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. 2025 Jul 22.
doi: 10.1007/s40271-025-00754-6. Online ahead of print.

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

Ella Brookes  1 , Ufuk Coşkun  2 , Christina O'Donnell  2 , Efstathios Zikos  3 , Renata Martincova  4 , Jingdong Chao  5 , Mohana Giruparajah  6   7 , Beverly Romero  6   7
Affiliations

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

Ella Brookes et al. Patient. .

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.

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Conflict of interest statement

Declarations. Funding: This study was sponsored by Sanofi and Regeneron Pharmaceuticals, Inc. Conflicts of interest/competing interests: Ufuk Coşkun and Christina O’Donnell are employees of ICON Clinical Research who were contracted to conduct the interviews and may hold stock or stock options in the company. Beverly Romero and Mohana Giruparajah were employed at ICON Clinical Research during the study; currently are employed by Sprout Health Solutions. Ella Brookes and Renata Martincova are employees of Sanofi and may hold stock or stock options in the company. Jingdong Chao is an employee of Regeneron Pharmaceuticals Inc. and may hold stock or stock options in the company. Efstathios Zikos is an external contractor working for Sanofi via Barrington James. Ethics approval: This study was conducted in accordance with the principles outlined in the Declaration of Helsinki. Ethics approval was obtained from a central institutional review board (Advarra, Inc. for USA and Canada), as well as by regional and local boards (Argentina: Comité de Ética de Protocols de Investigación del Hospital Italiano de Buenos Aires: Comité de Ética en Investigación and Center for the Study of Infectious Diseases SA [Stamboulian Health Services] Clinical Research Ethics Committee; Canada: Health Ethics Research Board of Alberta Community Health Committee; Germany: Landesärztekammer Rheinland-Pfalz Ethik-Kommission and Technische Universität Dresden: Ethikkommission an der TU Dresden). Consent to participate: This study adheres to the ICMJE Recommendations for patient privacy and follows ethical guidelines to ensure the protection of patient information. All participants in this study provided written informed consent as part of institutional review board-approved consent forms. The consent forms included information about the study’s purpose, the use of aggregated results in reports and publications, and the participants’ right to withdraw from the study at any time without penalty. Identifying information has been removed to ensure anonymity, and no individual identifiers are included in any reports or publications resulting from this study. The consent forms are securely filed. We have taken all necessary steps to ensure that identifying details are omitted from the article. Patient data have not been altered or falsified to achieve anonymity. The journal editorial office will not collect or archive consent forms but retains the right to request verification of their existence if needed. Consent for publication: Not applicable. Availability of data and material: This study involved qualitative interviews, and because of the confidential nature of the data, the complete transcripts cannot be shared publicly. Researchers interested in accessing the data for verification or further analysis may contact the corresponding author to discuss potential access under strict confidentiality agreements. Code availability: Not applicable. Authors’ contributions: Concept and design: EB, RM, BR, JC. Acquisition of data: UC, MG, BR. Analysis and interpretation of data: UC, CO, BR, EB, EZ, JC. Drafting of the article: CO, UC, MG. Critical revision of the article for important intellectual content: EB, UC, CO, EZ, RM, JC, MG, BR.

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