OnHealth FDA OK's First Drug to Treat and Prevent Rheumatoid Arthritis

[Guest guest]

Wednesday, January 03, 2001

FDA OK's First Drug to Treat and Prevent Rheumatoid Arthritis

FDA OK's First Drug to Treat and Prevent Rheumatoid Arthritis

Drug Promises to Limit Joint Damage While Helping Control the Pain

By Ori Twersky

WebMD Washington Correspondent

Reviewed by Dr.

Jan. 2, 2001 (Washington) -- Americans with rheumatoid arthritis may have yet

another reason to celebrate the beginning of 2001. For the first time ever,

federal health officials have approved a drug that limits the progression of

joint damage associated with this chronic disease and can help control the pain

and stiffness at the same time.

Called Remicade, the drug was first approved by the FDA in October 1999 for the

treatment of the signs and symptoms associated with rheumatoid arthritis. This

latest approval allows the drug to also be used in combination with methotrexate

(available as Rheumatrex or the generic form) to prevent the joint damage.

Methotrexate is a standard treatment for patients with rheumatoid arthritis.

About 2.1 million Americans suffer from the disease, which primarily affects

women. In patients with rheumatoid arthritis, joint damage occurs when the space

between bone joints narrows and the joints begin to erode. The approval was

based upon a clinical trial, in which Remicade was shown to both prevent joint

erosion and the narrowing of space between joints when used in conjunction with

methotrexate.

After 54 weeks of therapy, more than half of the patients treated with Remicade

and methotrexate demonstrated no worsening of their original condition. More

than half also reported a reduction in the symptoms associated with the disease,

compared to just 17% of those patients receiving methotrexate alone.

The two-year long trial involved more than 400 patients and was one of the

largest and longest running clinical trials with regards to rheumatoid

arthritis.

" This is excellent news for patients, " says Spiegel, MD, one of the

trial's principal investigators. " 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. "

" The prospect of having a therapy that can actually inhibit the damage caused by

rheumatoid arthritis is extremely exciting, " says Virginia Ladd, president and

executive director of the American Autoimmune Related Diseases Association.

But although Remicade was well tolerated during the clinical trials, health

officials say that caution should be exercised when considering its use. As a

drug that mediates inflammation and immune responses, Remicade can represent a

danger to patients with a chronic infection or history of recurrent infections,

they note.

Physicians also should exercise caution when considering the use of Remicade to

treat patients with tuberculosis or central nervous system disorders such as

multiple sclerosis, the FDA says.

The most common adverse events reported during the clinical trial were upper

respiratory infections, headaches, rashes, cough, sinusitis, and rashes or mild

bruising at the injection site.

Remicade is made by a wholly owned subsidiary of & . It initially

was cleared for sale in 1998 as treatment for Crohn's disease, a rare but

serious gastrointestinal disorder.

http://onhealth.webmd.com/conditions/news/webmd/item,110167.asp