Exit Interviews to Understand Meaningful Change from the Patient Perspective in a Clinical Study of Dupilumab for the Treatment of Chronic Inducible Cold Urticaria.

Abstract

Background: This study uses clinical trial exit interviews to understand patients' experience of meaningful change with respect to patient-reported outcomes and in order to confirm the content validity of some items from selected trial patient-reported outcomes (Urticaria Control Test [UCT], Cold Urticaria Activity Score [ColdUAS], Patient Global Impression of Severity [PGIS], Patient Global Impression of Change [PGIC]). Clinical trial exit interviews are an effective way to generate qualitative meaningful change insights. However, there is lack of data to provide an understanding of meaningful improvement from the chronic inducible cold urticaria patient perspective.

Methods: We conducted a cross-sectional, double-blind, stand-alone exit interview study intended to recruit participants aged 12-80 years with cold urticaria across centers in Argentina, Canada, USA, and Germany participating in LIBERTY-CINDU CUrIADS (EudraCT: 2020-003756-33), which analyzed the efficacy of dupilumab versus placebo. Exit interviews were conducted within 2 weeks of the end of treatment.

Results: Participants (N = 15) reported symptoms including rash/redness, itch, hives, swelling, burning, and pain. The study established patient-defined thresholds for meaningful improvement: approximately two response options for UCT items, slightly fewer than two response options for ColdUAS items, and 1-2 category changes on PGIS/PGIC. Most participants reporting symptom improvement found it meaningful, with satisfaction being related to the degree of symptom relief. Notably, patients distinguished between a general symptom change and clinically meaningful change.

Conclusions: Exit interviews revealed key insights into patients' experiences with cold urticaria. Despite some limitations, including recruitment challenges and an all-female adult participant pool, the study provided valuable evidence for understanding meaningful improvement in cold urticaria treatment from the patient perspective.