Lebrikizumab Combined with Topical Corticosteroids Improves Patient-reported Outcomes in Japanese Patients with Moderate-to-severe Atopic Dermatitis

Abstract

Lebrikizumab has previously demonstrated efficacy in Phase 3 trials: ADvocate1 and ADvocate2 (as monotherapy), ADhere, and ADhere-J (in combination with topical corticosteroids). Here, the impact of lebrikizumab combined with low- to mid-potency topical corticosteroids on patient-reported outcomes at 16 weeks in Japanese patients with moderate-to-severe atopic dermatitis is evaluated. Eligible patients (n = 286) were randomized 2:2:3 to receive placebo+ topical corticosteroids, 250 mg lebrikizumab every 4 weeks (LEBQ4W+topical corticosteroids, 500 mg loading dose at baseline), or 250 mg lebrikizumab every 2 weeks (LEBQ2W+ topical corticosteroids, 500 mg loading dose at baseline and Week 2) by subcutaneous injection. All PRO endpoints for the study were met; patients in the lebrikizumab in combination with topical corticosteroids groups demonstrated statistically significant and clinically meaningful improvements compared with placebo in combination with topical corticosteroids in Skin Pain NRS, DLQI, POEM, WPAI-AD, and SCORAD scales. Lebrikizumab combined with topical corticosteroids compared with placebo+topical corticosteroids improved patient-reported outcomes in Japanese patients with moderate-to-severe atopic dermatitis.

Fig. 1

Time Course Response for Skin Pain ≥ 4-point improvement from baseline. Percentage of patients (%) reporting a Skin Pain Numeric Rating Scale (NRS) score of ≥ 4 points at baseline achieving a ≥ 4-point improvement from baseline. *p ≤ 0.05, **p ≤ 0.01, ***p ≤ 0.001 vs placebo in combination with topical corticosteroids (TCS) using the Cochran–Mantel–Haenszel test with non-responder imputation. LEB: lebrikizumab; N: number of patients in the analysis population; PBO: placebo; Q2W: every 2 weeks; Q4W: every 4 weeks.

Fig. 2

Dermatology Life Quality Index (DLQI) and Children’s DLQI (CDLQI) total score change from baseline. Time course response from baseline to Week 16 for DLQI (A) and CDLQI (B) total scores. DLQI was measured starting at Week 4. DLQI assessment was completed by patients > 16 years old and patients ≤ 16 years old used the CDLQI. ***p < 0.001 vs placebo in combination with topical corticosteroids (TCS) using mixed model repeated measures. LEB: lebrikizumab; LSM: least squares mean; N: number of patients in the analysis population; PBO: placebo; Q2W: every 2 weeks; Q4W: every 4 weeks.

Fig. 3

Patient Oriented Eczema Measure (POEM) least squares mean (LSM) change from baseline. Time course response from baseline to Week 16 for POEM. **p < 0.01, ***p < 0.001 vs placebo in combination with TCS using mixed-model repeated measures. LEB: lebrikizumab; N: number of patients in the analysis population; PBO: placebo; Q2W: every 2 weeks; Q4W: every 4 weeks; TCS: topical corticosteroids.

Fig. 4

Change in Work Productivity and Activity Impairment – Atopic Dermatitis (WPAI-AD) score from baseline to week 16. Change in (A) WPAI-AD absenteeism, (B) presenteeism, (C) overall work impairment, and (D) impairment in activities performed outside of work scores from baseline to Week 16. ***p < 0.001 vs placebo in combination with topical corticosteroids (TCS) using mixed-model repeated measures. LEB: lebrikizumab; LSM: least squares mean; N: number of patients in the analysis population; PBO: placebo; Q2W: every 2 weeks; Q4W: every 4 weeks.

Fig. 5

SCORing Atopic Dermatitis (SCORAD) percentage change from baseline. Percentage change from baseline to Week 16 for SCORAD. ***p < 0.001 vs placebo in combination with topical corticosteroids (TCS) using mixed-model repeated measures. LEB: lebrikizumab; N: number of patients in the analysis population; PBO: placebo; Q2W: every 2 weeks; Q4W: every 4 weeks.