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Serious Infection Risk in Pediatric Psoriasis with Ustekinumab, Etanercept, or Methotrexate

Etanercept was FDA approved for use in pediatric psoriasis (PsO) in 2016 and ustekinumab was similarly approved  in 2020.  This comparative analysis looks at the risk of serious infections (SIE) requiring hospitalization in pediatric PSO patients treated with ustekinumab, etanercept, or methotrexate prior to 2016. 

Data were based on cohorts pulled from US insurance claims data on children under age 17 years receiving new treatment with ustekinumab, etanercept, or methotrexate. Infections rates were compare in two eras: before pediatric labeling (2009-2015) and after pediatric approval (2016-2021).

From a total of 2338 pediatric PSO patients, the propensity adjusted incidence of serious infection was:

  • 1.8 per 100 person-years for ustekinumab
  • 2.56 per 100 person-years for etanercept
  • 1.49 per 100 person-years for methotrexate  
  • (these were not significantly different from each other)

They also looked at adjusted rates for "outpatient infections" (mostly non-serious infections, but required outpatient identification and an antibiotic):

  • 25.5 per 100 person-years for ustekinumab
  • 43.6 per 100 person-years for etanercept
  • 43.4 per 100 person-years  for methotrexate
  • (these were not significantly different from each other)

Pediatric psoriasis treated with immunomodulating agents infrequently causes serious infections, with little difference between etanercept, ustekinumab or MTX. 


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The author has no conflicts of interest to disclose related to this subject