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You are here: Home / Articles / Dr. Wolfe & the National Data Bank for Rheumatic Diseases (NBD)

Dr. Wolfe & the National Data Bank for Rheumatic Diseases (NBD)

April 1, 2008 • By Norra MacReady

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The funds to support all of this work come mostly from independent research projects for private clients, including pharmaceutical company safety registries. In addition, NDB’s state-of-the-art data collection and analysis capabilities are used by its parent organization, The Arthritis Research Center Foundation, Inc. (ARCF), to perform other non–NDB-related activities.

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For example, in 2004, Abbott Laboratories used ARCF-NDB technology to conduct the Humira Efficacy Response Optimization (HERO) trial. This trial evaluated the efficacy of adalimumab using patient-reported outcomes. Regardless of funding source, however, all NDB research must be published in peer-reviewed journals.

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Today, the National Data Bank for Rheumatic Diseases holds information on more than 14,000 U.S. patients who have various forms of rheumatic disease.

Importance of Databases

Since its inception, the NDB has generated dozens of abstracts and publications on topics ranging from NSAID gastropathy to patients’ income and wage losses. (See “Topics of Research Generated by NDB,” above).

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Some of the findings have been unexpected. “I was surprised to learn that some of the newer drugs are safer than I thought they would be, but are less effective than shown in clinical trials,” says Dr. Wolfe.

Other data have reinforced what many rheumatologists already feared regarding the risks of prednisone and other corticosteroids. “Their side effects are real and measurable—things like shingles, infection, and fractures that may develop up to 10 years after the patient stops taking the drug.”

More subtle findings have also become evident as the data are sifted and analyzed. Among patients who take leflunomide, for example, diarrhea can have a significant impact on quality of life and is frequently the reason for its discontinuation. Another example concerns the side effects of the commonly used drug prednisone. As information in the database shows, people who take prednisone may struggle with weight gain, bruising, and edema. While clinicians may not always ask about these issues and patients may not volunteer them unless they are severe, the NDB shows in stark terms how the fallout from a chronic illness can reverberate through all aspects of a patient’s life.

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Information yielded by the NDB and other large databases like ARAMIS or the one started by the Consortium of Rheumatology Researchers of North America (CORRONA) is largely unobtainable through traditional randomized clinical trials of short duration.

“Rheumatologists develop lifelong relationships with their rheumatoid arthritis patients,” says Dr. Wolfe. “We take a long look at the outcomes of these illnesses. This allows us to conduct observational studies that tell us, for example, how well a drug works under real-life circumstances, unlike clinical trials, which tell you only how well a drug can work under idealized circumstances.”

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Filed Under: Information Technology, Technology Tagged With: ARAMIS, Frederick Wolfe, MD, National Data Bank for Rheumatic Diseases (NDB)., Practice toolsIssue: April 2008

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