Wyeth Pharmaceuticals, a division of Wyeth, today announced that the European Commission has approved ENBREL® (25 mg twice weekly), for use in combination with methotrexate for the treatment of active rheumatoid arthritis (RA) in adults when the response to disease-modifying antirheumatic drugs (DMARDs) (including methotrexate unless contraindicated) has been inadequate. This new indication is in addition to the previously approved indication for use of ENBREL as monotherapy in the treatment of active RA.
This approval is based on one-year results from the Trial of Etanercept and Methotrexate with Radiographic Patient Outcomes (TEMPO). In the study, RA patients treated with a combination of ENBREL and methotrexate demonstrated an improvement in X-ray findings as measured by the modified Total Sharp Score (TSS), and 80 percent of the patients experienced no progression of joint damage. Additionally, 37 percent of RA patients treated with combination therapy achieved clinical remission as measured by Disease Activity Score (DAS) improvement, and 43 percent experienced a 70 percent improvement in RA symptoms as measured by American College of Rheumatology (ACR) response criteria.
In the TEMPO study, patients were assigned to one of three treatment groups: ENBREL (25 mg twice weekly), methotrexate (up to 20 mg once weekly), or ENBREL (25 mg twice weekly) plus methotrexate. Progression of joint damage was evaluated using the modified TSS, an X-ray measurement of changes in joint damage. Patients receiving combination treatment with ENBREL and methotrexate achieved a mean improvement of -0.54 in the modified TSS compared to baseline. Eighty percent of patients in the combination group showed "no progression," which was defined as a change in modified TSS
"The data we've seen from the TEMPO trial - using ENBREL either alone or in combination with methotrexate for the treatment of RA - is truly exciting, offering many patients the option for effective treatment and possibly preventing radiographic progression in RA," says Dr. Joseph Camardo, Senior Vice President, Global Medical Affairs, Wyeth Pharmaceuticals.
"ENBREL has a history of proven efficacy and tolerability in RA, and new information gathered through clinical trials such as TEMPO allows us to explore new treatment options to help improve the lives of RA patients," says Dr. Magnus Jaderberg, Vice President of Global Medical Affairs and European Medical Director of Wyeth Pharmaceuticals. "We will also see the clinical two-year results from the TEMPO study presented at the European League Against Rheumatism (EULAR) congress in June, which will provide even more information that can help physicians make important treatment decisions for their RA patients."
ABOUT THE TEMPO STUDY
The TEMPO study randomized 682 patients with RA. Patients in the ENBREL TEMPO trial had active RA and had had an inadequate response to at least one DMARD other than methotrexate. In the study, treatment with ENBREL or combination therapy was generally well tolerated. No changes to the safety profile were observed, and the combination did not result in increased infections. No cases of tuberculosis or opportunistic infections were observed.
ABOUT RA
RA can be a painful and debilitating disease, and currently there is no known cure. RA can cause stiffness, swelling, and limitation in the motion and function of multiple joints. If RA is not aggressively treated or is left untreated, patients can become disabled from joint damage caused by the disease, limiting their ability to function.
ABOUT ENBREL
Wyeth Pharmaceuticals markets ENBREL outside North America. ENBREL was discovered by Immunex, now part of Amgen (NASDAQ: AMGN), and jointly developed with Wyeth Pharmaceuticals. The two companies co-promote ENBREL in North America.
In the European Union, ENBREL is approved alone or in combination with methotrexate for the treatment of active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrextate (unless contraindicated), has been inadequate. ENBREL is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. In patients with rheumatoid arthritis, ENBREL used alone or in combination with methotrexate has been shown to slow the progression of disease-associated structural damage as measured by X-ray. ENBREL is also approved for the treatment of active polyarticular-course juvenile chronic arthritis in children aged 4 to 17 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. ENBREL is also approved for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate and for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
Rheumatologists have become familiar with the benefits and long-term tolerability profile of ENBREL since it became commercially available nearly five years ago. More than 234,000 patients have been treated worldwide across indications. ENBREL (etanercept) acts by binding tumor necrosis factor (TNF), one of the dominant inflammatory cytokines or regulatory proteins that play an important role in both normal immune function and the cascade of reactions that causes the inflammatory process of psoriatic arthritis and RA. The binding of ENBREL to TNF renders the bound TNF biologically inactive, which can result in significant reduction in inflammatory activity.
Since the product was first introduced, serious infections, some involving death, have been reported in patients using ENBREL. Patients should tell their doctor if they currently have an infection or are prone to getting infections. Patients should not start ENBREL if they have an infection of any type or an allergy to ENBREL or its components. ENBREL should be used with caution in patients prone to infection.
There have been reports of serious nervous-system disorders such as multiple sclerosis and/or inflammation of the nerves of the eyes. Patients should inform their doctor if they have ever had any of these disorders or if they develop them after starting ENBREL. Patients should also tell their doctor if they have ever been treated for heart failure. There also have been rare reports of serious blood disorders, some involving death.
Patients should contact their doctor immediately if they develop symptoms such as persistent fever, bruising, bleeding, or paleness. It is unclear if ENBREL has caused these nervous-system or blood disorders. If a patient's doctor confirms serious blood problems, patients may need to stop using ENBREL.
The most frequent adverse events in clinical trials were injection-site reactions (ISRs) (36%), infections (35%), and headache (17%). Malignancies were rare. Only the rate of ISRs was higher than that of placebo. Adverse events in the psoriatic arthritis trial were similar to those reported in RA clinical trials.
ABOUT WYETH
Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women's health care, cardiovascular disease, central nervous system, inflammation, hemophilia, oncology and vaccines. Wyeth is one of the world's largest research-driven pharmaceutical and health care products companies. It is a leader in the discovery, development, manufacturing, and marketing of pharmaceuticals, vaccines, biotechnology products and non-prescription medicines that improve the quality of life for people worldwide. The Company's major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.
Media
Jenifer Antonacci
Wyeth Pharmaceuticals
484-865-5220
wyeth
View drug information on Enbrel.
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