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Multicenter Study
. 2024 Dec 23;50(1):104-112.
doi: 10.1093/ced/llae300.

Dupilumab treatment in paediatric atopic dermatitis (2-18 years): Spanish multicentre retrospective real-world study

Helena Iznardo  1 , Esther Roé  1 , Asunción Vicente  2 , Carolina Prat  2 , Miquel Casals  3 , Ana Martín-Santiago  4 , Altea Esteve  5 , Miguel Viñas  6 , Mónica Munera-Campos  7 , Francesca Corella  8 , Jordi Mollet  9 , Ignasi Figueras-Nart  10 , Aina Vila  11 , Xavier Soria  12 , Antoni Azón-Masoliver  13 , Laura Marqués-Martín  14 , Cristina Nadal-Lladó  15 , Susana Bel  16 , Josep Pujol-Montcusí  17 , Marta Bertolín-Colilla  18 , Laia Curto-Barredo  18 , Gemma Melé-Ninot  19 , Montserrat Evole  20 , Laura Berbegal  21 , Lluís Puig  1 , Eulàlia Baselga  2
Affiliations
Multicenter Study

Dupilumab treatment in paediatric atopic dermatitis (2-18 years): Spanish multicentre retrospective real-world study

Helena Iznardo et al. Clin Exp Dermatol. .

Abstract

Background: Moderate-to-severe atopic dermatitis (AD) can be difficult to manage in paediatric patients, and there are few licensed treatments available for this age group. Dupilumab is approved for the treatment of AD in children older than 6 months.

Objectives: To assess the effectiveness and safety of dupilumab in a real-world cohort of paediatric patients with AD in Spain.

Methods: A multicentre, retrospective real-world study on the effectiveness and safety of dupilumab in patients aged 2-18 years with moderate-to-severe AD was conducted. Demographic and clinical characteristics were analysed, and effectiveness (Eczema Area and Severity Index, Investigator's Global Assessment, Dermatology Life Quality Index, Numerical Rating Scale itch), safety and drug survival measures were assessed. A comparison of our results with other real-world outcomes and with clinical trials was made.

Results: Data from 243 patients from 19 centres were collected, with a mean follow-up of 85 weeks. Dupilumab exhibited significant effectiveness, with marked reductions in severity scores from week 4. By week 16, 79.4% of patients achieved ≥ 75% improvement in Eczema Area and Severity Index (EASI) score (EASI 75) and 40.5% achieved ≥ 90% improvement in EASI score (EASI 90). Mean percentage reduction in EASI was 79.7%. Increasing improvements were observed until week 52, with 85.8% and 49.6% of patients achieving EASI 75 and EASI 90, respectively. Forty-three patients developed adverse events (AEs) (43 of 243, 17.7%). The most frequent AEs were ocular surface diseases (20 of 243, 8.2%), injection site reactions (8 of 243, 3.3%) and facial redness (7 of 243, 2.9%). Drug survival was high (96.9% and 93.1% after 1 and 2 years of follow-up, respectively), with only 19 patients (7.8%) interrupting treatment: 7 (2.9%) owing to AEs; 2 (0.82%) owing to secondary failure; 5 (2.1%) were lost to follow-up; and 5 (2.1%) entered remission and stopped treatment.

Conclusions: Real-world use of dupilumab in paediatric AD demonstrated sustained effectiveness, high drug survival and acceptable safety profiles. Longer-term studies are crucial for AE surveillance and understanding how to manage disease remission.

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Conflict of interest statement

Conflicts of interest H.I. has received consultancy/speaker honoraria and/or participated in clinical trials sponsored by AbbVie, Amgen, Boehringer Ingelheim, Novartis, Pfizer, Leo Pharma, Sanofi and UCB. E.R. has received consultancy/speaker honoraria and/or participated in clinical trials sponsored by AbbVie, Amgen, AstraZeneca, Bayer, Biogen, Cantabria, Celgene, Galderma, Leo Pharma, Lilly, Pierre Fabre, Pfizer and Sanofi. A.V. has received consultancy/speaker’s honoraria from and/or participated in clinical trials sponsored by AbbVie, Almirall, Amgen, Amryt, Boehringer Ingelheim, Bristol Myers Squibb, Galderma, Janssen, Leo Pharma, Lilly, Novartis, Pfizer, Pierre Fabre, Sandoz, Sanofi and Viatris. A.M.-S. has received consultancy/speaker’s honoraria from and/or participated in clinical trials sponsored by AbbVie, Almirall, Amgen, Amryt, Janssen, Leo Pharma, Leti, Lilly, MSD, Mylan, Novartis, Pfizer, Pierre Fabre, Sanofi and UCB. M.M.-C. has participated as an investigator in clinical trials sponsored by Sanofi, AbbVie, Lilly, Leo Pharma, Pfizer, Almirall, Galderma and Novartis and has received speaker and consultant fees from Sanofi, Lilly, Leo Pharma, AbbVie and Galderma. M.C. has participated as an investigator in clinical trials and has received consultant fees from Sanofi and AbbVie. C.N.L. has received speaker honoraria from Sanofi. C.P. has received consultancy/speaker honoraria and/or participated in clinical trials sponsored by AbbVie, Sanofi, Novartis and Leo Pharma. A.E. has received consultancy/speaker honoraria and/or participated in clinical trials sponsored by AbbVie, Viñas, Leo Pharma, Sanofi, Novartis and Pfizer. M.V. has received consultancy/speaker’s honoraria from and/or participated in clinical trials sponsored by AbbVie, Almirall, Amgen, Biogen, Celgene, Gebro, Janssen, Leo Pharma, Lilly, Merck-Serono, MSD, Mylan, Novartis, Pfizer, Sanofi and UCB. J.P.-M. has received consultancy/speaker honoraria and/or participated in clinical trials sponsored by AbbVie, Sanofi, Celgene, Janssen-Cilag, Almirall, Lilly and Novartis. L.C.-B. has received consultancy/speaker honoraria and/or participated in clinical trials sponsored by Sanofi, Leo Pharma, AbbVie, Lilly, Almirall, Novartis, Amgen and Pfizer. M.B.-C. has received consultancy/speaker honoraria and/or participated in clinical trials sponsored by Sanofi, AbbVie, Lilly and Almirall. I.F. has received consultancy/speaker’s honoraria from and/or participated in clinical trials sponsored by AbbVie, Almirall, Amgen, AstraZeneca, Celgene, Celldex, Galderma, Galapagos, Gebro, L’Oreal, Leo Pharma, Eli-Lilly, MSD, Novartis, Pfizer, Regeneron, Sanofi and Sobi. G.M.-N. has been a Medical Advisor for AbbVie, Leo Pharma, Lilly, Sanofi and Novartis and has participated in educational activities for Almirall, Avène, AbbVie, Laboratorio Reig Jofre, Leo Pharma, Lilly, Meda, Novartis, Sanofi and Uriage. F.C. has received consultancy/speaker honoraria and/or participated in clinical trials sponsored by AbbVie, Novartis, Pfizer, Leo Pharma, Mylan, Sanofi and UCB. A.A.-M. has received consultancy/speaker honoraria and/or participated in clinical trials sponsored by AbbVie, Almirall, Amgen, Janssen, Leo Pharma, Lilly, Mylan, Novartis, Pfizer and Sanofi. J.M. has received consultancy/speaker’s honoraria from and/or participated in clinical trials sponsored by AbbVie, Almirall, Amgen, Boehringer Ingelheim, Celgene, Gebro, Janssen, Leo Pharma, Lilly, Novartis, Pfizer, Sanofi and UCB. X.S. has received consultancy/speaker honoraria from AbbVie, Sanofi and Lilly. S.B. has received speaker and consultant fees from Sanofi, AbbVie, Janssen, Lilly, Almirall and Novartis. L.P. has received consultancy/speaker’s honoraria from and/or participated in clinical trials sponsored by AbbVie, Almirall, Amgen, Baxalta, Biogen, Boehringer Ingelheim, Celgene, Gebro, Janssen, Leo Pharma, Lilly, Merck-Serono, MSD, Mylan, Novartis, Pfizer, Regeneron, Roche, Sandoz, Samsung-Bioepis, Sanofi and UCB. E.B. has received consultancy/speaker’s honoraria from and/or participated in clinical trials sponsored by AbbVie, Almirall, Galderma, Isdin, Leo Pharma, Leti, Lilly, Novartis, Pierre Fabre, Pfizer, Regeneron, Roche-Possay, Sanofi and Viatris.

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