Landmark Lupus Study Will Improve Care

National investigation to answer many complex questions

Dr. Maria Dall 'Era with study participant Patrick Keegan

The UCSF Division of Rheumatology is part of an ambitious research project that will collect detailed clinical and quality-of-life information from several thousand lupus patients during each of their office visits over five years. This unprecedented amount of data will provide a unique opportunity for scientists to better understand the course of the disease and the medications used to treat it.

The study receives partial support from the Rosalind Russell Medical Research Center for Arthritis, with major funding from the Lupus Clinical Trials Consortium.

Systemic lupus erythematosus is a chronic, sometimes life-threatening systemic inflammatory disease that can affect various parts of the body, especially the joints, skin, blood and kidneys.

Because lupus is relatively rare, a collaboration among 22 lupus clinics around the country is required to generate enough data for the study, according to UCSF lupus clinic and study director Maria Dall 'Era, MD. Like the other participants, UCSF will enroll 100 patient volunteers, and conduct physical exams and collect blood at every visit. Drs. Dall 'Era and Jinoos Yazdany, associate director of the lupus clinic, will see all patients. Both received support during their UCSF Rheumatology Fellowships from the Rosalind Russell Medical Research Center for Arthritis.

During clinic visits, each patient will also complete a thorough questionnaire to enable researchers to track quantitative information—about hospitalizations and disability and flares, for example—and qualitative data—about changes in stress and perceived disease status, among other things.

Unlike a clinical trial, where rigorous enrollment criteria strictly limits who can participate, this study will include all kinds of lupus patients, including pregnant women and those who also have cancer, heart disease and diabetes. Also in contrast to clinical trials, all lupus patients can participate, regardless of their medication history.

This study design is expected to enable scientists to answer a wide variety of questions: Are there biomarkers—biological indicators in the body—that predict the course of the disease or response to specific therapies? How do patients with both lupus and cancer fare over five years? Are there geographic differences in physicians' practice patterns? How often do patients flare, and what predicts flares?

"We're also going to be able to look at differences in outcomes between different racial/ethnic groups as well as at rare manifestations of lupus," says Dr. Dall 'Era. "For example, we should be able to get a good handle on understanding the course of disease among patients who experience neuropsychiatric features of lupus such as stroke and cognitive difficulties."

UCSF's David Wofsy, MD, who was the first scientific director of the Lupus Clinical Trials Consortium, says "This national study is likely to teach us far more about the course of treatment of lupus than any prior study."

"This national study is likely to teach us far more about the course of treatment of lupus than any prior study."
--- Dr. David Wofsy

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