Arava Improves Function, Quality-of-Life In Rheumatoid Arthritis Patients
KANSAS CITY, MO. -- September 30, 1999 -- Hoechst Marion Roussel's oral rheumatoid arthritis medication, AravaT (leflunomide), significantly improved physical function and health-related quality-of-life for people with active rheumatoid arthritis, according to a study published in the September issue of Arthritis & Rheumatism.
Arava is a disease-modifying antirheumatic drug (DMARD) that was approved for marketing by the U.S. Food and Drug Administration (FDA) in September 1998 for the treatment of active rheumatoid arthritis (RA) in adults.
Affecting more than two million people a year - 70 percent of whom are women - RA is a chronic and debilitating autoimmune disease in which the body's immune system attacks healthy joint tissue. The disease can lead to pain, deformity and disability that can be permanent. What makes the disease even worse is that it typically affects people in the prime of their lives.
Statistics show approximately 50 percent of all RA patients must stop working within 10 years of diagnosis.
Arava Improved Physical Function and Health-Related Quality-of-Life
The study was a 12-month, phase III, placebo-controlled clinical trial. The researchers randomly assigned 482 rheumatoid arthritis patients to receive 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.
The study demonstrated statistically significant improvement in physical function and health-related quality-of-life with Arava compared to placebo over a 12-month period. Improvement was assessed through a series of validated questionnaires designed to measure patients functional ability and health-related quality-of-life in terms of their ability to conduct daily activities (e.g., walking, eating, dressing, washing), their function in daily life, and their sense of well-being.
Study results showed that patients treated with Arava (leflunomide) experienced significant improvements compared to patients taking placebo in all questionnaires - including the Modified Health Assessment Questionnaire (MHAQ), the Disability Index, and all eight scales of Health Assessment Questionnaire (HAQ), the physical component score and five of eight subscores of the SF-36 health-related quality-of-life questionnaire, and work productivity.
Study results showed that patients treated with Arava experienced significant improvements compared to patients taking methotrexate in a number of assessments - including the MHAQ, the Disability Index, and five of the eight scales of the HAQ and the physical component score and two of the eight subscores of the SF-36.
In addition, the Problem Elicitation Technique (PET) analysis, which allows patients to assess their ability to perform the daily physical activities most important to them, showed that Arava-treated patients significantly improved in their ability to conduct their top five activities compared to patients taking methotrexate or placebo.
Methotrexate, the most commonly used DMARD for rheumatoid arthritis, also significantly improved these aspects of rheumatoid arthritis although improvement was less than that occurring with Arava in a number of the measures.
"Rheumatoid arthritis can have devastating effects on patients' ability to carry out normal daily activities and severely hinder their independence," said Peter Tugwell, M.D., head of the Department of Medicine, University of Ottawa and a lead investigator of the study. "This study shows that patients taking leflunomide exhibited significant progress in performing these daily activities."
Rheumatoid Arthritis: More than Just Sore Joints
In many cases, RA can limit a person's ability to carry out normal daily activities, including cooking, getting dressed or driving a car. Rheumatoid arthritis can be difficult to diagnose because of its subtle and varied symptoms. Symptoms which may indicate RA include: joint swelling, sensation of heat in the joints, limited ability to move certain joints and the appearance of nodules or lumps under the skin. In addition, rheumatoid arthritis patients often complain about overall fatigue and sickness as well as a feeling of persistent joint stiffness in the morning.
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