No risk of outpatient infections identified for pediatric psoriasis patients starting ustekinumab


New research into the use of ustekinumab compared to other treatments for psoriasis sheds light on risk for outpatient infections.

There is likely no increased risk of outpatient infections for younger patients with psoriasis starting treatment with ustekinumab compared with etanercept or methotrexate, according to recent findings.

Children with psoriasis have rapidly begun being treated with systemic medications, but risks of serious infection remain less widely-understood for clinicians.

Additionally, clinical trials in pediatric patients for systemic medications have previously been quite small. Consequently, this study was designed to assess the 6-month infection rate for younger psoriasis patients beginning treatment with ustekinumab, etanercept, or methotrexate.

The research was authored by Maria C. Schneeweiss, MD, from the Division of Pharmacoepidemiology at Brigham and Women’s Hospital and Harvard Medical School’s Department of Medicine and Department of Dermatology.

“This study used US claims data to evaluate the risk of infections, including serious infections and infections requiring treatment, among children with psoriasis who initiated additional treatment with ustekinumab, etanercept, or methotrexate,” Schneeweiss and colleagues wrote.

Background and Findings:

The investigators conducted their cohort study through the use of insurance claims data accessed from clinical practices all around the US, with the data being on pediatric psoriasis patients aged 17 years or younger

The younger patients being assessed had to have been treated with a topical medication for their skin condition and to have begun treatment with either ustekinumab, methotrexate, or etanercept.

The investigators organized their analysis into the time prior to pediatric labeling—from 2009 to 2015—and then the time following pediatric approval, from 2016 to 2021.

A single day after initiating the patients’ treatment, patient follow-up meetings continued up to 6 months. Rates of inpatient serious infections and outpatient infections were compared to one another during follow-ups.

The investigators’ study ended up identifying 2,338 psoriasis patients who met inclusion criteria—with 57.8% of the participants being female—who had an initiation of new immunomodulating agent treatment.

The team reported that 379 study participants began their treatment with ustekinumab, 779 began with etanercept, and 1,180 began with methotrexate in the period between 2009 and 2021.

In their analysis, the researchers found that data for the propensity score–adjusted incidence rate for serious infections in participants was as follows:

  • 3 events and a rate of 18.4 per 1000 person-years for the ustekinumab group
  • 8 events and a rate of 14.9 per 1000 person-years for the methotrexate group
  • 9 events and a rate of 25.6 per 1000 person-years for the etanercept group

The investigators also concluded that the study participants showed the following data on adjusted rate of outpatient infections:

  • 39 events and a rate of 254.9 per 1000 person-years for the ustekinumab group
  • 209 events and a rate of 433.6 per 1000 person-years for the methotrexate group
  • 139 events and a rate of 435.7 per 1000 person-years for the etanercept group

The team further added that the adjusted rate ratio for outpatient infections in the participants was 0.58 (95% CI, 0.41 to 0.83) for ustekinumab compared to etanercept, 0.95 (95% CI, 0.75 to 1.21) for etanercept compared to methotrexate, and 0.66 (95% CI, 0.48 to 0.91) for ustekinumab compared to methotrexate.

“In these data, we found no indication of an increased rate of serious infection among ustekinumab users,” they wrote. “We observed a 42% reduced risk of outpatient infections in users of ustekinumab compared with etanercept and methotrexate.”

This article was published by our sister publication HCP Live.


Schneeweiss MC, Savage TJ, Wyss R, et al. Risk of Infection in Children With Psoriasis Receiving Treatment With Ustekinumab, Etanercept, or Methotrexate Before and After Labeling Expansion. JAMA Dermatol. Published online February 08, 2023. doi:10.1001/jamadermatol.2022.6325

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