Skin and systemic inflammation in adults with atopic dermatitis before and after whole‐body topical betamethasone 17‐valerate 0.1% or tacrolimus 0.1% treatment: A randomized controlled study

Author:

Gether Lise123ORCID,Linares Helena P. I14ORCID,Kezic Sanja5,Jakasa Ivone6,Forman Julie7,Sørensen Ole E.3,Storgaard Heidi28,Skov Lone19ORCID,Røpke Mads A.34,Knop Filip K.289,Thyssen Jacob P.910ORCID

Affiliation:

1. Copenhagen Research Group for Inflammatory Skin (CORGIS), Department of Dermatology and Allergy, Herlev‐Gentofte Hospital University of Copenhagen Hellerup Denmark

2. Center for Clinical Metabolic Research, Herlev‐Gentofte Hospital University of Copenhagen Hellerup Denmark

3. LEO Pharma A/S Ballerup Denmark

4. Department of Immunology and Microbiology University of Copenhagen Copenhagen Denmark

5. Department of Public and Occupational Health Amsterdam UMC, University of Amsterdam Amsterdam The Netherlands

6. Laboratory for Analytical Chemistry, Department of Chemistry and Biochemistry, Faculty of Food Technology and Biotechnology University of Zagreb Zagreb Croatia

7. Section of Biostatistics University of Copenhagen Copenhagen Denmark

8. Steno Diabetes Center Copenhagen Herlev Denmark

9. Department of Clinical Medicine, Faculty of Health and Medical Sciences University of Copenhagen Copenhagen Denmark

10. Department of Dermatology and Venereology, Bispebjerg‐Frederiksberg Hospital University of Copenhagen Copenhagen Denmark

Abstract

AbstractBackgroundAtopic dermatitis (AD) is mainly driven by type 2 inflammation and often treated with topical agents. Studies comparing differences in biomarkers between these treatments are lacking.ObjectivesThe aim of this study was to evaluate the effects of topical betamethasone 17‐valerate 0.1% and tacrolimus 0.1% ointment on skin barrier function and inflammatory biomarkers in skin and blood in adults with AD.MethodsIn this randomized parallel‐group double‐blind double‐dummy active‐comparator study design, 36 adults with AD were treated with either whole‐body topical corticosteroid (betamethasone ointment 0.1% plus placebo once daily, n = 18) or calcineurin inhibitor (tacrolimus ointment 0.1% twice daily, n = 18). At baseline, after 2 weeks of daily treatment and after further 4 weeks of twice‐weekly maintenance treatment, we evaluated AD severity, levels of natural moisturizing factor (NMF) and cytokines in the skin and blood and characterized circulating T cells.ResultsMean AD severity at baseline corresponded to moderate disease and decreased significantly in both groups. Levels of NMF increased significantly in the tacrolimus group after 2 weeks of treatment (p = 0.002) and tended to increase more than betamethasone at week 6 (p = 0.06). Most skin cytokines decreased with both treatments. However, IL‐8, IL‐18, IL‐22, IP‐10, MDC, MMP‐9 and TARC were significantly more decreased with betamethasone than tacrolimus after 2 weeks, while after 6 weeks this was only the case for IL‐8 and MMP‐9. Approximate half of the systemic cytokines decreased significantly with both treatments, but betamethasone decreased MDC significantly more after 2 weeks of treatment. T‐cell characterization analyses indicated slight differences in the expression and activation of T cells between groups.ConclusionTopical treatment of AD with betamethasone and tacrolimus ointment effectively reduced disease severity, cutaneous and systemic inflammatory markers. Betamethasone was more effective in decreasing inflammation, but tacrolimus improved skin hydration (NMF levels) more than betamethasone.

Funder

LEO Pharma

Kongelig Hofbuntmager Aage Bangs Fond

Publisher

Wiley

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