Doppler Ultrasound-Based Non-Invasive Biomarkers in Hidradenitis Suppurativa: Evaluation of Analytical and Clinical Validity.

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There is a need for valid and reliable biomarkers in hidradenitis suppurativa (HS) for diagnosis and disease activity monitoring. Imaging-based biomarkers have the potential to fulfill this unmet need but no evaluation of analytical or clinical validity has yet been undertaken.To evaluate the analytical and clinical validity of sonographic epidermal thickness, Doppler ultrasound and dermal tunnel diameter in patients with Hidradenitis Suppurativa.22 participants with Hidradenitis Suppurativa were recruited and underwent a total of 65 matched ultrasound and skin biopsies of lesional, perilesional and unaffected tissue. Ultrasound measurements were performed in triplicate with mean values used. Skin biopsies underwent immunohistochemistry as per previously published methods. Analytical validity was assessed in individual ultrasound-biopsy pairs (n=65) by comparisons of sonographic variables with histological correlates. Clinical validity was assessed in individual patients (n=22) by comparing measures of overall disease activity with sonographic outcomes.(Epidermal thickness, dermal tunnel diameter and power Doppler intensity were assessed. Sonographic epidermal thickness and dermal tunnel diameter have high analytical validity with corresponding histological measurements. Power Doppler intensity demonstrated high correlation with dermal CD3+ and CD11c+ cell counts but not Neutrophil Elastase positive cells. Power Doppler ultrasound has significant correlation with pain scores, abscess and nodule (AN) count, IHS4 score and number of draining tunnels.Sonographic epidermal thickness and dermal tunnel diameter have acceptable levels of analytical validity in the assessment of HS lesions. Power Doppler intensity demonstrates acceptable clinical and analytical validity suggesting it is a valid imaging-based biomarker in HS.

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