Effectiveness and Safety of Adalimumab, Etanercept and Ustekinumab for Severe Psoriasis in Children Under 12 Years of Age: A French-Italian Daily Practice Cohort (BiPe Jr).

Abstract

Biological therapies are valuable treatments for severe psoriasis. Children aged under 12 years are underrepresented in therapeutic trials for these drugs. The objective of the 'BiPe Jr' cohort study was to evaluate the drug survival, effectiveness, tolerance and switching patterns of biological therapies in children under 12 years of age with psoriasis. We conducted a multicentre retrospective study of children with psoriasis who received at least one injection of a biological agent, even off-licence, before the age of 12 years in France and Italy, collecting the data betweenApril and August 2021. The data collected were from March 2012 up to August 2021. In total, 82 children (mean age: 9.1years; females: 61.0%) received 106 treatments. The drugs administered were adalimumab (n=49), etanercept (n=37), ustekinumab (n=15), anakinra (n=2), infliximab (n=2) and secukinumab (n=1). The most common form of psoriasis was plaque psoriasis (62.9%). The Physician Global Assessment and the Psoriasis Area Severity Index(PASI) scores decreased significantly from baseline to 3 months after treatment initiation for the three main biological drugs; PASI went from 14.1± 9.4 to 4.1± 11.3 for adalimumab (p=0.001), 14.9± 9.3 to 5.1± 4.0 for etanercept (p=0.002) and 11.6± 8.3 to 2.6± 2.2 for ustekinumab (p=0.007). A trend towards higher 2-year maintenance rates was observed for ustekinumab and adalimumab, compared with etanercept (p=0.06). 52 children discontinued their biological therapy, most frequently due to inefficacy (n=28) and remission (n=14). Seven serious adverse events (SAEs) were reported, including four severe infections. Our analyses of drug survival and treatment patterns, combined with those of previous studies conducted in older children, indicate that there is a trend towards higher 2-year survival rates of ustekinumab and adalimumab. The SAEs identified were rare, but highlight the need for increased vigilance concerning infections. Overall, the biological therapies showed good effectiveness and safety profiles when used in daily practice for the treatment of young children with psoriasis.