Despite guidelines, hydroxychloroquine prescriptions are lagging.

Despite published guidelines that pregnant lupus patients take both hydroxychloroquine and aspirin, those medications are often not prescribed for this population, according to a study by April Barnado, M.D., an assistant professor and research director at the Vanderbilt Lupus Center.

This year, Barnado will present her findings at the International Conference on Reproduction, Pregnancy and Rheumatic Disease and at the American College of Rheumatology annual meeting.

“Increasingly, the evidence has shown and the guidelines recommend that every pregnant lupus patient should take hydroxychloroquine because it has benefits to the mother and possibly to the fetus,” Barnado said. “It controls lupus flares and may reduce preterm delivery.” Data also strongly suggest that aspirin prevents preeclampsia, she added.

An Ingrained Mindset

There has been a longstanding cultural tendency among physicians to stop all medications in pregnant women to avoid birth defects, Barnado explained. “But it’s time for the tide to shift to a more evidence-based approach,” she said. “There is little evidence to show that these drugs significantly increase birth defects while there is increasing evidence that they improve outcomes in lupus pregnancies.”

“There is little evidence to show that these drugs significantly increase birth defects while there is increasing evidence that they improve outcomes in lupus pregnancies.”

Using deidentified data from Vanderbilt’s EHR, Barnado conducted a chart review on pregnant women with lupus who sought care at Vanderbilt University Medical Center between 1993 and 2017, approximately 208 patients. She and her colleagues did cross-sectional analyses and tracked trends. “We observed some slight upward trends in the use of the recommended medications over time but the peak use of hydroxychloroquine only reached a level of 62 percent, when it should be 100 percent,” she said. Aspirin use was consistently low over time and was used for only 28 percent of the patients.

In communities where there is less access to specialty care, rates of adherence to the guidelines are probably even lower, Barnado suggests.

Building a Multicenter Research Base

Previously, Barnado studied the impact of race on adverse outcomes in lupus at three tertiary care centers in the southeastern U.S. That study was the first of its type to assemble a large sample across multiple centers.

Both the multicenter study and the Vanderbilt-only trends analyses have involved more diverse patient populations than the traditional, single-center cohort studies that have long been the norm for studying lupus in pregnancy, Barnado said. Traditionally, those have recruited patients from clinics – which she notes skews toward a greater percentage of affluent women and those with higher health literacy.

“At tertiary care centers like Vanderbilt, we see sicker patients. We have a high level [of] NICU and sick mothers who are worried come to us,” Barnado said. “The patients in the multicenter study and in my Vanderbilt trends analysis are not recruited and enrolled. They’re drawn from the EHR. All comers are included.”

Improving Adherence

Guidelines supporting the use of the two medications, and certain other drugs, only came out in the U.S. this year, in contrast to Europe where similar guidelines have been in place since 2016.

Barnado hopes that better collaboration between rheumatologists and their colleagues in obstetrics and gynecology can improve practice in the U.S. “We have these guidelines but how do we ensure dissemination and uptake, not just in academic centers but also in the community? We need more research on what really propels implementation.”

“We have these guidelines but how do we ensure dissemination and uptake, not just in academic centers but also in the community?”

About the Expert

April Barnado, M.D.

April Barnado, M.D., M.Sci., is an assistant professor of medicine at Vanderbilt University Medical Center and research director at the Vanderbilt Lupus Center. Her research focuses on developing methods to use EHRs to study outcomes in systemic lupus erythematosus. She has developed algorithms that incorporate billing codes, labs and medications, and is working with biomedical informatics collaborators to assess outcomes in the EHR and risk-stratify patients.