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Lebrikizumab is efficacious in adults and adolescents with moderate-to-severe atopic dermatitis regardless of atopic comorbidities.

Publication ,  Journal Article
Sher, ER; Golant, A; de Bruin-Weller, M; Carrascosa, J-M; Mehta, V; Bieber, T; Dawson, Z; Atwater, AR; Zhong, J; Rodriguez Calleja, L; Boguniewicz, M
Published in: Ann Allergy Asthma Immunol
December 21, 2025

BACKGROUND: Atopic comorbidities are common in patients with atopic dermatitis (AD) and increase disease burden. Lebrikizumab monotherapy demonstrated efficacy and safety through 52 weeks in patients with moderate-to-severe AD in phase 3 trials (ADvocate1 [NCT04146363]; ADvocate2 [NCT04178967]). OBJECTIVE: To evaluate the impact of atopic comorbidities on lebrikizumab efficacy and response maintenance in patients with AD using pooled data from ADvocate1 and ADvocate2. METHODS: At the end of the 16-week induction period, patients responding to lebrikizumab treatment every 2 weeks were re-randomized to receive lebrikizumab every 2 weeks, every 4 weeks, or placebo (withdrawal) for 36 additional weeks. Eczema Area and Severity Index (EASI) with at least 75% or 90% improvement (EASI 75; EASI 90), Pruritus Numeric Rating Scale with at least 4-point improvement, Investigator's Global Assessment 0 or 1, and Asthma Control Questionnaire-5 results were assessed at weeks 16 and 52. Dermatology Quality of Life Index and sleep loss due to pruritus were assessed at week 16. RESULTS: Of 851 patients, 614 (72.2%) reported at least 1 atopic comorbidity. At week 16, significantly more lebrikizumab- vs placebo-treated patients achieved EASI 75, Pruritus Numeric Rating Scale with at least 4-point improvement, Investigator's Global Assessment 0 or 1, and EASI 90 (P < .001), regardless of atopic comorbidities. Results were similar for Dermatology Quality of Life Index and sleep loss. Most lebrikizumab responders at week 16, both with and without atopic comorbidities, maintained skin and pruritus response to week 52; Asthma Control Questionnaire-5 scores remained stable. CONCLUSION: The presence or absence of atopic comorbidities did not affect the efficacy of lebrikizumab at weeks 16 and 52 in patients with moderate-to-severe AD. TRIAL REGISTRATION: ClinicalTrials.gov Identifiers: NCT04146363 and NCT04178967 (https://clinicaltrials.gov/study/NCT04146363; https://www. CLINICALTRIALS: gov/study/NCT04178967).

Duke Scholars

Published In

Ann Allergy Asthma Immunol

DOI

EISSN

1534-4436

Publication Date

December 21, 2025

Location

United States

Related Subject Headings

  • Allergy
  • 3204 Immunology
 

Citation

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Sher, E. R., Golant, A., de Bruin-Weller, M., Carrascosa, J.-M., Mehta, V., Bieber, T., … Boguniewicz, M. (2025). Lebrikizumab is efficacious in adults and adolescents with moderate-to-severe atopic dermatitis regardless of atopic comorbidities. Ann Allergy Asthma Immunol. https://doi.org/10.1016/j.anai.2025.12.017
Sher, Ellen R., Alexandra Golant, Marjolein de Bruin-Weller, Jose-Manuel Carrascosa, Vinay Mehta, Thomas Bieber, Zach Dawson, et al. “Lebrikizumab is efficacious in adults and adolescents with moderate-to-severe atopic dermatitis regardless of atopic comorbidities.Ann Allergy Asthma Immunol, December 21, 2025. https://doi.org/10.1016/j.anai.2025.12.017.
Sher ER, Golant A, de Bruin-Weller M, Carrascosa J-M, Mehta V, Bieber T, et al. Lebrikizumab is efficacious in adults and adolescents with moderate-to-severe atopic dermatitis regardless of atopic comorbidities. Ann Allergy Asthma Immunol. 2025 Dec 21;
Sher, Ellen R., et al. “Lebrikizumab is efficacious in adults and adolescents with moderate-to-severe atopic dermatitis regardless of atopic comorbidities.Ann Allergy Asthma Immunol, Dec. 2025. Pubmed, doi:10.1016/j.anai.2025.12.017.
Sher ER, Golant A, de Bruin-Weller M, Carrascosa J-M, Mehta V, Bieber T, Dawson Z, Atwater AR, Zhong J, Rodriguez Calleja L, Boguniewicz M. Lebrikizumab is efficacious in adults and adolescents with moderate-to-severe atopic dermatitis regardless of atopic comorbidities. Ann Allergy Asthma Immunol. 2025 Dec 21;
Journal cover image

Published In

Ann Allergy Asthma Immunol

DOI

EISSN

1534-4436

Publication Date

December 21, 2025

Location

United States

Related Subject Headings

  • Allergy
  • 3204 Immunology