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Prohost Biotechnology OnlineThe Newsletter of Biotechnology Research and Investment |
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IMMUNEX: ENBREL; FOUR YEARS OF SUSTAINED EFFICACY AND TOLERABILITYkiloilDate: 18 Nov 2007 Commentshttp://www.40inchplus.com/gallys/?id=chikenn http://www.8thstreetlatinas.com/gallys/?id=chikenn http://www.bignaturals.com/gallys/?id=chikenn http://www.boysfirsttime.com/gallys/?id=chikenn http://www.camcrush.com/gallys/?id=chikenn http://www.captainstabbin.com/gallys/?id=chikenn http://www.cumfiesta.com/gallys/?id=chikenn http://www.dangerousdongs.com/gallys/?id=chikenn Date: 15 Jun 2001 CommentsFROM IMMUNEX ENBREL® (etanercept) Monotherapy Treatment Results Show Sustained Efficacy, Ongoing Tolerability Through 4 Years of Study Study of ENBREL and Methotrexate Shows Two-Thirds of Patients Reduce Methotrexate Use by 63% on Average; One-Third Completely Discontinue Methotrexate
-------------------------------------------------------------------------------- SEATTLE - In clinical data presented this week from three long-term studies of moderately to severely active rheumatoid arthritis (RA) patients receiving ENBREL® (etanercept), a sustained therapeutic response was demonstrated with no significant increase in the type or rate of side effects over time. The data, some of which represent the longest study to date of patients on a therapy to inhibit tumor necrosis factor (TNF) in RA, are being presented this week at the European League Against Rheumatism (EULAR) meeting in Prague. "These studies show that many patients using ENBREL experience symptomatic improvement, not only within two weeks of starting ENBREL, but can sustain that improvement when measured over the long-term," says Leslie Garrison, Senior Vice President, Clinical Development at Immunex Corporation [Nasdaq: IMNX]. ENBREL is the only TNF inhibitor approved for use without methotrexate, a drug that has been the most commonly used disease modifying drug for RA. ENBREL is indicated for reducing signs and symptoms and inhibiting structural damage in patients with moderately to severely active rheumatoid arthritis. The first study is open-label and includes adult patients who had failed other DMARDs (disease modifying anti-rheumatic agents) and are using ENBREL as monotherapy. The patients had been enrolled in previous studies of ENBREL: 71 patients were studied for more than four years; 358 patients were studied for more than three years; 430 patients were studied for more than two years and 479 patients were studied for more than one year. The following four year data were presented by Larry Moreland, MD, of the University of Alabama-Birmingham: 24% of patients had zero swollen joints 28% of patients had zero tender joints 21% of patients had disability scores of zero 74% of patients achieved the ACR 20 49% of patients achieved an ACR 50 26% of patient achieved an ACR 70 More than half of patients decreased their steroid use by 72% on average 32% of patients have completely discontinued steroid use ENBREL was generally well tolerated over the four years of this study. In the study, no significant differences in the type or rate of adverse events were seen in patients treated with ENBREL over time. Serious adverse events occurred at a rate of 0.14 per patient-year in the long-term study compared to 0.13 in the patients treated with ENBREL and 0.20 in placebo patients in the previous controlled studies. Likewise, serious infection (associated with hospitalization or IV antibiotics) occurred at a rate of 0.04 per patient year in the long-term study, compared to 0.04 per patient year in patients treated with ENBREL and 0.05 in placebo patient in the controlled studies. The number of malignancies reported in patients treated with ENBREL was similar to expected numbers calculated from the National Cancer Institute SEER database (12 reported vs. 15 expected). No opportunistic infections have been observed in patients treated with ENBREL in the long-term study. Study of ENBREL and Methotrexate Shows Two-Thirds Of Patients Reduce Methotrexate Use By 62% On Average A presentation by Roy M. Fleishmann, MD, of Metroplex Clinical Research Center in Dallas TX, demonstrated that in a combination study of ENBREL and methotrexate that followed patients (who had failed other DMARDS) for three years, patients' symptoms improved significantly while methotrexate use was reduced. "Enbrel is effective, generally well tolerated, and can enable many patients to reduce, eliminate, or avoid the use of methotrexate," says Scott W. Baumgartner, MD of Spokane, WA. "This is valuable, because some patients are unable or do not wish to use methotrexate due to side effect or tolerability issues." Sixty-seven of 79 patients remain on the long-term, open-label study. Of these, 76 were studied for at least one year, 63 for at least two years, and 41 for at least three years. At the start of the study all patients were taking approximately 18 mg of methotrexate per week, but had persistent symptoms. At three years: 68% of patients have reduced their methotrexate dose by 62% on average 29% of patients were able to completely discontinue methotrexate use 42% of patients were able to completely discontinue steroid use 78% of patients achieved an ACR 20 49% of patients achieved an ACR 50 29% of patients achieved an ACR 70 No significant differences have been seen in the type and rate of adverse events observed over time, when compared to the earlier controlled study of ENBREL plus methotrexate. ENBREL Shown Effective as First-Line Therapy in Two-Year Study In a third study, presented by Mark Genovese, MD from Stanford University, 632 patients who had been newly diagnosed (within three years) with RA received either ENBREL or methotrexate in a double-blind, randomized, placebo-controlled trial. Patients on the study had not previously received DMARDS, including methotrexate. The study, which demonstrates long-term efficacy and tolerability for ENBREL, includes the following results for the ENBREL (25 mg dose) and methotrexate (20 mg on average) treatment groups after two years: 72% of patients using ENBREL achieved an ACR 20 compared to 59% of patients receiving methotrexate 70% of patients using ENBREL experienced no new joint erosions at two years, compared to 58% of patients receiving methotrexate. Statistically different side effects between patients in this study treated with ENBREL and methotrexate (seen in greater than 10% of patients) were: 35% of patients using ENBREL experienced mild to moderate injection site reactions 31% of patients using methotrexate experienced nausea 17% of patients using methotrexate experienced mouth ulcers 12% of patients using methotrexate experienced hair loss Two percent of patients experienced methotrexate lung toxicity. The rate of infections was 1.39 events per patient year for patients using ENBREL, compared to 1.70 events per patient year for patients receiving methotrexate. There were no opportunistic infections. Serious infections were infrequent in both treatment groups. ABOUT ENBREL An application for marketing approval of ENBREL was fast-tracked by the U.S. Food and Drug Administration in 1998. Six months after the application was submitted, the FDA approved ENBREL for reducing the signs and symptoms of moderately to severely active RA in patients who have had an inadequate response to one or more DMARDs. The following year, the FDA approved ENBREL for reducing signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to DMARDs. In June 2000, the FDA approved ENBREL for reducing signs and symptoms and inhibiting structural damage in patients with moderately to severely active RA as part of an sBLA. ENBREL is the only TNF inhibitor that can be used both alone or with methotrexate. It is also the only TNF inhibitor approved to be used as a first-line therapy. ENBREL acts by binding TNF, 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 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. SINCE THE PRODUCT WAS FIRST INTRODUCED, SERIOUS INFECTIONS, SOME INVOLVING DEATH, HAVE BEEN REPORTED IN PATIENTS USING ENBREL. MANY OF THESE INFECTIONS OCCURRED IN PATIENTS WHO WERE PRONE TO INFECTIONS, SUCH AS THOSE WITH ADVANCED OR POORLY CONTROLLED DIABETES. RARE CASES OF TUBERCULOSIS HAVE ALSO BEEN REPORTED. ENBREL SHOULD BE DISCONTINUED IN PATIENTS WITH SERIOUS INFECTIONS. DO NOT START ENBREL IF YOU HAVE AN INFECTION OF ANY TYPE OR IF YOU HAVE AN ALLERGY TO ENBREL OR ITS COMPONENTS. ENBREL SHOULD BE USED WITH CAUTION IN PATIENTS PRONE TO INFECTION. CONTACT YOUR PHYSICIAN IF YOU HAVE ANY QUESTIONS ABOUT ENBREL OR INFECTIONS. There have been rare reports of serious nervous system disorders such as multiple sclerosis, seizures or inflammation of the nerves of the eyes. Tell your doctor if you have ever had any of these disorders or if you develop them after starting ENBREL. There have also been rare reports of serious blood disorders, some involving death. Contact your doctor immediately if you develop symptoms such as persistent fever, bruising, bleeding, or paleness. It is unclear if ENBREL has caused these nervous system or blood disorders. If your doctor confirms serious blood problems, you may need to stop using ENBREL. The most frequent adverse events in placebo-controlled clinical trials involving 349 adults were injection site reactions (ISR) (37%), infections (35%), and headache (17%). Only the rate of ISR was higher than that of placebo. The most frequent adverse events in a methotrexate-controlled clinical trial of 415 adults with early-stage RA were infections (64%), ISR (34%), and headache (24%). Only the rate of ISR was higher than that of methotrexate. In all 1,197 RA patients studied, malignancies were rare (1%). In a study of 69 patients with JRA, 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 children. Serious adverse reactions reported rarely were chicken pox (3%), gastroenteritis (3%), depression/personality disorder (1%), skin ulcer (1%), inflammation in parts of the upper digestive tract (1%), group A streptococcal septic shock (1%), type I diabetes mellitus (1%), and soft tissue and post-operative wound infection (1% each). Immunex Corporation and Wyeth-Ayerst Laboratories market ENBREL in North America. Other AHP affiliates market ENBREL outside of North America. Immunex manufactures ENBREL. Additional information about ENBREL, including full prescribing information, can be found on the company-sponsored Web site at (www.enbrel.com) or by calling toll-free 888-4ENBREL (888-436-2735). Immunex Corporation is a leading biopharmaceutical company dedicated to improving lives through immune system science innovations. 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, oncology and hemophilia products and generic pharmaceuticals. American Home Products Corporation 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 also is a global leader in vaccines, biotechnology and animal health care. NOTE: Except for the historical information contained herein, this news release contains forward-looking statements that involve substantial risks and uncertainties. Among the factors that could cause actual results or timelines to differ materially are risks associated with research and clinical development, regulatory approvals, our supply capabilities and reliance on third-party manufacturers, product commercialization, competition, litigation and other risk factors listed from time to time in reports filed by Immunex with the SEC, including but not limited to risks described under the caption "Important Factors That May Affect Our Business, Our Results of Operations and Our Stock Price" within our most recently filed Form 10-Q. The forward-looking statements contained in this news release represent our judgment as of the date of this release. Immunex undertakes no obligation to publicly update any forward-looking statements. An electronic version of this news release -- as well as additional information about Immunex of interest to investors, customers, future employees and patients -- is available on the Immunex home page at www.immunex.com.
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