Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis

Lisa A. Beck; Diamant Thaçi; Mette Deleuran; Andrew Blauvelt; Robert Bissonnette; Marjolein de Bruin-Weller; Michihiro Hide; Lawrence Sher; Iftikhar Hussain; Zhen Chen; Faisal A. Khokhar; Bethany Beazley; Marcella Ruddy; Naimish Patel; Neil M.H. Graham; Marius Ardeleanu; Brad Shumel

doi:10.1007/s40257-020-00527-x

Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis

Lisa A. Beck, Diamant Thaçi, Mette Deleuran, Andrew Blauvelt, Robert Bissonnette, Marjolein de Bruin-Weller, Michihiro Hide, Lawrence Sher, Iftikhar Hussain, Zhen Chen, Faisal A. Khokhar, Bethany Beazley, Marcella Ruddy, Naimish Patel, Neil M.H. Graham, Marius Ardeleanu, Brad Shumel^*

^*Corresponding author for this work

Institute of Inflammation Medicine

113 Citations (Scopus)

Abstract

Background: Management of moderate-to-severe atopic dermatitis (AD) commonly requires long-term treatment. Objective: The aim of this study was to report the safety and efficacy of dupilumab treatment for up to 3 years in adults with moderate-to-severe AD. Methods: This ongoing, multicenter, open-label extension study (LIBERTY AD OLE; NCT01949311) assessed dupilumab treatment in adults previously enrolled in dupilumab trials. Patients received dupilumab 300 mg weekly up to 148 weeks. The primary outcome was safety. Results: Of 2677 patients enrolled and treated, 347 reached week 148. Mean self-reported drug compliance was 98.2%. Safety data were consistent with previously reported trials (270.1 adverse events [AEs]/100 patient-years; 6.9 serious AEs/100 patient-years) and the known dupilumab safety profile. Common AEs (≥ 5% of patients) included nasopharyngitis, AD, upper respiratory tract infection, conjunctivitis, headache, oral herpes, and injection-site reactions. AD signs and symptoms showed sustained improvements during treatment with mean (standard deviation, mean percentage change from parent study baseline) Eczema Area and Severity Index 1.4 (3.2, − 95.4%) and weekly Pruritus Numerical Rating Scale 2.2 (1.8, − 65.4%) at week 148. Limitations: No control arm; fewer patients at later time points; regimen different from the approved 300 mg every 2 weeks dose. Conclusion: These safety and efficacy results support dupilumab as a continuous long-term treatment for adults with moderate-to-severe AD. Trial Registration: ClinicalTrials.gov: NCT01949311. Video abstract: [MediaObject not available: see fulltext.]

Original language	English
Journal	American Journal of Clinical Dermatology
Volume	21
Issue number	4
Pages (from-to)	567-577
Number of pages	11
ISSN	1175-0561
DOIs	https://doi.org/10.1007/s40257-020-00527-x
Publication status	Published - 01.08.2020

Funding

Open access was funded by Sanofi and Regeneron Pharmaceuticals, Inc. This research was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. (ClinicalTrials.gov identifier: NCT01949311). The study sponsors participated in the study design; collection, analysis, and interpretation of the data; writing of the report; and the decision to submit the article for publication. Medical writing and editorial assistance was provided by Carolyn Ellenberger, PhD, of Excerpta Medica, funded by Sanofi Genzyme and Regeneron Pharmaceuticals, Inc.

Research Areas and Centers

Academic Focus: Center for Infection and Inflammation Research (ZIEL)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

Access to Document

10.1007/s40257-020-00527-x

Cite this

Beck, L. A., Thaçi, D., Deleuran, M., Blauvelt, A., Bissonnette, R., de Bruin-Weller, M., Hide, M., Sher, L., Hussain, I., Chen, Z., Khokhar, F. A., Beazley, B., Ruddy, M., Patel, N., Graham, N. M. H., Ardeleanu, M., & Shumel, B. (2020). Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. American Journal of Clinical Dermatology, 21(4), 567-577. https://doi.org/10.1007/s40257-020-00527-x

@article{e5bd6ee1397b4215bed3cb8376dbff63,

title = "Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis",

abstract = "Background: Management of moderate-to-severe atopic dermatitis (AD) commonly requires long-term treatment. Objective: The aim of this study was to report the safety and efficacy of dupilumab treatment for up to 3 years in adults with moderate-to-severe AD. Methods: This ongoing, multicenter, open-label extension study (LIBERTY AD OLE; NCT01949311) assessed dupilumab treatment in adults previously enrolled in dupilumab trials. Patients received dupilumab 300 mg weekly up to 148 weeks. The primary outcome was safety. Results: Of 2677 patients enrolled and treated, 347 reached week 148. Mean self-reported drug compliance was 98.2\%. Safety data were consistent with previously reported trials (270.1 adverse events [AEs]/100 patient-years; 6.9 serious AEs/100 patient-years) and the known dupilumab safety profile. Common AEs (≥ 5\% of patients) included nasopharyngitis, AD, upper respiratory tract infection, conjunctivitis, headache, oral herpes, and injection-site reactions. AD signs and symptoms showed sustained improvements during treatment with mean (standard deviation, mean percentage change from parent study baseline) Eczema Area and Severity Index 1.4 (3.2, − 95.4\%) and weekly Pruritus Numerical Rating Scale 2.2 (1.8, − 65.4\%) at week 148. Limitations: No control arm; fewer patients at later time points; regimen different from the approved 300 mg every 2 weeks dose. Conclusion: These safety and efficacy results support dupilumab as a continuous long-term treatment for adults with moderate-to-severe AD. Trial Registration: ClinicalTrials.gov: NCT01949311. Video abstract: [MediaObject not available: see fulltext.]",

author = "Beck, \{Lisa A.\} and Diamant Tha{\c c}i and Mette Deleuran and Andrew Blauvelt and Robert Bissonnette and \{de Bruin-Weller\}, Marjolein and Michihiro Hide and Lawrence Sher and Iftikhar Hussain and Zhen Chen and Khokhar, \{Faisal A.\} and Bethany Beazley and Marcella Ruddy and Naimish Patel and Graham, \{Neil M.H.\} and Marius Ardeleanu and Brad Shumel",

year = "2020",

month = aug,

day = "1",

doi = "10.1007/s40257-020-00527-x",

language = "English",

volume = "21",

pages = "567--577",

journal = "American Journal of Clinical Dermatology",

issn = "1175-0561",

publisher = "Adis",

number = "4",

}

Beck, LA, Thaçi, D, Deleuran, M, Blauvelt, A, Bissonnette, R, de Bruin-Weller, M, Hide, M, Sher, L, Hussain, I, Chen, Z, Khokhar, FA, Beazley, B, Ruddy, M, Patel, N, Graham, NMH, Ardeleanu, M & Shumel, B 2020, 'Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis', American Journal of Clinical Dermatology, vol. 21, no. 4, pp. 567-577. https://doi.org/10.1007/s40257-020-00527-x

Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis. / Beck, Lisa A.; Thaçi, Diamant; Deleuran, Mette et al.
In: American Journal of Clinical Dermatology, Vol. 21, No. 4, 01.08.2020, p. 567-577.

Research output: Journal Articles › Journal articles › Research › peer-review

TY - JOUR

T1 - Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis

AU - Beck, Lisa A.

AU - Thaçi, Diamant

AU - Deleuran, Mette

AU - Blauvelt, Andrew

AU - Bissonnette, Robert

AU - de Bruin-Weller, Marjolein

AU - Hide, Michihiro

AU - Sher, Lawrence

AU - Hussain, Iftikhar

AU - Chen, Zhen

AU - Khokhar, Faisal A.

AU - Beazley, Bethany

AU - Ruddy, Marcella

AU - Patel, Naimish

AU - Graham, Neil M.H.

AU - Ardeleanu, Marius

AU - Shumel, Brad

PY - 2020/8/1

Y1 - 2020/8/1

N2 - Background: Management of moderate-to-severe atopic dermatitis (AD) commonly requires long-term treatment. Objective: The aim of this study was to report the safety and efficacy of dupilumab treatment for up to 3 years in adults with moderate-to-severe AD. Methods: This ongoing, multicenter, open-label extension study (LIBERTY AD OLE; NCT01949311) assessed dupilumab treatment in adults previously enrolled in dupilumab trials. Patients received dupilumab 300 mg weekly up to 148 weeks. The primary outcome was safety. Results: Of 2677 patients enrolled and treated, 347 reached week 148. Mean self-reported drug compliance was 98.2%. Safety data were consistent with previously reported trials (270.1 adverse events [AEs]/100 patient-years; 6.9 serious AEs/100 patient-years) and the known dupilumab safety profile. Common AEs (≥ 5% of patients) included nasopharyngitis, AD, upper respiratory tract infection, conjunctivitis, headache, oral herpes, and injection-site reactions. AD signs and symptoms showed sustained improvements during treatment with mean (standard deviation, mean percentage change from parent study baseline) Eczema Area and Severity Index 1.4 (3.2, − 95.4%) and weekly Pruritus Numerical Rating Scale 2.2 (1.8, − 65.4%) at week 148. Limitations: No control arm; fewer patients at later time points; regimen different from the approved 300 mg every 2 weeks dose. Conclusion: These safety and efficacy results support dupilumab as a continuous long-term treatment for adults with moderate-to-severe AD. Trial Registration: ClinicalTrials.gov: NCT01949311. Video abstract: [MediaObject not available: see fulltext.]

AB - Background: Management of moderate-to-severe atopic dermatitis (AD) commonly requires long-term treatment. Objective: The aim of this study was to report the safety and efficacy of dupilumab treatment for up to 3 years in adults with moderate-to-severe AD. Methods: This ongoing, multicenter, open-label extension study (LIBERTY AD OLE; NCT01949311) assessed dupilumab treatment in adults previously enrolled in dupilumab trials. Patients received dupilumab 300 mg weekly up to 148 weeks. The primary outcome was safety. Results: Of 2677 patients enrolled and treated, 347 reached week 148. Mean self-reported drug compliance was 98.2%. Safety data were consistent with previously reported trials (270.1 adverse events [AEs]/100 patient-years; 6.9 serious AEs/100 patient-years) and the known dupilumab safety profile. Common AEs (≥ 5% of patients) included nasopharyngitis, AD, upper respiratory tract infection, conjunctivitis, headache, oral herpes, and injection-site reactions. AD signs and symptoms showed sustained improvements during treatment with mean (standard deviation, mean percentage change from parent study baseline) Eczema Area and Severity Index 1.4 (3.2, − 95.4%) and weekly Pruritus Numerical Rating Scale 2.2 (1.8, − 65.4%) at week 148. Limitations: No control arm; fewer patients at later time points; regimen different from the approved 300 mg every 2 weeks dose. Conclusion: These safety and efficacy results support dupilumab as a continuous long-term treatment for adults with moderate-to-severe AD. Trial Registration: ClinicalTrials.gov: NCT01949311. Video abstract: [MediaObject not available: see fulltext.]

UR - https://www.scopus.com/pages/publications/85086715751

U2 - 10.1007/s40257-020-00527-x

DO - 10.1007/s40257-020-00527-x

M3 - Journal articles

C2 - 32557382

AN - SCOPUS:85086715751

SN - 1175-0561

VL - 21

SP - 567

EP - 577

JO - American Journal of Clinical Dermatology

JF - American Journal of Clinical Dermatology

IS - 4

ER -

Dupilumab Provides Favorable Safety and Sustained Efficacy for up to 3 Years in an Open-Label Study of Adults with Moderate-to-Severe Atopic Dermatitis

Abstract

Funding

Research Areas and Centers

UN SDGs

Access to Document

Other files and links

Fingerprint

Cite this