Lebrikizumab off-therapy remission sustained up to 38 weeks in atopic dermatitis

Authors

• Jonathan I. Silverberg, George Washington University School of Medicine and Health Sciences, Washington, DC, USA.
• Thomas Bieber, Department of Dermatology and Allergy, Ludwig-Maximilians University of Munich, Germany, and Medicine Campus Davos, Switzerland.
• Kilian Eyerich, Department of Dermatology, Medical Center, University of Freiburg, Germany.
• April W. Armstrong, Department of Dermatology, University of California Los Angeles, Los Angeles, California, USA.
• Brian J. Nickoloff, Net2Source Inc, Somerset, New Jersey, USA.
• Chitra R. Natalie, Eli Lilly and Company, Indianapolis, Indiana, USA.
• Gaia Gallo, Eli Lilly and Company, Indianapolis, Indiana, USA.
• Angela Okragly, Eli Lilly and Company, Indianapolis, Indiana, USA.
• Eric Wolf, Eli Lilly and Company, Indianapolis, Indiana, USA.
• Chenjia Xu, Eli Lilly and Company, Indianapolis, Indiana, USA.
• Brian A. Moser, Eli Lilly and Company, Indianapolis, Indiana, USA.
• Maria Jose Rueda, Eli Lilly and Company, Indianapolis, Indiana, USA.
• Hany Elmaraghy, Eli Lilly and Company, Indianapolis, Indiana, USA.
• Ozge Uluckan, Almirall R&D, S.A, Barcelona, Spain.
• Johann E. Gudjonsson, Departments of Dermatology and Internal Medicine, University of Michigan, Ann Arbor, MI, USA.

Document Type

Journal Article

Publication Date

12-1-2026

Journal

The Journal of dermatological treatment

Volume

37

Issue

1

DOI

10.1080/09546634.2026.2636417

Keywords

EASI 90; Lebrikizumab; atopic dermatitis; remission

Abstract

AIM OF THE STUDY: Lebrikizumab monotherapy demonstrated efficacy for adults and adolescents with moderate-to-severe atopic dermatitis (AD). This study aims to evaluate the relationship between lebrikizumab serum levels and stable deep response after treatment cessation in Week 16-responder patients who maintained stable EASI 90 response post-induction up to Week 52. MATERIALS AND METHODS: Analysis was pooled from two identically designed, randomized, double-blind, placebo-controlled, phase 3 trials, ADvocate1 (NCT04146363; conducted from September 24, 2019, to May 3, 2022) and ADvocate2 (NCT04178967; conducted from October 29, 2019, to April 28, 2022). The analysis subgroup includes those patients who were Week-16 responders, have been re-randomized to receive placebo (withdrawal arm), and maintained a stable EASI 90 response for at least 80% of visits up to 52 weeks, without rescue medication. Serum lebrikizumab was measured at Weeks 4, 16, 32, and 52. RESULTS: During withdrawal, 28% of responders (17/60) maintained a stable EASI 90 response with no or minimal fluctuations, including at Week 52, without rescue medication. Mean serum lebrikizumab decreased by 92% and over 99% from Week 16 to Weeks 32 and 52, respectively (Week 16 = 92.4 μg/mL; Week 32 = 7.3 μg/mL; Week 52 = 0.15 μg/mL). CONCLUSION: Lebrikizumab demonstrated off-therapy maintenance of response in an AD patient subset for at least 38 weeks post-discontinuation.

APA Citation

Silverberg, Jonathan I.; Bieber, Thomas; Eyerich, Kilian; Armstrong, April W.; Nickoloff, Brian J.; Natalie, Chitra R.; Gallo, Gaia; Okragly, Angela; Wolf, Eric; Xu, Chenjia; Moser, Brian A.; Rueda, Maria Jose; Elmaraghy, Hany; Uluckan, Ozge; and Gudjonsson, Johann E., "Lebrikizumab off-therapy remission sustained up to 38 weeks in atopic dermatitis" (2026). GW Authored Works. Paper 8794.
https://hsrc.himmelfarb.gwu.edu/gwhpubs/8794

Department

Dermatology