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Introduction <p>The efficacy and safety of lebrikizumab, a high-affinity monoclonal antibody targeting interleukin-13, were investigated in patients with moderate-to-severe atopic dermatitis (AD) up to 52&#xa0;weeks in phase&#xa0;3 trials. This analysis evaluates safety and maintenance of response through 104&#xa0;weeks of lebrikizumab treatment in patients with moderate-to-severe AD who achieved clinical response with lebrikizumab at week&#xa0;16.</p> Methods <p>ADjoin is a 100-week phase&#xa0;3 long-term extension study. Adult and adolescent patients with moderate-to-severe AD were enrolled into parent studies ADvocate1, ADvocate2, and ADhere. ADvocate1&amp;2 week&#xa0;16 lebrikizumab clinical responders (patients who achieved Investigator’s Global Assessment [IGA] [0, 1] or Eczema Area and Severity Index [EASI]&#xa0;75 without rescue) were re-randomized 2:2:1 to lebrikizumab 250&#xa0;mg&#xa0;Q2W, Q4W, or placebo (lebrikizumab withdrawal). Patients who completed week&#xa0;52 of ADvocate1&amp;2 could enroll into ADjoin. ADhere week&#xa0;16 lebrikizumab clinical responders could enroll into ADjoin and were randomized 2:1 to lebrikizumab 250&#xa0;mg&#xa0;Q2W or Q4W. Analyses were performed on patients who received 104&#xa0;weeks of lebrikizumab treatment in parent and extension studies combined. Efficacy analyses are reported as observed from week&#xa0;16 for patients who were re-randomized to lebrikizumab Q2W or Q4W. Safety assessments included monitoring adverse events.</p> Results <p>IGA&#xa0;(0, 1) was maintained by 86.4% (Q2W) and 76.4% (Q4W) patients from ADvocate1&amp;2 and 83.9% (Q2W) and 78.6% (Q4W) patients from ADhere at week&#xa0;104. EASI&#xa0;75 was maintained by 95.6% (Q2W) and 96.3% (Q4W) ADvocate1&amp;2 patients and 95.1% (Q2W) and 96.0% (Q4W) ADhere patients at week&#xa0;104. Pruritus NRS ≥ 4-point improvement was maintained by 100% (Q2W) and 89.7% (Q4W) ADvocate1&amp;2 patients at week&#xa0;104 and 81.8% (Q2W) and 90.0% (Q4W) ADhere patients at week&#xa0;68. During ADjoin, adverse events were reported by 62.2% of patients from ADvocate1&amp;2 and ADhere who received lebrikizumab Q2W or Q4W, with the majority being mild (31.5%) or moderate (27.0%) in severity, and 2.2% leading to discontinuation due to adverse event.</p> Conclusions <p>Skin and itch outcomes were maintained over 2&#xa0;years of continuous lebrikizumab 250&#xa0;mg treatment. The safety profile of lebrikizumab in ADjoin is consistent with previous lebrikizumab studies in patients with moderate-to-severe AD.</p> Trial Registration <p>ClinicalTrials.gov, NCT04392154.</p>

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Two-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：

    2025年6月23日

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  • Emma Guttman-Yassky,
  • Stephan Weidinger,
  • Eric L. Simpson,
  • Melinda Gooderham,
  • Alan D. Irvine,
  • Lynda Spelman,
  • Jonathan I. Silverberg,
  • Hany ElMaraghy,
  • Louise DeLuca-Carter,
  • Maria Lucia Buziqui Piruzeli,
  • Chaoran Hu,
  • Fan Emily Yang,
  • Evangeline Pierce,
  • Laia Bardolet,
  • Diamant Thaçi

摘要

Introduction

The efficacy and safety of lebrikizumab, a high-affinity monoclonal antibody targeting interleukin-13, were investigated in patients with moderate-to-severe atopic dermatitis (AD) up to 52 weeks in phase 3 trials. This analysis evaluates safety and maintenance of response through 104 weeks of lebrikizumab treatment in patients with moderate-to-severe AD who achieved clinical response with lebrikizumab at week 16.

Methods

ADjoin is a 100-week phase 3 long-term extension study. Adult and adolescent patients with moderate-to-severe AD were enrolled into parent studies ADvocate1, ADvocate2, and ADhere. ADvocate1&2 week 16 lebrikizumab clinical responders (patients who achieved Investigator’s Global Assessment [IGA] [0, 1] or Eczema Area and Severity Index [EASI] 75 without rescue) were re-randomized 2:2:1 to lebrikizumab 250 mg Q2W, Q4W, or placebo (lebrikizumab withdrawal). Patients who completed week 52 of ADvocate1&2 could enroll into ADjoin. ADhere week 16 lebrikizumab clinical responders could enroll into ADjoin and were randomized 2:1 to lebrikizumab 250 mg Q2W or Q4W. Analyses were performed on patients who received 104 weeks of lebrikizumab treatment in parent and extension studies combined. Efficacy analyses are reported as observed from week 16 for patients who were re-randomized to lebrikizumab Q2W or Q4W. Safety assessments included monitoring adverse events.

Results

IGA (0, 1) was maintained by 86.4% (Q2W) and 76.4% (Q4W) patients from ADvocate1&2 and 83.9% (Q2W) and 78.6% (Q4W) patients from ADhere at week 104. EASI 75 was maintained by 95.6% (Q2W) and 96.3% (Q4W) ADvocate1&2 patients and 95.1% (Q2W) and 96.0% (Q4W) ADhere patients at week 104. Pruritus NRS ≥ 4-point improvement was maintained by 100% (Q2W) and 89.7% (Q4W) ADvocate1&2 patients at week 104 and 81.8% (Q2W) and 90.0% (Q4W) ADhere patients at week 68. During ADjoin, adverse events were reported by 62.2% of patients from ADvocate1&2 and ADhere who received lebrikizumab Q2W or Q4W, with the majority being mild (31.5%) or moderate (27.0%) in severity, and 2.2% leading to discontinuation due to adverse event.

Conclusions

Skin and itch outcomes were maintained over 2 years of continuous lebrikizumab 250 mg treatment. The safety profile of lebrikizumab in ADjoin is consistent with previous lebrikizumab studies in patients with moderate-to-severe AD.

Trial Registration

ClinicalTrials.gov, NCT04392154.