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

Ethics Declarations: In France and Itlay, ethic declaration is not necessary for retrospective date. We only required the "non-opposition for participating to the study" Funding: No sources of funding were used to conduct this study or prepare this manuscript.

Biologics combined with conventional systemic agents for the treatment of children with severe psoriasis. Real‐life data from the BiPe cohorts and a practice survey among French and Italian pediatric dermatologists

“…Our evaluation of the changes in PGA and PASI scores after 3 months of combined treatment indicated that all of the combined treatments were effective. However, the levels of effectiveness observed in this study appeared to be similar or lower than those reported with biologic monotherapies in clinical trials 1–4 and in the BiPe cohort studies 8,9 . This finding is most likely related to the fact that the children receiving the combined treatments had particularly severe psoriasis or difficult‐to‐treat forms 28 .…”

“…48 The only combined treatments associated with SAEs in the BiPe cohorts were combinations involving TNF-alpha inhibitors, which were associated with three severe infections and one urticarial reaction. 8,9 Among the four events, three occurred when a TNF-alpha inhibitor was used in association with acitretin, and one when a TNFalpha inhibitor was used in association with cyclosporin. Taking into account the 43.6-year cumulative duration of combined therapy, the frequency of these events was very low: one severe infection during 14.5 years of combined therapy.…”

“…Children were included if they had received at least one injection of a biological agent for psoriasis before the age of 12 years. The BiPe Jr cohort included 82 children who had received 106 biologics 9 …”

“…Management of children and adolescents with severe psoriasis was, until recently, a major challenge. Over the past few years, the efficacy and safety of conventional systemic agents and biologics for the treatment of these young patients have been evaluated both in clinical trials, [1][2][3][4] and in large national [5][6][7][8][9] and international 10,11 real-life cohorts. In addition, national guidelines on the management of psoriasis in childhood have been published in Italy, the United States, and Germany.…”

Ustekinumab in Pediatric Dermatology: An Updated Review

“…For example, a recent, multicentre retrospective study was conducted in France and Italy that enrolled children under 12 years of age with psoriasis who received biological agents, including ustekinumab. 20 Ustekinumab was associated with a significant decrease in PASI score from 11.6 ± 8.3 at baseline to 2.6 ± 2.2 In response to several external triggers, activated keratinocytes release proinflammatory cytokines that recruit and activate plasmacytoid dendritic cells to produce large amounts of IFNα. This cytokine induces phenotypical and functional maturation of myeloid dendritic cells into fully activated antigen-presenting dendritic cells, thereby promoting the expansion and differentiation of autoreactive T cells through antigen presentation and secretion of cytokines, mainly IL12 and IL23.…”