377 Mapping Clinical Trial Outcome Measures for Atopic Dermatitis

Abstract

OBJECTIVES/GOALS: Atopic Dermatitis (AD) affects 10% of people globally and is studied widely in clinical trials. However, clinical outcomes assessment (COA) for AD are not standardized, hindering easy comparisons across different studies. This study examines AD studies to identify the most used COAs. METHODS/STUDY POPULATION: Clinicaltrials.gov was searched to identify AD trials conducted between 2011 and 2021. Ongoing and completed trials were classified according to the therapeutic modality: Biologic, Immunosuppressive, or Other (botanicals and antibiotics). Further, AD trials were examined to determine which of the COAs listed in the FDA compendium issued in 2021 were included: the Investigators Global Assessment (IGA), the Eczema Area and Severity Index (EASI-75), and the Pruritus Numeric Rating Scale (NRS). The results were analyzed to determine which COA is most frequently used and if there were differences across therapeutic modalities or trial phases. RESULTS/ANTICIPATED RESULTS: Across a total of 50 AD trials registered in clinicaltrials.gov, EASI-75 was the most used COA; the item was included in 12 of 16 biologics, 5 of 14 immunosuppressives, and 7 of 20 other products. Moreover, AD trials of biologics included more of the FDA-suggested COAs than those studying other modalities. There were also differences across the clinical trial phases in that most phase III AD trials (83.33%, n=8) included two of the three COAs listed (IGA and EASI-75) compared to less than half of phase I/II trials (vs. 43.75%, n=32). DISCUSSION/SIGNIFICANCE: Findings from this study indicate a lack of COA harmonization across AD trials, impeding comparative analysis of the trial results. Establishing a common standard for COA would foster communication and transparency among key stakeholders including researchers, healthcare providers, and patients.