FDA Approves Remicade with Methotrexate as First Drug to Inhibit Progression of Joint Damage.

2001 JAN 25 - (NewsRx.com) -- The U.S. Food and Drug Administration (FDA) has approved a drug to inhibit the progression of joint damage in patients with rheumatoid arthritis, which affects 2.1 million Americans, mostly women.

The FDA granted marketing approval to Remicade (infliximab), in combination with methotrexate, for inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate.

"For the first time, we now have a drug that can inhibit the progression of joint damage as well as control the pain and stiffness associated with this disease," said Michael Spiegel, MID, ATTRACT trial investigator, Danbury, Connecticut. "This is excellent news for patients. Remicade can have a tremendous impact on patients."

Remicade with methotrexate was first approved for marketing in October 1999 for the treatment of signs and symptoms of rheumatoid arthritis in patients who have had an inadequate response to methotrexate.

In patients with rheumatoid arthritis, joint damage is evident as narrowing of the joint space between bones and erosion of the bones at the joint space. Remicade inhibits both of these conditions.

"Joint damage progression in rheumatoid arthritis has two key components, joint space narrowing and joint erosion. Clinical data demonstrates that Remicade inhibits not only joint erosions but joint space narrowing as well. This provides considerable benefit to patients while also improving the pain and stiffness associated with the disease," said Thomas Schaible, PhD, Centocor.

Approval was based on 54-week data from the two-year ATTRACT trial (Anti-TNF Trial in Rheumatoid Arthritis with Concomitant Therapy), one of the largest and longest controlled rheumatoid arthritis clinical trials involving 428 patients at 34 centers in North America and Europe.