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Nemolizumab Improves Patient-Reported Symptoms of Atopic Dermatitis with Pruritus: Post Hoc Analysis of a Japanese Phase III Randomized Controlled Trial
INTRODUCTION: Atopic dermatitis (AD), with its signs and symptoms of pruritus, dryness, and erythema, severely reduces the quality of life (QOL) of affected patients. We investigated the impact of nemolizumab 60 mg on QOL in Japanese patients aged ≥ 13 years with AD and inadequately controlled moder...
Autores principales: | , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
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Springer Healthcare
2023
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10060612/ https://www.ncbi.nlm.nih.gov/pubmed/36905481 http://dx.doi.org/10.1007/s13555-023-00901-7 |
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author | Kabashima, Kenji Matsumura, Takayo Komazaki, Hiroshi Kawashima, Makoto |
author_facet | Kabashima, Kenji Matsumura, Takayo Komazaki, Hiroshi Kawashima, Makoto |
author_sort | Kabashima, Kenji |
collection | PubMed |
description | INTRODUCTION: Atopic dermatitis (AD), with its signs and symptoms of pruritus, dryness, and erythema, severely reduces the quality of life (QOL) of affected patients. We investigated the impact of nemolizumab 60 mg on QOL in Japanese patients aged ≥ 13 years with AD and inadequately controlled moderate-to-severe pruritus, using data derived from patient-reported outcome (PRO) measures. METHODS: PROs were the Insomnia Severity Index (ISI), Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), and Work Productivity and Activity Impairment: Atopic Dermatitis questionnaire (WPAI-AD). Correlations between PRO scores and symptom severity, assessed by the pruritus visual analog scale (VAS) and the Eczema Area and Severity Index (EASI), were explored. RESULTS: The mean percent change (standard error) from baseline in the pruritus VAS and EASI scores at week 16 was, respectively, −45.6% (2.7) and −46.0% (3.2) in the nemolizumab group, and −24.1% (3.7) and −33.2% (4.9) in the placebo group. By week 16, significantly more patients in the nemolizumab group versus the placebo group had an ISI score of 0 for difficulty falling asleep (41.6% versus 13.1%, nominal p < 0.01) or difficulty staying asleep (45.4% versus 10.9%; nominal p < 0.01). Similarly, more nemolizumab- than placebo-treated patients had a DLQI score of 0 for interference with shopping, or home/garden activities (45.2% versus 18.6%, nominal p < 0.01), and 0 days per week of nighttime sleep disturbance (50.8% versus 16.9%, nominal p < 0.01) or bleeding skin (43.4% versus 7.5%, nominal p < 0.01) measured by POEM at week 16. Based on WPAI-AD scores, long-term administration of nemolizumab also improved the ability to conduct work activities. CONCLUSIONS: Subcutaneous administration of nemolizumab ameliorated pruritus and skin signs, and thereby produced improvement in patient QOL across multiple PRO measures, including sleep, interpersonal relationships, and the ability to conduct social or work activities. CLINICAL TRIAL REGISTRATION: JapicCTI-173740 (registered 20 October 2017). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13555-023-00901-7. |
format | Online Article Text |
id | pubmed-10060612 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Springer Healthcare |
record_format | MEDLINE/PubMed |
spelling | pubmed-100606122023-03-31 Nemolizumab Improves Patient-Reported Symptoms of Atopic Dermatitis with Pruritus: Post Hoc Analysis of a Japanese Phase III Randomized Controlled Trial Kabashima, Kenji Matsumura, Takayo Komazaki, Hiroshi Kawashima, Makoto Dermatol Ther (Heidelb) Original Research INTRODUCTION: Atopic dermatitis (AD), with its signs and symptoms of pruritus, dryness, and erythema, severely reduces the quality of life (QOL) of affected patients. We investigated the impact of nemolizumab 60 mg on QOL in Japanese patients aged ≥ 13 years with AD and inadequately controlled moderate-to-severe pruritus, using data derived from patient-reported outcome (PRO) measures. METHODS: PROs were the Insomnia Severity Index (ISI), Dermatology Life Quality Index (DLQI), Patient-Oriented Eczema Measure (POEM), and Work Productivity and Activity Impairment: Atopic Dermatitis questionnaire (WPAI-AD). Correlations between PRO scores and symptom severity, assessed by the pruritus visual analog scale (VAS) and the Eczema Area and Severity Index (EASI), were explored. RESULTS: The mean percent change (standard error) from baseline in the pruritus VAS and EASI scores at week 16 was, respectively, −45.6% (2.7) and −46.0% (3.2) in the nemolizumab group, and −24.1% (3.7) and −33.2% (4.9) in the placebo group. By week 16, significantly more patients in the nemolizumab group versus the placebo group had an ISI score of 0 for difficulty falling asleep (41.6% versus 13.1%, nominal p < 0.01) or difficulty staying asleep (45.4% versus 10.9%; nominal p < 0.01). Similarly, more nemolizumab- than placebo-treated patients had a DLQI score of 0 for interference with shopping, or home/garden activities (45.2% versus 18.6%, nominal p < 0.01), and 0 days per week of nighttime sleep disturbance (50.8% versus 16.9%, nominal p < 0.01) or bleeding skin (43.4% versus 7.5%, nominal p < 0.01) measured by POEM at week 16. Based on WPAI-AD scores, long-term administration of nemolizumab also improved the ability to conduct work activities. CONCLUSIONS: Subcutaneous administration of nemolizumab ameliorated pruritus and skin signs, and thereby produced improvement in patient QOL across multiple PRO measures, including sleep, interpersonal relationships, and the ability to conduct social or work activities. CLINICAL TRIAL REGISTRATION: JapicCTI-173740 (registered 20 October 2017). SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s13555-023-00901-7. Springer Healthcare 2023-03-11 /pmc/articles/PMC10060612/ /pubmed/36905481 http://dx.doi.org/10.1007/s13555-023-00901-7 Text en © The Author(s) 2023 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) . |
spellingShingle | Original Research Kabashima, Kenji Matsumura, Takayo Komazaki, Hiroshi Kawashima, Makoto Nemolizumab Improves Patient-Reported Symptoms of Atopic Dermatitis with Pruritus: Post Hoc Analysis of a Japanese Phase III Randomized Controlled Trial |
title | Nemolizumab Improves Patient-Reported Symptoms of Atopic Dermatitis with Pruritus: Post Hoc Analysis of a Japanese Phase III Randomized Controlled Trial |
title_full | Nemolizumab Improves Patient-Reported Symptoms of Atopic Dermatitis with Pruritus: Post Hoc Analysis of a Japanese Phase III Randomized Controlled Trial |
title_fullStr | Nemolizumab Improves Patient-Reported Symptoms of Atopic Dermatitis with Pruritus: Post Hoc Analysis of a Japanese Phase III Randomized Controlled Trial |
title_full_unstemmed | Nemolizumab Improves Patient-Reported Symptoms of Atopic Dermatitis with Pruritus: Post Hoc Analysis of a Japanese Phase III Randomized Controlled Trial |
title_short | Nemolizumab Improves Patient-Reported Symptoms of Atopic Dermatitis with Pruritus: Post Hoc Analysis of a Japanese Phase III Randomized Controlled Trial |
title_sort | nemolizumab improves patient-reported symptoms of atopic dermatitis with pruritus: post hoc analysis of a japanese phase iii randomized controlled trial |
topic | Original Research |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10060612/ https://www.ncbi.nlm.nih.gov/pubmed/36905481 http://dx.doi.org/10.1007/s13555-023-00901-7 |
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