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

J Dermatolog Treat. 2024 Dec;35(1):2329240. doi: 10.1080/09546634.2024.2329240. Epub 2024 Apr 28.

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).

Keywords: Atopic dermatitis; itch; lebrikizumab; quality of life; sleep interference.

Publication types

  • Clinical Trial, Phase III
  • Randomized Controlled Trial

MeSH terms

  • Adult
  • Dermatitis, Atopic* / drug therapy
  • Double-Blind Method
  • Female
  • Humans
  • Male
  • Middle Aged
  • Pruritus* / drug therapy
  • Pruritus* / etiology
  • Quality of Life*
  • Severity of Illness Index*
  • Treatment Outcome

Associated data

  • ClinicalTrials.gov/NCT04178967
  • ClinicalTrials.gov/NCT04146363