Summaries of Must-Read Clinical Literature, Guidelines, and FDA Actions
Fetal Exposure to TNFi During Pregnancy Examined
Arthritis Rheumatol; ePub 2018 May 17; Vinet, et al
A recent study found no marked excess risk for serious infections in rheumatoid arthritis (RA) offspring exposed to tumor necrosis factor α inhibitors (TNFi) during pregnancy, vs unexposed RA offspring or general population controls. Researchers used US claim data (2011‐2015) to identify 2,989 RA offspring and a randomly selected group of 14,596 control children, matched ≥4:1 for maternal age, year of delivery, and state of residence. They defined TNFi exposure based on ≥1 filled prescription during pregnancy and ascertained serious infections based on ≥1 hospitalization with infection as a primary diagnosis, ≤12 months of life. They found:
- Among RA offspring, 380 (12.7%) were exposed to TNFi during pregnancy.
- The percent of serious infections in RA offspring with no TNFi exposure was similar (2.0%) to non‐RA offspring (1.9%), while the percent of serious infections in RA offspring with TNFi exposure was 3.2%.
- In multivariable analyses, there was an increased risk of serious infections in RA offspring exposed to TNFi vs both non‐RA offspring and RA offspring unexposed to TNFi.
Vinet É, D Moura C, Pineau CA, Abrahamowicz M, Curtis JR, Bernatsky S. Serious infections in rheumatoid arthritis offspring exposed to tumour necrosis factor α inhibitors: Cohort study. [Published online ahead of print May 17, 2018]. Arthritis Rheumatol. doi:10.1002/art.40536.
In this study, 2,989 infants born to mothers with rheumatoid arthritis (RA) were compared with 14,596 control infants matched for maternal age, year of delivery, and state of residence. 133 mothers with RA took TNFi during 12 weeks before pregnancy, 380 during pregnancy, and 2,476 had no TNFi exposure. 1.9% and 2% of infants from mothers without RA and those with RA without TNFi exposure, respectively, were hospitalized for infections during their first year, compared to 3.2% (12 infants) of RA offspring with TNFi exposure. Therefore, we conclude that most TNFi inhibitors be used cautiously during pregnancy.—Harold E. Paulus, M.D, Emeritus Professor; University of California, Los Angeles; Division of Rheumatology.