New Interim Results from the PRESERVE Study Evaluate ENBREL Therapy in Patients with Moderately Active Rheumatoid Arthritis
THOUSAND OAKS, Calif. and NEW YORK, May 25, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Pfizer Inc. (NYSE: PFE) today announced new results from multiple studies of ENBREL, further expanding the body of evidence supporting the efficacy and safety profile of ENBREL, the most prescribed biologic by rheumatologists in the United States (U.S.). Eighteen abstracts across four indications, including moderate-to-severe rheumatoid arthritis (RA), ankylosing spondylitis (AS), moderate-to-severe plaque psoriasis (PsO), and psoriatic arthritis (PsA), will be published at two global medical congresses, the European League Against Rheumatism (EULAR) and World Congress of Dermatology (WCD), this week.
"The breadth of data being presented at these congresses underscores our ongoing commitment to the rigorous study of these conditions where treatment has been shown to improve patient outcomes," said Yvonne Greenstreet, senior vice president and head of the Medicines Development Group for Pfizer's Specialty Care Business Unit. "With its first approval for RA in 1998, ENBREL has 2.5 million patient-years of collective clinical experience, and we continue to gain important knowledge about these conditions and the potential benefits of treating patients with certain chronic inflammatory diseases."
Selected abstracts of interest include:
Impact of Etanercept-Methotrexate (MTX) Therapy on Disease Activity and Radiographic Progression in Moderately Active Rheumatoid Arthritis: Interim Results of the PRESERVE Trial
Persistent inflammation and associated joint damage may play a critical role in causing impairment in joint function in RA. Previous studies exploring treatment with biologics focused primarily on patients with severe disease. The radiographic data are an exploratory endpoint and represent results from Period 1 of a 2-period study from the initial open-label portion of the PRESERVE trial examining patients with moderately active rheumatoid arthritis. The results demonstrated that treatment with ENBREL added to MTX reduced radiographic progression in 82 percent (modified Total Sharp Score [mTSS] change less than or equal to 0.5) of these patients, all of whom had an inadequate response to MTX alone. Results also showed that 86 percent of patients achieved Disease Activity Score (DAS) 28 low disease activity and 67 percent achieved DAS28 clinical remission with continuous treatment with ENBREL plus MTX.
Improvement in Patient-Reported Outcomes with Etanercept-Methotrexate (MTX) Therapy in Moderately Active Rheumatoid Arthritis: Interim Results of the PRESERVE Trial
Patients with RA often experience impairment in physical function, health-related quality of life (HR-QOL) and productivity at work. Patient-reported outcomes from the initial open-label portion of the PRESERVE trial examining patients with moderate rheumatoid arthritis showed clinically important improvements in measures of physical function, disease activity, pain, fatigue, HR-QOL and work productivity after 36 weeks of ENBREL added to MTX.
Association Between Nocturnal Back Pain and Fatigue in Ankylosing Spondylitis and Improvements in Both Patient-Reported Outcomes with Etanercept Therapy
Nocturnal back pain in AS patients is a strong predictor of fatigue. In an exploratory pooled analysis, data combined from four clinical trials of AS patients were analyzed and found that nocturnal back pain was a significant predictor of fatigue and showed that ENBREL provided reductions in nocturnal back pain and fatigue.
Psoriasis Patients with Psoriatic Arthritis and Axial Involvement Have a Higher Disease Burden than Those without Axial Involvement but Similar Treatment Outcomes: Results from PRESTA Trial
Patients who have PsO and PsA with axial disease (disease involvement in the spine) have a higher burden of disease than those without axial disease (patients who have disease in the peripheral joints only). Data from an exploratory analysis of the PRESTA trial examining patients with moderate-to-severe PsO and PsA found that patients presenting with and without axial disease showed benefit from treatment with ENBREL compared with baseline.
Effects of Etanercept on Cardiometabolic Biomarkers in Subjects with Moderate-to-Severe Plaque Psoriasis: The PRISTINE Trial
Psoriasis patients may have an increased incidence of co-morbid conditions, such as diabetes and cardiovascular disease. Data from this exploratory endpoint from the PRISTINE trial studying patients with moderate-to-severe plaque psoriasis found at week 12, ENBREL 50mg once or twice weekly did not negatively impact various biomarkers of cardiometabolic disease like apolipoprotein B/apolipoprotein A1 ratio, hsCRP, and NT-proBNP. The clinical significance of these findings needs to be studied further, but the results are important for consideration as the medical community continues to explore the potentially broader effects of inflammatory disease in the body.
About Rheumatoid Arthritis
Rheumatoid arthritis affects approximately 0.6 to 0.9 percent of the adult population worldwide and can start at any age, but usually occurs between 40 and 70 years. RA can cause pain, stiffness, swelling and limitation in the motion and function of multiple joints. In RA, joint damage can significantly worsen over time, especially if left untreated. Joint damage may impair function, and potentially disable some patients.
Psoriasis affects approximately 7.5 million American adults and is a chronic disease of the immune system that causes the skin cells to grow at an accelerated rate. Although there are several types of psoriasis, approximately 80 percent of patients suffer from plaque psoriasis, which can cause painful and itchy red, scaly patches to appear on the skin.
About Psoriatic Arthritis
Psoriatic arthritis is an auto-immune disease that causes pain, stiffness and swelling in and around the joints. In addition, psoriatic arthritis patients may experience skin lesions similar to those seen in plaque psoriasis.
Approximately 600,000 Americans have psoriatic arthritis. In fact, up to 30 percent of people diagnosed with plaque psoriasis may actually have psoriatic arthritis.
About Ankylosing Spondylitis
Ankylosing spondylitis is a debilitating condition that may affect two to three times as many men as women, and typically presents in patients during the second and third decades of life. AS typically causes inflammation, stiffness and pain in the spine (known as axial disease), but can also affect the peripheral joints. As a result of the disease, patients with symptomatic AS can lose productivity owing to work disability and unemployment, and may have substantial use of healthcare resources and an overall reduced quality of life.
ENBREL is a fully human soluble tumor necrosis factor (TNF) receptor antagonist. ENBREL was first approved in 1998 for moderate to severe rheumatoid arthritis and was approved in 2004 to treat adult chronic moderate to severe plaque psoriasis. ENBREL has more than 18 years (with more than 12 years of post-marketing experience in RA) and 2.5 million patient-years of collective clinical experience.
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 juvenile idiopathic arthritis (JIA) in children ages 2 years and older.
- 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.
If you have any questions about this information, be sure to discuss them with your doctor. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see Prescribing Information and Medication Guide at www.ENBREL.com.
ENBREL in the EU is approved for the following indications:
- Rheumatoid arthritis: ENBREL in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate (unless contraindicated), has been inadequate. ENBREL can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. ENBREL is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. ENBREL, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function.
- Polyarticular juvenile idiopathic arthritis: Treatment of active polyarticular juvenile idiopathic arthritis (JIA) in children and adolescents aged 4 to 17 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. ENBREL has not been studied in children aged less than 4 years.
- Psoriatic arthritis: Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. ENBREL has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.
- Ankylosing spondylitis: Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
- Plaque psoriasis: Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy including cyclosporine, methotrexate or PUVA. The European Commission recently approved a new 50mg ENBREL once-weekly dosage regimen as an alternative to the currently approved 25mg ENBREL twice-weekly regimen for the treatment of patients with moderate-to-severe plaque psoriasis.
- Pediatric plaque psoriasis: Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 8 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies.
For full information about ENBREL go to: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Summary_for_the_public/human/000262/WC500027364.pdf
Important Safety Information
Serious infections, including sepsis and tuberculosis, have been reported with the use of ENBREL. Some of these infections have been fatal. These infections were due to bacteria, mycobacteria, fungi, and viruses. Opportunistic infections have also been reported. Patients who develop a new infection while undergoing treatment with ENBREL should be monitored closely. Administration of ENBREL should be discontinued if a patient develops a serious infection.
Caution should be exercised when considering the use of ENBREL in patients with a history of recurring or chronic infections or underlying conditions which may predispose patients to infections. Treatment with ENBREL should not be initiated in patients with sepsis or risk of sepsis, or in patients with serious active infections.
Before initiation of therapy with ENBREL, any patient at increased risk for tuberculosis (TB) should be evaluated for active or latent infection. Prophylaxis of latent TB infection should be initiated prior to therapy with ENBREL. Physicians should monitor patients receiving ENBREL for signs and symptoms of active TB, including patients who tested negative for latent tuberculosis infection. Applicable local guidelines should be consulted.
Reports of malignancies affecting various sites have been received in the postmarketing period. In clinical trials of TNF antagonists, more cases of lymphoma were seen among patients receiving a TNF antagonist compared to control patients. However, there is an increased background lymphoma risk in RA patients with long-standing, highly active, inflammatory disease. Combining the results of controlled portions of clinical trials of ENBREL, more cases of melanoma and non-melanoma skin cancer were seen in patients receiving ENBREL compared with control patients, particularly in patients with psoriasis. A possible risk for the development of lymphomas or other malignancies in patients treated with an anti-TNF agent cannot be excluded.
Do not start ENBREL in patients with hypersensitivity to ENBREL or its components. Allergic reactions associated with ENBREL administration have been reported. If any serious allergic or anaphylactic reaction occurs, discontinue administration of ENBREL immediately.
There have been rare reports of CNS demyelinating disorders in patients treated with ENBREL.
Rare cases of pancytopenia, and very rare cases of aplastic anemia, some fatal, have been reported in patients treated with ENBREL. Exercise caution in patients who have a previous history of blood dyscrasias. Advise patients to seek immediate medical attention if they develop signs or symptoms of blood dyscrasias or infection. If blood dyscrasias are confirmed, discontinue ENBREL.
Reactivation of hepatitis B virus (HBV) in patients who are chronic carriers of this virus who are receiving anti-TNF agents, including ENBREL, has been reported. Patients at risk for HBV infection should be evaluated for prior evidence of the virus before initiating anti-TNF therapy. Although a causal relationship has not been established for ENBREL, caution should be exercised when administering ENBREL for patients identified as carriers for HBV.
There have been reports of worsening of hepatitis C in patients receiving ENBREL, although a causal relationship with ENBREL has not been established.
Physicians should use caution when using ENBREL in patients who also have moderate to severe alcoholic hepatitis.
About Amgen and Pfizer
Amgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.
At Pfizer, we apply science and our global resources to improve health and well-being at every stage of life. We strive to set the standard for quality, safety and value in the discovery, development and manufacturing of medicines for people and animals. Our diversified global health care portfolio includes human and animal biologic and small molecule medicines and vaccines, as well as nutritional products and many of the world's best-known consumer products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as the world's leading biopharmaceutical company, we also collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. To learn more about our commitments, please visit us at www.pfizer.com.
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