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Introduction <p>We report efficacy and safety of lebrikizumab up to 152&#xa0;weeks (W) of continuous treatment with/without topical corticosteroids in the ADjoin long-term extension study.</p> Methods <p>ADvocate1&amp;2 W16 lebrikizumab responders (Eczema Area and Severity Index (EASI)&#xa0;75 or Investigator’s Global Assessment (IGA) 0/1 without rescue) were re-randomized 2:2:1 lebrikizumab (LEB) 250&#xa0;mg&#xa0;Q2W, Q4W, or placebo (lebrikizumab withdrawal, not presented herein) to the 36W maintenance period before entering ADjoin. ADhere W16 lebrikizumab responders were re-randomized 2:1 LEBQ2W/Q4W upon entering ADjoin. Data are reported as observed for W16 lebrikizumab responders from ADvocate1&amp;2 (<i>N</i> = 181) and ADhere (<i>N</i> = 86) who received treatment up to ADjoin W100 (152W/116W for ADvocate1&amp;2/ADhere). The Supplement reports additional populations.</p> Results <p>In participants who achieved IGA&#xa0;0/1 at W16, 84.0% (Q4W) and 82.9% (Q2W) from ADvocate1&amp;2 maintained IGA&#xa0;0/1 at W152; 91.7% and 86.7% from ADhere maintained response at W116. Among participants achieving EASI&#xa0;75 at W16, 94.1% (Q4W) and 90.5% (Q2W) from ADvocate1&amp;2 maintained EASI&#xa0;75 at W152; 90.9% and 94.9% from ADhere maintained EASI&#xa0;75 at W116. Most adverse events (AEs) were mild (29.2%) or moderate (33.3%) in severity; 3.7% reported serious AEs; 2.6% reported AEs leading to treatment discontinuation.</p> Conclusion <p>Lebrikizumab maintained efficacy up to 3&#xa0;years of continuous treatment in LEB 250&#xa0;mg Q2W and Q4W W16 lebrikizumab per-protocol responders. The safety profile was consistent with previous studies.</p> Trial Registration <p>ClinicalTrials.gov identifier, NCT04392154.</p>

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Three-Year Efficacy and Safety of Lebrikizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Long-Term Extension (ADjoin)

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年6月19日

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  • Emma Guttman-Yassky,
  • Alan D. Irvine,
  • Melinda Gooderham,
  • Stephan Weidinger,
  • Lynda Spelman,
  • Jonathan I. Silverberg,
  • Heidi Crane,
  • Hany ElMaraghy,
  • Louise DeLuca-Carter,
  • Maria Lucia Buziqui Piruzeli,
  • Georgia Martimianaki,
  • Evangeline Pierce,
  • Helena Agell,
  • Diamant Thaçi

摘要

Introduction

We report efficacy and safety of lebrikizumab up to 152 weeks (W) of continuous treatment with/without topical corticosteroids in the ADjoin long-term extension study.

Methods

ADvocate1&2 W16 lebrikizumab responders (Eczema Area and Severity Index (EASI) 75 or Investigator’s Global Assessment (IGA) 0/1 without rescue) were re-randomized 2:2:1 lebrikizumab (LEB) 250 mg Q2W, Q4W, or placebo (lebrikizumab withdrawal, not presented herein) to the 36W maintenance period before entering ADjoin. ADhere W16 lebrikizumab responders were re-randomized 2:1 LEBQ2W/Q4W upon entering ADjoin. Data are reported as observed for W16 lebrikizumab responders from ADvocate1&2 (N = 181) and ADhere (N = 86) who received treatment up to ADjoin W100 (152W/116W for ADvocate1&2/ADhere). The Supplement reports additional populations.

Results

In participants who achieved IGA 0/1 at W16, 84.0% (Q4W) and 82.9% (Q2W) from ADvocate1&2 maintained IGA 0/1 at W152; 91.7% and 86.7% from ADhere maintained response at W116. Among participants achieving EASI 75 at W16, 94.1% (Q4W) and 90.5% (Q2W) from ADvocate1&2 maintained EASI 75 at W152; 90.9% and 94.9% from ADhere maintained EASI 75 at W116. Most adverse events (AEs) were mild (29.2%) or moderate (33.3%) in severity; 3.7% reported serious AEs; 2.6% reported AEs leading to treatment discontinuation.

Conclusion

Lebrikizumab maintained efficacy up to 3 years of continuous treatment in LEB 250 mg Q2W and Q4W W16 lebrikizumab per-protocol responders. The safety profile was consistent with previous studies.

Trial Registration

ClinicalTrials.gov identifier, NCT04392154.