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Background: Reports were recently published on hepatitis B virus reactivation (HBVr), tuberculosis (TB), and atypical mycobacterial infection (AMI) in patients with ustekinumab treatment. However, the literature is limited to case reports and series. The study was aimed to investigate their relationships by using an extensive population-based database.Methods: Using the United States Food and Drug Administration Adverse Event Reporting System (FAERS) database, we collected all cases of HBVr, TB, and AMI between 1 January 2009 and 30 September 2021, for ustekinumab and other drugs. Disproportionality was analyzed using the reporting odds ratio (ROR), which was considered significant when the lower limit of the 95% confidence interval (95% CI) was >1.Results: Of the 18,760,438 adverse cases reported to FAERS for all drugs, 56,581 cases had been exposed to ustekinumab. Adverse events of HBVr, TB, and AMI were reported in 21, 210, and 20 cases, respectively. The ROR for HBVr with ustekinumab was 2.33 (95% CI, 1.52–3.58), for TB was 5.09 (95% CI, 4.44–5.84), and for AMI was 2.09 (95% CI, 1.35–3.24). In the ustekinumab exposure group, no death occurred in patients with HBVr, but one patient experienced life-threatening liver failure. For those with TB, 24 cases experienced hospitalization and 2 deaths occurred. No death occurred in patients with AMI but eight experienced hospitalization.Conclusion: We identified positive signals between ustekinumab exposure and HBVr, TB, and AMI in FAERS. Although these complications are rare, clinicians using ustekinumab should be aware of the risks.

BackgroundMost infections of Epstein-Barr virus (EBV), which is potentially neurotropic, occurred in childhood, but little is known about its association with child neurodevelopmental outcomes.MethodsWe determined whether EBV seropositivity was associated with parent-reported attention deficit hyperactivity disorder (ADHD), learning disability, or special education utilization among children, using data from the National Health and Nutrition Examination Survey (NHANES) 2003-2004. Potential confounding factors were adjusted using survey logistic regression models.ResultsEBV seroprevalence was 69.6% (95% CI, 67.1%-72.1%) for U.S. children aged 6-19. The prevalence was 8.86% (95% CI, 7.47%-10.47%) for ADHD among 6-19 year olds, 11.70% (95% CI, 9.84%-13.87%) for learning disability among 6-15 year olds, and 10.18% (95% CI, 8.58%-12.05%) for special education among 6-17 year olds. Children with positive anti-EBV had higher crude prevalence rates of learning disability and special education but not ADHD compared with those with negative anti-EBV. The adjusted odds ratios were 2.76 (95% CI, 1.53-4.96) for learning disability, 3.58 (95% CI, 1.92-6.55) for special education, and 0.77 (95% CI, 0.42-1.38) for ADHD, when comparing children with positive and negative anti-EBV.ConclusionsEBV seropositivity was associated with learning disability and special education among U.S. children. Future studies that longitudinally examine the associations are warranted.

Background Most infections of Epstein-Barr virus (EBV), which is potentially neurotropic, occur in childhood, but little is known about its association with child neurodevelopmental outcomes. Patients and Methods We investigated whether EBV seropositivity was associated with parent-reported attention deficit hyperactivity disorder (ADHD), learning disability, or special education utilization among children, using data from the National Health and Nutrition Examination Survey (NHANES) 2003–2004. Potential confounding factors were adjusted using survey logistic regression models. Results EBV seroprevalence was 69.6% (95% CI, 67.1–72.1%) for US children aged 6–19. The prevalence was 8.86% (95% CI, 7.47–10.47%) for ADHD among 6–19 year olds, 11.70% (95% CI, 9.84–13.87%) for learning disability among 6–15 year olds, and 10.18% (95% CI, 8.58–12.05%) for special education among 6–17 year olds. Children with positive anti-EBV had higher crude prevalence rates of learning disability and special education but not ADHD compared with those with negative anti-EBV. The adjusted odds ratios were 2.76 (95% CI, 1.53–4.96) for learning disability, 3.58 (95% CI, 1.92–6.55) for special education, and 0.77 (95% CI, 0.42–1.38) for ADHD, when comparing children with positive and negative anti-EBV. Conclusion EBV seropositivity was associated with learning disability and special education among US children. Future studies that longitudinally examine the associations are warranted.