Jinane Zitouni1, Alain Beauchet2, Raphaëlle Curmin3, Vito Di Lernia4, Anne-Claire Bursztejn5, Juliette Mazereeuw-Hautier6, Jérémy Gottlieb7, Audrey Lasek8, Hélène Aubert9, Catherine Droitcourt10, Cristina Bulai-Livideanu11, Anna Belloni Fortina12, Francesca Caroppo12, Nathalie Quiles-Tsimaratos13, Stéphanie Mallet14, Hugues Barthélémy15, Eve Puzenat16, Danielle Bouilly-Auvray17, Iria Neri18, Céline Phan1, Emmanuel Mahé19. 1. Dermatology Department, Hôpital Victor Dupouy, Argenteuil, France. 2. Public Health Department, Centre Hospitalier Universitaire Ambroise Paré, Boulogne-Billancourt, France. 3. Sorbonne University, INSERM, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Paris, France. 4. Dermatology unit, Arcispedale S. Maria Nuova IRCCS, Reggio Emilia, Italy. 5. Dermatology Department, Hôpitaux de Brabois, Centre Hospitalier Universitaire de Nancy, Vandoeuvre-lès-Nancy, France. 6. Dermatology Department, Centre de référence des maladies rares de la peau et des muqueuses, Hôpital Larrey, Toulouse, France. 7. Immunology and Dermatology Department, Hôpital Bicêtre, CHU de Bicêtre, Assistance Publique-Hôpitaux de Paris, Université Paris-Saclay, Le Kremlin Bicêtre, France. 8. Dermatology Department,, Hôpital Saint Vincent de Paul, Université Catholique de Lille, Lille, France. 9. Dermatology Department, Centre Hospitalier Universitaire de Nantes, Nantes, France. 10. Dermatology Department, Centre Hospitalier Universitaire Pontchaillou, Rennes, France. 11. Dermatology Department, Hôpital Larrey, Toulouse, France. 12. Pediatric Dermatology Unit, Department of Medicine DIMED, University of Padova, Padua, Italy. 13. Dermatology Department, Hôpital Saint-Joseph, Marseille, France. 14. Dermatology Department, Hôpital de la Timone, Assistance-publique-Hôpitaux de Marseille, Marseille, France. 15. Dermatology Department, Centre Hospitalier d'Auxerre, Auxerre, France. 16. Dermatology Department, Centre Hospitalier Universitaire Saint-Jacques, Besançon, France. 17. Dermatology Department, Centre Hospitalier Universitaire de Dijon, Dijon, France. 18. Dermatology, Department of Experimental, Diagnostic, and Specialty Medicine, Sant'Orsola-Malpighi Hospital, University of Bologna, Bologna, Italy. 19. Dermatology Department, Hôpital Victor Dupouy, Argenteuil, France. emmanuel.mahe@ch-argenteuil.fr.
Abstract
INTRODUCTION: 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. METHODS: 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 between April and August 2021. The data collected were from March 2012 up to August 2021. RESULTS: In total, 82 children (mean age: 9.1 years; 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. DISCUSSION: 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.
INTRODUCTION: 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. METHODS: 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 between April and August 2021. The data collected were from March 2012 up to August 2021. RESULTS: In total, 82 children (mean age: 9.1 years; 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. DISCUSSION: 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.
Authors: Lisa Eisert; Matthias Augustin; Sabine Bach; Martin Dittmann; Renate Eiler; Regina Fölster-Holst; Sascha Gerdes; Henning Hamm; Peter Höger; Gerd Horneff; Ralph von Kiedrowski; Sandra Philipp; Marc Pleimes; Martin Schlaeger; Volker Schuster; Petra Staubach; Tobias Weberschock; Ricardo Niklas Werner; Alexander Nast; Michael Sticherling Journal: J Dtsch Dermatol Ges Date: 2019-09 Impact factor: 5.584