The safety profile of adalimumab in pediatric patients with polyarticular juvenile idiopathic arthritis (pJIA), enthesitis-related arthritis, psoriasis, and Crohn disease was similar across indications, according to an analysis of data from 7 global randomized open-label clinical trials and open-label extensions published in The Journal of Pediatrics.
The studies were conducted between September 2002 and December 31, 2015 and included 3 studies examining pJIA, 1 study of enthesitis-related arthritis, 1 study of pediatric psoriasis, and 2 studies of pediatric Crohn disease (ClinicalTrials.gov identifiers: NCT00048542, NCT00775437, NCT00690573, NCT01166282, NCT01251614, NCT00409682, and NCT00686374).
Pediatric patients who received ≥1 dose of adalimumab subcutaneously were included in the analysis. Adverse events that occurred following the first dose of adalimumab and up to 70 days after the last dose were reported. Events per 100 patients-years were computed. Overall, there were 577 pediatric patients in the analysis, representing 1440.7 patient-years of adalimumab exposure.
Across all indications, the most frequently reported adverse events included upper respiratory tract infections (24.3 events/100 patient-years), headache (19.9 events/100 patient-years), and nasopharyngitis (17.3 events/100 patient-years). Serious infections, defined as 4.0 events/100 patient-years, were the most frequently reported serious adverse events across indications, with pneumonia being the most common infection (0.6 events/100 patient-years).
Raters of serious infection in patients with pJIA, psoriasis, and Crohn disease were 2.7, 0.8, and 6.6 events/100 patient-years, respectively. Serious adverse events occurred in 29% of patients (19.6 events/100 patient-years). Rates of serious adverse events in pediatric patients included 13.5, 7.4, and 32.2 events/100 patient-years in patients with pJIA, psoriasis, and Crohn disease, respectively. No cases of malignancy were reported. One death due to an accidental fall was reported in a patient with psoriasis.
The investigators concluded that in pediatric patients with pJIA, enthesitis-related arthritis, psoriasis, and Crohn disease, the overall safety profile of adalimumab is comparable and similar to that in adult patients. The current analysis included patients with medium to long-term exposure to adalimumab (median duration of exposure, 1.1 to 2.9 years across indications), which collectively represents the largest number of pediatric patients exposed to the agent for the longest length of time to date.
Horneff G, Seyger MMB, Arikan D, et al. Safety of adalimumab in pediatric patients with polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriasis, and Crohn’s disease [published online July 25, 2018]. J Pediatr. doi:10.1016/j.jpeds.2018.05.042