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Etanercept was effective at 6 months of follow-up and remained so at 12 months, with low rates of adverse events.
In children with juvenile psoriatic arthritis (JPsA), treatment with etanercept (Enbrel; Amgen) was safe and effective, according to a study published in RMD Open.1
“These results inform treatment choice for JPsA…including in children under 12 years old, an age group for whom there is no drug approval,” noted Colleen K Correll, MD, assistant professor at the department of pediatrics, University of Minnesota in Minneapolis, and colleagues.
JPsA constitutes around 5% of juvenile idiopathic arthritis (JIA) and is commonly treated with etanercept. Due to the low incidence of JPsA, information is limited on the drug’s safety and effectiveness in the treatment of these patients in real-world clinical practice.
In this study, investigators used the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry, which contains data from over 10,000 children with JIA, to evaluate the safety and effectiveness of etanercept in JPsA. Of the 226 patients with JPsA who had received etanercept, 191 were included in the safety analysis and 43 were included in the effectiveness analysis. The patients in both groups were mainly White, female, and initiated etanercept at age 10. The researchers looked at the incidence of 31 prespecified adverse events of special interest (AESIs) and serious adverse events (SAEs) in the safety group. Effectiveness was assessed at 6 months and 12 months by a variety of disease activity measures, including the American College of Rheumatology Pediatric Response (ACR-Pedi Response: 30/50/70/90/100), the clinical Juvenile Arthritis Disease Activity Score 10-joint (cJADAS-10), and ACR provisional inactive disease criteria.
There were 5 AESIs and SAEs, with 3 reports of uveitis, 1 new-onset neuropathy, and 1 malignancy. For uveitis, neuropathy and malignancy, the respective incidence rates were .55 (95% confidence interval [CI]: .18, 1.69), .18 (95% CI: .03, 1.29) and .13 (95% CI: .02, .09) per 100 patient-years.
The results suggested etanercept was an effective JPsA treatment. For the 15 patients evaluable for the ACR-Pedi Response at 6 months, 80% showed an ACR30 response and 46.7% showed an ACR90 response. Only 5 patients were evaluable for the ACR-Pedi Response at 12 months, with 80% and 20% showing ACR30 and ACR90 responses, respectively. For the 25 patients evaluable for cJADAS-10 at 6 months, 36% had cJADAS-10 ≤1.0. Only 13 patients were evaluable for the cJADAS-10 at 12 months and 53.8% had cJADAS-10 ≤ 1.1. The ACR provisional criteria for inactive disease were met by 51.9% of 27 patients at 6 months and 43.8% of 16 patients at 12 months.
“Etanercept treatment in JPsA was effective at 6 months of follow-up and remained effective at 12 months, with low rates of adverse events of special interest (including malignancy and uveitis) and serious adverse events,” investigators concluded. “The analysis also showed that etanercept dosing for JPsA was consistent with the product label dose for JIA of .8 mg/kg weekly, with a maximum of 50 mg/week.”
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