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© 2023. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the "License"). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.

Abstract

Background

The Janus kinase (JAK)1/JAK2 inhibitor baricitinib in combination with topical corticosteroids (TCS) improved moderate‐to‐severe atopic dermatitis (AD) in the phase 3 BREEZE‐AD7 trial. Patients with previous systemic therapy may have more severe, treatment‐resistant disease.

Objectives

To assess the efficacy of baricitinib 4 mg in adults with moderate‐to‐severe AD with and without previous use of systemic therapy.

Methods

Patients were randomized 1:1:1 to TCS plus once‐daily oral placebo, 2 mg baricitinib or 4 mg baricitinib for 16 weeks. Outcomes were assessed in patients treated with baricitinib 4 mg with and without previous use of systemic therapy (N = 68, N = 43) versus placebo (N = 75, N = 34). Prior use of systemic therapy was defined as treatment of AD with oral corticosteroids, immunosuppressants or biologics. Endpoints included the proportions of patients achieving a vIGA‐AD® score 0 or 1 with >2‐point improvement from baseline, 75% improvement in the Eczema area and severity index score (EASI75), ≥4‐point improvement on the Itch numeric rating scale (NRS) and ≥4‐point improvement in the dermatology life quality index (DLQI). Logistic regression was used to evaluate consistent treatment effects across subgroups.

Results

At Week 16, among patients with and without previous use of systemics treated with baricitinib 4 mg versus placebo, respectively, vIGA‐AD score (0, 1) was achieved in 27.9% and 34.9% versus 13.3% and 17.6%, EASI75 was met in 47.1% and 48.8% versus 22.7% and 23.5%, Itch NRS ≥ 4‐point improvement was observed in 44.4% and 43.2% versus 14.1% and 33.3% and DLQI ≥ 4‐point improvement was seen in 75.8% and 69.2% versus 52.1% and 54.8%. Consistent treatment effects were observed between patients with or without prior use of systemics (treatment‐by‐subgroup interactions p = 0.085 for Itch NRS, p > 0.1 for all others).

Conclusions

Baricitinib 4 mg significantly reduced disease severity in AD compared to placebo regardless of prior systemic therapy.

Details

Title
Efficacy of baricitinib 4 mg in patients with moderate‐to‐severe atopic dermatitis previously treated with systemic therapy
Author
Costanzo, Antonio 1 ; Tanaka, Akio 2 ; Torres, Tiago 3   VIAFID ORCID Logo  ; Pérez‐García, Bibiana 4 ; Sontag, Angelina 5 ; Chen, Yun‐Fei 5 ; Yang, Fan Emily 5 ; Kolodsick, Jill 5 ; Torisu‐Itakura, Hitoe 5 ; Somani, Najwa 5 

 Dermatology IRCSS Humanitas Research Hospital, Milan, Italy 
 Department of Dermatology, Graduate School of Biomedical and Health Sciences, Hiroshima University, Hiroshima, Japan 
 Department of Dermatology, Centro Hospitalar Universitário do Porto, University of Porto, Porto, Portugal 
 Departamento de Dermatología, Hospital Universitario Ramón y Cajal, Madrid, Spain 
 Eli Lilly and Company, Indianapolis, Indiana, USA 
Pages
583-589
Section
SHORT REPORTS
Publication year
2023
Publication date
Sep 1, 2023
Publisher
John Wiley & Sons, Inc.
ISSN
27686566
Source type
Scholarly Journal
Language of publication
English
ProQuest document ID
3090616319
Copyright
© 2023. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the "License"). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.