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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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, Vol. 82, No. 2, 02.2020, p. 377-388.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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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
N1 - Copyright © 2019 American Academy of Dermatology, Inc. Published by Elsevier Inc. All rights reserved.
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 -