July 6, 2006
Contact: Tom Cappezzuto
Phone: (973) 972-7273
UMDNJ Researcher Finds Oral Medication Improves
Breathing for Scleroderma Patients
-Study Published in New England Journal of Medicine--
NEWARK - An oral medication improves overall lung function and reduces lung-related inflammation associated with the deadly skin disease scleroderma, says a researcher at the University of Medicine and Dentistry of New Jersey who was part of a national study.
The 12-month, 13-site clinical trial involved 158 patients treated with the drug cyclophosphamide. The oral medication had a modest but significant effect on the lung functions of scleroderma patients stricken with alveolitis, a chronic inflammation of the lung tissue commonly diagnosed in those with systemic scleroderma, said Dr. Vivien M. Hsu, a scleroderma specialist at the UMDNJ-Robert Wood Johnson Medical School in New Brunswick and a principal investigator in the study.
Subjects with dyspnea, or breathlessness due to interstitial lung disease, also felt better after being given daily doses of cyclophosphamide for one year, Dr. Hsu said. The study was published recently (June 22, 2006) in the New England Journal of Medicine.
“We used a double-blind, randomized, placebo-controlled clinical trial to determine the drug’s ability to suppress labored breathing and restrictive lung physiology in these patients,” Dr. Hsu said. “We assessed their pulmonary function every three months to determine their forced vital capacity regarding breathing, and then closely followed the patients for one year thereafter.”
The patients in the study received 2 milligrams per kilogram of body weight each day, or matching placebo, for one year. The forced vital capacity measured in these subjects at the end of two years remained stable in the majority of patients who received cyclophosphamide.
Scleroderma is a rheumatic disease that primarily affects women, and is characterized by skin thickening due to over-production of scar (collagen) and connective tissue. This disease often scars the organs, including the lungs, kidneys, gastro-intestinal tract and heart. Scleroderma frequently can damage the smallest blood vessels leading to further damage of these vital organs.
The cause of the disease is unknown but it is widely regarded by medical experts as an autoimmune disorder. There are no proven drugs that may reverse the damage due to scleroderma-related interstitial lung disease. Different drugs may be used to treat its manifestations, but patients whose vital organs are attacked and adversely affected by scleroderma may die from complications of this unpredictable disease.
UMDNJ is the nation’s largest free-standing public health sciences university with more than 5,500 students attending the state’s three medical schools, its only dental school, a graduate school of biomedical sciences, a school of health related professions, a school of nursing and its only school of public health, on five campuses. Last year, there were more than two million patient visits to UMDNJ facilities and faculty at campuses in Newark, New Brunswick/Piscataway, Scotch Plains, Camden and Stratford. UMDNJ operates University Hospital, a Level 1 Trauma Center in Newark, and University Behavioral HealthCare, a mental health and addiction services network.