Bosentan Effectively Treats Painful Ulcer Condition

Newswise — An effective new treatment exists for the thousands of people who experience painful and disabling open sores on their hands and toes related to a condition known as systemic sclerosis, or scleroderma, according to research presented this week at the American College of Rheumatology Annual Scientific Meeting in Orlando, Florida.

A double-blind, placebo-controlled study of 122 scleroderma patients who had a history of open sores on their fingers or toes (known as digital ulcers) within the previous year was conducted in 14 centers in North America and Europe. Investigators wanted to know if blocking endothelin, a potent constrictor of blood vessels, would reduce these painful lesions. Patients received an oral dose of either bosentan or placebo for 16 weeks, and were monitored for changes in the total number of digital ulcers from the start of treatment to the end of the study period. In addition, an assessment was made of various functions of the hands, such as dressing, grooming, hygiene and grip, which are all important to a patient's quality of life. At the conclusion of the study, investigators found that patients on bosentan developed fewer digital ulcers than those on placebo. In addition, patients treated with bosentan showed improvement in all aspects of hand functionality.

Systemic sclerosis is a chronic autoimmune disease characterized by changes in the skin, blood vessels, skeletal muscles, and internal organs. About 150,000 Americans have the disease. Digital ulcers are a common complication of scleroderma, occurring in 25% or more of patients.

"Ulcers on the hands are a major cause of pain and functional disability for patients with systemic sclerosis. They also affect some patients' ability to work," said Carol Black MD, Royal Free Hospital, London, England, and lead investigator in the study. "In this trial, bosentan has been shown to reduce this ulcer burden. This is an important step towards improved treatment for our patients. "

The American College of Rheumatology is the professional organization for rheumatologists and health professionals who share a dedication to healing, preventing disability and curing arthritis and related rheumatic and musculoskeletal diseases. For more information on the ACR's annual meeting, see http://www.rheumatology.org/annual.