Off-label use of dupilumab for pediatric patients with atopic dermatitis: A multicenter retrospective review - 09/01/20
, Umar Sheikh, BS a, Ashley McWilliams, MD a, Eric Armbrecht, PhD a, Stephanie R. Jackson Cullison, MD, PhD b, Douglas W. Kress, MD b, Anna Smith, BS c, Leslie Castelo-Soccio, MD, PhD c, James Treat, MD c, William D. Boothe, MD d, Lucia Z. Diaz, MD d, Moise L. Levy, MD d, Avni Patel, BS e, Lara Wine Lee, MD e, M. Carmen Fraile-Alonso, MD f, Richard J. Antaya, MD f, Sonal Shah, MD g, Nicole Kittler, MD g, Lisa Arkin, MD h, Elaine Siegfried, MD aAbstract |
Background |
Atopic dermatitis (AD) is a common, chronic type 2 inflammatory skin disease, typically starting in infancy, with increased risk for subsequent extracutaneous atopic morbidities. Dupilumab is the first biologic agent targeting type 2 inflammation approved by the U.S. Food and Drug Administration (USFDA); it was licensed in 2017 for adults with moderate to severe AD and 2 years later for adolescents. Systemic treatment for pediatric AD remains a significant unmet medical need.
Objective |
To analyze off-label use of dupilumab in children with AD.
Methods |
Multicenter retrospective review that evaluated children who were prescribed dupilumab for moderate to severe AD.
Results |
One hundred eleven of 124 patients (89.5%) gained access to dupilumab after a mean of 9 weeks. The dosing range was 4 to 15.5 mg/kg for the loading dose and 2.0 to 15.3 mg/kg every other week for maintenance. The range was widest for 6- to 11-year-olds and was related to use of either full or half of adult dosing. Associated morbidities, treatment response, and adverse events were comparable to those in previous adolescent and adult trials.
Limitations |
The retrospective design of the study limited uniform data collection.
Conclusion |
Access to dupilumab was achievable for the majority of children after a mean 9-week delay because of insurance payment denial. This review supports dupilumab response and tolerability in children. Optimal dosing for patients younger than 12 years has not been defined. Availability of the drug in 2 different concentrations is an important safety issue.
Le texte complet de cet article est disponible en PDF.Key words : atopic dermatitis, dupilumab access, dupilumab dosing, eczema, pediatric
Abbreviations used : AD, AE, IGA, USFDA
Plan
| Funding sources: None. |
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| Disclosure: Dr Levy—Possibly related: Regeneron: consultant. Unrelated: Castle Creek: consultant/Data Monitoring Committee (DMC); Janssen: principal investigator, study; Mayne: consultant/Data and Safety Monitoring Board (DSMB); Pfizer: study (closed); Sun Pharmaceuticals: consultant; UCB: consultant; Up to Date: author and section editor (Pedi Derm); Aldeyra: consultant (study result review). Douglas W. Kress, MD—Possibly related: Regeneron and Sanofi: speaker's bureau. Unrelated: Pfizer and Eucrisa: speaker's bureau. Lara Wine Lee, MD: Investigator. Elaine Siegfried, MD—Possibly related: Regeneron: principal investigator, clinical trial, consulting fees, honorarium; Sanofi Genzyme: consulting fees, honorarium; UCB: consulting fees; AbbVie: consulting fees. Unrelated: Verrica: consulting fees, honorarium; Leo: consulting fees, Data Safety Monitoring Committee; Novan: consulting fees; Data Safety Monitoring Committee; Pfizer: consulting fee; Pierre Fabre: consulting fee; Janssen: principal investigator, clinical trial; Lilly: principal investigator, clinical trial. Mr Igelman; Dr Kurta; Mr Sheikh; Drs McWilliams, Armbrecht, Boothe, Diaz, Fraile-Alonso, and Antaya; Ms Smith; Drs Castelo-Soccio, Treat, Cullison, Shah, Kittler, and Arkin; and Ms Patel have no conflicts of interest to declare. |
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| Presented at the 2019 American Academy of Dermatology Annual Meeting in Washington, DC, March 2, 2019. |
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| Reprints not available from the authors. |
Vol 82 - N° 2
P. 407-411 - février 2020 Retour au numéro
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