FDA Approves Expanded Use of Remicade for Rheumatoid Arthritis

The U.S. Food and Drug Administration has approved the use of Remicade (infliximab), in combination with the anti-inflammatory drug methotrexate, to improve physical function in patients with rheumatoid arthritis.

Remicade is the first and only drug shown to improve physical function for the 2 million Americans suffering from rheuatoid arthritis. The latest approval expands its previously approved use as a stand-alone treatment for people who had failed to benefit from methotrexate.

"This is groundbreaking news for patients and physicians," said David Yocum, Professor of Medicine and Director of the Arizona Arthritis Center. "The results clearly demonstrate that Remicade fulfills a significant unmet medical need in the treatment of (rheumatoid arthritis)."

In one of the largest trials ever conducted, 428 patients at 34 centers were randomly were given Remicade or a placebo, in combination with methotrexate.

Dr.Gregory Keenan, Director of Medical Affairs at Centocor, the company that markets and manufactures Remicade in the United States, said patients who received the drug showed a "statistically significant improvement" in their abilities to perform daily activities such as dressing, eating and walking. Moreover, patients experienced improved physical quality of life, while maintaining mental quality as well.

"By using both measurement tools, we have been able to comprehensively quantify and understand the full magnitude of improvement in physical ability and the impact on overall health-related quality of life achieved with Remicade in combination with methotrexate, " he said. "Patients taking Remicade not only feel better, they also preserve their physical abilities, leading to a more promising outlook on life."

Other sources: Johnson & Johnson