- Lack of diagnostic, predictive and prognostic biomarkers for lupus and lack of biomarkers to predict drug response in clinical trials;
- Flawed clinical trial design;
- Lack of access to clinicians familiar with lupus/limited awareness of lupus among non-expert medical professionals;
- Barriers to effective management of lupus due to social determinants of care in predominantly lower socioeconomic status areas; and
- Lack of treatment adherence.
Disparities
One of the motivations behind the ALPHA project was an attempt to address lupus mortality rates, which dropped in the later decades of the 20th century but have remained stagnant ever since, the study authors say. Mortality rates for lupus patients are three times higher than in the general population without lupus.
Disparities within the lupus patient population also remain a challenge. The disease disproportionately threatens the health of young women from communities of color and low socioeconomic status. Among those with chronic inflammatory diseases, lupus is the leading cause of death in women aged 15–24, higher than diabetes mellitus and HIV.
“One of the big barriers to effective management of lupus is due to social determinants of health,” says Dr. Costenbader. “People of lower socioeconomic status often have many other things on their plates, and there are issues of healthcare access, health literacy and understanding, adherence to medications, and other health problems. These are all compounded in the populations we’re trying to help.”
Research Funding & Drug Development
Additionally—and despite funding increases by the U.S. Department of Defense and the Centers for Disease Control & Prevention—overall funding for lupus research has dropped over the past decade, particularly from the largest source of support, the National Institutes of Health, despite increased interest in lupus-related research.
Drug development, too, remains a challenge.
“There has only been one new lupus medication to receive FDA approval in this country, belimumab, and it’s the first new medication approved in 60 years,” says Dr. Costenbader. “The armamentarium of lupus medications approved worldwide is very thin.”
Overcoming some of the barriers to more effective and robust clinical trials could help advance treatments, ALPHA authors say. More than 30 companies are currently investing in clinical trials for lupus.
“We talked about clinical trial designs that are lumping people together who don’t belong together, or using composite measures that might be effective for one organ system but not another,” says Dr. Costenbader. “We have to be smart about clinical trials so we’re enrolling a specific kind of patient with a specific kind of lupus and designing stronger clinical trials.”
