Dupilumab treatment in adults with moderate-to-severe atopic dermatitis

Lisa A. Beck, Diamant Thaçi, Jennifer D. Hamilton, Neil M. Graham, Thomas Bieber, Ross Rocklin, Jeffrey E. Ming, Haobo Ren, Richard Kao, Eric Simpson, Marius Ardeleanu, Steven P. Weinstein, Gianluca Pirozzi, Emma Guttman-Yassky, Mayte Suárez-Fariñas, Melissa D. Hager, Neil Stahl, George D. Yancopoulos, Allen R. Radin

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Abstract

BACKGROUND: Dupilumab, a fully human monoclonal antibody that blocks interleukin-4 and interleukin-13, has shown efficacy in patients with asthma and elevated eosinophil levels. The blockade by dupilumab of these key drivers of type 2 helper T-cell (Th2)-mediated inflammation could help in the treatment of related diseases, including atopic dermatitis. METHODS: We performed randomized, double-blind, placebo-controlled trials involving adults who had moderate-to-severe atopic dermatitis despite treatment with topical glucocorticoids and calcineurin inhibitors. Dupilumab was evaluated as monotherapy in two 4-week trials and in one 12-week trial and in combination with topical glucocorticoids in another 4-week study. End points included the Eczema Area and Severity Index (EASI) score, the investigator's global assessment score, pruritus, safety assessments, serum biomarker levels, and disease transcriptome. RESULTS: In the 4-week monotherapy studies, dupilumab resulted in rapid and dose-dependent improvements in clinical indexes, biomarker levels, and the transcriptome. The results of the 12-week study of dupilumab monotherapy reproduced and extended the 4-week findings: 85% of patients in the dupilumab group, as compared with 35% of those in the placebo group, had a 50% reduction in the EASI score (EASI-50, with higher scores in the EASI indicating greater severity of eczema) (P

Original languageEnglish (US)
Pages (from-to)130-139
Number of pages10
JournalNew England Journal of Medicine
Volume371
Issue number2
DOIs
StatePublished - 2014

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Atopic Dermatitis
Eczema
Transcriptome
Glucocorticoids
Therapeutics
Biomarkers
Placebos
Th2 Cells
Interleukin-13
Pruritus
Eosinophils
Interleukin-4
SAR231893
Asthma
Monoclonal Antibodies
Research Personnel
Inflammation
Safety
Serum

ASJC Scopus subject areas

  • Medicine(all)

Cite this

Beck, L. A., Thaçi, D., Hamilton, J. D., Graham, N. M., Bieber, T., Rocklin, R., ... Radin, A. R. (2014). Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. New England Journal of Medicine, 371(2), 130-139. https://doi.org/10.1056/NEJMoa1314768

Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. / Beck, Lisa A.; Thaçi, Diamant; Hamilton, Jennifer D.; Graham, Neil M.; Bieber, Thomas; Rocklin, Ross; Ming, Jeffrey E.; Ren, Haobo; Kao, Richard; Simpson, Eric; Ardeleanu, Marius; Weinstein, Steven P.; Pirozzi, Gianluca; Guttman-Yassky, Emma; Suárez-Fariñas, Mayte; Hager, Melissa D.; Stahl, Neil; Yancopoulos, George D.; Radin, Allen R.

In: New England Journal of Medicine, Vol. 371, No. 2, 2014, p. 130-139.

Research output: Contribution to journalArticle

Beck, LA, Thaçi, D, Hamilton, JD, Graham, NM, Bieber, T, Rocklin, R, Ming, JE, Ren, H, Kao, R, Simpson, E, Ardeleanu, M, Weinstein, SP, Pirozzi, G, Guttman-Yassky, E, Suárez-Fariñas, M, Hager, MD, Stahl, N, Yancopoulos, GD & Radin, AR 2014, 'Dupilumab treatment in adults with moderate-to-severe atopic dermatitis', New England Journal of Medicine, vol. 371, no. 2, pp. 130-139. https://doi.org/10.1056/NEJMoa1314768
Beck LA, Thaçi D, Hamilton JD, Graham NM, Bieber T, Rocklin R et al. Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. New England Journal of Medicine. 2014;371(2):130-139. https://doi.org/10.1056/NEJMoa1314768
Beck, Lisa A. ; Thaçi, Diamant ; Hamilton, Jennifer D. ; Graham, Neil M. ; Bieber, Thomas ; Rocklin, Ross ; Ming, Jeffrey E. ; Ren, Haobo ; Kao, Richard ; Simpson, Eric ; Ardeleanu, Marius ; Weinstein, Steven P. ; Pirozzi, Gianluca ; Guttman-Yassky, Emma ; Suárez-Fariñas, Mayte ; Hager, Melissa D. ; Stahl, Neil ; Yancopoulos, George D. ; Radin, Allen R. / Dupilumab treatment in adults with moderate-to-severe atopic dermatitis. In: New England Journal of Medicine. 2014 ; Vol. 371, No. 2. pp. 130-139.
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AU - Thaçi, Diamant

AU - Hamilton, Jennifer D.

AU - Graham, Neil M.

AU - Bieber, Thomas

AU - Rocklin, Ross

AU - Ming, Jeffrey E.

AU - Ren, Haobo

AU - Kao, Richard

AU - Simpson, Eric

AU - Ardeleanu, Marius

AU - Weinstein, Steven P.

AU - Pirozzi, Gianluca

AU - Guttman-Yassky, Emma

AU - Suárez-Fariñas, Mayte

AU - Hager, Melissa D.

AU - Stahl, Neil

AU - Yancopoulos, George D.

AU - Radin, Allen R.

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N2 - BACKGROUND: Dupilumab, a fully human monoclonal antibody that blocks interleukin-4 and interleukin-13, has shown efficacy in patients with asthma and elevated eosinophil levels. The blockade by dupilumab of these key drivers of type 2 helper T-cell (Th2)-mediated inflammation could help in the treatment of related diseases, including atopic dermatitis. METHODS: We performed randomized, double-blind, placebo-controlled trials involving adults who had moderate-to-severe atopic dermatitis despite treatment with topical glucocorticoids and calcineurin inhibitors. Dupilumab was evaluated as monotherapy in two 4-week trials and in one 12-week trial and in combination with topical glucocorticoids in another 4-week study. End points included the Eczema Area and Severity Index (EASI) score, the investigator's global assessment score, pruritus, safety assessments, serum biomarker levels, and disease transcriptome. RESULTS: In the 4-week monotherapy studies, dupilumab resulted in rapid and dose-dependent improvements in clinical indexes, biomarker levels, and the transcriptome. The results of the 12-week study of dupilumab monotherapy reproduced and extended the 4-week findings: 85% of patients in the dupilumab group, as compared with 35% of those in the placebo group, had a 50% reduction in the EASI score (EASI-50, with higher scores in the EASI indicating greater severity of eczema) (P

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