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Serious Infections in Rheumatoid Arthritis Offspring Exposed to Tumor Necrosis Factor Inhibitors: A Cohort Study
Évelyne Vinet1, Cristiano De Moura2, Christian A Pineau3
1McGill University Health Center and McGill University, Montreal, Quebec, Canada.
Insights
Exposure to tumor necrosis factor inhibitors (TNFi) during pregnancy did not significantly increase the risk of serious infections in rheumatoid arthritis (RA) offspring. This finding applies when compared to both unexposed RA offspring and the general population.
Area of Science:
- Rheumatology
- Pediatric Health
- Pharmacovigilance
Background:
- Rheumatoid arthritis (RA) affects women of childbearing age.
- Tumor necrosis factor inhibitors (TNFi) are used to treat RA but their use during pregnancy raises safety concerns.
- The risk of serious infections in offspring exposed to TNFi in utero is not well-established.
Purpose of the Study:
- To evaluate the risk of serious infections in rheumatoid arthritis (RA) offspring exposed to tumor necrosis factor inhibitors (TNFi) during gestation.
- To compare infection risk between TNFi-exposed RA offspring, unexposed RA offspring, and controls from the general population.
Main Methods:
- Retrospective analysis of US claims data (2011-2015).
- Identified 2,989 RA offspring and 14,596 controls, matched for maternal demographics.
- Defined TNFi exposure by prescription fill during pregnancy; serious infections by hospitalization within 12 months of life.
- Multivariable analyses adjusted for confounders.
Main Results:
- 12.7% of RA offspring were exposed to TNFi during pregnancy.
- Serious infection rates were 2.0% in unexposed RA offspring, 1.9% in controls, and 3.2% in TNFi-exposed RA offspring.
- Multivariable analysis did not show a significantly increased risk of serious infections in TNFi-exposed RA offspring compared to unexposed RA offspring (OR 1.4) or controls (OR 1.7).
Conclusions:
- No marked excess risk of serious infections was observed in RA offspring exposed to TNFi during pregnancy.
- Findings suggest TNFi use in pregnant RA patients may not substantially elevate offspring infection risk.
- Further research may be warranted to confirm these findings in larger cohorts.
Objective:
To evaluate the risk of serious infections in rheumatoid arthritis (RA) offspring exposed to tumor necrosis factor inhibitors (TNFi) in the gestational period compared to unexposed RA offspring, as well as to children from the general population.
Methods:
We used US claim data (2011-2015) to identify 2,989 offspring born to women who have RA and a randomly selected group of 14,596 control children, matched ≥4:1 for maternal age, year of delivery, and state of residence. We defined TNFi exposure based on ≥1 filled prescription during pregnancy. We ascertained serious infections based on ≥1 hospitalization, with infection as a primary diagnosis, at ≤12 months of life. We performed multivariable analyses, adjusting for maternal demographics, comorbidities, pregnancy complications, and drugs.
Results:
Among RA offspring, 380 (12.7%) were exposed to TNFi during pregnancy. The percentage of serious infections in RA offspring with no TNFi exposure (2.0%; 95% confidence interval [95% CI] 1.5, 2.6) was similar to that in non-RA offspring (1.9%; 95% CI 1.9, 2.2), while the percentage of serious infections in RA offspring with TNFi exposure was 3.2% (95% CI 1.5, 5.6). In multivariable analyses, we were unable to establish an increased risk of serious infections in RA offspring exposed to TNFi versus both non-RA offspring (odds ratio [OR] 1.7, 95% CI 0.8, 3.7) and RA offspring unexposed to TNFi (OR 1.4, 95% CI 0.7, 2.8).
Conclusion:
We did not demonstrate a marked excess risk for serious infections in RA offspring exposed to TNFi during pregnancy versus unexposed RA offspring or general population controls.
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