![Sample our Medicine, Dentistry, Nursing & Allied Health journals, sign in here to start your FREE access for 14 days]({"type":"image" , "src" : "/sda/5944/TOC-Subject-Sample-2021-Medicine-Dentistry-Nursing-Allied-Health.jpg"})
Abstract
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).
Acknowledgments
We gratefully acknowledge the contributions of the patients who participated in this study. Sarah Ryan of Eli Lilly and Company provided medical writing and editorial assistance.
Ethical approval
Informed consent was obtained from all patients before study procedures were initiated. For patients considered to be minors, the written consent of the parent or legal guardian, as well as the assent of the minor, was obtained.
Disclosure statement
No potential conflict of interest was reported by the author(s).
Data availability statement
Data and documents, including the study protocol, statistical analysis plan, clinical study report, and blank, or annotated case report forms, will be provided in a secure data sharing environment. For details on submitting a request, see the instructions provided at www.vivli.org.