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Patient‐reported outcomes from the JADE COMPARE randomized phase 3 study of abrocitinib in adults with moderate‐to‐severe atopic dermatitis
BACKGROUND: In JADE COMPARE, abrocitinib improved severity of atopic dermatitis (AD) and demonstrated rapid itch relief. OBJECTIVES: We examined clinically meaningful improvements in selected patient‐reported outcomes (PROs). METHODS: JADE COMPARE was a multicentre, phase 3 randomized, double‐blind,...
Autores principales: | , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
John Wiley and Sons Inc.
2021
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9300205/ https://www.ncbi.nlm.nih.gov/pubmed/34779063 http://dx.doi.org/10.1111/jdv.17813 |
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author | Thyssen, J.P. Yosipovitch, G. Paul, C. Kwatra, S.G. Chu, C.‐Y. DiBonaventura, M. Feeney, C. Zhang, F. Myers, D. Rojo, R. Valdez, H. |
author_facet | Thyssen, J.P. Yosipovitch, G. Paul, C. Kwatra, S.G. Chu, C.‐Y. DiBonaventura, M. Feeney, C. Zhang, F. Myers, D. Rojo, R. Valdez, H. |
author_sort | Thyssen, J.P. |
collection | PubMed |
description | BACKGROUND: In JADE COMPARE, abrocitinib improved severity of atopic dermatitis (AD) and demonstrated rapid itch relief. OBJECTIVES: We examined clinically meaningful improvements in selected patient‐reported outcomes (PROs). METHODS: JADE COMPARE was a multicentre, phase 3 randomized, double‐blind, placebo‐controlled trial. Adults with moderate‐to‐severe AD were randomized 2:2:2:1 to receive 16 weeks of oral abrocitinib 200 or 100 mg once daily, dupilumab 300 mg subcutaneous injection every 2 weeks, or placebo, with background topical therapy. PROs included Dermatology Life Quality Index (DLQI), Patient‐Oriented Eczema Measure (POEM), Night Time Itch Scale (NTIS), Pruritus and Symptoms Assessment for Atopic Dermatitis, Patient Global Assessment, SCORing Atopic Dermatitis, and Hospital Anxiety and Depression Scale. RESULTS: At week 16, the proportion of patients achieving POEM scores <3 was 21.3% and 11.7% for 200 and 100 mg abrocitinib, 12.4% for dupilumab, and 4.8% for placebo (vs. abrocitinib, P < 0.0001 and P = 0.04). Proportion achieving ≥4‐point improvement from baseline in NTIS severity was 64.3% and 52.4% for 200 and 100 mg abrocitinib, 54.0% for dupilumab, and 34.4% for placebo (vs. abrocitinib, P < 0.0001 and P = 0.007). Proportion achieving ≥4‐point improvement from baseline in DLQI was 85.0% and 74.4% for 200 and 100 mg abrocitinib, 83.4% for dupilumab, and 59.7% for placebo (vs. abrocitinib, P < 0.0001 and P = 0.005). CONCLUSION: Significant improvements in PROs were demonstrated with both abrocitinib doses vs. placebo, and abrocitinib 200 mg provided numerically greater effects compared with dupilumab in patients with moderate‐to‐severe AD. |
format | Online Article Text |
id | pubmed-9300205 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2021 |
publisher | John Wiley and Sons Inc. |
record_format | MEDLINE/PubMed |
spelling | pubmed-93002052022-07-21 Patient‐reported outcomes from the JADE COMPARE randomized phase 3 study of abrocitinib in adults with moderate‐to‐severe atopic dermatitis Thyssen, J.P. Yosipovitch, G. Paul, C. Kwatra, S.G. Chu, C.‐Y. DiBonaventura, M. Feeney, C. Zhang, F. Myers, D. Rojo, R. Valdez, H. J Eur Acad Dermatol Venereol Allergy and Eczema BACKGROUND: In JADE COMPARE, abrocitinib improved severity of atopic dermatitis (AD) and demonstrated rapid itch relief. OBJECTIVES: We examined clinically meaningful improvements in selected patient‐reported outcomes (PROs). METHODS: JADE COMPARE was a multicentre, phase 3 randomized, double‐blind, placebo‐controlled trial. Adults with moderate‐to‐severe AD were randomized 2:2:2:1 to receive 16 weeks of oral abrocitinib 200 or 100 mg once daily, dupilumab 300 mg subcutaneous injection every 2 weeks, or placebo, with background topical therapy. PROs included Dermatology Life Quality Index (DLQI), Patient‐Oriented Eczema Measure (POEM), Night Time Itch Scale (NTIS), Pruritus and Symptoms Assessment for Atopic Dermatitis, Patient Global Assessment, SCORing Atopic Dermatitis, and Hospital Anxiety and Depression Scale. RESULTS: At week 16, the proportion of patients achieving POEM scores <3 was 21.3% and 11.7% for 200 and 100 mg abrocitinib, 12.4% for dupilumab, and 4.8% for placebo (vs. abrocitinib, P < 0.0001 and P = 0.04). Proportion achieving ≥4‐point improvement from baseline in NTIS severity was 64.3% and 52.4% for 200 and 100 mg abrocitinib, 54.0% for dupilumab, and 34.4% for placebo (vs. abrocitinib, P < 0.0001 and P = 0.007). Proportion achieving ≥4‐point improvement from baseline in DLQI was 85.0% and 74.4% for 200 and 100 mg abrocitinib, 83.4% for dupilumab, and 59.7% for placebo (vs. abrocitinib, P < 0.0001 and P = 0.005). CONCLUSION: Significant improvements in PROs were demonstrated with both abrocitinib doses vs. placebo, and abrocitinib 200 mg provided numerically greater effects compared with dupilumab in patients with moderate‐to‐severe AD. John Wiley and Sons Inc. 2021-12-13 2022-03 /pmc/articles/PMC9300205/ /pubmed/34779063 http://dx.doi.org/10.1111/jdv.17813 Text en © 2021 Pfizer Inc. Journal of the European Academy of Dermatology and Venereology published by John Wiley & Sons Ltd on behalf of European Academy of Dermatology and Venereology. https://creativecommons.org/licenses/by-nc/4.0/This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes. |
spellingShingle | Allergy and Eczema Thyssen, J.P. Yosipovitch, G. Paul, C. Kwatra, S.G. Chu, C.‐Y. DiBonaventura, M. Feeney, C. Zhang, F. Myers, D. Rojo, R. Valdez, H. Patient‐reported outcomes from the JADE COMPARE randomized phase 3 study of abrocitinib in adults with moderate‐to‐severe atopic dermatitis |
title | Patient‐reported outcomes from the JADE COMPARE randomized phase 3 study of abrocitinib in adults with moderate‐to‐severe atopic dermatitis |
title_full | Patient‐reported outcomes from the JADE COMPARE randomized phase 3 study of abrocitinib in adults with moderate‐to‐severe atopic dermatitis |
title_fullStr | Patient‐reported outcomes from the JADE COMPARE randomized phase 3 study of abrocitinib in adults with moderate‐to‐severe atopic dermatitis |
title_full_unstemmed | Patient‐reported outcomes from the JADE COMPARE randomized phase 3 study of abrocitinib in adults with moderate‐to‐severe atopic dermatitis |
title_short | Patient‐reported outcomes from the JADE COMPARE randomized phase 3 study of abrocitinib in adults with moderate‐to‐severe atopic dermatitis |
title_sort | patient‐reported outcomes from the jade compare randomized phase 3 study of abrocitinib in adults with moderate‐to‐severe atopic dermatitis |
topic | Allergy and Eczema |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9300205/ https://www.ncbi.nlm.nih.gov/pubmed/34779063 http://dx.doi.org/10.1111/jdv.17813 |
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