Long‐term safety and efficacy in paediatric psoriasis: Remaining challenges

Psoriasis is a common disease, including in children, particularly from the age of 10 years. It is a chronic and stigmatizing condition,1 which requires long-term and targeted treatment, including in the paediatric population. Consequently, long-term data on efficacy and safety are essential. A recent study by Kaszuba et al.,2 sponsored by Novartis (secukinumab), provides the longest follow-up data currently available for any biologic in children with severe psoriasis (over more than 4 years). Biologics—particularly anti-IL-17 agents—are attractive therapeutic options in the paediatric population because they require less frequent injections and minimal laboratory monitoring. With the increasing number of biologics now available for the treatment of children with psoriasis, long-term data are particularly needed in this population to guide the choice of systemic treatment in clinical practice. In addition to secukinumab (monoclonal antibody targeting interleukin 17A), several other biologics have been approved by the European Medical Agency (EMA) for the management of psoriasis in paediatric population: anti-TNF alpha agents (etanercept from age of 6 years and adalimumab from age of 4 years), ustekinumab (monoclonal antibody anti-ILs12/23, from age of 6 years), ixekizumab (monoclonal antibody anti-interleukin 17A, from age of 6 years)3 and followed very recently by guselkumab (monoclonal antibody anti-interleukin 23, from age of 6 years). In total, six EMA-approved biologics are currently recommended as first-line treatment options in children and adolescents with moderate-to-severe psoriasis. Despite this expansion of biologics use in chronic inflammatory skin diseases, there are only few data regarding long-term biologic use in children with psoriasis (data with etanercept and ixekizumab).4 This study referenced offers important insights into long-term safety. The safety data of this study are particularly reassuring. Data on long-term safety are indeed needed: biologic therapies have been introduced more recently in children than in adults, and adult data5 cannot be directly extrapolated to the paediatric population; the clinical trials that supported marketing authorization do not allow for the assessment of outcomes specific to children—particularly linear growth and pubertal development—given their limited duration; preschool- and school-aged children are at higher risk of infections, and the regular updates to their vaccination schedules require particular attention.6 In terms of efficacy, although the PASI has been used in clinical trials, extrapolating this outcome to the paediatric population may be inappropriate. For instance, the PASI may be less suitable for children, as their lesions are often lighter in colour and less scaly. Finally, from a pathophysiological perspective, some evidence suggests cytokine profiles that differ from those observed in adults, with a more pronounced elevation of IL-22 and lower levels of IL-17 in paediatric skin lesions.7 Such differences could potentially influence the response to biologics. Although European recommendations/guidelines for the management of adult psoriasis are regularly revised based on the living Cochrane review,8 dedicated paediatric psoriasis guidelines at the European level are still lacking, and substantial gaps persist in current paediatric dermatology practice. Consequently, therapeutic decision-making relies heavily on clinical trial data—which predominantly provide short-term outcomes, supplemented by limited real-world evidence in children9, 10 (due to the recent approval of these treatments in children), and the physician's clinical experience. Retrospective studies in real-life settings in paediatric psoriasis provide additional information to long-term data from clinical trials by using real-world measure ‘time on drug’ as a proxy for efficacy, safety and both children and parents preferences to chronic treatment.9 In summary, as the treatment paradigm for paediatric psoriasis continues to evolve towards earlier use of biologics, these long-term data become increasingly valuable for shared decision-making with patients and families. The demonstration that secukinumab maintains efficacy and safety over nearly 5 years provides reassurance that biologic therapy can be a sustainable long-term strategy for managing this chronic disease in children and adolescents. Open access publication funding provided by COUPERIN CY26. None. N. Le Goaziou has no competing interests to declare that are relevant to the content of this article. C. Droitcourt has received speaker honoraria from Sanofi-Genzyme, Almirall, Pfizer, AbbVie and Eli Lilly & Co and support for attending meetings and/or travel from Leo Pharma, AbbVie and Sanofi-Genzyme. Not applicable. Not applicable. Data sharing is not applicable to this article as no datasets were generated or analysed during the current study.