Lebrikizumab Improved Itch Symptoms and Reduced Itch Interference on Sleep over 52 Weeks in Patients with Moderate-to-Severe Atopic Dermatitis in Two Phase 3 Trials.

Abstract

Introduction: Lebrikizumab significantly reduced itch and itch interference on sleep in patients with moderate-to-severe atopic dermatitis (AD) at week 16 in two phase 3 trials. We investigated itch reduction and the efficacy of improving itch interference on sleep in lebrikizumab-treated patients over 52 weeks.

Methods: At week 16 in ADvocate1 and ADvocate2, patients who met protocol-defined response criteria to lebrikizumab 250 mg every 2 weeks (Q2W) were re-randomized 2:2:1 to lebrikizumab Q2W, lebrikizumab 250 mg every 4 weeks (Q4W), or placebo Q2W to week 52; patients who did not achieve protocol-defined response continued open-label lebrikizumab Q2W. The Pruritus Numeric Rating Scale (NRS) evaluated the worst itch intensity over the previous 24 h in daily electronic diaries; the Sleep-Loss Scale measured the interference of itch on sleep over the last night. For week 16 responders, data after systemic rescue medication or discontinuation due to lack of efficacy were imputed with non-responder imputation; data after topical corticosteroid usage and discontinuation due to other reasons were set as missing; all missing data were imputed with multiple imputation. Descriptive statistics using observed data are reported for week 16 by non-responders.

Results: At week 52 among patients who met week-16 protocol-defined response criteria, 73.4% and 71.8% receiving lebrikizumab Q4W and Q2W, respectively, reported ≥3-point improvement in the Pruritus NRS. Mean percent improvement from baseline to week 52 in the Pruritus NRS was 59.9% and 59.6% with lebrikizumab Q4W and Q2W, respectively. For patients who did not achieve a week-16 protocol-defined response, 73.3% achieved ≥3-point improvement on the Pruritus NRS at week 52, with mean percent improvement from baseline to week 52 of 59.2%. At week 52 in responders, ≥1-point improvement in the Sleep-Loss Scale was achieved by 77.9% and 78.9% of patients receiving lebrikizumab Q4W and Q2W, respectively, with a mean percent improvement from baseline to week 52 of 64.4% and 65.9%. For week-16 non-responders, 86.1% of patients achieved ≥1-point improvement in the Sleep-Loss Scale at week 52, with a mean percent improvement of 74.9%.

Conclusion: These findings indicate that lebrikizumab is an effective AD treatment to reduce itch and improve sleep loss due to itch over the long term for both patients who did and did not meet protocol-defined response criteria at week 16.