Major Study Launched to Test Whether Patient Response to Rheumatoid Arthritis Drugs Can be Predicted by Common Genetic Markers.Business Editors and Health/Medical Writers
WALTHAM, Mass.--(BW HealthWire)--May 29, 2002
-- Study to Be Conducted by Interleukin interleukin
Any of a class of naturally occurring proteins important in regulation of lymphocyte function. Several known types are recognized as crucial constituents of the body's immune system (see immunity). Genetics and UnitedHealth Group UnitedHealth Group Incorporated NYSE: UNH is a managed health care company. It is the parent of United Healthcare, one of the largest health insurers in the U.S. It was created in 1977, as UnitedHealthCare Corporation (it renamed itself in 1998), but traces its origin to a , a Novel Partnership Between Biotechnology and Managed Care --
Interleukin Genetics, Inc. (NASDAQ NASDAQ
in full National Association of Securities Dealers Automated Quotations
U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on :ILGN) and researchers at UnitedHealth Group's Center for Health Care Policy & Evaluation announced today the launch of a new clinical study to determine the influence of genetic markers on an individual's response to anti-IL-1 and anti-TNFa therapy in adults with rheumatoid arthritis rheumatoid arthritis
Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course. . While new biologic agents for the treatment of rheumatoid arthritis offer tremendous hope to some patients, many may receive little to no clinical benefit. Furthermore, these drugs have been associated with an increasing risk of adverse side effects Side effects
Effects of a proposed project on other parts of the firm. and treatment costs can exceed $10,000 per year. Interleukin Genetics plans to combine the results of this study with economic modeling data and additional clinical study results to develop an inexpensive test to assist physicians and patients in selecting which of the biologic rheumatoid arthritis drugs would bring the greatest clinical benefit.
Rheumatoid arthritis (RA) is a chronic disease of unknown cause characterized by prolonged inflammation, swelling, and pain of multiple joints. RA is a debilitating de·bil·i·tat·ing
Causing a loss of strength or energy.
Weakening, or reducing the strength of.
Mentioned in: Stress Reduction and costly disease that affects quality of life. Although the underlying cause of the variable clinical expression is not known, results of several studies indicate that differences in individual genetic factors play a central role.
"By combining our expertise in the genetics of inflammation with the clinical leadership provided by UnitedHealth Group, we believe this study will elucidate a strong association between an individual's genetic make-up and response to rheumatoid arthritis therapy," said Dr. Paul (Kip) Martha, Chief Medical Officer at Interleukin Genetics. "This study is part of our TARxGET RA program, a worldwide, comprehensive clinical, economic and functional genetics program directed toward the development of a pharmacogenetic test to help doctors and patients choose the best course of rheumatoid arthritis therapy. We believe that this test will not only enhance the quality of life for rheumatoid arthritis patients, but will also serve as a valuable tool to help the managed care industry better allocate their resources by enabling patients to get on the right treatment path from the start."
Dr. Martha added, "In the next phase of our TARxGET RA program, Interleukin Genetics will conduct a cost modeling study of our pharmacogenetic test with the School of Health and Related Research (ScHARR - UK) to determine its economic impact on the healthcare systems in both the U.S. and U.K."
The study has recently received IRB IRB
See: Industrial Revenue Bond approval (Institutional Review Board) and will be conducted through collaboration between UnitedHealth Group's Center for Health Care Policy & Evaluation, Interleukin Genetics and the University of Sheffield The University of Sheffield is a research university, located in Sheffield in South Yorkshire, England. Reputation
Sheffield was the Sunday Times University of the Year in 2001 and has consistently appeared as their top 20 institutions. , U.K. Investigators will examine whether specific variations in the IL-1 and TNF TNF
tumor necrosis factor
n an abbreviation for tumor
f (alpha) gene families, alone or in combination, are associated with the response to anti-TNFa therapy in adults with rheumatoid arthritis. The study will enroll approximately 2000 patient volunteers with a previous history of RA and use of the drugs Enbrel(R) or Remicade(R) within a 12-month period. The study will test responders and non-responders to determine if there is a useful clinical difference between the two groups based on their genotypes. Participants will be asked to sign an informed consent form, complete a questionnaire and provide a cheek swab sample for genotyping. Each sample will be coded and blinded to ensure the confidentiality of each volunteer's genetic information. Individual identities and records will not be shared with Interleukin Genetics and UnitedHealth group personnel.
Background on IL-1 and TNFa Variability in Rheumatoid Arthritis
Inflammation in rheumatoid arthritis involves the action of several proteins in the body known as inflammatory cytokines Cytokines
Chemicals made by the cells that act on other cells to stimulate or inhibit their function. Cytokines that stimulate growth are called "growth factors. . Two of these cytokines, IL-1 (Interleukin-1) and TNFa (Tumor Necrosis Factor tumor necrosis factor
n. Abbr. TNF
A protein that is produced in the presence of an endotoxin, especially by monocytes and macrophages, is able to attack and destroy tumor cells, and exacerbates chronic inflammatory diseases. Alpha), influence the overall disease severity through their relative levels of activity. Recent research indicates that the contribution of IL-1 versus TNFa to disease activity differs among individuals with rheumatoid arthritis. As is true for all regulatory proteins regulatory proteins
1. proteins which regulate the contraction of muscle by controlling the interaction of myosin and actin. Calcium is an essential component of this reaction. The two proteins are troponin and tropomyosin.
2. , individual genes direct production of IL-1 and TNFa, and some of the common differences in these genes (called single nucleotide polymorphisms or SNPs) produce significant alterations in the level of IL-1 or TNFa activity in the human body.
Currently, there are three protein-based drugs on the market in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area. and Europe for rheumatoid arthritis that act by blocking IL-1 or TNFa activity, Enbrel(R), Remicade(R) and more recently, Kineret(R). Enbrel(R) and Remicade(R) act by blocking TNFa action, while Kineret(R) selectively blocks IL-1. There is substantial variation in individual responses to each compound.
About Interleukin Genetics' TARxGET RA Program
This study with UnitedHealth Group's Center for Health Care Policy & Evaluation is part of Interleukin Genetics' TARxGET program (Translating Advanced Research in Genomics into more Effective Therapeutics) for rheumatoid arthritis. The TARxGET RA Program is comprised of several clinical, economic and functional genomics Noun 1. functional genomics - the branch of genomics that determines the biological function of the genes and their products
genomics - the branch of genetics that studies organisms in terms of their genomes (their full DNA sequences) studies to examine the role that common variations in genes involved in the critical pathways play in determining an individual's response to anti-IL-1 and anti-TNFa rheumatoid arthritis therapies. Interleukin Genetics will use the results of these studies to develop a single, pharmacogenetic test to help doctors choose the right treatment for patients based on an individual's genetic make-up.
Note to editors: For a copy of a statement released by the Arthritis Foundation This article or section needs sources or references that appear in reliable, third-party publications. Alone, primary sources and sources affiliated with the subject of this article are not sufficient for an accurate encyclopedia article. on the value of pharmacogenetics Pharmacogenetics Definition
Pharmacogenetics is the study of how the actions of and reactions to drugs vary with the patient's genes.
Description research to the treatment and care of rheumatoid arthritis patients, please call one of the company contacts listed below or Debbie Gruver, Arthritis Foundation, at (404) 965-7857.
Enbrel(R) is a registered and marketed in the U.S. by Immunex.
Remicade(R) is a registered and marketed in the U.S. by Centocor.
Kineret(R)(anakinra) is registered and marketed in the U.S. by Amgen.
Interleukin Genetics is a biotechnology company focused on inflammation. The company uses functional genomics to develop diagnostic and therapeutic products based on the genetic variations in people to help prevent or treat diseases of inflammation. Interleukin's TARxGET (Translating Advanced Research in Genomics into more Effective Therapeutics) programs focus on the areas of cardiovascular disease Cardiovascular disease
Disease that affects the heart and blood vessels.
Mentioned in: Lipoproteins Test
cardiovascular disease , rheumatoid arthritis and osteoporosis and include the development of tests to assess a person's risk for heart disease and osteoporosis as well as a test to help doctors and patients choose the best course of therapy for rheumatoid arthritis. These products will enable the managed care industry to improve patient care and better allocate resources. In addition to its research partnerships with numerous academic centers in the U.S. and Europe, Interleukin's corporate collaborators include the leading healthcare organizations, Kaiser Permanente and UnitedHealth Group. For more information about Interleukin and its ongoing programs, please visit http://www.ilgenetics.com
Certain statements contained herein are "forward-looking" statements (as such term is defined in the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995). Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, risk of market acceptance of Company products, ability of the Company to raise necessary capital, risk of technology and products obsolescence ob·so·les·cent
1. Being in the process of passing out of use or usefulness; becoming obsolete.
2. Biology Gradually disappearing; imperfectly or only slightly developed. , delays in development of products, reliance on partners, competitive risks and those risks and uncertainties described in the Company's Form 10-K Form 10-K
A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.
See 10-K. as filed on March 28, 2002, and in other filings made by the Company with Securities and Exchange Commission. The Company disclaims any obligation to update these forward-looking statements.