ENBREL (etanercept) long-term clinical trial data

November 16, 1999

BOSTON - Data from patients receiving ENBREL® (etanercept) for as long as 41 months were presented at the 63rd National Scientific Meeting of the American College of Rheumatology (ACR) today.

The FDA approved ENBREL on November 2, 1998 to treat moderately to severely active rheumatoid arthritis in patients who have an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). The FDA included children and teen-agers (age 4-17 years) in the ENBREL label when it granted the drug a new indication on May 28, 1999 for the treatment of moderately to severely active polyarticular-course juvenile rheumatoid arthritis patients who have had an inadequate response to one or more DMARDs.

Study participants were treated with 25 mg of ENBREL twice weekly and continue to be followed in an ongoing study being conducted in the United States and Canada. Patients described in this presentation had moderate to severely active RA and had failed at least one DMARD. The data presented have not been reviewed by the Food and Drug Administration.

Response to ENBREL was sustained over time. Of patients treated for 12 months (n=480), 72, 47 and 21 percent achieved 20, 50 and 70 percent reductions in ACR response criteria, respectively. Of patients treated for 30 months (n=83), 80, 60 and 33 percent achieved 20, 50 and 70 per cent reductions in ACR response criteria, respectively. In controlled trials, of patients treated for 3 months (n=78), 62, 41 and 15 percent achieved 20, 50 and 70 percent reductions in ACR response criteria, respectively.

No significant differences in rate or type of adverse event were seen when patients continued to receive ENBREL over time. Infections occurred at a rate of 1.55 per patient year compared to 1.82 in controlled clinical trials. Headache occurred at a rate of 0.27 per patient year compared to 0.68 in controlled trials. Serious infections occurred at a rate of 0.050 per patient year compared to 0.043 per patient year in controlled trials. There were nine reports of cancer, similar to the expected number (10.7) calculated from the NCI SEER database. None of the patients has developed a new autoimmune rheumatic disease.

IN POSTMARKETING USE, SERIOUS INFECTIONS AND SEPSIS, INCLUDING FATALITIES, HAVE BEEN REPORTED. MANY OF THESE EVENTS OCCURRED IN PATIENTS PREDISPOSED TO INFECTIONS, SUCH AS THOSE WITH ADVANCED OR POORLY CONTROLLED DIABETES. DISCONTINUE ENBREL IN PATIENTS WITH SERIOUS INFECTIONS OR SEPSIS. DO NOT START ENBREL IN THE PRESENCE OF SEPSIS, INFECTION (INCLUDING CHRONIC OR LOCALIZED), OR ALLERGY TO ENBREL OR ITS COMPONENTS. USE CAUTION IN PATIENTS PREDISPOSED TO INFECTION. The most frequent adverse events in adult clinical trials in rheumatoid arthritis (n=349) were injection site reactions (ISR) 37%, infections (35%) and headache (17%). Malignancies were rare (<1%). Only the rate of ISR was higher than placebo.

In a JRA study (n=69), infections (62%), headache (19%), abdominal pain (19%), vomiting (13%) and nausea (9%) occurred more frequently than in adults. The types of infections reported in JRA patients were generally mild and consistent with those commonly seen in outpatient pediatric populations. Serious adverse reactions reported rarely were varicella (3%), gastroenteritis (3%), depression/personality disorder (1%), cutaneous ulcer (1%), and esophagitis/gastritis (1%).
-end-
Immunex is the manufacturer of ENBREL. Immunex and Wyeth-Ayerst Laboratories market ENBREL in North America. Other Wyeth-Ayerst affiliates will market ENBREL outside of North America. Additional information about ENBREL, including full prescribing information, can be found on the company-sponsored website at ( www.enbrel.com ) or by calling toll-free 1-888-4ENBREL (1-888-436-2735).

Immunex is a biopharmaceutical company dedicated to developing immune system science to protect human health. The company's products offer hope to patients with cancer, inflammatory and infectious diseases.

American Home Products Corporation's Wyeth-Ayerst division is a major research-oriented pharmaceutical company with leading products in the areas of women's health care, cardiovascular disease therapies, central nervous system drugs, anti-inflammatory agents, vaccines and generic pharmaceuticals.

American Home Products owns a majority interest in Immunex. AHP is one of the world's largest research-based pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing and marketing of prescription drugs and over-the-counter medications. It is also a leader in vaccines, biotechnology, agricultural products and animal health care.

NOTE: This release contains forward-looking statements that involve risks and uncertainties, including risks associated with clinical development, regulatory approvals, patent litigation, product commercialization and other risks described from time to time in the SEC reports filed by Immunex, including the most recently filed 10-K and 10-Q. For more information, please refer to www.immunex.com .

Immunex Corporation

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.