If this is not your name, click here.
| | If this is not your name, click here. | | |
| | Contact Us | Order Now | Journals | Bookstore | Register a colleague | | |
| |  Steroid Dosages May Be Decreased When Thalomid Is Added To Crohn's Treatment WARREN, NJ -- November 30, 1999 -- Study results published today in the current edition of Gastroenterology, suggest that the drug Thalomid(R) (thalidomide) may be active in patients suffering from Crohn's disease. Seventy percent of the patients who completed at least five weeks of the twelve-week trial demonstrated a response when treated with thalidomide, with 20 percent of these patients experiencing remission.
Investigators at the Inflammatory Bowel Disease Center at Cedar's Sinai, Los Angeles, evaluated the safety, tolerance and efficacy of low-dose thalidomide (50-100 mg/day) in treating moderate-to-severe, steroid-dependant Crohn's disease, an inflammatory disease of the intestinal tract. During the course of the pilot study, all patients completing 12 weeks of therapy were able to reduce their steroid regimen by greater than or equal to 50 percent, with 44 percent of patients discontinuing steroids entirely. Patient responses were measured using the Crohn's Disease Activity Index (CDAI). The side effects reported were mild and mostly transient, including drowsiness, peripheral neuropathy, edema and dermatitis. Celgene Corporation's Thalomid (R) (thalidomide) was recently awarded orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of Crohn's disease. This designation affords seven years of marketing exclusivity following FDA approval of the indication. "We are very encouraged by these findings and their publication," said Dr. Sol Barer, chief operating officer of Celgene Corporation." This represents another important milestone in our continuing effort to develop Thalomid as a treatment option for several serious and debilitating diseases. " The December issue of Gastroenterology also reports similar results from a second study on thalidomide therapy for Crohn's disease, conducted by researchers at the University of Chicago, Pritzker School of Medicine and the University of Toronto. There are approximately 200,000 people in the United States who have moderate to severe Crohn's disease, with approximately 5000-10,000 new cases diagnosed annually. According to researchers, Crohn's disease tends to run in families and is most common in North America, Europe and Scandanavia, with a greater incidence of the disease in urban and northern environments. Thalidomide is contraindicated in pregnant women and women capable of becoming pregnant. Even a single capsule taken by a pregnant woman can cause severe birth defects or death to an unborn baby. To minimize this risk, only prescribers and pharmacies registered with the System for Thalidomide Education and Prescribing Safety (S.T.E.P.S.) distribution program may prescribe or dispense Thalomid (R) (thalidomide). Other adverse drug reactions known to be associated with thalidomide therapy include: peripheral neuropathy, a common, potentially severe side effect that may be irreversible; drowsiness/somnolence; dizziness/orthostatic hypotension; neutropenia; hypersensitivity reactions; and increased HIV-viral load. Physicians should consult full prescribing information about these and other adverse reactions prior to initiating treatment with Thalomid (R).
Related Link: Thalomid (R) (thalidomide).
|
