Background <p>Atopic dermatitis is a chronic immune-inflammatory skin disease that significantly impairs quality of life, with itch representing a key, but not exclusive, contributor to this burden.</p> Objective <p>We aimed to evaluate itch relief and quality-of-life improvements with abrocitinib or dupilumab for 16 weeks alongside topical therapy in patients with moderate-to-severe atopic dermatitis.</p> Methods <p>This post hoc analysis included pooled data from patients who received abrocitinib (200 mg/day) or dupilumab (300 mg/every 2 weeks) in phase III JADE COMPARE and JADE DARE. Assessments included proportions of patients achieving a ≥ 4-point improvement from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS4), itch-free state (PP-NRS 0/1) by baseline itch severity, and proportions of patients with residual itch achieving Dermatology Life Quality Index score of 0/1 (DLQI 0/1), total Patient-Oriented Eczema Measure (POEM) score ≤ 2, SCORing Atopic Dermatitis (SCORAD) sleep loss visual analog scale score of 0/1 (SCORAD&#xa0;sleep loss visual analog scale 0/1), and POEM sleep item score of 0 (POEM sleep 0).</p> Results <p>Among 1196 patients (abrocitinib, <i>n</i> = 588; dupilumab, <i>n</i> = 608), those with greater baseline itch severity experienced greater atopic dermatitis severity and worse quality of life than patients with less severe itch. At week 16, numerically more patients achieved PP-NRS4 (67% vs 63%) and PP-NRS 0/1 (36% vs 27%) with abrocitinib versus dupilumab, respectively, regardless of baseline itch severity, although 95% confidence intervals overlapped for both measures. Median time to achieve PP-NRS4 (11 vs 29 days) and PP-NRS 0/1 (57 vs 139 days) was shorter with abrocitinib versus dupilumab, respectively. Numerically greater proportions of patients achieving PP-NRS 0/1 also achieved DLQI 0/1, POEM ≤ 2, SCORAD sleep loss visual analog scale 0/1, or POEM sleep 0 than patients with residual itch (PP-NRS ≥ 2).</p> Conclusions <p>In this post hoc pooled analysis of the JADE COMPARE and JADE DARE trials, the proportion of patients with moderate-to-severe atopic dermatitis achieving clinically meaningful itch responses, including an itch-free state, was generally higher with abrocitinib compared with dupilumab. Median time to achievement of both PP-NRS4 and an itch-free state was shorter with abrocitinib than with dupilumab. Patients who achieved an itch-free state experienced greater improvements in quality of life and sleep compared with patients with residual itch.</p> Clinical Trial Registration <p>JADE COMPARE (NCT03720470; registration date: 2018/10/24); JADE DARE (NCT04345367; registration date: 2020/04/10).</p>

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Itch Relief and Quality-of-Life Improvement with Abrocitinib and Dupilumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Post Hoc Analysis of JADE COMPARE and JADE DARE

  • Gil Yosipovitch,
  • Melinda J. Gooderham,
  • Sarina B. Elmariah,
  • Gianluca Bonfanti,
  • Roger A. Edwards,
  • Stamatios Gregoriou,
  • Pinaki Biswas,
  • Daniela E. Myers,
  • Justine Alderfer,
  • Erman Güler,
  • Christopher Koulias

摘要

Background

Atopic dermatitis is a chronic immune-inflammatory skin disease that significantly impairs quality of life, with itch representing a key, but not exclusive, contributor to this burden.

Objective

We aimed to evaluate itch relief and quality-of-life improvements with abrocitinib or dupilumab for 16 weeks alongside topical therapy in patients with moderate-to-severe atopic dermatitis.

Methods

This post hoc analysis included pooled data from patients who received abrocitinib (200 mg/day) or dupilumab (300 mg/every 2 weeks) in phase III JADE COMPARE and JADE DARE. Assessments included proportions of patients achieving a ≥ 4-point improvement from baseline in Peak Pruritus Numerical Rating Scale (PP-NRS4), itch-free state (PP-NRS 0/1) by baseline itch severity, and proportions of patients with residual itch achieving Dermatology Life Quality Index score of 0/1 (DLQI 0/1), total Patient-Oriented Eczema Measure (POEM) score ≤ 2, SCORing Atopic Dermatitis (SCORAD) sleep loss visual analog scale score of 0/1 (SCORAD sleep loss visual analog scale 0/1), and POEM sleep item score of 0 (POEM sleep 0).

Results

Among 1196 patients (abrocitinib, n = 588; dupilumab, n = 608), those with greater baseline itch severity experienced greater atopic dermatitis severity and worse quality of life than patients with less severe itch. At week 16, numerically more patients achieved PP-NRS4 (67% vs 63%) and PP-NRS 0/1 (36% vs 27%) with abrocitinib versus dupilumab, respectively, regardless of baseline itch severity, although 95% confidence intervals overlapped for both measures. Median time to achieve PP-NRS4 (11 vs 29 days) and PP-NRS 0/1 (57 vs 139 days) was shorter with abrocitinib versus dupilumab, respectively. Numerically greater proportions of patients achieving PP-NRS 0/1 also achieved DLQI 0/1, POEM ≤ 2, SCORAD sleep loss visual analog scale 0/1, or POEM sleep 0 than patients with residual itch (PP-NRS ≥ 2).

Conclusions

In this post hoc pooled analysis of the JADE COMPARE and JADE DARE trials, the proportion of patients with moderate-to-severe atopic dermatitis achieving clinically meaningful itch responses, including an itch-free state, was generally higher with abrocitinib compared with dupilumab. Median time to achievement of both PP-NRS4 and an itch-free state was shorter with abrocitinib than with dupilumab. Patients who achieved an itch-free state experienced greater improvements in quality of life and sleep compared with patients with residual itch.

Clinical Trial Registration

JADE COMPARE (NCT03720470; registration date: 2018/10/24); JADE DARE (NCT04345367; registration date: 2020/04/10).