New TNF Inhibitor for Rheumatoid Arthritis

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New TNF Inhibitor for Rheumatoid Arthritis

By Schorr

SAN FRANCISCO (MedscapeWire) Nov 15 - A new experimental therapy that may reduce

treatment schedules for patients suffering from rheumatoid arthritis was found

to be safe and well tolerated, according to research presented here Thursday at

the 65th annual meeting of the American College of Rheumatology.

Study author Dr. Keystone, a professor of medicine at the University of

Toronto, and collaborators conducted a multicenter phase II trial testing the

safety and efficacy of various doses of the new drug, called CDP870, which is

administered once a month.

" We can say that CDP870 was tolerated in all dose groups, there was a rapid

onset of action, and the (highest) dose was more efficacious than the placebo at

12 weeks, " he said.

CDP870 is the latest drug known as a tumor necrosis factor (TNF) inhibitor,

which works by binding to a protein overproduced by those with rheumatoid

arthritis and interrupting the inflammation process. Current TNF inhibitors on

the market, such as etanercept (Enbrel), need to be delivered twice a week, and

infliximab (Remicade) requires IV infusions. The CDP870 drug has a half-life of

12 to 15 days in the body, Keystone noted.

In this study, researchers randomized 203 patients who had suffered from

rheumatoid arthritis for an average of 9 years to receive either 50, 100, 200,

or 400 mg of the drug, or a placebo, subcutaneously every 4 weeks for 3 months.

The patients were primarily women with an average age of disease onset of 55 who

had suffered significant rheumatoid arthritis an average of 11 years.

The researchers reported that after 12 weeks of therapy, 60% of the patients on

the highest dose of the drug had a 20% reduction in swelling and tenderness of

joints, and reduction of other pain symptoms, classified as the ACR20 response.

" What you notice is a very rapid onset of action, so that 75% of patients who

make an ACR20 response, make that response at one week, " Keystone said.

Compared with patients receiving placebo, the patients taking the 400-mg dose of

the drug showed a significant improvement on all factors of the ACR core set,

which includes measurements of arthritis symptoms such as swollen and tender

joints, a patient self-assessment, and inflammatory response, he noted.

Adverse effects of the drug included headaches, nausea and diarrhea, infections,

and injection site reactions. " The injection site reactions were similar among

placebo and 400 mg dose, " he noted. However, those taking the drug were more

likely to report headaches than those on placebos.

There were also 16 patients who had serious adverse events, with 5 of those

related to musculoskeletal issues with aggravation of rheumatoid arthritis

symptoms. " However, there was no consistency with adverse events across the

doses, " Keystone noted.

The study was funded by drugmakers Celltech and Pharmacia. Researchers are

currently looking into experimenting with even higher doses of the drug used in

this study, Keystone noted.