New drug blocks rheumatoid arthritis early on, with few side effects

November 29, 2000

A large nationwide study concludes that a drug called etanercept dramatically slows or even stops the progress of rheumatoid arthritis (RA) at the earliest stages of the disease, helping nearly three-quarters of those taking it. Etanercept also shows fewer side effects than the current best medicine.

While the drug has been on the market for several years as a symptom-easing therapy for people with advanced rheumatoid arthritis, this study marks a new use for etanercept as an early treatment. The study compared etanercept with the standard therapy, a drug called methotrexate.

"Both methotrexate and etanercept slow or actually halt the progress of the disease, but etanercept is more effective for more patients and has a low incidence of side effects," says rheumatologist Joan Bathon, M.D. Bathon led the year-long multicenter trials comparing the effect of the two drugs on 632 patients in the earliest stages of RA.

"The major drawback at this point," she adds, "is that etanercept is expensive -- some $12,000 per patient per year, as compared with methotrexate's $1,000 a year."

The research, funded by the makers of etanercept and reported this week in the New England Journal of Medicine, forms the basis for new Food and Drug Administration guidelines governing use of the drug for early treatment. Physicians may now prescribe it, not only for symptom relief, but to prevent joint damage in the first place.

Rheumatoid arthritis is marked by an immune system attack on joints -- both on bone and on the cartilage that surrounds the bone -- bringing permanent joint damage. It affects joints in the hands and feet as well as all large joints. More than 6 million people in this country, most of them women, suffer from the disease. Symptoms include joint stiffness and pain and great fatigue.

Methotrexate, an anti-cancer drug, brought a treatment advance about 15 years ago, Bathon says. "But methotrexate's side effects can be significant, and nearly 50 percent of the patients taking it aren't helped."

Etanercept is a genetically engineered "designer drug" that blocks the action of a hormone-like chemical called tumor necrosis factor (TNF). TNF triggers much of the joint inflammation that comes with the disease, says Bathon, and also prompts cascades of reactions that end in destruction of cartilage in joints, as well as in bone erosion.

In the trial, people suffering from RA for three years or less received a 12-month course of either methotrexate or etanercept. Researchers selected subjects at especially high risk for joint destruction.

Using criteria from the American College of Rheumatology, the scientists looked for a decrease in swollen, tender joints, a drop in the laboratory measures of inflammation, for the improved evaluation of the disease by both patient and physician and -- most important -- for hard evidence from X-rays, says Bathon.

In the X-ray evaluation, patients were scored on a standard scale that measures how much bone erodes and, indirectly, how much cartilage disappears. At the end of the study, the majority of patients on either drug had no increase in bone erosion, with the progress of the disease completely stopped in 72 percent of the etanercept patients and in 60 percent of the methotrexate group. Patients on either drug also had a minimal increase in cartilage destruction.

The incidence of side effects serious enough to make patients stop taking methotrexate was about double that of the etanercept group, says Bathon. "We followed these patients for two years and it appears that the good effects are holding," she says.

Bathon cautions that neither drug is a cure. "But now if you start someone on methotrexate and see that person doesn't do well, you have an alternative," she says. "Also, combining the drugs seems to have no ill effects." Because TNF is a major immune system player though, physicians must watch patients carefully for increased signs of infection, she explains.
-end-
The study was funded by the Immunex Corporation, which makes Enbrel, the trade name for etanercept.

Other researchers were Richard W. Martin, M.D., of Michigan State University, Roy Fleischmann, M.D., of the Metroplex Clinical Research Center, Dallas, John Tesser, M.D., of the Phoenix Center for Clinical Research, Michael Schiff, M.D., of the Denver Arthritis Clinic, Edward Keystone, M.D., of Mt. Sinai hospital, Toronto, Mark Genovese, M.D., of Stanford University, Mary Chester Wasko, M.D., of the University of Pittsburgh Medical Center, Larry Moreland, M.D., of the University of Alabama at Birmingham, Arthur Weaver, M.D.,the Arthritis Center for Nebraska at Lincoln, Joseph Markenson, M.D., at the Hospital for Special Surgery, New York, and Barbara Finck, M.D, of Immunex Corporation, Seattle.

Related Web sites: For the Arthritis Foundation's page on RA, click on to http://www.arthritis.org/Answers/DiseaseCenter/ra.asp Also see this site: http://content.health.msn.com/content/dmk/dmk_summary_account_1437

Johns Hopkins Medical Institutions' news releases are available on an EMBARGOED basis on EurekAlert at http://www.eurekalert.org, and from the Office of Communications and Public Affairs' direct e-mail news release service. To enroll, call 410-955-4288 or send e-mail to bsimpkins@jhmi.edu.

Johns Hopkins Medicine

Related Rheumatoid Arthritis Articles from Brightsurf:

Reducing dementia in patients with rheumatoid arthritis
The incidence of dementia in patients with rheumatoid arthritis is lower in patients receiving biologic or targeted synthetic disease modifying antirheumatic drugs (DMARDs) than in patients who receive conventional synthetic DMARDs, according to a new study.

Is rheumatoid arthritis two different diseases?
While disease activity improves over time for most rheumatoid arthritis (RA) patients, long-term outcomes only improve in RA patients with autoantibodies, according to a new study published this week in PLOS Medicine by Xanthe Matthijssen of Leiden University Medical Center, Netherlands, and colleagues.

Does the Mediterranean diet protect against rheumatoid arthritis?
Previous research has demonstrated a variety of health benefits associated with the Mediterranean diet, which is rich in olive oil, cereals, fruit and vegetables, fish, and a moderate amount of dairy, meat, and wine.

Reducing corticosteroid use in rheumatoid arthritis
Is the long-term use of glucocorticoids essential in people with chronic inflammatory diseases such as rheumatoid arthritis, or can early discontinuation prevent characteristic side effects?

Rheumatoid arthritis patients under treatment with methotrexate
Patients with rheumatoid arthritis (RA) often suffer from what is referred to as interstitial lung disease (ILD).

Rheumatoid arthritis -- can its onset be delayed or prevented?
Rheumatoid arthritis (RA) is a chronic inflammatory autoimmune disorder that leads to significant health issues as well as high treatment costs.

Disease burden in osteoarthritis is similar to rheumatoid arthritis
Osteoarthritis (OA) has traditionally been viewed as a highly prevalent but milder condition when compared with rheumatoid arthritis (RA), and some may believe that it is part of a normal aging process requiring acceptance, not treatment.

Prospect of a new treatment for rheumatoid arthritis
An international research group led by Charité -- Universitätsmedizin Berlin has completed testing a new drug to treat rheumatoid arthritis.

Can rare lymphocytes combat rheumatoid arthritis?
Immunologists at Friedrich-Alexander-Universität Erlangen-Nürnberg have demonstrated that ILC2, a group of rare lymphoid cells, play a key role in the development of inflammatory arthritis.

Rheumatoid arthritis meets precision medicine
Scientists are bringing precision medicine to rheumatoid arthritis for the first time by using genetic profiling of joint tissue to see which drugs will work for which patients, reports a new multi-site study.

Read More: Rheumatoid Arthritis News and Rheumatoid Arthritis Current Events
Brightsurf.com is a participant in the Amazon Services LLC Associates Program, an affiliate advertising program designed to provide a means for sites to earn advertising fees by advertising and linking to Amazon.com.