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Introduction <p>The Aiming High in Eczema/Atopic Dermatitis (AHEAD) guidelines recommend achieving minimal disease activity (MDA) in atopic dermatitis (AD), defined as simultaneous achievement of optimal treatment targets for at least one clinician- and one patient-reported outcome (ClinRO + PRO). We assessed the effect of upadacitinib on achieving optimal ClinROs, optimal PROs, and MDA in Measure Up 1 (NCT03569293) and Measure Up 2 (NCT3607422) studies for patients with moderate to severe AD. </p> Methods <p>Patients were randomized to receive upadacitinib (15&#xa0;mg or 30&#xa0;mg) or placebo. Achievement of ≥ 1 optimal target in ClinROs, ≥ 1 optimal target in PROs, and MDA (≥ 1 optimal ClinROs and ≥ 1 optimal PROs) were reported at weeks 16 (upadacitinib vs placebo) and 52 (upadacitinib only). MDAs in selected combinations were also assessed at weeks 16 and 52. A total of 1683 and 1124 patients were included in the week 16 and 52 analysis, respectively. </p> Results <p>At week 16, a significantly higher proportion of patients receiving upadacitinib (15&#xa0;mg: 42.5%, 30&#xa0;mg: 55.9%) compared with placebo (6.4%) achieved MDA. At week 52, 57.4% and 69.9% of patients receiving 15&#xa0;mg and 30&#xa0;mg of upadacitinib achieved MDA, respectively. Specifically, patients receiving upadacitinib attained higher rates of ≥ 90% reduction from baseline in Eczema Area and Severity Index (EASI 90) + Worst Pruritus-Numerical Rating Scale (WP-NRS) 0/1 at week 16 (15&#xa0;mg: 25.3%, 30&#xa0;mg: 39.4% vs placebo: 1.8%) and maintained at week 52 (15&#xa0;mg: 38.1%, 30&#xa0;mg: 46.9%). </p> Conclusion <p>Treatment with upadacitinib achieved both ClinRO and PRO optimal treatment targets as well as MDA and may optimize overall disease management in patients with moderate-to-severe AD. </p>

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Achieving Optimal Treatment Targets and Minimal Disease Activity with Upadacitinib for Moderate-to-Severe Atopic Dermatitis: Integrated Analysis of Phase 3 Studies (Measure Up 1 and 2)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年7月14日

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  • Jonathan I. Silverberg,
  • Melinda Gooderham,
  • Norito Katoh,
  • Valeria Aoki,
  • Andrew E. Pink,
  • Yousef Binamer,
  • Brad Glick,
  • Petra Staubach,
  • Brian Calimlim,
  • Chao Li,
  • Ayman Grada,
  • Alvaro Moreira,
  • Wan-Ju Lee,
  • Andreas Wollenberg

摘要

Introduction

The Aiming High in Eczema/Atopic Dermatitis (AHEAD) guidelines recommend achieving minimal disease activity (MDA) in atopic dermatitis (AD), defined as simultaneous achievement of optimal treatment targets for at least one clinician- and one patient-reported outcome (ClinRO + PRO). We assessed the effect of upadacitinib on achieving optimal ClinROs, optimal PROs, and MDA in Measure Up 1 (NCT03569293) and Measure Up 2 (NCT3607422) studies for patients with moderate to severe AD.

Methods

Patients were randomized to receive upadacitinib (15 mg or 30 mg) or placebo. Achievement of ≥ 1 optimal target in ClinROs, ≥ 1 optimal target in PROs, and MDA (≥ 1 optimal ClinROs and ≥ 1 optimal PROs) were reported at weeks 16 (upadacitinib vs placebo) and 52 (upadacitinib only). MDAs in selected combinations were also assessed at weeks 16 and 52. A total of 1683 and 1124 patients were included in the week 16 and 52 analysis, respectively.

Results

At week 16, a significantly higher proportion of patients receiving upadacitinib (15 mg: 42.5%, 30 mg: 55.9%) compared with placebo (6.4%) achieved MDA. At week 52, 57.4% and 69.9% of patients receiving 15 mg and 30 mg of upadacitinib achieved MDA, respectively. Specifically, patients receiving upadacitinib attained higher rates of ≥ 90% reduction from baseline in Eczema Area and Severity Index (EASI 90) + Worst Pruritus-Numerical Rating Scale (WP-NRS) 0/1 at week 16 (15 mg: 25.3%, 30 mg: 39.4% vs placebo: 1.8%) and maintained at week 52 (15 mg: 38.1%, 30 mg: 46.9%).

Conclusion

Treatment with upadacitinib achieved both ClinRO and PRO optimal treatment targets as well as MDA and may optimize overall disease management in patients with moderate-to-severe AD.