Clinical Trial Eligibility in Atopic Dermatitis: Data from a Large Real-World International Cohort

Area of Science:

• Dermatology
• Clinical Trials
• Pharmacology

Background:

• Randomized clinical trials (RCTs) for atopic dermatitis (AD) often exclude older adults and those with comorbidities.
• This limits the generalizability of findings to real-world patient populations.
• The real-world effectiveness and safety of biologics and Janus kinase inhibitors (JAKis) in these excluded groups remain unclear.

Purpose of the Study:

• To assess the proportion of real-world AD patients meeting RCT eligibility criteria.
• To compare the safety outcomes of biologics and JAKis in eligible versus ineligible patients.

Main Methods:

• Retrospective analysis of 2154 adolescent and adult AD patients across 16 international dermatology centers (Oct 2017-Mar 2023).
• Patients treated with biologics (dupilumab, tralokinumab) or systemic JAKis (abrocitinib, baricitinib, upadacitinib).
• Ineligibility defined by common RCT exclusion criteria; demographic, clinical, and safety data analyzed.

Main Results:

• 514 patients (23.9%) were ineligible, primarily due to low Eczema Area and Severity Index (EASI) scores, advanced age, or cardiovascular disease.
• Ineligibility patterns varied by treatment: JAK inhibitor users often had low EASI scores, while biologic users were more frequently ineligible due to age or comorbidities.
• Safety profiles were generally favorable. Biologic users showed similar adverse event rates regardless of eligibility. JAK inhibitor users who were ineligible experienced more adverse events, notably acneiform eruptions and lipid abnormalities.

Conclusions:

• Approximately 24% of real-world AD patients do not meet pivotal RCT eligibility criteria.
• Both biologics and JAK inhibitors demonstrate acceptable safety in these broader populations.
• Further investigation is needed to understand the clinical relevance of increased adverse events in ineligible JAK inhibitor users, especially concerning long-term cardiovascular outcomes.