October 1999 Bulletin

Seek biomarkers to speed tests for new drugs

A collaboration of public and private organizations is taking shape to identify biomarkers for osteoarthritis that may speed the testing of new interventions to prevent or delay the onset of the disease that affects as many as 20 million Americans.

Arthritis is the leading cause of disability in the United States and has a major impact on the health care system, accounting for up to 39 million physician visits and more than 500,000 hospitalization. By the year 2020, arthritis is expected to affect almost 60 million people and limit the activity of 11.6 million people.

Osteoarthritis was characterized as "a clear and growing health need" at a meeting of the Osteoarthritis Initiative Steering Committee in June, chaired by Stephen Katz, MD, PhD, director, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The committee is guiding the development of the collaborative effort.

Current therapies for osteoarthritis are viewed as "pallative, surgical or pain-alleviating modalities." There are no disease-modifying pharmacologic interventions for osteoarthritis.

While scientists are trying to develop drugs that provide long-term treatment for osteoarthritis and address more than the symptoms, the safety and efficacy evaluation of new drugs is slowed by the need for lengthy clinical trials which require very large numbers of patients. The National Institute of Health (NIH) and Food and Drug Administration (FDA) recognize that scientific advances today and what may develop from the Human Genome Project in the future demands methods to evaluate more rapidly new interventions that may relieve or prevent osteoarthritis and other diseases.

The two agencies sponsored a multidisciplinary, international conference in April focusing on concepts and approaches for using biomarkers for a variety of diseases-osteoporosis and joint destruction and repair to chronic lung diseases and cancer therapeutics.

The osteoarthritis steering committee which includes officials of NIH; NIAMS; FDA; medical organizations, including the American Academy of Orthopaedic Surgeons and Orthopaedic Research Society; and pharmaceutical manufacturers has met twice to build the foundation for a collaborative effort. The mission is to "support, sponsor and conduct clinical and laboratory evaluations of biomarkers as potentially surrogate endpoints for clinical trials that assess the efficacy of osteoarthritis disease-modifying interventions."

Richard Hodes, MD, director, National Institute of Aging, welcomed the participants to the first meeting of the steering committee in April, calling it a "potentially historic event," having government and pharmaceutical representatives in the same room together. Indeed, drug companies that sign-on to the project and finance their work will be sharing their results with others. The search for biomarkers will be conducted in laboratories of academic institutions and drug companies.

It's not known if there are biochemical biomarkers, says Joan McGowan, PhD, director, Musculoskeletal Diseases Branch, NIAMS. That will be determined by a cohort study which follows patients at risk and analyzes blood and other fluid samples.

MRIs, X-rays and other technologies may provide the imaging biomarkers. Victor Goldberg, MD, chairman, department of orthopaedics, Case Western Reserve University, who represents the Academy, is chairman of the imaging subcommittee that reviewed at the June meeting what technologies hold promise for measuring the risk for/or progression of osteoarthritis. New technologies, particularly for imaging the joint space, bone and related tissues, even at the molecular level, offer benefits to measure the disease. Other subcommittees focused on biochemical biomarkers; epidemiology, biostatistics and genetics; and administration and management of the project.

McGowan said the discussions at the June steering committee meeting set the stage for another meeting Feb. 28, 2000 to address the issues that face the formation of the collaborative effort.

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