ArticleDermatology and therapy2025
Two-Year Efficacy and Safety of Lebrikizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Long-Term Extension (ADjoin).
Article in Dermatology and therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04392154 (A Long-term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis), which is not on this map. Cited by 7 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Long-term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis (ADjoin)
Who cites it
7 citing papers in PubMed.
- Absolute Eczema Area and Severity Index Responses with Lebrikizumab in Patients with Moderate-to-severe Atopic Dermatitis: A Secondary Analysis of Two Phase 3 Trials.Acta dermato-venereologica · 2026Trial
- Three-Year Efficacy and Safety of Lebrikizumab in Patients with Moderate-to-Severe Atopic Dermatitis: A Long-Term Extension (ADjoin).Dermatology and therapy · 2026Article
- Comparative Data on Long-Term Efficacy of Biologics in Moderate-to-Severe AD: An Expert Perspective on Using Indirect Comparison Methodology.Dermatology and therapy · 2026Review
- Atopic Dermatitis Beyond the Skin Barrier: Precision Medicine Approaches to Immunological Profiling and Therapeutic Innovation.International journal of molecular sciences · 2026Review
- Efficacy of Lebrikizumab on Pruritus: A Narrative Review.Advances in therapy · 2026Review
- Ease of Use of the Lebrikizumab Prefilled Pen for Individuals with Atopic Dermatitis.Patient preference and adherence · 2026Article
- Lebrikizumab for atopic dermatitis.Australian prescriber · 2025Review
Corrections and comments
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Authors and funding
15 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThe 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.
methodsADjoin 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.
resultsIGA (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.
conclusionsSkin 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 registrationClinicalTrials.gov, NCT04392154.
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