Pregnant women with systemic inflammatory conditions have a similar risk of serious infections regarding use of steroids, non-biologics, and tumor necrosis factor α (TNF) inhibitors, according to a study published in the BMJ. However, use of high-dose steroids is an independent risk factor of serious infections in pregnancy.
Rishi J Desai, PhD, from Brigham and Women’s Hospital at Harvard University in Boston, and colleagues, conducted an observational cohort study of 4961 women aged 12 to 55 years with completed pregnancies resulting in live-born infants. The study was restricted to women with a recorded diagnosis of systemic inflammatory conditions (rheumatoid arthritis, systemic lupus erythematosus, ankylosing spondylitis, psoriatic arthritis, or inflammatory bowel disease), who filled at least one outpatient prescription for an immunosuppressive agent during pregnancy.
The first date of immunosuppressive prescription fulfillment was defined as the index date. The researchers categorized the participants into 1 of 3 mutually exclusive groups hierarchically based on the index prescription: steroids, non-biologic agents, and TNF inhibitors. The outcome of interest was occurrence of serious infections during pregnancy after the index date. Bacterial infections such as meningitis, encephalitis, cellulitis, endocarditis, pneumonia, pyelonephritis, septic arthritis, osteomyelitis, and bacteremia, or opportunistic infections such as tuberculosis, systemic candidiasis, cryptococcosis, and aspergillosis were included in the outcome.
Among the women in the study, 71 (0.2%) experienced serious infections. The incidence rates of serious infections per 100 person years in 2598 steroid users, 1587 non-biologic users, and 776 TNF inhibitors users were 3.4, 2.3, and 1.5, respectively. There were no statistically significant differences in the risk of serious infections during pregnancy among users of the three immunosuppressive drug classes: non-biologics vs steroids 0.81, TNF inhibitors vs steroids 0.91, and TNF inhibitors v non-biologics 1.36. There was, however, an increased risk of serious infection during pregnancy for higher steroid dose.
“We observed no meaningful difference in the risk of serious infections among users of steroid monotherapy, non-biologics (monotherapy or in combination with steroids), and TNF inhibitors (monotherapy or in combination with steroids or non-biologics),” the authors stated. “However, steroid dose was found to be an independent risk factor of serious infections during pregnancy.”
- Desai RJ, Bateman BT, Huybrechts KF, et al. Risk of serious infections associated with use of immunosuppressive agents in pregnant women with autoimmune inflammatory conditions: cohort study. BMJ. 6 March 2017. doi: https://doi.org/10.1136/bmj.j895