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
© 2022 European Academy of Dermatology and Venereology..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2022 |
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| Erschienen: |
2022 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:36 |
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| Enthalten in: |
Journal of the European Academy of Dermatology and Venereology : JEADV - 36(2022), 12 vom: 20. Dez., Seite 2423-2429 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Lasek, A [VerfasserIn] |
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| Links: |
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| Themen: |
420K487FSG |
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| Anmerkungen: |
Date Completed 15.11.2022 Date Revised 15.11.2022 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1111/jdv.18450 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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NLM343747499 |
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| 245 | 1 | 0 | |a Effectiveness and safety of dupilumab in the treatment of atopic dermatitis in children (6-11 years) |b data from a French multicentre retrospective cohort in daily practice |
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| 500 | |a Date Revised 15.11.2022 | ||
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| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2022 European Academy of Dermatology and Venereology. | ||
| 520 | |a BACKGROUND: Dupilumab is the first biotherapy available for the treatment of moderate-to-severe childhood atopic dermatitis (AD) | ||
| 520 | |a OBJECTIVE: The aim of this study was to evaluate the effectiveness and safety of dupilumab in daily practice | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
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