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Drug Safety and Efficacy Confirmed For Rheumatoid Arthritis

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By News Release • • January 21, 2000

BOSTON, MA -- Hoechst Marion Roussel's, the pharmaceutical company of Hoechst AG, oral disease-modifying rheumatoid arthritis (RA) medication, Arava™ (leflunomide), demonstrated continued efficacy and safety at two years, according to data highlighted today at a press conference held during the American College of Rheumatology annual meeting in Boston. In patients entering a second year of therapy, Arava showed statistically significant improvement at two years in ACR 20 response rates* compared to the active control drug, methotrexate.
Arava, a disease-modifying antirheumatic drug (DMARD), was approved for marketing by the U.S. Food and Drug Administration (FDA) in September 1998 for the treatment of adults with active RA. RA - one of the most common forms of arthritis - is a potentially crippling autoimmune disease that affects more than two million Americans, 70 percent of whom are women.

"These data further support the use of Arava as an effective and safe first-line rheumatoid arthritis therapy," said Dr. Stanley B. Cohen, clinical associate professor, Department of Internal Medicine at Southwestern Medical School. "Two-year prospective, well-controlled safety and efficacy data are rarely seen in the RA treatment arena. This study marks an advancement in RA research as it is one of the longest controlled trials ever conducted comparing methotrexate - a standard RA treatment - to a newer RA therapy."

In a one-year, phase III, placebo-controlled trial, 482 patients were given one of three treatments: Arava 20 mg/day after a loading dose of 100 mg/day for three days, placebo (dummy pill), or methotrexate 7.5 mg/week with an increase to 15 mg/week for continued active disease. Sixty percent of the methotrexate patients were increased to 15mg/week during weeks seven through nine. The efficacy and safety of Arava at the one-year primary endpoint was presented at the ACR last year. In a second year continuation of the trial to look for maintained effect at two years, methotrexate dose could be increased as high as 20 mg/week. Two hundred and thirty-five patients continued for a second year of therapy (Arava was compared only to methotrexate because of the predictably small number of patients continuing on placebo).

"The data showed that clinical and radiographic improvement observed with Arava and methotrexate at one year was maintained at two years, providing evidence of the durability and consistency of Arava efficacy and safety," said Dr. Vibeke Strand, clinical associate professor at Stanford University. "Additionally, at two years Arava demonstrated statistically significant improvements in ACR 20 response rates compared to the active control, methotrexate. Disease progression was stabilized with both Arava and methotrexate at two years."

In this same study, improvement in physical function with Arava remained consistent over two years. Improvement was statistically significant compared to methotrexate. This improvement was assessed through a series of validated questionnaires designed to measure patients' functional ability in terms of their ability to conduct daily activities (e.g., walking, eating, dressing, washing) and their function in daily life. These questionnaires included the Health Assessment Questionnaire (HAQ) and the Problem Elicitation Technique (PET).
"Rheumatoid arthritis can have devastating effects on patients' ability to carry out normal daily activities and can severely hinder their independence," said Dr. Peter Tugwell, head of the Department of Medicine, University of Ottawa. "This study shows that patients taking leflunomide exhibited significant improvement in performing these daily activities and this is
maintained over a significant period of time."

In a separate scientific analysis presented at ACR, Arava was assessed to determine the consistency of its effect for slowing RA disease progression. Results from three large multinational, controlled trials were compared and analyzed. Arava consistently retarded the structural damage across all three clinical trials regardless of patient disease duration. The treatment effect was observed at both six months and at one year.

RA is a chronic and often debilitating autoimmune disease in which the body's immune system attacks healthy tissue lining the joints. 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.

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.

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. Before starting treatment with Arava, patients must be fully counseled on the potential for serious risks to the fetus. Pregnancy must be avoided during Arava treatment or prior to the completion of a drug elimination procedure with cholestyramine after Arava treatment. It is recommended that all women of childbearing potential undergo this elimination procedure upon discontinuing Arava as the drug may increase the risk of fetal death or teratogenic effects when administered to a pregnant woman.

If this drug is used during pregnancy or if the patient becomes pregnant when taking this drug, the patient should be apprised of potential hazard to the fetus. In addition, men wishing to father a child should consider discontinuing use of Arava and taking cholestyramine eight grams three times daily for 11 days to minimize any possible risk to the fetus.

Arava was associated with elevations in liver enzymes, primarily ALT and AST, in a significant number of patients in clinical trials. Although these effects were generally reversible with dose reduction or discontinuation of treatment, marked elevations (greater than three times the upper limit of normal) occurred as well. Therefore, at minimum, ALT levels should be measured at the beginning of therapy (baseline) and monitored initially at monthly intervals, then, if stable, at intervals determined by the individual clinical situation. 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.

*American College of Rheumatology's (ACR) criteria for response 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.

Source: Doctor’s Guide

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