Benefit-risk profile comparison between dupilumab and upadacitinib: a structured benefit-risk assessment of the Heads Up trial

OBJECTIVES: Structured benefit-risk assessments evaluate multiple patient-relevant endpoints simultaneously, weighing therapeutic benefits against risks, enabling healthcare professionals and patients to select the most suitable treatment. Such assessments evaluating therapeutic options for atopic dermatitis (AD) have not yet been published. We performed a structured benefit-risk assessment based on multicriteria decision analysis, using data from the 24-week Heads Up trial comparing dupilumab versus upadacitinib in adults with moderate-to-severe AD.

METHODS: A benefit-risk score (0-100) measured overall performance of both treatments as the weighted sum of values of outcomes selected from an independent patient preference study identified during a literature search.

RESULTS: Using efficacy and safety data up to week 24, the benefit-risk score for dupilumab was 66, compared with 61 for upadacitinib. A sensitivity analysis varying the total weight assigned to benefits showed that the overall benefit-risk score of dupilumab was consistently higher than that of upadacitinib. Another sensitivity analysis, using week 16 data, showed that dupilumab and upadacitinib had the same overall benefit-risk score of 65.

CONCLUSIONS: This benefit-risk assessment using 24-week Heads Up trial data considered all key benefits and risks and demonstrated a higher benefit-risk score for dupilumab than upadacitinib.