Introduction: Psoriasis affects 0.5% of children in Europe, with moderate to severe clinical forms in 15–35% of cases warranting the use of systemic treatments. Few treatments are licensed for childhood psoriasis. In this study, we analyzed the frequency of such prescriptions. Materials and methods: Our study was based on 3 retrospective cohort trials conducted in France between 2012 and 2018: χ-Psocar (313 children with psoriasis seen in hospitals), PsoLib (207 children seen in a private practice), and BiPe (134 children on biotherapies). Our evaluation was centered on off-label use. To avoid duplicates between cohorts, analysis focused on each cohort independently. Results: In the χ-Psocar study, in 34.8% of cases, use of at least one off-label treatment, mainly topical vitamin D (36.0%), and systemic treatments (methotrexate and cyclosporine) was noted, on account of either the clinical type of psoriasis (13.7%) or patient age (24.6%). In the PsoLib study, in 41.5% of cases, at least one off-label treatment was noted, mainly combined calcipotriol-betamethasone (24.2%), ciclopirox shampoo (7.2%) and systemic treatments (n = 20). The main reason was patient age (41.5%). In the BiPe study, in 97.0% of cases, at least one off-label treatment was noted. These prescriptions mainly concerned a combination of calcipotriol-betamethasone (68.7%) and tacrolimus (11.2%) along with systemic treatment comprising methotrexate, cyclosporin, methoxsalen or apremilast (n = 125), but also biotherapies (n = 85). The biotherapies were used off-label since at that time they had not yet been granted marketing authorisation. Discussion: This study focused on 3 cohorts of children with psoriasis seen either in private practice or in a hospital setting, and it involved all types of treatment. Off-label prescriptions ranged from one-third to almost 100% of the children, depending on the individual cohorts. The prescribed drugs were topical treatments, conventional systemic drugs and biotherapies. Off-label prescription is not strictly prohibited in France provided it is within a well-defined regulatory framework. Where there is a rich bibliography, confident recommendations may be made. Unfortunately, in childhood psoriasis, the literature and recommendations are very limited, leaving prescribers with considerable individual responsibilities. Review of the license concerning children with psoriasis, a push to conduct therapeutic studies and the drafting of recommendations all appear necessary.
Prescriptions hors AMM (autorisation de mise sur le marché) dans le psoriasis de l'enfant
Résumé
en
Introduction: Psoriasis affects 0.5% of children in Europe, with moderate to severe clinical forms in 15–35% of cases warranting the use of systemic treatments. Few treatments are licensed for childhood psoriasis. In this study, we analyzed the frequency of such prescriptions. Materials and methods: Our study was based on 3 retrospective cohort trials conducted in France between 2012 and 2018: χ-Psocar (313 children with psoriasis seen in hospitals), PsoLib (207 children seen in a private practice), and BiPe (134 children on biotherapies). Our evaluation was centered on off-label use. To avoid duplicates between cohorts, analysis focused on each cohort independently. Results: In the χ-Psocar study, in 34.8% of cases, use of at least one off-label treatment, mainly topical vitamin D (36.0%), and systemic treatments (methotrexate and cyclosporine) was noted, on account of either the clinical type of psoriasis (13.7%) or patient age (24.6%). In the PsoLib study, in 41.5% of cases, at least one off-label treatment was noted, mainly combined calcipotriol-betamethasone (24.2%), ciclopirox shampoo (7.2%) and systemic treatments (n = 20). The main reason was patient age (41.5%). In the BiPe study, in 97.0% of cases, at least one off-label treatment was noted. These prescriptions mainly concerned a combination of calcipotriol-betamethasone (68.7%) and tacrolimus (11.2%) along with systemic treatment comprising methotrexate, cyclosporin, methoxsalen or apremilast (n = 125), but also biotherapies (n = 85). The biotherapies were used off-label since at that time they had not yet been granted marketing authorisation. Discussion: This study focused on 3 cohorts of children with psoriasis seen either in private practice or in a hospital setting, and it involved all types of treatment. Off-label prescriptions ranged from one-third to almost 100% of the children, depending on the individual cohorts. The prescribed drugs were topical treatments, conventional systemic drugs and biotherapies. Off-label prescription is not strictly prohibited in France provided it is within a well-defined regulatory framework. Where there is a rich bibliography, confident recommendations may be made. Unfortunately, in childhood psoriasis, the literature and recommendations are very limited, leaving prescribers with considerable individual responsibilities. Review of the license concerning children with psoriasis, a push to conduct therapeutic studies and the drafting of recommendations all appear necessary.
1
Service de Dermatologie - Centre Hospitalier Victor Dupouy
( 225721 )
- Argenteuil
- France
Fédération Hospitalière de France ( 329877 )
2
Imagine - U1163 -
Imagine - Institut des maladies génétiques (IHU)
( 1004662 )
- IHU Imagine,
156 rue de Vaugirard, 75015 PARIS
et
24 Boulevard du Montparnasse, 75015 Paris
- France
Institut National de la Santé et de la Recherche Médicale U1163 ( 303623 )
;
Université Paris Cité UMR_S 1163 ( 557826 )
3
Hôpital Pellegrin
( 29316 )
- Bordeaux
- France
CHU Bordeaux ( 300122 )
;
Groupe hospitalier Pellegrin ( 300169 )
4
Hôtel-Dieu de Nantes
( 303292 )
-
- France
5
PhAN -
Physiopathologie des Adaptations Nutritionnelles
( 1002475 )
- 1 place Alexis Ricordeau 44093 Nantes Cedex 1 France
- France
Université de Nantes - UFR de Médecine et des Techniques Médicales ( 531638 )
;
Université de Nantes ( 93263 )
;
Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement UMR_A1280 ( 577435 )
6
CHRU Nancy -
Centre Hospitalier Régional Universitaire de Nancy
( 300157 )
- Siège social : 29 avenue du Maréchal de Lattre de Tassigny, CO 60034, 54035 NANCY CEDEX
Hôpital Central : 29 Avenue du Maréchal de Lattre de Tassigny, 54035 Nancy
Hôpitaux de Brabois / Enfants : Rue du Morvan, 54500 Vandœuvre-lès-Nancy
Maternité régionale :10 Avenue Dr Heydenreich, 54000 Nancy
- France
7
CHRU Besançon -
Centre Hospitalier Régional Universitaire de Besançon
( 300165 )
- 3, boulevard A. Fleming - 25030 Besançon Cedex
- France
8
CHA -
Centre hospitalier d'Auxerre
( 499039 )
- 2 bd de Verdun
89011 AUXERRE Cedex
- France
9
Hôpital Victor Dupouy
( 469342 )
- France
10
UVSQ -
Université de Versailles Saint-Quentin-en-Yvelines
( 81173 )
- 55 avenue de Paris - 78035 Versailles cedex
- France
11
UVSQ Santé -
Université de Versailles Saint-Quentin-en-Yvelines - UFR Sciences de la santé Simone Veil
( 472222 )
- 2 avenue de la Source de la Bièvre - 78180 Montigny-le-Bretonneux
- France
Université de Versailles Saint-Quentin-en-Yvelines ( 81173 )
Langue du document
Anglais
Nom de la revue
Ann Dermatol Venereol -
Annales de Dermatologie et de Vénéréologie
(ISSN : 0151-9638)
Publié par Elsevier Masson
Revue non référencée dans Sherpa-Romeo
Vulgarisation
Non
Comité de lecture
Oui
Audience
Internationale
Date de publication
2020
Volume
147
Numéro
6-7
Page/Identifiant
429-438
Public visé
Scientifique
Domaine(s)
Sciences du Vivant [q-bio]
Financement
Les auteurs tenaient ? remercier les investigateurs des 3 ?tudes.
Emmanuel Mahé, Florence Corgibet, François Maccari, Smaïl Hadj-Rabia, Céline Phan, et al.. Off-label drugs in childhood psoriasis. Annales de Dermatologie et de Vénéréologie, 2020, 147 (6-7), pp.429-438. ⟨10.1016/j.annder.2020.01.021⟩. ⟨hal-02927542⟩