Do you have patients treated with adalimumab? Know the safety profile

Abstract

Adalimumab, a fully human antibody to tumor necrosis factor (TNF), was first approved by the Food and Drug Administration (FDA) in 2002 for the treatment of rheumatoid arthritis. In 2008, it was approved for treatment of polyarthritis juvenile idiopathic arthritis and has since been approved for other pediatric indications that cross several subspecialties, including dermatology, gastroenterology and ophthalmology. Thus, it is important for a growing number of pediatricians, including those in primary care, to be aware of the safety profile of this widely used biologic medication. Horneff et al described the medium- to long-term safety profile of adalimumab in 577 patients (median use of 1.6 years, maximum 7.7 years) who participated in 7 Abbvie-sponsored clinical trials across several diseases, including 2 subtypes of juvenile idiopathic arthritis, Crohn's disease, and psoriasis. The major finding was that the safety profile is similar to that seen in adults. Although almost all patients developed adverse effects, especially infections, most were usual pediatric infections (including the serious infections) with very few opportunistic infections. The most common opportunistic infection was Herpes zoster with only one case of active tuberculosis. There appeared to be more serious adverse events and infections in patients with Crohn's disease, many from disease flares or infections related to disease complications, like perianal of fistula-related infections. There were also higher rates of infection among those treated concomitantly with corticosteroids. There were no malignancies and no deaths related to the medication in this cohort. Although encouraging, the median follow-up of patients in the study was relatively short and further post-marketing surveillance in “real-life” settings is necessary, in addition to data from industry sponsored clinical trials. Article page 166 ▶ Safety of Adalimumab in Pediatric Patients with Polyarticular Juvenile Idiopathic Arthritis, Enthesitis-Related Arthritis, Psoriasis, and Crohn's DiseaseThe Journal of PediatricsVol. 201PreviewTo evaluate the safety of adalimumab in pediatric patients who participated in clinical trials of juvenile idiopathic arthritis (polyarticular juvenile idiopathic arthritis and pediatric enthesitis-related arthritis), psoriasis, and Crohn's disease. Full-Text PDF Open Access