Efficacy and safety of dupilumab for the treatment of moderate-to-severe atopic dermatitis in adults: A pooled analysis of two phase 2 clinical trials

Susan Tofte, Kim Papp, Neil Sadick, Krista Bohnert, Eric Simpson, Diamant Thaçi, Thomas Bieber, Andrew Blauvelt, Howard Sofen, Melinda Gooderham, Zhen Chen, Abhijit Gadkari, Laurent Eckert, Neil M.H. Graham, Gianluca Pirozzi, Marius Ardeleanu

Research output: Contribution to journalArticle

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Abstract

BACKGROUND AND PURPOSE: There is a need for new treatment options for moderate-to-severe atopic dermatitis (AD) in adults. Dupilumab, a fully human anti-interleukin-4 receptor α monoclonal antibody, has recently been approved for this indication. METHODS: A pooled analysis of a phase 2a (NCT01548404) and a phase 2b (NCT01859988) study and a subanalysis of the 2b study evaluated the efficacy and safety of subcutaneous dupilumab 300 mg once weekly (qw) and every 2 weeks (q2w) in adults with moderate-to-severe AD. RESULTS: Dupilumab significantly improved clinical outcomes in both analyses at week 12. Itch was significantly improved in the pooled analysis as measured by peak pruritus Numerical Rating Scale, 5-dimension pruritus scale, and SCORing Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) pruritus scores (all p < .0001 vs. placebo at week 12). Sleep loss was significantly improved (SCORAD VAS sleep loss score; p < .0001 vs. placebo at week 12); similar results were shown for the q2w dose. Dupilumab had an acceptable safety profile. CONCLUSIONS: Consistent with previous studies, dupilumab qw and q2w significantly improved signs and symptoms of AD at week 12, including improvements in itch and sleep loss. IMPLICATIONS FOR PRACTICE: Subcutaneous dupilumab is an effective new treatment option for adults with moderate-to-severe AD.

Original languageEnglish (US)
Pages (from-to)529-541
Number of pages13
JournalJournal of the American Association of Nurse Practitioners
Volume30
Issue number9
DOIs
StatePublished - Sep 1 2018

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Atopic Dermatitis
Clinical Trials
Safety
Pruritus
Sleep
Visual Analog Scale
Therapeutics
Placebos
Signs and Symptoms
SAR231893
Monoclonal Antibodies

ASJC Scopus subject areas

  • Nursing(all)

Cite this

Efficacy and safety of dupilumab for the treatment of moderate-to-severe atopic dermatitis in adults : A pooled analysis of two phase 2 clinical trials. / Tofte, Susan; Papp, Kim; Sadick, Neil; Bohnert, Krista; Simpson, Eric; Thaçi, Diamant; Bieber, Thomas; Blauvelt, Andrew; Sofen, Howard; Gooderham, Melinda; Chen, Zhen; Gadkari, Abhijit; Eckert, Laurent; Graham, Neil M.H.; Pirozzi, Gianluca; Ardeleanu, Marius.

In: Journal of the American Association of Nurse Practitioners, Vol. 30, No. 9, 01.09.2018, p. 529-541.

Research output: Contribution to journalArticle

Tofte, S, Papp, K, Sadick, N, Bohnert, K, Simpson, E, Thaçi, D, Bieber, T, Blauvelt, A, Sofen, H, Gooderham, M, Chen, Z, Gadkari, A, Eckert, L, Graham, NMH, Pirozzi, G & Ardeleanu, M 2018, 'Efficacy and safety of dupilumab for the treatment of moderate-to-severe atopic dermatitis in adults: A pooled analysis of two phase 2 clinical trials', Journal of the American Association of Nurse Practitioners, vol. 30, no. 9, pp. 529-541. https://doi.org/10.1097/JXX.0000000000000088
Tofte, Susan ; Papp, Kim ; Sadick, Neil ; Bohnert, Krista ; Simpson, Eric ; Thaçi, Diamant ; Bieber, Thomas ; Blauvelt, Andrew ; Sofen, Howard ; Gooderham, Melinda ; Chen, Zhen ; Gadkari, Abhijit ; Eckert, Laurent ; Graham, Neil M.H. ; Pirozzi, Gianluca ; Ardeleanu, Marius. / Efficacy and safety of dupilumab for the treatment of moderate-to-severe atopic dermatitis in adults : A pooled analysis of two phase 2 clinical trials. In: Journal of the American Association of Nurse Practitioners. 2018 ; Vol. 30, No. 9. pp. 529-541.
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AU - Sadick, Neil

AU - Bohnert, Krista

AU - Simpson, Eric

AU - Thaçi, Diamant

AU - Bieber, Thomas

AU - Blauvelt, Andrew

AU - Sofen, Howard

AU - Gooderham, Melinda

AU - Chen, Zhen

AU - Gadkari, Abhijit

AU - Eckert, Laurent

AU - Graham, Neil M.H.

AU - Pirozzi, Gianluca

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N2 - BACKGROUND AND PURPOSE: There is a need for new treatment options for moderate-to-severe atopic dermatitis (AD) in adults. Dupilumab, a fully human anti-interleukin-4 receptor α monoclonal antibody, has recently been approved for this indication. METHODS: A pooled analysis of a phase 2a (NCT01548404) and a phase 2b (NCT01859988) study and a subanalysis of the 2b study evaluated the efficacy and safety of subcutaneous dupilumab 300 mg once weekly (qw) and every 2 weeks (q2w) in adults with moderate-to-severe AD. RESULTS: Dupilumab significantly improved clinical outcomes in both analyses at week 12. Itch was significantly improved in the pooled analysis as measured by peak pruritus Numerical Rating Scale, 5-dimension pruritus scale, and SCORing Atopic Dermatitis (SCORAD) Visual Analog Scale (VAS) pruritus scores (all p < .0001 vs. placebo at week 12). Sleep loss was significantly improved (SCORAD VAS sleep loss score; p < .0001 vs. placebo at week 12); similar results were shown for the q2w dose. Dupilumab had an acceptable safety profile. CONCLUSIONS: Consistent with previous studies, dupilumab qw and q2w significantly improved signs and symptoms of AD at week 12, including improvements in itch and sleep loss. IMPLICATIONS FOR PRACTICE: Subcutaneous dupilumab is an effective new treatment option for adults with moderate-to-severe AD.

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