Lebrikizumab monotherapy impacts on quality of life scores through improved itch and sleep interference in two Phase 3 trials

Background Lebrikizumab improved itch, interference of itch on sleep, and quality of life (QoL) in patients with moderate-to-severe atopic dermatitis (AD), in two Phase 3 trials at 16 weeks compared to placebo.Objectives We assess improvements in itch and sleep interference due to itch and their imp...

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Main Authors: Jennifer Soung, Sonja Ständer, Jan Gutermuth, Ignasi Pau-Charles, Zach Dawson, Fan Emily Yang, Luna Sun, Evangeline Pierce, Hany Elmaraghy, Linda Stein-Gold
Format: Article
Language:English
Published: Taylor & Francis Group 2024-12-01
Series:Journal of Dermatological Treatment
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Online Access:https://www.tandfonline.com/doi/10.1080/09546634.2024.2329240
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author Jennifer Soung
Sonja Ständer
Jan Gutermuth
Ignasi Pau-Charles
Zach Dawson
Fan Emily Yang
Luna Sun
Evangeline Pierce
Hany Elmaraghy
Linda Stein-Gold
author_facet Jennifer Soung
Sonja Ständer
Jan Gutermuth
Ignasi Pau-Charles
Zach Dawson
Fan Emily Yang
Luna Sun
Evangeline Pierce
Hany Elmaraghy
Linda Stein-Gold
author_sort Jennifer Soung
collection DOAJ
description Background Lebrikizumab improved itch, interference of itch on sleep, and quality of life (QoL) in patients with moderate-to-severe atopic dermatitis (AD), in two Phase 3 trials at 16 weeks compared to placebo.Objectives We assess improvements in itch and sleep interference due to itch and their impact on QoL measurements after treatment.Methods Data were analyzed from ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967) in patients with moderate-to-severe AD. QoL was evaluated using Dermatology Life Quality Index (DLQI) at Week 16 in patients (>16 years of age) who were itch responders/non-responders (defined as ≥4-point improvement in Pruritus Numeric Rating Scale) or Sleep-Loss Scale responders/non-responders (defined as ≥2-point improvement in itch interference on sleep).Results In ADvocate1 and ADvocate2, significantly greater proportions of itch responders had a clinically meaningful improvement in measures related to QoL (DLQI scores (0/1), ≤5 DLQI total score and ≥4-point DLQI improvement) compared to itch non-responders. In both studies, a significantly greater proportion of Sleep-Loss Scale responders, reported a DLQI score of (0/1), DLQI total score of ≤5 and DLQI improvement of ≥4 points compared to Sleep-Loss Scale non-responders.Conclusions Improvement in itch and sleep interference due to itch is associated with improvement in the QoL of patients after treatment with lebrikizumab for moderate-to-severe AD.ClinicalTrials.gov registration NCT04146363 (ADvocate1) and NCT04178967 (ADvocate2).
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spelling doaj-art-c56bdf7a7a8a4644adf346f54f2ae8d32025-08-20T02:49:32ZengTaylor & Francis GroupJournal of Dermatological Treatment0954-66341471-17532024-12-0135110.1080/09546634.2024.2329240Lebrikizumab monotherapy impacts on quality of life scores through improved itch and sleep interference in two Phase 3 trialsJennifer Soung0Sonja Ständer1Jan Gutermuth2Ignasi Pau-Charles3Zach Dawson4Fan Emily Yang5Luna Sun6Evangeline Pierce7Hany Elmaraghy8Linda Stein-Gold9Southern California Dermatology, Inc, Santa Ana, CA, USAUniversity Hospital Westphalian Wilhems University, Munster, GermanyDepartment of Dermatology, Vrije Universiteit Brussel (VUB), Universitair Ziekenhuis Brussel (UZ Brussel), Jette, BelgiumAlmirall, Barcelona, SpainEli Lilly and Company, Indianapolis, IN, USAEli Lilly and Company, Indianapolis, IN, USAEli Lilly and Company, Indianapolis, IN, USAEli Lilly and Company, Indianapolis, IN, USAEli Lilly and Company, Indianapolis, IN, USAClinic for Dermatology, Henry Ford Health System, Detroit, MI, USABackground Lebrikizumab improved itch, interference of itch on sleep, and quality of life (QoL) in patients with moderate-to-severe atopic dermatitis (AD), in two Phase 3 trials at 16 weeks compared to placebo.Objectives We assess improvements in itch and sleep interference due to itch and their impact on QoL measurements after treatment.Methods Data were analyzed from ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967) in patients with moderate-to-severe AD. QoL was evaluated using Dermatology Life Quality Index (DLQI) at Week 16 in patients (>16 years of age) who were itch responders/non-responders (defined as ≥4-point improvement in Pruritus Numeric Rating Scale) or Sleep-Loss Scale responders/non-responders (defined as ≥2-point improvement in itch interference on sleep).Results In ADvocate1 and ADvocate2, significantly greater proportions of itch responders had a clinically meaningful improvement in measures related to QoL (DLQI scores (0/1), ≤5 DLQI total score and ≥4-point DLQI improvement) compared to itch non-responders. In both studies, a significantly greater proportion of Sleep-Loss Scale responders, reported a DLQI score of (0/1), DLQI total score of ≤5 and DLQI improvement of ≥4 points compared to Sleep-Loss Scale non-responders.Conclusions Improvement in itch and sleep interference due to itch is associated with improvement in the QoL of patients after treatment with lebrikizumab for moderate-to-severe AD.ClinicalTrials.gov registration NCT04146363 (ADvocate1) and NCT04178967 (ADvocate2).https://www.tandfonline.com/doi/10.1080/09546634.2024.2329240Atopic dermatitislebrikizumabquality of lifeitchsleep interference
spellingShingle Jennifer Soung
Sonja Ständer
Jan Gutermuth
Ignasi Pau-Charles
Zach Dawson
Fan Emily Yang
Luna Sun
Evangeline Pierce
Hany Elmaraghy
Linda Stein-Gold
Lebrikizumab monotherapy impacts on quality of life scores through improved itch and sleep interference in two Phase 3 trials
Journal of Dermatological Treatment
Atopic dermatitis
lebrikizumab
quality of life
itch
sleep interference
title Lebrikizumab monotherapy impacts on quality of life scores through improved itch and sleep interference in two Phase 3 trials
title_full Lebrikizumab monotherapy impacts on quality of life scores through improved itch and sleep interference in two Phase 3 trials
title_fullStr Lebrikizumab monotherapy impacts on quality of life scores through improved itch and sleep interference in two Phase 3 trials
title_full_unstemmed Lebrikizumab monotherapy impacts on quality of life scores through improved itch and sleep interference in two Phase 3 trials
title_short Lebrikizumab monotherapy impacts on quality of life scores through improved itch and sleep interference in two Phase 3 trials
title_sort lebrikizumab monotherapy impacts on quality of life scores through improved itch and sleep interference in two phase 3 trials
topic Atopic dermatitis
lebrikizumab
quality of life
itch
sleep interference
url https://www.tandfonline.com/doi/10.1080/09546634.2024.2329240
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