“Only about half of patients on chronic steroids today are getting any type of osteoporosis testing and care, although we know for certain that chronic steroids are a major cause of osteoporosis.”—Kenneth G. Saag, MD
According to Leslie J. Crofford, MD, president of REF, the foundation’s Within Our Reach program is the largest private fundraising campaign in REF’s history. Since November 2006, the campaign has raised more than $18 million from the pharmaceutical industry, biotech companies, physicians, and patients. Clinical practice grant heads from the bedside into the streets
Perhaps the most novel study funded in this round of REF grants is in the clinical practice category, which explores the issues that directly affect the clinical practice of rheumatology and patient access.
Kenneth G. Saag, MD, MSc, and colleagues at the University of Alabama at Birmingham are conducting a new intervention aimed at improving bone health among RA patients on chronic glucocorticoids. Their goal is to increase RA patient demand for bone density testing and osteoporosis prevention and management.
“We can come up with the best drugs, biologics, or devices, but if they don't go to the right patients, or patients don't use them, they don't do any good. The major problem in osteoporosis care right now is underdiagnosis and undertreatment. Only about half of patients on chronic steroids today are getting any type of osteoporosis testing and care, although we know for certain that chronic steroids are a major cause of osteoporosis,” Dr. Saag told MSKreport.com. He is working with the CareMark pharmacy benefits management firm to try and change that.
“This is really type 2 translational research, which looks at better ways to transfer best practices from the bedside to the community. Type 1 translational research is the earlier stage of translating research into clinical practice. Our goal is to get physicians, patients, and health systems practicing state of the art medicine,” Dr. Saag said.
The study will include several thousand CareMark patients who have RA and have been prescribed chronic steroids. They will be randomized to an intervention group and a control group. Along with their meds, the intervention group will receive a DVD and printed brochure tailored to RA patients on steroids. Dr. Saag said that the DVD will include interviews with RA patients who developed steroid-associated bone loss, information on bone density testing, and a section on how to talk to one’s doctor about osteoporosis risk. Dr. Saag said that the program is built on well-validated behavioral therapy methods.
Follow-up will be at about 1 year after the initial intervention. Study endpoints will be rates of osteoporosis preventions and/or treatment in both groups. All patients will also be surveyed to determine whether they had bone density testing and whether they are taking calcium and vitamin D supplements.
“We are hoping that this approach will also have some generalizability to other chronic health problems,” Dr. Saag said.
Translational research moving fast from bench to bedside
The Within Our Reach campaign has built a reputation for supporting research not done elsewhere, and these grants are evidence of that. Translational research is the direct study of patients and patient-derived materials to improve the understanding of RA. Research in this area will study the joint and its cells and tissues to develop methods to repair and replace damaged cartilage and bone. One goal of the work is to develop ways to predict which RA patients will respond to which treatment approaches.
Robert M. Plenge, MD, PhD, of Brigham and Women's Hospital in Boston, received a grant to continue work on a genomewide association study of response to anti-TNF therapy in RA.
“This is a very important clinical question. Anti-TNF therapy is a mainstay of RA treatment, yet there are no predictors of who will respond and who will not respond. The research in my lab, in close collaboration with several other labs, has been very successful at conducting genomewide association studies of RA susceptibility. We hypothesize that a similar approach will also be successful at identifying genetic predictors of response to anti-TNF therapy.”
The researchers are seeking gene variants that predict who will/will not respond to anti-TNF therapy and which genes might be useful in routine clinical practice.
“We expect that the effect size of any individual DNA variant will be small,” Dr. Plenge said. “That is, we expect that no single variant will predict absolutely who will respond and who will not respond. Thus, it is likely that there will be a collection of DNA variants that cumulatively will predict response.”
In other REF-funded translational research projects, Larry W. Moreland, MD, of the University of Pittsburgh, will examine how multicytokine profiles correlate with outcome measures and treatment responses in early RA.
Peter K. Gregersen, MD, of the Feinstein Institute for Medical Research in New York, will develop cross-racial strategies for gene identification in RA. William F. C. Rigby, MD, of Dartmouth Medical School in Lebanon, New Hampshire, will study CD154 CA repeat polymorphisms and RA pathogenesis. Carl Grunfeld, MD, PhD, of the University of California, San Francisco, will look for novel cardiovascular disease risk factors in patients with RA.
“We are confident the research Within Our Reach yields will enhance rheumatologists’ ability to diagnose and treat patients suffering from this painful and potentially debilitating disease,” Dr. Crofford said.
Reference
1. American College of Rheumatology Research and Ed. Found. Awards New Research Grants for Rheumatoid Arthritis Research [press release]. Newswire Website. http://www.newswise.com/institutions/view/?id=102.
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