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Introduction <p>Atopic dermatitis (AD) can be treated with topical or systemic therapies. Here, we review baseline disease severity and burden in clinical trials of topical and systemic therapies to describe the patient populations in which they may be effective.</p> Methods <p>PubMed and the Cochrane database were searched from January 1, 2010, to May 1, 2025, to identify manuscripts reporting randomized controlled clinical trials (≥ 30 patients) of topical AD therapies, including those considered advanced (crisaborole ointment, roflumilast cream, ruxolitinib cream, tapinarof cream), and pivotal clinical trials of advanced systemic AD therapies (abrocitinib, baricitinib, dupilumab, lebrikizumab, nemolizumab, tralokinumab, upadacitinib). Results were presented descriptively using published disease severity thresholds.</p> Results <p>Included clinical trials of topical AD therapies (<i>n</i> = 59) reported mean assessments of baseline clinician-rated disease severity (affected body surface area [<i>n</i> = 38], Eczema Area and Severity Index [<i>n</i> = 41]), and patient-reported disease burden (itch numerical rating scale/visual analog scale [<i>n</i> = 35], Dermatology Life Quality Index [<i>n</i> = 13], Patient-Oriented Eczema Measure [<i>n</i> = 19]). For clinician-rated disease severity assessments, mean baseline values and SDs generally fell in the moderate categories. For patient-reported disease burden, baseline mean values fell in the moderate category, and SDs overlapped the severe or “very large effect” categories in most studies. Baseline mean values for clinician-rated disease severity measures were substantially higher in pivotal systemic therapy versus topical therapy studies, and SDs generally did not overlap. Baseline mean values for patient-reported disease burden measures were generally lower in pivotal clinical trials of advanced topical therapies versus those conducted for advanced systemic therapies, but SDs overlapped between studies for both treatment categories.</p> Conclusion <p>Many patients with AD treated in clinical trials of topical therapies report high levels of disease burden, overlapping with some patients eligible for systemic therapies. These results suggest that advanced topical therapies may be effective in patients with more extensive AD.</p>

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Pushing the Boundaries of Topical Therapy in Patients with Atopic Dermatitis: A Review of Baseline Disease Severity and Burden in Clinical Trials

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年7月14日

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  • Melinda J. Gooderham,
  • H. Chih-ho Hong,
  • Charles Lynde,
  • Yvette Miller-Monthrope,
  • Vimal H. Prajapati,
  • Julien Ringuet,
  • Irina Turchin,
  • Jensen Yeung,
  • Kim A. Papp

摘要

Introduction

Atopic dermatitis (AD) can be treated with topical or systemic therapies. Here, we review baseline disease severity and burden in clinical trials of topical and systemic therapies to describe the patient populations in which they may be effective.

Methods

PubMed and the Cochrane database were searched from January 1, 2010, to May 1, 2025, to identify manuscripts reporting randomized controlled clinical trials (≥ 30 patients) of topical AD therapies, including those considered advanced (crisaborole ointment, roflumilast cream, ruxolitinib cream, tapinarof cream), and pivotal clinical trials of advanced systemic AD therapies (abrocitinib, baricitinib, dupilumab, lebrikizumab, nemolizumab, tralokinumab, upadacitinib). Results were presented descriptively using published disease severity thresholds.

Results

Included clinical trials of topical AD therapies (n = 59) reported mean assessments of baseline clinician-rated disease severity (affected body surface area [n = 38], Eczema Area and Severity Index [n = 41]), and patient-reported disease burden (itch numerical rating scale/visual analog scale [n = 35], Dermatology Life Quality Index [n = 13], Patient-Oriented Eczema Measure [n = 19]). For clinician-rated disease severity assessments, mean baseline values and SDs generally fell in the moderate categories. For patient-reported disease burden, baseline mean values fell in the moderate category, and SDs overlapped the severe or “very large effect” categories in most studies. Baseline mean values for clinician-rated disease severity measures were substantially higher in pivotal systemic therapy versus topical therapy studies, and SDs generally did not overlap. Baseline mean values for patient-reported disease burden measures were generally lower in pivotal clinical trials of advanced topical therapies versus those conducted for advanced systemic therapies, but SDs overlapped between studies for both treatment categories.

Conclusion

Many patients with AD treated in clinical trials of topical therapies report high levels of disease burden, overlapping with some patients eligible for systemic therapies. These results suggest that advanced topical therapies may be effective in patients with more extensive AD.