Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study

Mette Deleuran; Diamant Thaçi; Lisa A Beck; Marjolein de Bruin-Weller; Andrew Blauvelt; Seth Forman; Robert Bissonnette; Kristian Reich; Weily Soong; Iftikhar Hussain; Peter Foley; Michihiro Hide; Jean-David Bouaziz; Joel M Gelfand; Lawrence Sher; Marie L A Schuttelaar; Chen Wang; Zhen Chen; Bolanle Akinlade; Abhijit Gadkari; Laurent Eckert; John D Davis; Manoj Rajadhyaksha; Heribert Staudinger; Neil M H Graham; Gianluca Pirozzi; Marius Ardeleanu

doi:10.1016/j.jaad.2019.07.074

Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study

Mette Deleuran
, Diamant Thaçi
, Lisa A Beck
, Marjolein de Bruin-Weller
, Andrew Blauvelt
, Seth Forman
, Robert Bissonnette
, Kristian Reich
, Weily Soong
, Iftikhar Hussain
, Peter Foley
, Michihiro Hide
, Jean-David Bouaziz
, Joel M Gelfand
, Lawrence Sher
, Marie L A Schuttelaar
, Chen Wang
, Zhen Chen
, Bolanle Akinlade
, Abhijit Gadkari

Laurent Eckert, John D Davis, Manoj Rajadhyaksha, Heribert Staudinger, Neil M H Graham, Gianluca Pirozzi, Marius Ardeleanu

Research output: Contribution to journal › Article › Academic › peer-review

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Abstract

BACKGROUND: Significant unmet need exists for long-term treatment of moderate to severe atopic dermatitis (AD).

OBJECTIVE: To assess the long-term safety and efficacy of dupilumab in patients with AD.

METHODS: This ongoing, multicenter, open-label extension study (NCT01949311) evaluated long-term dupilumab treatment in adults who had previously participated in phase 1 through 3 clinical trials of dupilumab for AD. This analysis examined patients given 300 mg dupilumab weekly for up to 76 weeks at data cutoff (April 2016). Safety was the primary outcome; efficacy was also evaluated.

RESULTS: Of 1491 enrolled patients (1042.9 patient-years), 92.9% were receiving treatment at cutoff. The safety profile was consistent with previously reported trials (420.4 adverse events/100 patient-years and 8.5 serious adverse events/100 patient-years), with no new safety signals; common adverse events included nasopharyngitis, conjunctivitis, and injection-site reactions. Sustained improvement was seen up to 76 weeks in all efficacy outcomes, including measures of skin inflammation, pruritus, and quality of life.

LIMITATIONS: Lack of control arm, limited number of patients with 76 weeks or longer of treatment (median follow-up, 24 weeks), and patients not receiving the approved dose regimen of 300 mg every 2 weeks.

CONCLUSION: The safety and efficacy profile from this study supports the role of dupilumab as continuous long-term treatment for patients with moderate to severe AD.

Original language	English
Pages (from-to)	377-388
Number of pages	12
Journal	Journal of the American Academy of Dermatology
Volume	82
Issue number	2
DOIs	https://doi.org/10.1016/j.jaad.2019.07.074
Publication status	Published - Feb 2020

Keywords

IL-13
IL-4
atopic dermatitis
biologic therapy
dupilumab
efficacy
long-term
monoclonal antibody
open label
quality of life
safety

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Deleuran, M., Thaçi, D., Beck, L. A., de Bruin-Weller, M., Blauvelt, A., Forman, S., Bissonnette, R., Reich, K., Soong, W., Hussain, I., Foley, P., Hide, M., Bouaziz, J.-D., Gelfand, J. M., Sher, L., Schuttelaar, M. L. A., Wang, C., Chen, Z., Akinlade, B., ... Ardeleanu, M. (2020). Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study. Journal of the American Academy of Dermatology, 82(2), 377-388. https://doi.org/10.1016/j.jaad.2019.07.074

@article{8ac09d9e622246c5bb9d5f60580a58d5,

title = "Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study",

abstract = "BACKGROUND: Significant unmet need exists for long-term treatment of moderate to severe atopic dermatitis (AD).OBJECTIVE: To assess the long-term safety and efficacy of dupilumab in patients with AD.METHODS: This ongoing, multicenter, open-label extension study (NCT01949311) evaluated long-term dupilumab treatment in adults who had previously participated in phase 1 through 3 clinical trials of dupilumab for AD. This analysis examined patients given 300 mg dupilumab weekly for up to 76 weeks at data cutoff (April 2016). Safety was the primary outcome; efficacy was also evaluated.RESULTS: Of 1491 enrolled patients (1042.9 patient-years), 92.9\% were receiving treatment at cutoff. The safety profile was consistent with previously reported trials (420.4 adverse events/100 patient-years and 8.5 serious adverse events/100 patient-years), with no new safety signals; common adverse events included nasopharyngitis, conjunctivitis, and injection-site reactions. Sustained improvement was seen up to 76 weeks in all efficacy outcomes, including measures of skin inflammation, pruritus, and quality of life.LIMITATIONS: Lack of control arm, limited number of patients with 76 weeks or longer of treatment (median follow-up, 24 weeks), and patients not receiving the approved dose regimen of 300 mg every 2 weeks.CONCLUSION: The safety and efficacy profile from this study supports the role of dupilumab as continuous long-term treatment for patients with moderate to severe AD.",

keywords = "IL-13, IL-4, atopic dermatitis, biologic therapy, dupilumab, efficacy, long-term, monoclonal antibody, open label, quality of life, safety",

author = "Mette Deleuran and Diamant Tha{\c c}i and Beck, \{Lisa A\} and \{de Bruin-Weller\}, Marjolein and Andrew Blauvelt and Seth Forman and Robert Bissonnette and Kristian Reich and Weily Soong and Iftikhar Hussain and Peter Foley and Michihiro Hide and Jean-David Bouaziz and Gelfand, \{Joel M\} and Lawrence Sher and Schuttelaar, \{Marie L A\} and Chen Wang and Zhen Chen and Bolanle Akinlade and Abhijit Gadkari and Laurent Eckert and Davis, \{John D\} and Manoj Rajadhyaksha and Heribert Staudinger and Graham, \{Neil M H\} and Gianluca Pirozzi and Marius Ardeleanu",

note = "Publisher Copyright: {\textcopyright} 2019 American Academy of Dermatology, Inc.",

year = "2020",

month = feb,

doi = "10.1016/j.jaad.2019.07.074",

language = "English",

volume = "82",

pages = "377--388",

journal = "Journal of the American Academy of Dermatology",

issn = "0190-9622",

publisher = "Elsevier",

number = "2",

}

Deleuran, M, Thaçi, D, Beck, LA, de Bruin-Weller, M, Blauvelt, A, Forman, S, Bissonnette, R, Reich, K, Soong, W, Hussain, I, Foley, P, Hide, M, Bouaziz, J-D, Gelfand, JM, Sher, L, Schuttelaar, MLA, Wang, C, Chen, Z, Akinlade, B, Gadkari, A, Eckert, L, Davis, JD, Rajadhyaksha, M, Staudinger, H, Graham, NMH, Pirozzi, G & Ardeleanu, M 2020, 'Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study', Journal of the American Academy of Dermatology, vol. 82, no. 2, pp. 377-388. https://doi.org/10.1016/j.jaad.2019.07.074

Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study. / Deleuran, Mette; Thaçi, Diamant; Beck, Lisa A et al.
In: Journal of the American Academy of Dermatology, Vol. 82, No. 2, 02.2020, p. 377-388.

Research output: Contribution to journal › Article › Academic › peer-review

TY - JOUR

T1 - Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study

AU - Deleuran, Mette

AU - Thaçi, Diamant

AU - Beck, Lisa A

AU - de Bruin-Weller, Marjolein

AU - Blauvelt, Andrew

AU - Forman, Seth

AU - Bissonnette, Robert

AU - Reich, Kristian

AU - Soong, Weily

AU - Hussain, Iftikhar

AU - Foley, Peter

AU - Hide, Michihiro

AU - Bouaziz, Jean-David

AU - Gelfand, Joel M

AU - Sher, Lawrence

AU - Schuttelaar, Marie L A

AU - Wang, Chen

AU - Chen, Zhen

AU - Akinlade, Bolanle

AU - Gadkari, Abhijit

AU - Eckert, Laurent

AU - Davis, John D

AU - Rajadhyaksha, Manoj

AU - Staudinger, Heribert

AU - Graham, Neil M H

AU - Pirozzi, Gianluca

AU - Ardeleanu, Marius

PY - 2020/2

Y1 - 2020/2

N2 - BACKGROUND: Significant unmet need exists for long-term treatment of moderate to severe atopic dermatitis (AD).OBJECTIVE: To assess the long-term safety and efficacy of dupilumab in patients with AD.METHODS: This ongoing, multicenter, open-label extension study (NCT01949311) evaluated long-term dupilumab treatment in adults who had previously participated in phase 1 through 3 clinical trials of dupilumab for AD. This analysis examined patients given 300 mg dupilumab weekly for up to 76 weeks at data cutoff (April 2016). Safety was the primary outcome; efficacy was also evaluated.RESULTS: Of 1491 enrolled patients (1042.9 patient-years), 92.9% were receiving treatment at cutoff. The safety profile was consistent with previously reported trials (420.4 adverse events/100 patient-years and 8.5 serious adverse events/100 patient-years), with no new safety signals; common adverse events included nasopharyngitis, conjunctivitis, and injection-site reactions. Sustained improvement was seen up to 76 weeks in all efficacy outcomes, including measures of skin inflammation, pruritus, and quality of life.LIMITATIONS: Lack of control arm, limited number of patients with 76 weeks or longer of treatment (median follow-up, 24 weeks), and patients not receiving the approved dose regimen of 300 mg every 2 weeks.CONCLUSION: The safety and efficacy profile from this study supports the role of dupilumab as continuous long-term treatment for patients with moderate to severe AD.

AB - BACKGROUND: Significant unmet need exists for long-term treatment of moderate to severe atopic dermatitis (AD).OBJECTIVE: To assess the long-term safety and efficacy of dupilumab in patients with AD.METHODS: This ongoing, multicenter, open-label extension study (NCT01949311) evaluated long-term dupilumab treatment in adults who had previously participated in phase 1 through 3 clinical trials of dupilumab for AD. This analysis examined patients given 300 mg dupilumab weekly for up to 76 weeks at data cutoff (April 2016). Safety was the primary outcome; efficacy was also evaluated.RESULTS: Of 1491 enrolled patients (1042.9 patient-years), 92.9% were receiving treatment at cutoff. The safety profile was consistent with previously reported trials (420.4 adverse events/100 patient-years and 8.5 serious adverse events/100 patient-years), with no new safety signals; common adverse events included nasopharyngitis, conjunctivitis, and injection-site reactions. Sustained improvement was seen up to 76 weeks in all efficacy outcomes, including measures of skin inflammation, pruritus, and quality of life.LIMITATIONS: Lack of control arm, limited number of patients with 76 weeks or longer of treatment (median follow-up, 24 weeks), and patients not receiving the approved dose regimen of 300 mg every 2 weeks.CONCLUSION: The safety and efficacy profile from this study supports the role of dupilumab as continuous long-term treatment for patients with moderate to severe AD.

KW - IL-13

KW - IL-4

KW - atopic dermatitis

KW - biologic therapy

KW - dupilumab

KW - efficacy

KW - long-term

KW - monoclonal antibody

KW - open label

KW - quality of life

KW - safety

UR - https://www.scopus.com/pages/publications/85075595726

U2 - 10.1016/j.jaad.2019.07.074

DO - 10.1016/j.jaad.2019.07.074

M3 - Article

C2 - 31374300

SN - 0190-9622

VL - 82

SP - 377

EP - 388

JO - Journal of the American Academy of Dermatology

JF - Journal of the American Academy of Dermatology

IS - 2

ER -

Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study

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Keywords

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