ArticleRheumatology (Oxford, England)2026
Diarrhoea events in offspring exposed to tumour necrosis factor inhibitors and rotavirus vaccine: a population-based cohort study.
Article in Rheumatology (Oxford, England), 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
objectivesPreviously, TNF inhibitor (TNFi)-exposed infants were recommended to withhold rotavirus vaccination until 6 months due to infection risk. Guidelines have recently supported earlier vaccination, although safety data remain limited. We aimed to compare diarrhoea risk (during early [1.5-6 months] and later [6-24 months] infancy) in TNFi-exposed infants who received rotavirus vaccination before 6 months vs those unvaccinated by 6 months.
methodsWe identified 3167 TNFi-exposed offspring in MarketScan commercial claims born to mothers with chronic inflammatory diseases between 2011 and 2021. Early vaccination was defined as ≥1 rotavirus dose between 1.5 and 6 months and modelled as time-varying. Diarrhoea events were identified using ICD-9/10 codes from hospitalizations, outpatient visits or emergency department visits. Cox proportional hazards models estimated hazard ratios (HR) and 95% CI for diarrhoea events in vaccinated vs unvaccinated infants.
resultsAmong TNFi-exposed offspring, no statistically significant association was found between early vaccination and diarrhoea risk during early (101 events; HR 1.04; 95% CI 0.65, 1.68) or later infancy (283 events; HR 1.16; 95% CI 0.87, 1.55). Patterns remained consistent among infants exposed to TNFi in the third trimester (1.5-6 months: HR 1.07; 95% CI 0.62, 1.85; 6-24 months: HR 1.10; 95% CI 0.79, 1.52) and those exposed to high-placental transfer TNFi in the third trimester (1.5-6 months: HR 0.93; 95% CI 0.51, 1.70; 6-24 months: HR 1.09; 95% CI 0.77, 1.56).
conclusionEarly rotavirus vaccination in TNFi-exposed infants did not increase diarrhoea risk, even for those exposed late in pregnancy. Findings support early vaccination and reinforce updated recommendations.
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