Modern Clinical Trials: ADmirable and DISCOVER Data Insights for a Diverse Patient Population

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The ADmirable trial represents a landmark phase 3B study of lebrikizumab (an IL-13 inhibitor) specifically designed to include patients with Fitzpatrick skin types IV to VI, encompassing adolescents and adults with moderate to severe atopic dermatitis and more pigmented skin. This open-label study followed patients over 16 weeks and demonstrated that nearly 70% achieved at least 75% improvement (EASI-75) compared with baseline across different skin types. Importantly, subgroup analyses confirmed efficacy across different racial groups, providing crucial evidence for treatment effectiveness in traditionally underrepresented populations.

The DISCOVER study, a phase 4 investigation of dupilumab in adolescents and adults with skin of color, extended follow-up to 24 weeks and included more than 80% African American participants. Results showed that more than 70% of patients achieved EASI-75 response, with consistent efficacy demonstrated across the diverse study population. Both trials revealed safety profiles in patients with skin of color that were comparable to those observed in the original pivotal phase 3 studies, providing reassurance about treatment safety across different populations.

These studies represent a paradigm shift in atopic dermatitis research by intentionally enrolling patients with darker skin tones and generating population-specific efficacy and safety data. The trials evaluated not only traditional end points but also addressed concerns specific to patients with skin of color, such as postinflammatory pigmentation changes using specialized assessment tools. This comprehensive approach provides clinicians with evidence-based confidence when recommending these therapies to their diverse patient populations and addresses the historical gap in representative clinical trial data.