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Improvement of head and neck symptoms in patients with atopic dermatitis treated with baricitinib with in five Phase III clinical trials Volume 32, issue 4, 2022-07-01

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Authors
1 Klinikum der Universität München, Dept. of Dermatology and Allergy, Munich, Germany
2 Medical Dermatology Associates, Chicago IL, USA
3 University of Manchester, Manchester, UK
4 Innovaderm Research, Montreal, H2X 2V1, Canada
5 Eli Lilly and Co., Indianapolis, IN, USA
6 Precision Statistics Consulting Inc., Woodbury, MN, USA
7 Oregon Health & Science University, Portland, OR, USA
Reprints: Andreas Wollenberg

Background

In adults with atopic dermatitis (AD), head and/or neck involvement is frequent, bothersome, and impacts quality of life, however, long-term topical corticosteroids (TCS) are contraindicated for this difficult-to-treat region. Baricitinib, an oral, selective, reversible inhibitor of Janus kinase 1/2 has demonstrated efficacy in adult patients with moderate-to-severe AD.

Objectives

For this post hoc analysis, data from five Phase III trials were used to investigate the efficacy of baricitinib in patients with head and neck involvement.

Materials & Methods

Data were obtained from BREEZE-AD1, -AD2, -AD4, -AD5, and -AD7; Phase III, multicenter, randomized, double-blind, placebo-controlled studies conducted in patients ≥18 years with moderate-to-severe AD. BREEZE-AD1, -AD2, and -AD5 evaluated baricitinib as monotherapy, and BREEZE-AD4 and -AD7 evaluated baricitinib in combination with TCS, topical calcineurin inhibitors, or topical PDE-4 inhibitors, where available. The proportion of patients with improvement of Eczema Area and Severity Index (EASI) total score from baseline of ≥50% (EASI50) and ≥75% (EASI75), as well as head/neck EASI50 and EASI75 and erythema head/neck EASI50 and EASI75 response rates were assessed up to Week 16.

Results

Across the studies, 93-98% of patients had head/neck involvement at baseline (EASI head/neck score ≥1). Baricitinib was similarly effective based on EASI total score for the entire body in all studies. In the monotherapy studies, the proportion of patients achieving head/neck EASI50 and EASI75 scores was significantly higher for baricitinib 2-mg and 4-mg versus placebo at Weeks 1 and 16.

Conclusion

Baricitinib 2-mg and 4-mg treatment showed rapid and substantial reduction in AD head and neck severity, including erythema.