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.
Unlabelled: ClinicalTrials.gov registration NCT04146363 (ADvocate1) and NCT04178967 (ADvocate2).
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http://dx.doi.org/10.1080/09546634.2024.2329240 | DOI Listing |
Clin Exp Dermatol
December 2024
Department of Dermatology, Emory University, Atlanta, USA.
Pruritus is a hallmark symptom of atopic dermatitis (AD) and is known to worsen patients' health-related quality of life. Lebrikizumab is a high-affinity monoclonal antibody which binds IL-13, a dominant cytokine implicated in AD. This study includes data from two Phase 3 randomized controlled trials assessing the efficacy and safety of lebrikizumab in patients with moderate-to-severe AD, ADvocate1 (NCT04146363) and ADvocate2 (NCT04178967).
View Article and Find Full Text PDFBr J Dermatol
December 2024
Department of Dermatology, University of Maryland School of Medicine, Baltimore, MD, USA.
Qual Life Res
December 2024
Acaster Lloyd Consulting Ltd, London, UK.
Background: The objective of this study was to assess the content validity of the EQ-5D-5L and four bolt-ons: skin irritation, self-confidence, social relationships and sleep, for people with atopic dermatitis (AD) and chronic urticaria (CU).
Methods: Adults with AD or CU in the United Kingdom, with varying levels of severity, participated in either online or in-person semi-structured interviews. During the interviews, participants were first asked about the symptoms and impacts of their condition.
Clin Kidney J
October 2024
Arbor Research Collaborative for Health, Ann Arbor, USA.
Background: The associations between self-reported chronic kidney disease-associated pruritus (CKD-aP) and patient-reported outcomes (PROs) have been reported using various instruments to assess itch. Data collection via multiple CKD-aP instruments allows the evaluation of different domains and measurements of CKD-aP burden and may help tailor data capture for future research or clinical care.
Methods: An electronic PRO (ePRO) survey was distributed to European hemodialysis (HD) patients enrolled in the Dialysis Outcomes and Practice Patterns Study (DOPPS) in 2021-23.
J Dermatolog Treat
December 2024
Departments of Dermatology and Pediatrics, Feinberg School of Medicine, Northwestern University, Chicago, IL, USA.
In atopic dermatitis (AD), the real-world impact of achieving itch and skin lesion treatment targets compared to partial improvement remains unclear. We assessed the relationship between itch relief (reduction in Worst Itch Numeric Rating Scale [WI-NRS]) and skin clearance (Investigator Global Assessment [IGA] 0/1) with other patient-reported outcomes. Using TARGET-DERM AD registry data on adults receiving standard-of-care treatment, we described and modeled the relationship of itch severity (Worst Itch Numeric Rating Scale [WI-NRS]) and skin lesion severity (IGA) outcomes with patient-reported (quality of life ([DLQI)], AD severity [(POEM]), sleep ([Sleep-NRS]), and skin pain [(Pain-NRS]).
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