Baricitinib treatment rapidly improves the four signs of atopic dermatitis assessed by Eczema Area and Severity Index (EASI) clinical subscores

Author:

Wollenberg Andreas12ORCID,Simon Dagmar3ORCID,Kulthanan Kanokvalai4ORCID,Figueras‐Nart Ignasi5ORCID,Misery Laurent6ORCID,Tangsirisap Nithi7ORCID,Spina Lara7ORCID,Lu Na8ORCID,Grond Susanne7ORCID,Eyerich Kilian9ORCID

Affiliation:

1. Department of Dermatology and Allergy Ludwig Maximilian University of Munich Munich Germany

2. Department of Dermatology and Allergy Augsburg University Hospital Augsburg Germany

3. Department of Dermatology Inselspital, Bern University Hospital, University of Bern Berne Switzerland

4. Allergy and Immunology Unit, Department of Dermatology, Faculty of Medicine Siriraj Hospital Mahidol University Bangkok Thailand

5. Department of Dermatology Hospital Universitari de Bellvitge, University of Barcelona Barcelona Spain

6. Department of Dermatology, Venereology, and Allergology and French Expert Centre on Pruritus University Hospital of Brest Brest France

7. Eli Lilly and Company Indianapolis Indiana USA

8. Precision Statistics Consulting Woodbury Minnesota USA

9. Department of Dermatology and Venerology, Medical Center University of Freiburg Freiburg Germany

Abstract

AbstractBackgroundBaricitinib treatment in adults with moderate‐to‐severe atopic dermatitis (AD) has demonstrated rapid improvements in itch as well as AD sign severity and affected body surface area as assessed by the Eczema Area and Severity Index (EASI) total score, whether administered as monotherapy or in combination with topical corticosteroids (TCS). As EASI clinical signs differ in time course and associated antecedents, the effects of baricitinib on each individual clinical sign are of interest.ObjectivesIn this post hoc analysis, we aimed to investigate the effects of baricitinib on individual EASI subscores, namely excoriation, oedema/papulation, erythema and lichenification, in both monotherapy and TCS combination therapy trials.MethodsWe analysed the percent change from baseline in individual EASI subscores from three phase‐III, double‐blind, 16‐week trials of baricitinib in monotherapy (BREEZE‐AD1/BREEZE‐AD2) and TCS combination therapy (BREEZE‐AD7) cohorts via mixed model repeated measures (MMRM).ResultsBaricitinib 4 mg showed rapid and sustained improvements in all four clinical signs in both cohorts. Significant effects emerged at week 1 for excoriation, oedema/papulation and erythema scores in monotherapy (p < 0.001) and TCS combination therapy (p < 0.001, p < 0.01, p < 0.001), plateaued at week 4, and remained significant versus placebo through week 16. The effect on lichenification scores also emerged early, at week 1 in monotherapy (p < 0.05) and week 2 in combination therapy (p < 0.001), with scores continuously improving without a clear plateau. Effect magnitude was highest in excoriation scores, exhibiting near‐maximal reduction in week 1 of monotherapy and remaining highest across all timepoints in combination therapy.ConclusionsRapid and sustained improvements were observed across clinical signs of inflammation and particularly on excoriation following baricitinib treatment. Our findings suggest that selective inhibition of janus kinases 1 and 2 leads to rapid and sustained control of skin inflammation, and that rapid reductions in itch translate into early disruption of the itch‐scratch cycle.

Funder

Eli Lilly and Company

Publisher

Wiley

Subject

Infectious Diseases,Dermatology

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