Adalimumab appears to be safe for treating pediatric patients with polyarticular juvenile idiopathic arthritis (JIA), enthesitis-related arthritis (ERA), psoriasis and Crohn's disease (CD), according to data from company-sponsored clinical trials
Adalimumab is an anti-tumor necrosis factor monoclonal antibody with demonstrated efficacy in these conditions, but pediatric safety data remains limited.
Dr. Gerd Horneff from Asklepios Klinik Sankt Augustin, in Sankt Augustin, Germany, and colleagues evaluated safety findings from seven clinical trials of adalimumab in 577 pediatric patients, with a special focus on infections, malignancies, and hypersensitivity.
Infections, the most frequently reported adverse events, occurred in 82% of patients with JIA, 74% of patients with psoriasis and 76% of patients with CD, the researchers report in The Journal of Pediatrics, online July 25.
Study of growth impaired patients with JIA and CD
Infectious adverse events were more common in patients who received concomitant systemic corticosteroids (84%) than in those who did not (75%). Allergic reactions occurred in 15% of patients with JIA, 6% of patients with psoriasis and 10% of patients with CD.
More than a third of patients with JIA (37%) had injection-site reactions, compared with 10% of patients with psoriasis and 22% of patients with CD. There were no reported cases of malignancy, demyelinating disorders, reactivation of hepatitis B or Stevens-Johnson syndrome.
Serious adverse events (SAEs) occurred in 29% of all patients, with serious infections being the most frequent SAE across indications (8%). Disease exacerbations were also important causes of SAEs, especially in patients with CD. Adalimumab treatment was associated with improvement and maintenance of growth in studies of growth-impaired patients with JIA and CD
"The overall safety profile was comparable and consistent with that in adults," the researchers conclude. "No new safety signals were identified in the treatment of pediatric patients with adalimumab."
AbbVie funded the study, paid for medical-writing assistance, employed most of the authors of the report and had financial ties to the rest, including Dr. Horneff.