Magazine article Drug Topics

Hitting RA Head-On

Magazine article Drug Topics

Hitting RA Head-On

Article excerpt

Well-tolerated

arthritis drug

close to FDA

approval

Food & Drug Administration advisory committee recently recommended approval of Arava (leflunomide), a new disease-modifying antirheumatic drug (DMARD). Developed specifically for the treatment of active rheumatoid arthritis (RA) in adults, the drug appears to be in sync with the reconstruction of the once worshiped RA treatment pyramid.

For years, clinicians followed the well-known pyramid scheme calling for initial treatment of this chronic inflammatory autoimmune disorder with nonsteroidal anti-inflammatory drugs (NSAIDs). Use of DMARDsselected immunosuppressive agents (e.g., methotrexate and cyclosporine A) shown to alter the disease process by diminishing the long-term joint destruction-was held off and added only when RA progressed, which was already three to four years into the course of the disease. Since then, researchers have learned that in many RA patients, structural damage to the joints is done by active inflammation in the first few years of the illness. As a result, experts urge the use of DMARDs earlier on in RA.

If approved, leflunomide, manufactured by Hoechst Marion Roussel, will be indicated for retardation of structural damage in RA and for relief of signs and symptoms of the debilitating condition. According to Elaine Waller, Pharm.D., regulatory affairs, HMR, the new agent exhibits antiproliferative effects by inhibiting the synthesis of pyrimidine, a substance known to play a role in the inflammatory process.

Marc C. Hochberg, M.D., M.P.H., professor of medicine, epidemiology, and preventative medicine, and the head of the division of rheumatology & clinical immunology at the University of Maryland School of Medicine, Baltimore, claimed that leflunomide was shown to be effective in both early and more advanced RA by slowing joint deterioration. Results of phase II clinical trials indicate that the drug improves primary outcome measures, such as swollen and tender joints, as well as secondary outcome measures, such as pain, and laboratory indices of inflammation. The clinical effectiveness of leflunomide in the 24-week study was similar to or greater than that reported with methotrexate, sulfasalazine, injectable gold, and cyclosporine A in 18- to 26-week trials. …

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