Researchers observed no difference in rate ratios between a 2009 to 2015 cohort and a 2016 to 2021 cohort.
Serious infections were infrequent among children with psoriasis who started treatment ustekinumab (Stelara, Janssen Pharmaceutical Companies of Johnson & Johnson), compared with etanercept (Enbrel)
or methotrexate (MTX), according to a new study.1
The cohort study used insurance claims data accessed from US clinical practices. Researchers used data from patients aged 17 years or younger with psoriasis who were receiving treatment with a topical medication for psoriasis and started a new treatment with ustekinumab, etanercept, or methotrexate. The analysis was stratified by the time before pediatric labeling (2009-2015) and after pediatric approval (2016-2021). Patient follow-up started 1 day after initiating treatment and ended at 6 months.
The study identified 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. 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.
The study found the incidence of serious infection was 18.4 per 1000 person-years for ustekinumab users, 25.6 per 1000 person-years for etanercept users, and 14.9 per 1000 person-years for methotrexate users. Ustekinumab showed no increased rate of outpatient infections compared with etanercept and methotrexate and researchers say that may suggest a trend toward a decreased risk for ustekinumab. The adjusted rate of outpatient infections was 254.9 per 1000 person-years (39 events) for ustekinumab users, 435.7 per 1000 person-years (139 events) for etanercept users, and 433.6 per 1000 person-years (209 events) for methotrexate users.
Lead author 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 said the study was important because pediatric psoriasis is increasingly treated with systemic medications, yet their risk of serious infection is not well characterized in clinical practice. Previous clinical trials for these medications were often small and placebo controlled.
About 25% of psoriasis cases begin presenting in patients before the age of 18 years. A variety of clinical psoriasis types are seen in childhood, including plaque-type, guttate, erythrodermic, napkin, and nail-based disease.2
The US Food and Drug Administration (FDA) approved ustekinumab for treatment of moderate-to-severe plaque psoriasis in pediatric patients ages 6-11 years in August 2020.
1. 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
2. Silverberg NB. Pediatric psoriasis: an update. Ther Clin Risk Manag. 2009;5:849-56. doi: 10.2147/tcrm.s4908. Epub 2009 Nov 2. PMID: 19898649; PMCID: PMC2773753.