Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced that data from a multicenter, randomized, double-blind trial of ENBREL plus methotrexate showed that 50 percent of patients with active early rheumatoid arthritis achieved clinical remission at one year. In contrast, 28 percent of patients achieved clinical remission who were treated with methotrexate alone. The population under study had less than two years (median seven months) of moderately to severely active disease. Results from the COMET (COmbination of Methotrexate and ETanercept in Active Early Rheumatoid Arthritis) trial will be presented at the American College of Rheumatology (ACR) Scientific Meeting in Boston, Massachusetts.
"Clinical remission, as measured by DAS28, is an important goal in clinical practice, and is perhaps the most relevant to patients’ daily lives as they struggle with their symptoms,” said Paul Emery, professor of Rheumatology, University of Leeds, UK. "We hope that both patients and physicians are encouraged by these findings as they set a new standard for earlier treatment of RA."
The COMET study’s secondary endpoints included proportions of patients achieving ACR 20, ACR 50 and ACR 70 scores at week 52 following treatment with ENBREL plus methotrexate, compared to methotrexate alone. The study showed 48 percent of patients receiving ENBREL plus methotrexate achieved an ACR 70 score, versus 28 percent of the methotrexate-only group. Additionally, 71 percent of patients receiving combination therapy achieved an ACR 50 score, versus 49 percent of patients treated with methotrexate alone. The percentage of patients who achieve an ACR 50 or ACR 70 score represent those who achieve a 50 percent or 70 percent improvement in select RA symptoms, including joint swelling and tenderness, pain, level of disability, overall patient and physician disease assessment, and an objective marker of inflammation, such as erythrocyte sedimentation rate.
More than 2 million Americans suffer from RA, which can cause stiffness, swelling, and limitation in the motion and function of multiple joints. If RA is left untreated, patients can become disabled from irreversible joint damage caused by the disease, limiting their ability to function.
There were no differences in rates of serious infections or malignancies among patients in the ENBREL plus methotrexate group compared with the methotrexate-only group. No cases of TB or demyelinating disease were reported. No new safety signals were identified. In other RA clinical trials, the most common adverse events were injection site reaction, infection, and headache.
STUDY DESIGNThis study was designed to compare the clinical efficacy and safety of ENBREL and methotrexate combination therapy with methotrexate alone in patients with active early rheumatoid arthritis. Patients in this study had disease duration of ≤ 2 years, had not previously received methotrexate, and had active disease based on DAS28 (≥ 3.2) and elevation of erythrocyte sedimentation rate (≥ 28 mm/hr) or C-reactive protein (≥ 20 mg/L). Patients were randomized to receive either ENBREL plus methotrexate (n = 274) or methotrexate alone (n = 268). The primary endpoint was proportion of patients achieving DAS28 clinical remission (
ENBREL is a fully human soluble tumor necrosis factor (TNF) receptor. ENBREL was first approved in 1998 and has since been used in more than 460,000 patients worldwide across indications.
ENBREL indications in the U.S.:
ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderate to severe rheumatoid arthritis. ENBREL can be taken with methotrexate or used alone.
ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular-course juvenile rheumatoid arthritis in patients who have had an inadequate response to one or more disease modifying antirheumatic drugs.
ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with psoriatic arthritis. ENBREL can be used in combination with methotrexate in patients who do not respond adequately to methotrexate 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 years or older) with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
What important information do I need to know about taking prescription Enbrel® (etanercept)?
ENBREL is a type of protein called a tumor necrosis factor (TNF) blocker that blocks the action of a substance your body's immune system makes called TNF. People with an immune disease, such as rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and psoriasis, have too much TNF in their bodies. ENBREL can reduce the amount of 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.
All medicines have side effects, including ENBREL. Possible side effects of ENBREL include:Serious infections
-Tell your doctor if you have ever had any of these disorders or if you develop them after starting ENBRELRare reports of serious blood disorders (some fatal)
-The role of TNF blockers, including ENBREL, in the development of lymphoma is unknown
ENBREL can cause injection site reactionIn a medical study of patients with JRA, infection, headache, abdominal pain, vomiting, and nausea occurred more frequently than in adults
-Other serious adverse reactions were reported rarely, including serious infection (2 percent) and depression/personality disorder (1 percent)
Sonia Fiorenza | EurekAlert!
Scientists develop tiny tooth-mounted sensors that can track what you eat
22.03.2018 | Tufts University
NIH scientists describe potential antibody treatment for multidrug-resistant K. pneumoniae
14.03.2018 | NIH/National Institute of Allergy and Infectious Diseases
An international team of researchers has discovered a new anti-cancer protein. The protein, called LHPP, prevents the uncontrolled proliferation of cancer cells in the liver. The researchers led by Prof. Michael N. Hall from the Biozentrum, University of Basel, report in “Nature” that LHPP can also serve as a biomarker for the diagnosis and prognosis of liver cancer.
The incidence of liver cancer, also known as hepatocellular carcinoma, is steadily increasing. In the last twenty years, the number of cases has almost doubled...
In just a few weeks from now, the Chinese space station Tiangong-1 will re-enter the Earth's atmosphere where it will to a large extent burn up. It is possible that some debris will reach the Earth's surface. Tiangong-1 is orbiting the Earth uncontrolled at a speed of approx. 29,000 km/h.Currently the prognosis relating to the time of impact currently lies within a window of several days. The scientists at Fraunhofer FHR have already been monitoring Tiangong-1 for a number of weeks with their TIRA system, one of the most powerful space observation radars in the world, with a view to supporting the German Space Situational Awareness Center and the ESA with their re-entry forecasts.
Following the loss of radio contact with Tiangong-1 in 2016 and due to the low orbital height, it is now inevitable that the Chinese space station will...
Fraunhofer Institute for Organic Electronics, Electron Beam and Plasma Technology FEP, provider of research and development services for OLED lighting solutions, announces the founding of the “OLED Licht Forum” and presents latest OLED design and lighting solutions during light+building, from March 18th – 23rd, 2018 in Frankfurt a.M./Germany, at booth no. F91 in Hall 4.0.
They are united in their passion for OLED (organic light emitting diodes) lighting with all of its unique facets and application possibilities. Thus experts in...
A new scenario seeking to explain how Mars' putative oceans came and went over the last 4 billion years implies that the oceans formed several hundred million...
For the first time, an interdisciplinary team from the University of Basel has succeeded in integrating artificial organelles into the cells of live zebrafish embryos. This innovative approach using artificial organelles as cellular implants offers new potential in treating a range of diseases, as the authors report in an article published in Nature Communications.
In the cells of higher organisms, organelles such as the nucleus or mitochondria perform a range of complex functions necessary for life. In the networks of...
19.03.2018 | Event News
16.03.2018 | Event News
13.03.2018 | Event News
22.03.2018 | Trade Fair News
22.03.2018 | Earth Sciences
22.03.2018 | Earth Sciences