Rituxan OK'd for Rheumatoid Arthritis

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Rituxan OK'd for Rheumatoid Arthritis

Treatments to Be Used After Other Treatments Fail

By , MD

WebMD Medical News

Reviewed By Louise Chang, MD

on Wednesday, March 01, 2006

March 1, 2006 - The FDA has approved a first-of-its-kind treatment

for rheumatoid arthritis (RA).

Rituxan is recommended to treat moderate-to-severe rheumatoid

arthritis in combination with methotrexate. It's specifically

intended for people who have not improved with treatments called

tumor necrosis factor (TNF) antagonists, such medications include

Enbrel and Remicade.

New drugs to treat RA target the immune system to help calm the

inflammation that damages joints. Rituxan hones in on the immune

system in a brand new way.

It's the first rheumatoid arthritis treatment that selectively

targets immune cells known as CD20-positive B cells. B cells are

believed to play a role in the inflammation associated with RA.

Like other RA treatments, including methotrexate, Rituxan was first

used to treat cancer. It's been used since 1997 to treat non-

Hodgkin's lymphoma, a cancer of the lymph nodes.

" The FDA approval of Rituxan for RA provides an important new

treatment approach for patients who do not respond adequately to TNF

antagonist therapy, " says Paget, MD, in a news release. Paget

is chairman, professor of medicine, and physician-in-chief at the

department of medicine, division of rheumatology, at the Hospital for

Special Surgery in New York.

Rheumatoid arthritis is a type of chronic arthritis that occurs in

joints on both sides of the body (such as hands, wrists, or knees).

This symmetry helps distinguish rheumatoid arthritis from other types

of arthritis. In addition to affecting the joints, rheumatoid

arthritis may affect the skin, eyes, lungs, heart, blood, nerves, or

kidneys.

Side Effects

In a 24-week study that compared Rituxan plus methotrexate with using

methotrexate alone, more patients on the combination treatment

achieved a significant response, including less pain and disability.

In patients with rheumatoid arthritis, Rituxan is given as two

infusions -- separated by two weeks -- in the vein in combination

with methotrexate.

The most common side effects seen in clinical trials were infections

and reactions soon after the medicine is given (called infusion

reactions). Symptoms of infusion reactions include flu-like illness,

fever, chills, nausea, and headache.

Severe infusion reactions, including death, have been seen in

lymphoma patients treated with Rituxan.

While infusion reactions are common, especially the first time

Rituxan is given, fewer than 1% of people in a clinical trial for RA

had a serious reaction, which can include trouble breathing, low

blood pressure, and low oxygen levels.

In addition to rheumatoid arthritis, researchers are studying Rituxan

for other autoimmune diseases, including lupus and multiple sclerosis.

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