Adalimumab Shows No New Safety Concerns in Pediatric Patients With Autoimmune Disorders
A meta-analysis of data from 7 global, randomized, open-label clinical trials and their open-label extensions showed a similar safety profile with adalimumab across autoimmune conditions assessed, including polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriasis, and Crohn’s disease. Currently, adalimumab has several indications in pediatric patients, including juvenile idiopathic arthritis and Crohn’s disease.
The analysis included 577 pediatric patients who received at least 1 dose of adalimumab, with a cumulative adalimumab exposure a 1440.7 patient-years. Across indications, the most commonly observed adverse effects (AE) included upper respiratory tract infections, nasopharyngitis, and headache. The most serious AE was infection, with 4.0 events per 100 patient-years reported. Pneumonia was the most common infection at 0.6 events per 100 patients-years. Patients with Crohn’s disease had the highest rate of serious infection at 6.6 events per 100 patient-years, followed by patients with juvenile idiopathic arthritis and psoriasis at 2.7 and 0.8 events per 100 patient-years, respectively. No malignancies were reported.
The study had several limitations, including a low number of patients in certain age groups (eg, <4 years) or with certain disease indications (eg, enthesitis-related arthritis). Read more here. Reference 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. J Pediatr. 2018 Jul 25. pii: S0022-3476(18)30755-8. doi: 10.1016/j.jpeds.2018.05.042.