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

Standard

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

in: J AM ACAD DERMATOL, Jahrgang 82, Nr. 2, 02.2020, S. 377-388.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

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', J AM ACAD DERMATOL, Jg. 82, Nr. 2, S. 377-388. https://doi.org/10.1016/j.jaad.2019.07.074

APA

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. J AM ACAD DERMATOL, 82(2), 377-388. https://doi.org/10.1016/j.jaad.2019.07.074

Vancouver

Deleuran M, Thaçi D, Beck LA, de Bruin-Weller M, Blauvelt A, Forman S et al. Dupilumab shows long-term safety and efficacy in patients with moderate to severe atopic dermatitis enrolled in a phase 3 open-label extension study. J AM ACAD DERMATOL. 2020 Feb;82(2):377-388. https://doi.org/10.1016/j.jaad.2019.07.074

Bibtex

@article{1de6b75402f24f2a9f847c4bd832f5d0,

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 = "Adult, Antibodies, Monoclonal, Humanized/adverse effects, Cohort Studies, Dermatitis, Atopic/drug therapy, Female, Humans, Male, Middle Aged, Severity of Illness Index, Time Factors, Treatment Outcome",

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",

year = "2020",

month = feb,

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

language = "English",

volume = "82",

pages = "377--388",

journal = "J AM ACAD DERMATOL",

issn = "0190-9622",

publisher = "Mosby Inc.",

number = "2",

}

RIS

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 - Adult

KW - Antibodies, Monoclonal, Humanized/adverse effects

KW - Cohort Studies

KW - Dermatitis, Atopic/drug therapy

KW - Female

KW - Humans

KW - Male

KW - Middle Aged

KW - Severity of Illness Index

KW - Time Factors

KW - Treatment Outcome

U2 - 10.1016/j.jaad.2019.07.074

DO - 10.1016/j.jaad.2019.07.074

M3 - SCORING: Journal article

C2 - 31374300

VL - 82

SP - 377

EP - 388

JO - J AM ACAD DERMATOL

JF - J AM ACAD DERMATOL

SN - 0190-9622

IS - 2

ER -