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| |  EULAR: Enbrel (Etanercept) Provides Long-Term Reduction Of Joint Pain And Swelling NICE, FRANCE -- June 26, 2000 -- Patients with active rheumatoid arthritis who responded to Enbrel®, (etanercept) experienced sustained reduction of joint pain and swelling for as long as 43 months of treatment, according to results from an on-going long-term open-label study. Approximately two thirds of the patients in this study responded to Enbrel as measured by ACR20. Interim results of this study were presented at the 15th Annual Meeting of the European League Against Rheumatism (EULAR) by Dr. Larry Moreland of the University of Alabama, Birmingham. These data have not been submitted to the U.S. Food and Drug Administration. Enbrel was generally well tolerated for up to 43 months. In the study, no significant differences in the rate or type of adverse events were seen in patients treated with Enbrel over time. Injection site reactions occurred in 43 percent of patients; less than 0.5 percent of patients withdrew from the study due to injection site reactions. A total of 16 percent of patients have discontinued treatment: five percent due to adverse events and four percent due to lack of efficacy. No opportunistic infections have been observed. Adverse events resulting in hospitalization and/or treatment with IV antibiotics observed in long-term follow-up have occurred at rates similar to those seen in placebo and etanercept groups in controlled trials. There were ten malignancies reported, of various types, similar to the number (11.5) expected in the general population (calculated from the NCI SEER database). Additional highlights from the U.S. long-term study of Enbrel include: -- Decreased use of corticosteroids was seen in 56 percent of 383 patients. Discontinuation of corticosteroids was seen in 26 percent of the patients while 9 percent increased steroid use. -- The numbers of tender and swollen joints rapidly declined from a median of 30 and 25 to 8 and 10 at three months and continued to decline to four and five at 30 months (n=139). -- After 30 months of treatment (n=139), no tender joints were seen in 28 percent of patients and no swollen joints were seen in 27 percent of patients. -- 553 patients on Enbrel have been followed for more than one year and 500 have been followed for over 18 months. 373 patients on Enbrel were followed for two years and 139 have been followed for 30 months. 53 patients on Enbrel were followed for 36 to 43 months. All patients in this trial had moderately to severely active rheumatoid arthritis and had failed treatment with one or more disease modifying anti-rheumatic drugs prior to starting Enbrel. In a second trial, a European three-year study with 549 patients, all of whom have already participated in an Enbrel European double-blind trial, have received etanercept for up to 15 months thus far. The participants are being treated with 25 mg of Enbrel twice weekly at 58 centers throughout Europe. All patients previously had an inadequate response to DMARDs and the majority are receiving NSAIDS and corticosteroids. In the European study, after three months of open-label treatment, mean number of painful joints was reduced by 64 percent (swollen joints by 66 percent) from the baseline of the preceding double-blind study, indicating maintenance of the therapeutic response. The most frequent adverse events reported were upper respiratory infection and injection site reaction. The occurrence of serious infections and malignancies appeared stable over the current exposure period. 84 percent of patients will continue in the study. Lack of efficacy (5 percent) and adverse reactions (7 percent) account for the majority of patient discontinuations. Enbrel is now considered to be a first-line treatment for moderately to severely active rheumatoid arthritis. After careful review of clinical data, the U.S. Food and Drug Administration on June 6, 2000 confirmed that Enbrel not only reduces signs and symptoms but also delays structural joint damage in patients with moderately to severely active rheumatoid arthritis (RA). Approximately five million people in Europe and North America suffer from the crippling effects of rheumatoid arthritis, a chronic disorder that causes the body's immune system to attack the lining of the joints, resulting in pain, swelling, fatigue and disability. The exact cause of the disease is unknown although biotechnology research has advanced understanding of the role of genes and factors causing inflammation. Enbrel is indicated for reducing signs and symptoms and delaying structural damage in patients with moderately to severely active rheumatoid arthritis. In post-marketing 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 placebo-controlled trials in rheumatoid arthritis (n=349) were injection site reactions (ISR) (37 percent), infections (35 percent) and headache (17 percent). Only the rate of ISR was higher than placebo. The most frequent adverse events in the methotrexate-controlled trial (n=415) were infection (64 percent), ISR (34 percent) and headache (24 percent). Only the rate of ISR was higher than methotrexate. In all RA patients treated in clinical trials (n= 1197), malignancies were rare (1 percent). Enbrel acts by binding tumor necrosis factor (TNF). TNF is one of the dominant cytokines or proteins that play an important role in normal immune function and the cascade of reactions that cause the inflammatory process of RA. Enbrel competitively inhibits the binding of TNF molecules to the TNF receptor (TNFR) sites. The binding of Enbrel to TNF renders the bound TNF biologically inactive, resulting in significant reduction in inflammatory activity. Related Link: Enbrel (etanercept).
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