A Lasek1, N Bellon2, S Mallet3, E Puzenat4, A C Bursztejn5, C Abasq6, J Mazereeuw-Hautier7, C Chiaverini8, T Hubiche8, N Raison Peyron9, A Du Thanh9, S Barbarot10, H Aubert10, Z Reguiai11, C Droitcourt12, C Fievet13, A Bellissen14, M Bachelerie15, A Nosbaum16, A Leymarie17, P Armingaud18, M Masson Regnault19, E Mahé20. 1. Department of Dermatology, Hôpital Saint Vincent de Paul, GHICL, Lille, France. 2. Department of Dermatology, Centre Hospitalier Universitaire Necker-Enfants Malades, Assistance Publique-Hôpitaux de Paris, Paris, France. 3. Department of Dermatology, Venereology, and Cancerology, Hôpital de la Timone, Assistance-publique-Hôpitaux de Marseille, Marseille, France. 4. Department of Dermatology, Centre Hospitalier Universitaire de Besançon, Besançon, France. 5. Department of Dermatology, Hôpitaux de Brabois, CHRU Nancy, Vandœuvre-Lès-Nancy, France. 6. Department of Dermatology, Centre Hospitalier Universitaire de Brest, Brest, France. 7. Department of Dermatology, Centre Hospitalier Universitaire de Toulouse, Université Paul Sabatier Toulouse, Toulouse, France. 8. Department of Dermatology, Hospital Archet 2, ESPIC CHU-Lenval, Nice, France. 9. Department of Dermatology, Centre Hospitalier Universitaire de Montpellier, Montpellier, France. 10. Department of Dermatology, Centre Hospitalier Universitaire Hôtel-Dieu, Nantes, France. 11. Department of Dermatology, Polyclinique de Courlancy, Reims, France. 12. Department of Dermatology, Centre Hospitalier Universitaire Pontchaillou, Université de Rennes, Rennes, France. 13. Department of Dermatology, Centre Hospitalier Régional Universitaire Lille, Lille, France. 14. Department of Dermatology, Centre Hospitalier d'Aubagne, Aubagne, France. 15. Department of Dermatology, Centre Hospitalier Universitaire de Clermond Ferrand, Clermont-Ferrand, France. 16. Department of Clinical Immunology and Allergy, Lyon-Sud University Hospital, Pierre Bénite, Lyon, France. 17. Department of Dermatology, Centre Hospitalier Universitaire de Caen, Caen, France. 18. Department of Dermatology, Centre Hospitalier d'Orléans, Orléans, France. 19. Department of Dermatology, Centre Hospitalier de Poitiers, Poitiers Cedex, France. 20. Department of Dermatology, Centre Hospitalier Victor Dupouy, Argenteuil, France.
Abstract
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.
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.