deposited as scar tissue. Patients suffer thickening and tightening of the skin that is disfiguring and restricts movement. In its most severe, systemic form Scleroderma= causes scarring of internal organs including the heart, kidney and lungs that can be fatal. Large clinical trials to test new therapies are difficult to implement due to the rarity of the disease.

The pilot study was funded in part from The Road Back Foundation and a grant from the National Institutes of Health.

Beth Israel Deaconess Medical Center is a major clinical, research, and teaching affiliate of Harvard Medical School.

Beth Israel Deaconess Medical Center, Boston, is a major teaching hospital of Harvard Medical School.
A founding member of CAREGROUP,"' all organized system of quality healthcare serving the individual, family, and community.