Lebrikizumab Improves Quality of Life and Patient-Reported Symptoms of Anxiety and Depression in Patients with Moderate-to-Severe Atopic Dermatitis

Peter A Lio; April Armstrong; Jan Gutermuth; Audrey Nosbaum; Howard Sofen; Esther Garcia Gil; Marta Casillas; Sherry Chen; Luna Sun; Evangeline Pierce; Hany Elmaraghy; Zach Dawson; Tiago Torres

doi:10.1007/s13555-024-01199-9

Lebrikizumab Improves Quality of Life and Patient-Reported Symptoms of Anxiety and Depression in Patients with Moderate-to-Severe Atopic Dermatitis

Dermatol Ther (Heidelb). 2024 Jul;14(7):1929-1943. doi: 10.1007/s13555-024-01199-9. Epub 2024 Jun 26.

Authors

Peter A Lio^{1

2}, April Armstrong^{3

4}, Jan Gutermuth⁵, Audrey Nosbaum⁶, Howard Sofen⁷, Esther Garcia Gil⁸, Marta Casillas⁹, Sherry Chen¹⁰, Luna Sun⁹, Evangeline Pierce⁹, Hany Elmaraghy⁹, Zach Dawson⁹, Tiago Torres¹¹

Affiliations

¹ Northwestern University Feinberg School of Medicine, Chicago, IL, USA. peterlio@gmail.com.
² Medical Dermatology Associates of Chicago, Chicago, IL, USA. peterlio@gmail.com.
³ Keck School of Medicine at University of California Los Angeles, Los Angeles, CA, USA.
⁴ Clinical Research for the Southern California Clinical and Translational Research Institute (SC CTSI), Los Angeles, CA, USA.
⁵ Department of Dermatology, Universitair Ziekenhuis Brussel (UZ Brussel), Vrije Universiteit Brussel (VUB), Jette, Belgium.
⁶ Service d'Allergologie et Immunologie Clinique, Hospices Civils de Lyon, Centre Hospitalier Lyon Sud, Pierre Bénite, France.
⁷ Department of Dermatology, School of Medicine, University of California, Los Angeles, CA, USA.
⁸ Almirall, Barcelona, Spain.
⁹ Eli Lilly and Company, Indianapolis, USA.
¹⁰ Tigermed, Somerset, NJ, USA.
¹¹ Department of Dermatology, Centro Hospitalar Universitario de Santo António, ICBAS, University of Porto, Porto, Portugal.

Abstract

Introduction: Atopic dermatitis (AD) is a chronic inflammatory skin disease for which signs and symptoms have a negative impact on a patient's quality of life (QoL) and mental health. Here, we assess the impact of lebrikizumab on QoL and mental health after 16 weeks of treatment in patients with moderate-to-severe AD.

Methods: Data were analyzed over 16 weeks from two separate phase 3, randomized, placebo-controlled, monotherapy trials (ADvocate1 and ADvocate2). Patient-reported outcomes were assessed using the following measures: Dermatology Life Quality Index (DLQI), EQ-5D-5L visual analogue scale (VAS), EQ-5D-5L index scores (UK and US), Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety, and PROMIS Depression.

Results: Treatment with lebrikizumab 250 mg every 2 weeks in two studies led to statistically significant improvements (based on nominal p values) versus placebo in DLQI since week 4 (the first timepoint assessed) for the following measures: change from baseline in DLQI total score (ADvocate1 - 7.8 vs - 2.8; ADvocate2 - 7.3 vs - 3.9), proportion of patients with DLQI ≥ 4-point improvement (ADvocate1 69.5% vs 36.2%; ADvocate2 60.5% vs 42.6%), DLQI total score ≤ 5 (ADvocate1 36.7% vs 8.8%; ADvocate2 29.6% vs 10.8%), and DLQI (0, 1) (ADvocate1 12.3% vs 1.7%; ADvocate2 9.2% vs 1.7%). Improvements in DLQI measures, EQ-5D-5L index scores (UK and US), and EQ-5D-5L VAS were sustained through week 16. Additionally, lebrikizumab improved PROMIS Anxiety and PROMIS Depression scores, and improvements were higher in patients with at least a mild score (≥ 55) versus placebo for PROMIS Anxiety (ADvocate1 - 7.43 vs - 1.51; ADvocate2 - 4.95 vs - 0.82) and PROMIS Depression (ADvocate1 - 7.42 vs - 2.46; ADvocate2 - 4.28 vs - 2.00).

Conclusions: Treatment with monotherapy 250 mg lebrikizumab for 16 weeks provided clinically meaningful improvements in outcomes related to QoL and mental health for patients with moderate-to-severe AD. Lebrikizumab-treated patients reported improvements in DLQI as early as week 4, the first measure since baseline.

Trial registration: ClinicalTrials.gov Registration NCT04146363 (ADvocate1) and NCT04178967 (ADvocate2).

Keywords: Anxiety; Atopic dermatitis; Depression; Lebrikizumab; Mental health; Quality of life.

Associated data

ClinicalTrials.gov/NCT04178967
ClinicalTrials.gov/NCT04146363