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Introduction <p>The treat-to-target concept established goals to guide treatment with systemic therapies in atopic dermatitis (AD), including goals for itch improvement, reported as the most burdensome symptom. The aim of this study is to assess optimal itch response onset and long-term maintenance using treat-to-target criteria in dupilumab-treated patients.</p> Methods <p>This post hoc analysis assessed patients ≥ 18&#xa0;years with moderate-to-severe AD in two phase&#xa0;3, randomized, double-blind, placebo-controlled studies. Patients received dupilumab 300&#xa0;mg every 2&#xa0;weeks or placebo with concomitant topical corticosteroids (TCS) for 52&#xa0;weeks (CHRONOS); or dupilumab monotherapy 300&#xa0;mg every week/every 2&#xa0;weeks/every 4&#xa0;weeks/every 8&#xa0;weeks or placebo for 36&#xa0;weeks after achieving Eczema Area and Severity Index improvement of 75% or Investigator’s Global Assessment 0/1 with dupilumab in SOLO1/2 (SOLO-CONTINUE). Optimal itch response was defined as Peak Pruritus Numeric Rating Scale ≤ 4.</p> Results <p>Patients receiving dupilumab + TCS achieved optimal itch response faster and in higher proportion than those receiving placebo + TCS (<i>P</i> &lt; 0.0001) and maintained optimal response longer (median [Q1–Q3] 40 [11–50] vs 3 [0–23] weeks; <i>P</i> &lt; 0.0001). Patients achieving optimal itch response with dupilumab monotherapy who continued treatment maintained response longer compared with those transitioned to placebo, although duration decreased with less frequent dosing (<i>P</i> &lt; 0.0001 for all dupilumab regimens vs placebo).</p> Conclusion <p>Optimal itch response was achieved rapidly and maintained long&#xa0;term in adult patients treated with dupilumab with or without concomitant TCS therapy.</p> Trial Registration <p>NCT02395133 and NCT02260986.</p>

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Onset and Long-Term Maintenance of Optimal Itch Response in Adult Patients with Moderate-to-Severe Atopic Dermatitis Treated with Dupilumab: Post Hoc Analysis from Two Phase 3 Trials

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  • 发表日期：

    2025年2月19日

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  • Sonja Ständer,
  • Gil Yosipovitch,
  • Eric L. Simpson,
  • Brian S. Kim,
  • Kenji Kabashima,
  • Diamant Thaçi,
  • Martin Metz,
  • Zhen Chen,
  • Sandra Hagen,
  • Mike Bastian

摘要

Introduction

The treat-to-target concept established goals to guide treatment with systemic therapies in atopic dermatitis (AD), including goals for itch improvement, reported as the most burdensome symptom. The aim of this study is to assess optimal itch response onset and long-term maintenance using treat-to-target criteria in dupilumab-treated patients.

Methods

This post hoc analysis assessed patients ≥ 18 years with moderate-to-severe AD in two phase 3, randomized, double-blind, placebo-controlled studies. Patients received dupilumab 300 mg every 2 weeks or placebo with concomitant topical corticosteroids (TCS) for 52 weeks (CHRONOS); or dupilumab monotherapy 300 mg every week/every 2 weeks/every 4 weeks/every 8 weeks or placebo for 36 weeks after achieving Eczema Area and Severity Index improvement of 75% or Investigator’s Global Assessment 0/1 with dupilumab in SOLO1/2 (SOLO-CONTINUE). Optimal itch response was defined as Peak Pruritus Numeric Rating Scale ≤ 4.

Results

Patients receiving dupilumab + TCS achieved optimal itch response faster and in higher proportion than those receiving placebo + TCS (P < 0.0001) and maintained optimal response longer (median [Q1–Q3] 40 [11–50] vs 3 [0–23] weeks; P < 0.0001). Patients achieving optimal itch response with dupilumab monotherapy who continued treatment maintained response longer compared with those transitioned to placebo, although duration decreased with less frequent dosing (P < 0.0001 for all dupilumab regimens vs placebo).

Conclusion

Optimal itch response was achieved rapidly and maintained long term in adult patients treated with dupilumab with or without concomitant TCS therapy.

Trial Registration

NCT02395133 and NCT02260986.