THOUSAND OAKS, Calif. and NEW YORK, Nov. 5, 2011 /PRNewswire/ -- Amgen (NASDAQ: AMGN) and Pfizer Inc. (NYSE: PFE) today announced results of the second and final period of the PRESERVE trial. PRESERVE is a two-period multi-center trial in patients with moderately active rheumatoid arthritis (RA) who achieved Disease Activity Score (DAS) 28 low disease activity (LDA) or clinical remission on combination Enbrel® (etanercept) plus methotrexate (MTX) in Period one and were randomized to continue on ENBREL plus MTX or MTX alone in Period two. Results of Period two showed that the percentage of patients who maintained LDA or achieved clinical remission at week 88 was significantly higher in patients receiving ENBREL plus MTX than those on MTX alone. These results have been accepted in the late-breaker poster presentation at the 2011 American College of Rheumatology Annual Scientific Meeting in Chicago, from Nov. 5-9, 2011.
Patients with moderately active RA represent the largest RA population, yet they have not been widely studied as a distinct group in prospective clinical studies. The PRESERVE (A Prospective, Randomized Etanercept Study to Evaluate Reduced dose Etanercept + MTX v. full dose Etanercept + MTX v. MTX alone for efficacy and radiographic endpoints in a moderate RA population) study is the largest completed clinical trial of a biologic therapy in adults with moderately active RA, despite MTX treatment.
The PRESERVE trial met both its primary and conditional primary endpoints by demonstrating a statistically superior response in moderately active RA patients taking ENBREL 50mg weekly (QW) plus MTX or ENBREL 25mg QW plus MTX compared with those taking MTX monotherapy at 88 weeks. Specifically, after achieving LDA ( [DAS] 28 <3.2) at 36 weeks on ENBREL 50mg QW plus MTX, the percentage of patients maintaining LDA at week 88 was significantly higher in the ENBREL 50mg QW (82.6 percent, primary endpoint) and ENBREL 25mg QW (79.1 percent, conditional primary endpoint) treatment groups than the MTX- alone group (42.6 percent, P<0.0001 versus either ENBREL group). The U.S. Food and Drug Administration (FDA)- and the European Medicines Agency (EMA)- recommended dose for ENBREL for the treatment of moderate to severe RA is 50mg QW.
Additionally, for DAS 28 clinical remission (DAS28<2.6) HAQ < 0.5,ACR20/50/70, and European League Against Rheumatism (EULAR) good response, the percentage of patients who achieved these secondary endpoints was significantly higher in the ENBREL treatment groups than the MTX-alone group (P<0.05).
"The medical community has recently questioned whether clinical remission or LDA could be sustained if a biologic agent is discontinued," said Josef S. Smolen, M.D., lead PRESERVE trial investigator and chairman of the Department of Rheumatology, Medical University of Vienna, Austria. "These data show that patients with moderately active disease who achieve LDA or clinical remission with ENBREL treatment may lose these clinical benefits if ENBREL is discontinued."
There were no new safety signals, and the safety profile from PRESERVE was consistent with that seen in previous ENBREL studies. Thirty-five subjects (5.8 percent) reported at least one serious adverse event (SAE) during Period two. The proportion of subjects with at least one SAE was similar among treatment groups (13 [6.4 percent], 7 [3.5 percent], and 15 [7.5 percent] in the full-dose, dose reduction, and MTX-only groups, respectively). No specific SAE was observed in more than two subjects. Two deaths, which were considered to be unrelated to the study medication, occurred in the ENBREL 50mg QW plus MTX group.
About PRESERVEThe 88-week PRESERVE study, the largest completed clinical trial of biologic therapy conducted in patients with moderately active RA (DAS28 >3.2 and < 5.1), consisted of two study periods. During Period one, patients received open-label ENBREL 50mg QW plus MTX for 36 weeks. Those who responded to treatment (n=604; DAS28 <3.2 at week 36 and an average DAS28 <3.2 from week 12 through 36) were randomized to one of three treatment arms (ENBREL 50mg QW, ENBREL 25mg QW, or placebo) plus MTX, and followed for an additional 52 weeks. The FDA- and EMA- recommended dose for ENBREL for the treatment of moderate to severe RA is 50mg QW.
About ENBREL Data at the American College of Rheumatology Annual Scientific MeetingAmgen and Pfizer will also be presenting new analyses of data from several studies of ENBREL at the American College of Rheumatology Annual Scientific Meeting. Selected abstracts and presentations include:
About Rheumatoid ArthritisRA is a chronic inflammatory disease that affects approximately one 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 limitations 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.
About ENBREL ENBREL is a soluble form of a fully human tumor necrosis factor (TNF) receptor with a clinical efficacy and safety profile established over 18 years of collective clinical experience. ENBREL was first approved in the U.S. in 1998 for moderate to severe rheumatoid arthritis and was later approved to treat children and adolescents with moderate to severe juvenile rheumatoid arthritis (now called juvenile idiopathic arthritis) in 1999. In 2004, ENBREL was approved in the U.S. to treat adult chronic moderate to severe plaque psoriasis. Prescription ENBREL is given by injection.
ENBREL indications in the U.S.:
IMPORTANT SAFETY INFORMATION What is the most important information I should know about ENBREL?ENBREL is a medicine that affects your immune system. ENBREL can lower the ability of your immune system to fight infections. Serious infections have happened in patients taking ENBREL. These infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some patients have died from these infections. Your doctor should test you for TB before you take ENBREL and monitor you closely for TB before, during, and after ENBREL treatment, even if you have tested negative for TB.
There have been some cases of unusual cancers reported in children and teenage patients who started using tumor necrosis factor (TNF) blockers before 18 years of age. Also, for children, teenagers, and adults taking TNF blockers, including ENBREL, the chances of getting lymphoma or other cancers may increase. Patients with RA or psoriasis may be more likely to get lymphoma.
Before starting ENBREL, tell your doctor if you:
What are the possible side effects of ENBREL?ENBREL can cause serious side effects including: New infections or worsening of infections you already have; hepatitis B can become active if you already have had it; nervous system problems, such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes; blood problems (some fatal); new or worsening heart failure; new or worsening psoriasis; allergic reactions; autoimmune reactions, including a lupus-like syndrome and autoimmune hepatitis.
Common side effects include: Injection site reactions, upper respiratory infections (sinus infections), and headache.
These are not all the side effects with ENBREL. Tell your doctor about any side effect that bothers you or does not go away.
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.comAbout Amgen and Pfizer About AmgenAmgen 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. Follow us on www.twitter.com/amgen.
About Pfizer 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.
Amgen Forward-Looking StatementThis news release contains forward-looking statements that are based on Amgen's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to Amgen's business. Unless otherwise noted, Amgen is providing this information as of Nov. 5, 2011 and expressly disclaims any duty to update information contained in this news release.
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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 can determine whether the product candidates are safe and effective for the use(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 U.S. Food and Drug Administration (FDA) for the products. The products are not approved for the investigational use(s) discussed in this news release, and no conclusions can or should be drawn regarding the safety or effectiveness of the products for these uses. Only the FDA can determine whether the products are safe and effective for these uses. Healthcare professionals should refer to and rely upon the FDA-approved labeling for the products, and not the information discussed in this news release.CONTACT:AmgenPfizerChristine Regan (media)
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