Systemic medications do not increase serious infection risk in pediatric psoriasis
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Systemic medications for the treatment of pediatric psoriasis failed to increase serious infection risk, according to a study.
“Psoriasis in children is increasingly treated with systemic medications, yet their risk of serious infection is not well characterized in clinical practice,” Maria C. Schneeweiss, MD, of the division of pharmacoepidemiology in the department of medicine and department of dermatology at Brigham and Women’s Hospital and Harvard Medical School, and colleagues wrote.
It is difficult to draw conclusions about infection risk in psoriasis because many of the clinical trials of systemic medications are small and placebo controlled, the researchers added.
In the current cohort study of insurance claims data, Schneeweiss and colleagues estimated the 6-month rate of infections in children with psoriasis who underwent treatment with ustekinumab, etanercept or methotrexate.
Eligible participants were aged 17 years or younger and had been treated with topical psoriasis medications before initiating one of the study drugs.
Findings were stratified by time. One cohort included patients treated between 2009 and 2015, which was before pediatric labeling, and the second was for 2016 to 2021, which was after pediatric approval.
Follow-up started from 1 day after treatment initiation and ended at 6 months, according to the findings.
Outcomes of interest included frequency of inpatient serious infections and outpatient infections requiring intervention.
The final cohort included 2,338 patients (57.8% girls). There were 379 patients who initiated ustekinumab, 779 etanercept and 1,180 who started on methotrexate between 2009 and 2021.
There were three serious infection events among patients who initiated ustekinumab, which broke down to a propensity score-adjusted incidence rate of 18.4 per 1,000 person-years. The serious infection rates were 25.6 per 1,000 person-years (nine events) for etanercept and 14.9 per 1,000 person-years (eight events) for methotrexate, according to the findings.
For outpatient infections, there were 39 events in the ustekinumab group, for an adjusted rate of 254.9 per 1,000 person-years. The 139 events in the etanercept group yielded an adjusted rate of 435.7 per 1,000 person-years, whereas the 209 events in the methotrexate group was associated with an adjusted outpatient infection rate of 433.6 per 1,000 person-years.
The researchers also conducted comparative analyses. For outpatient infections, the adjusted rate ratio for ustekinumab vs. etanercept was 0.58 (95% CI, 0.41-0.83). The adjusted rate ratio for outpatient infections was 0.66 (95% CI, 0.48-0.91) for ustekinumab vs. methotrexate. This rate was 0.95 (95% CI, 0.75-1.21) for etanercept vs. methotrexate.
The researchers observed no difference in rate ratios between the 2009 to 2015 cohort and the 2016 to 2021 cohort.
“Among children with psoriasis who started treatment with immunomodulating agents, serious infections were infrequent,” Schneeweiss and colleagues concluded. “This cohort study suggests that there was no increase in the risk of outpatient infections for children who started treatment with ustekinumab compared with etanercept or methotrexate.”
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