2/28/06 - Rituzimab (Rituxan) Approved for use in RA

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Arthritis Foundation Statement on Rituximab for Rheumatoid Arthritis

March 2006

Summary

The U.S. Food and Drug Administration’s (FDA) approval of rituximab (Rituxan®)

in combination with methotrexate to reduce the signs and symptoms of rheumatoid

arthritis (RA) brings a new treatment option to adult patients with

moderately-to-severely active RA who have had an inadequate response to one or

more tumor necrosis factor (TNF) antagonist therapies. The Arthritis Foundation

applauds the FDA’s decision and believes that new RA therapies targeting key

pathways responsible for the disease will better enable physicians to both

reduce patients’ disease symptoms and their risk of disability. Full Statement

On February 28, 2006, the FDA approved an expanded indication for rituximab, a

biologic agent that selectively targets immune cells involved in RA. Rituximab

was approved in 1997 for the treatment of CD20-positive, B-cell, non-Hodgkin’s

lymphoma (NHL) and has shown significant benefits in RA clinical trials.

Rituximab is the first RA treatment that targets and selectively depletes

CD20-positive B-cells, which are involved in the joint inflammation that occurs

in RA.

Phase III clinical trial results of rituximab were recently presented at the

American College of Rheumatology Annual Scientific Meeting in November 2005. In

the study, also known as REFLEX, patients who received one course of treatment

of rituximab with methotrexate had statistically significant improvements

through six months in the number of swollen and tender joints and disease

activity measures such as pain, compared to those who received placebo and

methotrexate. This research showed improvements in patients who had an

inadequate response to prior treatment with one or more TNF antagonist

therapies, bringing hope to this difficult-to-treat patient population.

“Rituximab provides an important treatment option to improve the quality of

life of people with RA, one of the most serious and debilitating forms of

arthritis,” said H. Klippel, M.D., president and CEO, Arthritis Foundation.

“Enormous progress has been made in the treatment of RA over the past decade;

however, many patients cannot tolerate or do not respond adequately to the

anti-TNF agents that are currently available. Rituximab expands the treatment

options for these patients.”

Rituximab is administered as a treatment course of two intravenous infusions.

In clinical trials for RA, the most common adverse events observed in patients

treated with rituximab were infusion reactions and infections. Severe infusion

reactions, which typically occur during the first infusion, have been reported

in patients treated with rituximab, some with fatal outcomes in patients with

NHL.

About Rheumatoid Arthritis

Rheumatoid arthritis (RA) is one of the more serious forms of arthritis and

affects 2.1 million Americans. It is characterized by the inflammation of the

synovium – the membrane lining the joint – which causes pain, stiffness, warmth,

redness and swelling. The inflamed synovium can invade and damage bone and

cartilage, leading to deformities of the joint, loss of joint movement, and

limitations of activities requiring use of the joint. The disease usually

begins in middle age, but can start at any age, including childhood. RA affects

two to three times more women than men.

For more information

The Arthritis Foundation offers a number of resources to assist people with RA

in finding information about treatments and managing their activities, including

a free consumer brochure on RA and a free Arthritis Today Drug Guide, as well as

books such as The Arthritis Foundation’s Guide to Good Living with Rheumatoid

Arthritis and The Essential Guide to Arthritis Medications. For more

information, contact the Arthritis Foundation at .

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May you have enough happiness to make you kind, enough trials to make you

strong, enough sorrow to keep you human, enough hope to make you happy.

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