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 | | |
| |  Arava Effectively Reduces Symptoms Of Rheumatoid Arthritis SAN DIEGO, CA -- Nov. 9, 1998 -- Hoechst Marion Roussel's new oral rheumatoid arthritis medication, Arava, significantly reduced the signs and symptoms of rheumatoid arthritis (RA), according to a study presented today at the American College of Rheumatology (ACR) annual meeting in San Diego, CA. Arava is a disease-modifying antirheumatic drug (DMARD) that was approved for marketing by the United States Food and Drug Administration (FDA) in September for the treatment of adults with active rheumatoid arthritis. RA is a potentially crippling autoimmune disease that affects more than two million Americans, 70 percent of whom are women. Arava is the first and only drug to be indicated to retard structural damage caused by RA. It also is the first new disease-modifying drug developed specifically for RA in more than a decade. "Rheumatoid arthritis is a serious and debilitating disease with no known cure," said Arthur Weaver, M.D., medical director, Arthritis Center of Nebraska and a lead investigator of the study. "This study confirms that the signs and symptoms of RA were effectively treated by this new DMARD. This study included both patients who had not received a previous DMARD and patients who had failed previous DMARDs." In a 12-month, phase III, placebo-controlled clinical trial, 482 rheumatoid arthritis patients were given one of three treatments: Arava 20 mg/day after a loading dose of 100 mg/day for three days, placebo or methotrexate 7.5 mg/week with an increase to 15 mg/wk for continued active disease. Sixty percent of the methotrexate patients were increased to 15 mg/wk during weeks seven through nine. Arava was statistically significantly superior to placebo and the effect was consistent with the active control drug, methotrexate (41 percent response rate for Arava versus 19 percent for placebo versus 35 percent for methotrexate) in reducing the signs and symptoms of RA as measured by ACR success rate defined as completing 12 months of treatment and ACR response at endpoint. Efficacy was assessed by the American College of Rheumatology's (ACR) criteria for response which include the following: 1) at least a 20 percent improvement in both tender and swollen joint count and 2) at least a 20 percent improvement in three of the following five criteria: patient's assessment of disease activity; investigator's assessment of disease activity; pain intensity; functional/disability measure; and acute phase reactants. Patients treated with Arava began showing improvements as early as one month after treatment initiation and sustained improvement throughout the course of treatment. In fact, a greater percentage of Arava-treated patients were ACR responders overall compared to patients receiving placebo (52 percent for Arava versus 26 percent for placebo versus 46 percent for methotrexate). Additionally, separate results from this same study show that Arava is effective in slowing the progression of RA. Arava is also the first and only drug to be indicated to retard structural joint damage caused by RA. Pregnancy must be excluded before the start of treatment with Arava. Arava is contraindicated in pregnant women, or women of childbearing potential who are not using reliable contraception. Pregnancy must be avoided during Arava treatment or prior to the completion of the drug elimination procedure after Arava treatment. Important hepatic information: Arava is associated with elevations in liver enzymes, primarily ALT and AST, in a significant number of patients. Arava is not recommended in patients with significant hepatic impairment or positive hepatitis B or C serologies given the risk of increased hepatotoxicity. Adverse reactions associated with the use of Arava include diarrhea, elevated liver enzymes (ALT and AST), alopecia and rash. Rheumatoid arthritis is one of the most common forms of arthritis and can be severe. It is a chronic and often debilitating autoimmune disease in which the body's immune system attacks joint tissue, leading to pain and inflammation. Often deformity and disability occur and can be permanent. While the cause of RA is not yet known, genetic predisposition plays a role and hormonal influences and environmental factors such as a bacterial or viral infection may be triggered. RA generally begins with inflammation (for example, redness, warmth and swelling) in the joints, most commonly the wrist and finger joints closest to the hands, but can also affect the elbows, shoulders, neck, jaw, hips, knees, ankles and feet. In some patients, RA can involve internal organs causing serious damage including inflammation of blood vessels, the lung and the lining surrounding the heart. RA can affect people of all ages, but usually begins in middle age.
|
