INFO Arthritis Foundation Statement on the Rituximab for Rheumatoid Arthritis

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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.â€

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_

(http://www.arthritis.org/conditions/DiseaseCenter/RA/default.asp) (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.