Data were obtained from two insurance databases for two time periods: Medicaid (2001–2010) and a private insurance database (2004–2012). Women ages 12–55 were included if their pregnancies were completed and resulted in liveborn infants, if they had a recorded diagnosis of RA, SLE, AS or PsA and had filled at least one outpatient prescription for an immunomodulatory agent three months before the date of their last menstrual period. On the basis of the date on which the prescription was filled, the researchers classified use into one of three trimesters.
The sharp rise seen in the use of biologic agents during pregnancy highlights the need for continuing research evaluating the safety of biologic agents in terms of their effects on various maternal & fetal outcomes.
For the time trend analysis, the researchers aggregated usage data at any time in pregnancy at the class level annually for all nonbiologic disease-modifying agents (except hydroxychloroquine) and for all biologic agents. The researchers thought it was important to separate out hydroxychloroquine for the time trend analysis because “it is actually the preferred agent during pregnancy for rheumatic conditions, and for good reasons,” Dr. Desai says. He cited a large cohort study published in 20069 that showed “taking hydroxychloroquine didn’t result in any significant increases in fetal abnormalities or any risk to the fetus.”
In Dr. Desai’s study, women were split into subgroups by disease: SLE, RA and PsA or AS (but not more than one condition). Results from the analysis indicated the following for each group:
- SLE—Women took steroids (64.1%) and hydroxychloroquine (60.9%) most frequently; 26% stopped filling prescriptions for these agents during pregnancy;
- RA—The most common therapies were steroids (60.4%), hydroxychloroquine (19.5%), etanercept (17.0%), methotrexate (14.9%) and adalimumab (8.1%); 34.5% did not fill a prescription for an immunomodulatory agent during pregnancy; and
- PsA or AS—The most common therapies were steroids (73.0%) and etanercept (16.0%); 61% stopped treatment with immunomodulatory agents during pregnancy.
Steroids and hydroxychloroquine were the most commonly used immunomodulatory agents during pregnancy over the 12-year study period (2001–2012); however, declining trends in the use of steroids were observed over time and there was an increasing trend in the use of biologic agents. The reason for this is likely “a combination of a few things,” Dr. Desai says.
“Steroids are associated with the risk of increased gestational maladies, including gestational diabetes and potentially hypertension, if used in pregnancy. Combined with safety data on other agents (such as hydroxychloroquine) and the availability of other biologic agents that physicians are more comfortable prescribing, it’s expected the use of steroids will decrease even further.”
