Diarrhoea events in offspring exposed to tumour necrosis factor inhibitors and rotavirus vaccine: a population-based cohort study
Authors' conclusion
Early rotavirus vaccination in TNFi-exposed infants did not increase diarrhoea risk, even for those exposed late in pregnancy.
Study context
- Population
- TNF inhibitor (TNFi)-exposed offspring born to mothers with chronic inflammatory diseases, MarketScan commercial claims, 2011–2021
- Participants
- 3,167 TNFi-exposed offspring
- Exposure
- Rotavirus vaccination before 6 months vs unvaccinated by 6 months in TNFi-exposed infants
- Outcome
- Diarrhoea events (ICD-9/10 codes from hospitalizations, outpatient or ED visits) in early (1.5-6 months) and later (6-24 months) infancy
- Follow-up
- 1.5-6 months and 6-24 months
Methodological detailsclaims database (MarketScan commercial claims), time-varying exposure, Cox proportional hazards models
- Claims database (MarketScan commercial claims)
- Time-varying exposure
- Cox proportional hazards models
Main finding
As reported in the abstract
Diarrhoea events, early infancy (1.5-6 months)
- No statistically significant association between early vaccination and diarrhoea risk
- Early vaccination modelled as time-varying
Observational data: associations, not effects.
Further findings
| Outcome | HR (95% CI) | |
|---|---|---|
| Diarrhoea events in infants exposed to TNFi in the third trimester (subgroup)Vaccinatedvs Unvaccinated1.5-6 months | 1.07 (0.62–1.85) | |
| Diarrhoea events in infants exposed to TNFi in the third trimester (subgroup)Vaccinatedvs Unvaccinated6-24 months | 1.10 (0.79–1.52) | |
| Diarrhoea events in infants exposed to high-placental transfer TNFi in the third trimester (subgroup)Vaccinatedvs Unvaccinated1.5-6 months | 0.93 (0.51–1.70) | |
| Diarrhoea events in infants exposed to high-placental transfer TNFi in the third trimester (subgroup)Vaccinatedvs Unvaccinated6-24 months | 1.09 (0.77–1.56) | |
| 0.512Hazard ratio (log scale) |
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Diarrhoea events in offspring exposed to tumour necrosis factor inhibitors and rotavirus vaccine: a population-based cohort study. Rheumatology (Oxford). Published 3 April 2026. doi:10.
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