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Patients with Atopic Dermatitis with High Itch, Low BSA Improve with Lebrikizumab
In an ADvocate study subpopulation, new findings suggest lebrikizumab therapy leads to significant disease control and positive itch impacts.
In a subpopulation of patients living with atopic dermatitis with low levels of body surface area (BSA) involvement and high itch, new findings suggest lebrikizumab therapy leads to significant disease control and positive itch impacts.1
This recent data was presented in a poster titled ‘Lebrikizumab Improves Atopic Dermatitis in Patients with Limited Skin Involvement and High Itch,’ and presented at the Dermatology Education Foundation (DERM) 2025 NP/PA CME Conference in Las Vegas, Nevada. The research was authored by such investigators as Shawn Kwatra, MD, a Joseph Warren Burnett Professor of Dermatology at the University of Maryland School of Medicine.
Kwatra and his coauthors highlighted in their poster that this low BSA and high itch subpopulation is commonly underrepresented within clinical research in the dermatology space. However, the investigators added that this subpopulation is frequently seen in clinical practice settings.
The investigative team highlighted that translations in atopic dermatitis disease severity from clinical trials to real-world practice can pose a challenge. They pointed to the inconsistency that is often seen in the use of the Eczema Area Severity Index (EASI) and Investigator's Global Assessment for atopic dermatitis (IGA) within clinical settings.
Kwatra et al commented that the use of the pruritus numeric rating score (NRS) and BSA is more common within such settings. They added that it could more effectively evaluate skin disease severity and burden of atopic dermatitis in real-world settings. In this poster, the team reported on lebrikizumab’s efficacy when used in a subpopulation of patients in from the ADvocate 1 and showing limited BSA and high pruritus.
The studies were identically designed, with both being 52-week, randomized, double-blind, placebo-controlled, phase 3 analyses.2 Each study involved the use of a 16-week induction period along with a 36-week maintenance period. Those included as subjects were randomly assigned in a 2:1 ratio to either be treated with a 250 mg dose of lebrikizumab (loading dose of 500 mg at baseline and the 2-week mark) or a placebo, with subcutaneous administration taking place every 2 weeks (Q2W).
Among the participants in the pooled ADvocate 1 and 2 study population, the investigative team found that 14.0% had limited BSA (10-25%) and reported having high itch (≥6 Pruritus NRS). This amounted to 79 individuals in the lebrikizumab Q2W cohort and 40 individuals given a placebo.
The analyses were not adjusted by Kwatra and colleagues for multiplicity. Cochran-Mantel-Haenszel (for binary endpoints) test and MMRM model (for continuous endpoints) were both utilized by the investigators for their comparisons between the treatment cohorts.
Following the ADvocate studies’ 16 weeks, treatment with lebrikizumab was found by the Kwatra et al to have demonstrated efficacy in those with limited skin involvement (BSA 10-25%) and high levels of itch (≥6 Pruritus NRS) across all of the study measures.1 Despite their lower BSA levels at the point of baseline, EASI evaluations suggested moderate to severe disease and a severe or very severe effects on patient quality of life.
To find out more covered during the DERM 2025 conference, view our latest coverage of the meeting here.
References
Kwatra S, Werfel T, Mayo T, et al. Lebrikizumab Improves Atopic Dermatitis in Patients with Limited Skin Involvement and High Itch. Poster presented at the DERM 2025 NP/PA CME Conference; July 23 - 26, 2025; Las Vegas, Nevada.
Silverberg JI, Guttman-Yassky E, Seneschal J, et al. ADvocate1 and ADvocate2 Investigators. Two Phase 3 Trials of Lebrikizumab for Moderate-to-Severe Atopic Dermatitis. N Engl J Med. 2023 Mar 23;388(12):1080-1091. doi: 10.1056/NEJMoa2206714. Epub 2023 Mar 15. PMID: 36920778.
