Effectiveness and safety of dupilumab in the treatment of atopic dermatitis in children (6-11 years): data from a French multicentre retrospective cohort in daily practice

Autor: Lasek, A., Bellon, N., Mallet, S., Puzenat, E., Bursztejn, A.C., Abasq, C., Mazereeuw‐hautier, J, Chiaverini, C., Hubiche, T., Raison Peyron, N., Du Thanh, A., Barbarot, Sébastien, Aubert, H., Reguiai, Z., Droitcourt, C., Fievet, C., Bellissen, A., Bachelerie, M., Nosbaum, A., Leymarie, A., Armingaud, P., Masson Regnault, M., Mahé, E.
Přispěvatelé: Groupe Hospitalier de l'Institut Catholique de Lille (GHICL), Université catholique de Lille (UCL), CHU Necker - Enfants Malades [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Hôpital de la Timone [CHU - APHM] (TIMONE), Centre Hospitalier Régional Universitaire de Besançon (CHRU Besançon), Service de Dermatologie et Allergologie [CHRU Nancy], Centre Hospitalier Régional Universitaire de Nancy (CHRU Nancy), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Centre Hospitalier Universitaire de Nice (CHU Nice), Hôpital Archet 2 [Nice] (CHU), Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Physiopathologie des Adaptations Nutritionnelles (PhAN), Institut National de Recherche pour l’Agriculture, l’Alimentation et l’Environnement (INRAE)-Nantes Université - UFR de Médecine et des Techniques Médicales (Nantes Univ - UFR MEDECINE), Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ)-Nantes Université - pôle Santé, Nantes Université (Nantes Univ)-Nantes Université (Nantes Univ), Centre hospitalier universitaire de Nantes (CHU Nantes), Centre Hospitalier Universitaire de Reims (CHU Reims), CHU Pontchaillou [Rennes], Institut de recherche en santé, environnement et travail (Irset), Université d'Angers (UA)-Université de Rennes (UR)-École des Hautes Études en Santé Publique [EHESP] (EHESP)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Structure Fédérative de Recherche en Biologie et Santé de Rennes ( Biosit : Biologie - Santé - Innovation Technologique ), CHU Lille, CHU Marseille, CHU Clermont-Ferrand, Université de Lyon, CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Centre Hospitalier Régional d'Orléans (CHRO), Centre hospitalier universitaire de Poitiers (CHU Poitiers), Centre Hospitalier Victor Dupouy, None
Rok vydání: 2022
Předmět:
Zdroj: Journal of the European Academy of Dermatology and Venereology
Journal of the European Academy of Dermatology and Venereology, 2022, 36 (12), pp.2423-2429. ⟨10.1111/jdv.18450⟩
ISSN: 1468-3083
0926-9959
Popis: International audience; Background: Dupilumab is the first biotherapy available for the treatment of moderate-to-severe childhood atopic dermatitis (AD).Objective: The aim of this study was to evaluate the effectiveness and safety of dupilumab in daily practice.Methods: Patients aged 6-11, who had received a first dose of dupilumab, were included in this multicentre retrospective cohort study. The primary endpoint was change in SCORAD after 3 months of treatment. Secondary endpoints were change in IGA score at 3 months, proportion of patients with SCORAD50 and SCORAD75, description of adverse events and proportion of children in our cohort who would be excluded from pivotal phase 3 clinical trial.Results: Eighty patients were included. After 3 months of treatment, there was a significant decrease in SCORAD (mean: 21.8 ± 13.8 vs 53.9 ± 18.5; P < 0.0001) and IGA (1.3 ± 0.8 vs 3.5 ± 0.7; P < 0.0001). Conjunctivitis was observed in 11.3% (n = 9/80); three patients experienced dupilumab facial redness (DFR); 17.5% (n = 14/80) reported injection site reactions; 6.3% (n = 5/80) discontinued treatment. 61.2% (n = 49/80) children were ineligible in the phase 3 trial.Limitations: There is no control group. Because it was a real life study based on information from patient medical records in a French multicentre cohort, we cannot rule out the presence of reporting bias generated by the use of patient reported characteristics and missing information.Conclusion: These real-life data confirm the efficacy and safety of dupilumab in children with moderate to severe AD extended to dyshidrosis and atopic prurigo, but it also revealed a lower frequency of DFR and conjunctivitis. However, administration in injectable form may be a barrier in this age group.
Databáze: OpenAIRE
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