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Lebrikizumab monotherapy for 16 weeks resulted in clinically meaningful improvements in quality of life (QoL) and mental health outcomes among patients with moderate-to-severe atopic dermatitis (AD), according to a study published in Dermatology Therapy.

In the analysis of 2 phase 3 clinical trials, researchers also noted that participants with moderate-to-severe AD who received lebrikizumab 250 mg every 2 weeks reported improvements in QoL as early as week 4, which was the first timepoint assessed. The improvements were sustained through week 16.

“Symptoms of moderate-to-severe AD, such as increased itch and sleep disturbance due to itch, can have a detrimental impact on [QoL] and mental health,” first author Peter Lio, MD, of Northwestern University Feinberg School of Medicine in Chicago, Illinois, and colleagues wrote. “Emotional distress and impaired physical and social functioning are among some of the main factors negatively affecting QoL in patients with AD.”

Lio and colleagues added that approximately 30% of patients with AD report symptoms of anxiety or depression. Current research on AD focuses more on cutaneous signs and symptoms, which has led to an unmet need for data on AD control and its associated impact on QoL and mental health conditions.

To help fill this knowledge gap, investigators analyzed data from the ADvocate1 (NCT04146363) and ADvocate 2 (NCT04178967) phase 3 randomized, placebo-controlled lebrikizumab monotherapy trials. The studies were identically designed 52-week, double-blind, parallel group trials that enrolled adults aged over 18 years and adolescents (aged 12 to 18 years and weighed more than 40 kg). All participants had moderate-to-severe AD for more than 1 year and had an Eczema Area and Severity Index (EASI) score of ≥16 (range, 0-72), Investigator’s Global Assessment (IGA) score of ≥3 (range, 0-4), and an affected body surface area of ≥10% (range, 0%-100%).

In the current study, Lio and coauthors focused on the induction treatment period (week 0 to week 16). Participants received either lebrikizumab 500 mg loading doses at baseline and week 2, followed by 250 mg subcutaneous injection every 2 weeks until week 16, or placebo. There were 424 patients who received lebrizkumab in ADvocate1 and 427 who received the drug in ADvocate2. Baseline mean scores for QoL and Patient-Reported Outcomes Measurement Information System (PROMIS) were similar between lebrizkumab-treated patients and placebo-treated participants, according to researchers.

In both studies, patient-reported outcomes were evaluated at baseline and at week 16 using the PROMIS Anxiety and Depression tools, the EQ-5D-5L visual analogue scale (VAS), and EQ-5D-5L index scores including both the UK and US algorithms. The EQ-5D-5L measures health-related QoL. Patient-reported QoL was also assessed using the Dermatology Life Quality Index (DLQI), which was measured at baseline and weeks 4, 8, 12, and 16. The DLQI evaluates 6 domains over the previous week, including daily activities, symptoms and feelings, leisure, work and school, personal relationships, and treatment.

Findings

Researchers observed statistically significant improvements as early as week 4 with lebrikizumab compared to placebo in DLQI scores for the following measures:

• Change from baseline (CFB) in total score (ADvocate1, least squares mean [LSM] -7.8 vs -2.8; ADvocate2, LSM -7.3 vs -3.9; both P < .001).
• Proportion of patients with a 4-point or greater improvement in DLQI (ADvocate1, 69.5% vs 36.2%, P < .001; ADvocate2, 60.5% vs 42.6%, P = .001).
• DLQI total score of 5 or less, indicating little-to-no effect (ADvocate1, 36.7% vs 8.8%; ADvocate2, 29.6% vs 10.8%; both P < .001).
• DLQI score of 0-1, indicating no impact on QoL (ADvocate1, 12.3% vs 1.7%, P < .001; ADvocate2, 9.2% vs 1.7%, P = .006).

Results showed sustained improvements among participants who received lebrikizumab through week 16 for DLQI measures, EQ-5D-5L index scores, and EQ-5D-5L VAS scores compared to placebo-treated individuals, investigators noted.

In addition, after 16 weeks, lebrikizumab-treated participants showed significant improvements in PROMIS Anxiety scores compared to placebo in both studies (ADvocate1, CFB LSM -3.91 vs -0.60; ADvocate2, CFB LSM -3.18 vs -0.45; both P < .001), as well as in PROMIS Depression scores (ADvocate1, CFB LSM -3.07 vs -0.37; ADvocate2, CFB LSM -2.59 vs 0.16; both P < .001). Improvements were higher among patients with symptoms categorized as mild at baseline for PROMIS Anxiety scores (ADvocate1, -7.43 vs -1.51; ADvocate2, -4.95 vs -0.82; both P < .001) and PROMIS Depression scores (ADvocate1, -7.42 vs -2.46, P = .002; ADvocate2, -4.28 vs -2.0, P = .065)

Lio and colleagues stated that because these findings were measured only after 16 weeks, “the long-term impact of lebrikizumab treatment on the mental health of patients should be explored.”

Reference: Lio PA, Armstrong A, Gutermuth J, et al. Lebrikizumab improves quality of life and patient-reported symptoms of anxiety and depression in patients with moderate-to-severe atopic dermatitis. Dermatol Ther. 2024;14:1929-1943