�Wyeth Pharmaceuticals, a section of Wyeth (NYSE: WYE) and Amgen (NASDAQ:AMGN) proclaimed the publication of data from the COMET (COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis) trial demonstrating that half of patients treated with the combination of ENBREL and methotrexate achieved Disease Activity Score (DAS) clinical remission and well-nigh all had no procession of stick damage. These findings were published on-line on July 15 by The Lancet, a in the lead global medical journal.
According to study results at unrivalled year, 50 percent of patients (n = 265) with active early moderate-to-severe rheumatoid arthritis who received a combination of ENBREL and amethopterin therapy achieved DAS clinical remission (DAS28 less than 2.6) versus 28 percent (n = 263) of those treated with methotrexate alone. DAS28 is a step of spliff swelling and tenderness (based on 28 joints), as well as overall disease activity mensural by a global health assessment and an objective marker of inflammation (red blood cell sedimentation rate). DAS28 is a limited measure of the DAS44, which is a validated tool secondhand in clinical trials and serves as the base for the European League Against Rheumatism (EULAR) response criteria.
"We leslie Townes Hope that these data encourage physicians to use clinical remission as a new standard for evaluating symptom control in the treatment of former RA," aforementioned Paul Emery, M.D., lead COMET visitation investigator and Professor of Rheumatology, University of Leeds, UK. "Clinical remission is highly relevant to patients' daily lives as they cope with their symptoms."
Additionally, at one year, 80 percent of patients (n = 246) receiving ENBREL and amethopterin had no evidence of progression of joint damage as seen on x-ray photograph, compared to 59 percentage (n = 230) of those toughened with amethopterin alone.
Combination therapy with ENBREL plus methotrexate sodium also helped patients stay more functionally active. Based on the Health Assessment Questionnaire (used to assess certain casual life activities), 61 percent (n = 256) of patients treated with combination therapy demonstrated improvement in their functionality versus 44 percent (n = 241) of those treated with only amethopterin. Further, the COMET trial showed that patients wHO were treated with combination therapy had a almost three-fold reduction in work on stoppage compared with those who received methotrexate alone.
"It's important for people living with a chronic disease like moderate to dangerous rheumatoid arthritis to be able to continue with their casual life activities," said Dr. Emery. "These data establish that if patients receive combination treatment early, they are more than likely to be capable to continue with their daily activities, including going to work, than those treated with methotrexate alone."
American College of Rheumatology (ACR) scores were also assessed in the COMET field of study and were comparable to the DAS clinical remission data. Nearly half of patients receiving ENBREL summation methotrexate achieved an ACR 70 score, versus 28 percent of the methotrexate-only group. The percentage of patients world Health Organization achieve an ACR 70 score represent those wHO achieve a 70 per centum improvement in select RA symptoms, including joint hump and tenderness, pain, horizontal surface of handicap, overall patient and mD disease assessment, and an objective marker of fervor, such as erythrocyte alluviation rate.
The COMET study is a 24-month, double-blind, randomised, parallel chemical group, multicenter, outpatient study. The data promulgated in The Lancet represent the results of the first year of handling, in which patients were randomly assigned to receive combination ENBREL 50 mg plus methotrexate sodium therapy, or methotrexate unique, once a week for 52 weeks. The population under study had less than two years (median seven months) of somewhat to badly active disease.
At one year, there were no differences in rates of unplayful infections or malignancies among patients in the ENBREL plus methotrexate sodium group compared with the methotrexate-only group. No cases of t.B. or demyelinating disease were reported. No new safety signals were identified.
In other RA clinical trials of ENBREL, the most common adverse events were injectant site reaction, infection, and headache. Rare cases of tuberculosis and demyelinating diseases have been reported in post-marketing surveillance.
ABOUT ENBREL
ENBREL is a soluble form of a fully human neoplasm necrosis factor (TNF) receptor and has 16 age of collective clinical experience with an established prophylactic profile. ENBREL was first approved in 1998 for moderate to severe creaky arthritis and was later approved to treat children and adolescents with puerile rheumatoid arthritis (now called juvenile idiopathic arthritis) in 1999. ENBREL was approved in 2004 to treat moderate to severe brass psoriasis in adults.
ENBREL indications in the U.S:
-- ENBREL is indicated for reducing signs and symptoms, keeping joint impairment from acquiring worse, and improving forcible function in patients with moderate to severe rheumy arthritis. ENBREL can be taken with methotrexate or used lonely.
-- ENBREL is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients ages 2 and older.
-- ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and up physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients world Health Organization do not respond adequately to methotrexate sodium alone.
-- ENBREL is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.
-- ENBREL is indicated for the treatment of adult patients (18 long time or old) with chronic moderate to severe plaque psoriasis wHO are candidates for systemic therapy or phototherapy.
Important Safety Information
What significant safety information do I need to know around taking prescription ENBREL?
ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a core your body's immune system makes called TNF. People with an immune disease, such as rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis, or psoriasis, hold too much TNF in their bodies. ENBREL john reduce the amount of active TNF in the body to normal levels, helping to treat your disease. But, in doing so, ENBREL can also lower the ability of your immune system to fight infections.
Serious infections, including tuberculosis (TB), have happened in patients taking ENBREL. Some of these serious infections receive been fateful. Many serious infections occurred in people prone to infection. Serious infections get also occurred in patients with advanced or unwell controlled diabetes. Do not start ENBREL if you have an infection or are supersensitive to ENBREL or its components. Once on ENBREL, if you get an infection or have whatsoever sign of an infection, including fever, cough, or flu-like symptoms, or have open sores, tell your doctor. Your doctor should test you for TB before starting ENBREL and should monitor you intimately for signs and symptoms of TB.
Serious nervous system disorders, such as multiple sclerosis, seizures, or firing of the nerves of the eyes have been reported. There have been rare reports of good blood disorders (some fatal).
In medical studies, more cases of lymphoma (a type of cancer) were seen in patients taking TNF blockers compared to similar patients world Health Organization were non taking TNF blockers. The risk of lymphoma may be several-fold higher in people with rheumatoid arthritis and psoriasis; the role of TNF blockers in the development of malignancies is unknown.
Tell your doctor if you:
-- Think you have, are being treated for, throw signs of, or are prone to infection
-- Have whatever open sores
-- Have or possess had TB or operations.
The scientific information discussed in this news release related to Amgen's product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration (FDA), and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates. Only the FDA tin determine whether the product candidates ar safe and effective for the role(s) being investigated. Further, the scientific information discussed in this news release relating to new indications for Amgen's products is preliminary and investigative and is not part of the labeling approved by the FDA for the products. The products ar not approved for the investigational use(s) discussed in this news release, and no conclusions tin or should be raddled regarding the safety or effectiveness of the products for these uses. Only the FDA can square up whether the products ar safe and effective for these uses. Healthcare professionals should denote to and rely upon the FDA-approved labeling for the products, and not the entropy discussed in this news release.
Wyeth Forward-Looking Statement
The statements in this press release that ar not historical facts are forward-looking statements based on current expectations of next events and are topic to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include the inherent dubiety of the timing and success of, and expense associated with, research, development, regulatory approval and commercialisation of our products, including with respect to our pipeline products; government cost-containment initiatives; restrictions on third party payments for our products; substantial competitor in our industry, including from branded and generic products; information generated on our products; the grandness of unassailable performance from our principal products and our awaited new product introductions; the highly regulated nature of our business; product liability, intellectual holding and other litigation risks and environmental liabilities; doubtfulness regarding our intellectual place rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currentness exchange pace fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulative compliance; risks and uncertainties associated with global trading operations and sales; and other risks and uncertainties, including those elaborated from time to prison term in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the word under the caption "Item 1A, RISK FACTORS." The forward-looking statements in this press release are qualified by these risk factors. We take on no obligation to publicly update any forward-looking statements, whether as a final result of fresh information, future developments or otherwise.
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