Numerous targeted treatments for atopic dermatitis (AD) are currently under investigation in clinical trials. Comparability of the efficacy of new drugs is therefore becoming more important. Serum biomarkers may offer an objective outcome measure for disease severity in AD. A combination of serum biomarkers TARC, IL-22, and sIL-2R as a signature (predicted EASI) may offer an objective measurement tool for disease severity in AD patients treated with topical steroids, cyclosporin A, or dupilumab. To validate the predicted EASI (p-EASI) in AD patients treated with tralokinumab in a clinical trial setting. Serum samples were collected from 198 patients with moderate to severe AD in the Phase 3 ECZTRA 1(NCT03131648) trial. Patients were randomized (3:1) to subcutaneous tralokinumab 300mg(n=149), or placebo(n=49) every other week for 16 weeks. Disease severity was assessed by EASI, and serum was collected at baseline and after 16 weeks of treatment. Serum biomarkers TARC, IL-22, and sIL-2R were measured by Luminex. EASI and p-EASI scores highly correlated in tralokinumab treated patients(r=.59, P<.0001). In patients treated with tralokinumab, median EASI and p-EASI decreased from 30.9(IQR, 22.5-42.3) and 32.9(IQR, 25.6-40.2), respectively, to 13.5(IQR, 6.6-22.5) and 24.8(IQR, 20.6-59.0) after 16 weeks of treatment. In the placebo group, median EASI and p-EASI were 31.1 (IQR, 22.5-40.4) and 31.3(IQR, 25.0-37.5), respectively, at baseline; 19.0(IQR, 10.2-29.1) and 29.2(IQR, 25.5-32.5) after 16 weeks.These findings suggest that p-EASI may better reflect accurate effects of treatment. The biomarker signature p-EASI correlated with disease severity in moderate-severe AD patients treated with tralokinumab in a clinical trial setting. The use of objective biomarkers such as p-EASI may be considered as a tool to objectively assess treatment effect of new drugs for AD.

New targeted therapies for treatment of atopic dermatitis (AD) have been developed and are currently under investigation in clinical trials. However, the comparison of results from different studies remains challenging, giventhe high intra-observer and inter-observer variability of primary endpoints. A combination of serum biomarkers TARC, IL-22, and sIL-2R as a signature (predicted EASI) may offer an objective measurement tool for disease severity in AD patients treated with topical steroids, cyclosporin A, or dupilumab. To validate the predicted EASI (p-EASI) in AD patients treated with tralokinumab in a clinical trial setting. Serum samples were collected from 198 patients with moderate to severe AD in the Phase 3 ECZTRA 1(NCT03131648) trial. Patients were randomized (3:1) to subcutaneous tralokinumab 300mg (n=149), or placebo(n=49) every other week for 16 weeks. Disease severity was assessed by EASI, and serum was collected at baseline and after 16 weeks of treatment. Serum biomarkers TARC, IL-22, and sIL-2R were measured by Luminex. EASI and p-EASI scores moderately correlated in tralokinumab treated patients (r=.59, P<.0001). In patients treated with tralokinumab, median EASI and p-EASI decreased from 30.9 (IQR, 22.5-42.3) and 32.9 (IQR, 25.6-40.2), respectively, to 13.5 (IQR, 6.6-22.5) and 24.8 (IQR, 20.6-59.0) after 16 weeks of treatment. In the placebo group, median EASI and p-EASI were 31.1 (IQR, 22.5-40.4) and 31.3 (IQR, 25.0-37.5), respectively, at baseline; 19.0 (IQR, 10.2-29.1) and 29.2 (IQR, 25.5-32.5) after 16 weeks.These findings suggest that p-EASI may better reflect accurate effects of treatment. The biomarker signature p-EASI correlated with disease severity in moderate-severe AD patients treated with tralokinumab in a clinical trial setting. The use of objective biomarkers such as p-EASI may be considered as a tool to objectively assess treatment effect of new drugs for AD.

ESDR409 - EASI p-EASI: predicting disease severity in atopic dermatitis patients treated with tralokinumab

The scientific meeting of the European Society for Dermatological Research (ESDR) is held yearly, usually in September. With an international attendance of more than 1000 skin scientists from around the globe, the four-day event includes short oral presentations from peer-reviewed abstracts, keynote lectures from international experts, sponsored symposia, satellite programs, educational events as well as an important focus on posters, networking and building collaborations amongst scientists. For more information about this year’s meeting visit our website.