Evaluating the Safety of Adalimumab for Pediatric Plaque Psoriasis

The efficacy of adalimumab for the treatment of moderate to severe plaque psoriasis is supported by data from a literature review published in Expert Opinion on Drug Safety. However, safety data for adalimumab use in children remain sparse; recommendations for the pediatric population are typically extrapolated from studies conducted in adults. As such, investigators advocated for further study of adalimumab in pediatric populations.  

Investigators conducted a systematic search of PubMed for studies investigating the safety of adalimumab in pediatric patients. Treatment guidelines from the European Medicines Agency and the US Food and Drug Administration were also assessed. Due to the lack of literature on the use of adalimumab for pediatric psoriasis, data were extrapolated from studies on other inflammatory diseases, including juvenile idiopathic arthritis (JIA) and inflammatory bowel disease (IBD). Data from trials conducted in adults were also included in analyses.

Across several pediatric cohort studies, the most common adalimumab-associated adverse events were injection site reactions and infections. Data were pooled from 7 clinical trials of adalimumab in patients with pediatric JIA (n=274), pediatric Crohn’s disease (n=192), and pediatric plaque psoriasis (n=111). Treatment-emergent infections were observed in 82% of patients with JIA (150.7 events per 100 person-years [PY]), 74% of patients with psoriasis (168.7 events/100 PY) and 76% of patients with Crohn’s disease (132.0 events/100 PY). Injection site reactions were observed at rates of 15% (7.7 events/100 PY), 6% (7.4 events/100 PY), and 10% (4.9 events/100 PY) in  the JIA, psoriasis, and Crohn’s disease cohorts, respectively. In a randomized clinical trial of adalimumab vs methotrexate for severe chronic plaque psoriasis in children (n=114), the most common adverse events were nasopharyngitis and headache (>20% of participants). Injection site reactions occurred in 3.7% of patients. The principle severe adverse events in patients randomized to adalimumab were urinary tract infection, bronchospasm, and manifest tonsillitis. In a comparable trial of adalimumab for psoriasis in adults, similar safety events were observed: upper respiratory infections, other nonserious infections, itching, headache, and nausea. In both trials, patients receiving adalimumab typically experienced improvements in psoriasis symptoms and self-reported quality of life.

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Per the current literature, adalimumab appears effective for treating plaque psoriasis, although safety data remain sparse. In trials of adults and children with other inflammatory diseases, the most common adverse events were infections and injection site reactions. In the few clinical trials conducted in children with plaque psoriasis, similar safety signals were observed. Investigators emphasized the necessity of further research, such that treatment with adalimumab and biosimilars may be better guided by clinical data.  

Disclosure: One study author declared affiliations with the pharmaceutical industry.

Please see the original reference for a full list of authors’ disclosures.

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Zangrilli A, Bavetta M, Bianchi L. Adalimumab in children and adolescents with severe plaque psoriasis: a safety evaluation [published online April 6, 2020]. Expert Opin Drug Saf. doi: 10.1080/14740338.2020.1752659