Changes in Skin Myco- and Microbiome After Lebrikizumab Treatment

Changes in Fungal Mycobiome, Bacterial Microbiome, and Abundance of Staphylococcus Species After Lebrikizumab Treatment - a Prospective Multicenter Observational Cohort Study

The goal of this observational study is to characterize the skin myco- and microbiome of patients with atopic dermatitis before and after initiation of treatment with lebrikizumab. The main questions it aims to answer are:

Does the skin mycobiome change with treatment? Does the skin microbiome change with treatment? Does the abundance of Staphylococcus species change with treatment?

Research hypothesis: Lebrikizumab changes the skin micro- and mycobiome.

Primary objective:

To observe changes in the skin micro- and mycobiome during treatment with lebrikizumab, a newly available biologic used in adult patients with moderate-to-severe atopic dermatitis (AD). Lebrikizumab is a high-affinity monoclonal antibody that selectively targets interleukin-13; its effect on the skin microbiome and mycobiome has not previously been investigated.

Primary endpoint: Quantification and characterization of bacterial and fungal population diversity on the skin.

Secondary objectives:

To investigate the correlation between changes in the skin micro- and mycobiome and objective and subjective clinical improvement in AD, as measured by validated disease evaluation tools and patient-reported outcomes. Objective improvement will be measured using the Eczema Area and Severity Index (EASI), modified Total Lesion Symptom Score (mTLSS), and affected Body Surface Area (BSA). Subjective patient-reported outcomes will be measured using the Dermatology Life Quality Index (DLQI), Pruritus Numeric Rating Scale (Pruritus NRS), Sleep NRS, and Patient-Oriented Eczema Measure (POEM).

Findings on the microbiome and mycobiome from this study will be compared with findings from previous microbiome and mycobiome research on other AD treatments, including topical therapies and biologics.

Secondary endpoint: Quantification and characterization of bacterial and fungal population diversity on the skin in correlation with AD symptoms.

Inclusion Criteria:

• Adults ≥18 years diagnosed with atopic dermatitis and initiating treatment with lebrikizumab

Exclusion Criteria:

• Previous treatment with lebrikizumab
• Current treatment with other biologics or JAK-inhibitors
• Hypersensitivity to lebrikizumab or any of its constituents
• Pregnancy or breastfeeding
• Active helminth infection