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Introduction <p>Long-term disease and symptom control is a goal of atopic dermatitis (AD) therapy. This study assessed the long-term maintenance of disease and symptom control with as-needed application of ruxolitinib cream.</p> Methods <p>Patients aged ≥ 12&#xa0;years with AD, an Investigator’s Global Assessment (IGA) score of 2/3, and 3–20% affected body surface area were included in the phase&#xa0;3 TRuE-AD1 and TRuE-AD2 studies. This analysis included patients randomized to twice-daily (BID) 1.5% ruxolitinib cream for 8&#xa0;weeks and then as-needed (IGA ≥ 1) BID for up to 44&#xa0;weeks (long-term safety [LTS] period).</p> Results <p>Among patients evaluated for disease control in the as-needed period (<i>N</i> = 428), IGA&#xa0;0/1 (skin/almost clear skin) was achieved by 67.1% of patients at week&#xa0;8. From week&#xa0;8, 80–90% of patients with IGA&#xa0;0/1 at a given visit maintained or improved their response at the next visit. Median time to worsening disease (IGA ≥ 2) was 36.1&#xa0;weeks during the as-needed period, and IGA&#xa0;0/1 was quickly recaptured. Patients spent a median 43.9% of the as-needed period off treatment due to lesion clearance. No itch/no sleep disturbance (Patient-Oriented Eczema Measure questions&#xa0;1 and 2) was reported in 32.7%/71.8% of patients at week&#xa0;8 and 36.2%/74.5% of patients at week&#xa0;52. No new safety concerns emerged in the LTS period.</p> Conclusion <p>Continued disease and symptom control with substantial time off treatment makes 1.5% ruxolitinib cream an effective long-term option for patients with mild to moderate AD.</p> Trial Registration <p>Clinicaltrials.gov, NCT03745638 and NCT03745651 (studies registered November 19, 2018).</p>

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Ruxolitinib Cream As-Needed Monotherapy Demonstrates Sustained Disease and Symptom Control in Patients with Mild to Moderate Atopic Dermatitis: Pooled Analysis from Two Phase 3 Studies

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  • 出版模式：

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  • 发表日期：

    2026年2月12日

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  • Andrew Blauvelt,
  • Leon Kircik,
  • Eric L. Simpson,
  • Peter Lio,
  • Lawrence F. Eichenfield,
  • Vimal H. Prajapati,
  • Parbeer Grewal,
  • Charles Lynde,
  • H. Chih-ho Hong,
  • Daniel Sturm,
  • Howard Kallender,
  • Haobo Ren,
  • Dilan Paranagama,
  • Grace K. W. Wong,
  • Bob Geng

摘要

Introduction

Long-term disease and symptom control is a goal of atopic dermatitis (AD) therapy. This study assessed the long-term maintenance of disease and symptom control with as-needed application of ruxolitinib cream.

Methods

Patients aged ≥ 12 years with AD, an Investigator’s Global Assessment (IGA) score of 2/3, and 3–20% affected body surface area were included in the phase 3 TRuE-AD1 and TRuE-AD2 studies. This analysis included patients randomized to twice-daily (BID) 1.5% ruxolitinib cream for 8 weeks and then as-needed (IGA ≥ 1) BID for up to 44 weeks (long-term safety [LTS] period).

Results

Among patients evaluated for disease control in the as-needed period (N = 428), IGA 0/1 (skin/almost clear skin) was achieved by 67.1% of patients at week 8. From week 8, 80–90% of patients with IGA 0/1 at a given visit maintained or improved their response at the next visit. Median time to worsening disease (IGA ≥ 2) was 36.1 weeks during the as-needed period, and IGA 0/1 was quickly recaptured. Patients spent a median 43.9% of the as-needed period off treatment due to lesion clearance. No itch/no sleep disturbance (Patient-Oriented Eczema Measure questions 1 and 2) was reported in 32.7%/71.8% of patients at week 8 and 36.2%/74.5% of patients at week 52. No new safety concerns emerged in the LTS period.

Conclusion

Continued disease and symptom control with substantial time off treatment makes 1.5% ruxolitinib cream an effective long-term option for patients with mild to moderate AD.

Trial Registration

Clinicaltrials.gov, NCT03745638 and NCT03745651 (studies registered November 19, 2018).