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

Audrey Lasek (1) , Nathalia Bellon (2) , Sylvain Mallet (3) , Ève Puzenat (4) , Anne-Claire Bursztejn (5) , Claire Abasq (6) , Juliette Mazereeuw-Hautier (7, 8) , Christine Chiaverini (9) , Thomas Hubiche (10) , Nadia Raison‐peyron (11, 12) , Aurélie Du-Thanh (13, 11) , Sébastien Barbarot (14, 15) , Hélène Aubert (15) , Ziad Reguiaï , Catherine Droitcourt (16) , Charlotte Fievet (17) , Astrid Bellissen , Marie Bachelerie (18) , Audrey Nosbaum (19, 20) , A. Leymarie (21) , Pierre Armingaud (22) , M. Masson Regnault (23) , Emmanuel Mahé (24)

1 Hôpital Saint Vincent de Paul de Lille
2 Hôpital Necker - Enfants Malades [AP-HP]
3 TIMONE - Hôpital de la Timone [CHU - APHM]
4 CHRU Besançon - Centre Hospitalier Régional Universitaire de Besançon
5 CHRU Nancy - Centre Hospitalier Régional Universitaire de Nancy
6 CHRU Brest - Centre Hospitalier Régional Universitaire de Brest
7 CHU Toulouse - Centre Hospitalier Universitaire de Toulouse
8 UT3 - Université Toulouse III - Paul Sabatier
9 CHU Nice - Centre Hospitalier Universitaire de Nice
10 UniCA - Université Côte d'Azur
11 CHRU Montpellier - Centre Hospitalier Régional Universitaire [Montpellier]
12 UM - Université de Montpellier
13 PCCEI - Pathogenesis and Control of Chronic and Emerging Infections
14 PhAN - Physiopathologie des Adaptations Nutritionnelles
15 CHU Nantes - Centre Hospitalier Universitaire de Nantes
16 Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Ponchaillou]
17 CHRU Lille - Centre Hospitalier Régional Universitaire [CHU Lille]
18 CHU Clermont-Ferrand
19 HCL - Hospices Civils de Lyon
20 CHLS - Centre Hospitalier Lyon Sud [CHU - HCL]
21 CHU Caen
22 CHRO - Centre Hospitalier Régional d'Orléans
23 CHU de Poitiers [La Milétrie] - Centre hospitalier universitaire de Poitiers = Poitiers University Hospital
24 Centre Hospitalier Victor Dupouy

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.

Mots clés: Atopic dermatitis; Dupilumab; Children; Daily practice

Domaines: Dermatologie

Audrey Lasek, Nathalia Bellon, Sylvain Mallet, Ève Puzenat, Anne-Claire Bursztejn, et al.. 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. Journal of the European Academy of Dermatology and Venereology, 2022, 36 (12), pp.2423 - 2429. ⟨10.1111/jdv.18450⟩. ⟨hal-03903398⟩