EXPLORING THE BURDEN OF CHRONIC INDUCIBLE URTICARIA AND THE MEANINGFULNESS OF TREATMENT USING IN-TRIAL INTERVIEWS
Author(s)
Jason A. Randall, PhD1, Sarah Sauchelli, PhD2, Miriam Porter, MD3, Sibylle Haemmerle, MD3, Karine Lheritier, PhD3, Cassia White, MSc4, Diane Whalley, PhD4.
1NOVARTIS, London, United Kingdom, 2RTI- Health Solutions, Didsbury, Manchester, United Kingdom, 3NOVARTIS, Basel, Switzerland, 4RTI Health Solutions, Manchester, United Kingdom.
1NOVARTIS, London, United Kingdom, 2RTI- Health Solutions, Didsbury, Manchester, United Kingdom, 3NOVARTIS, Basel, Switzerland, 4RTI Health Solutions, Manchester, United Kingdom.
OBJECTIVES: Chronic inducible urticaria (CIndU) has substantial symptom burden and impairs daily functioning. Qualitative in-trial interviews were conducted with clinical trial participants to explore the lived experience of CIndU, impact of treatment, and meaningfulness of change.
METHODS: The trial was a multinational, phase 3, basket study of remibrutinib in participants with CIndU inadequately controlled by H1-antihistamines. Optional, semi-structured interviews were conducted with 74 participants with symptomatic dermographism (n=12), cold urticaria (n=26), and cholinergic urticaria (n=36) in Argentina, Canada, France, Germany, Spain, and the United States. Interviews were conducted after the 24-week double-blind, placebo-controlled treatment period and analysed using thematic analysis methods.
RESULTS: Interview participants reported pre-trial experiences of hives (100.0%), itch (98.6%), burning (85.1%), and pain (55.4%), which caused physical discomfort, disruption to daily activities and sleep, and emotional distress. Itch was most often the most bothersome symptom (MBS) (72.2%), although burning (16.7%) and pain (8.3%) were also identified. Most participants (92.6%) who reported improvements in their symptoms, described meaningful benefits in their daily functioning, sleep, and emotional well-being. Participants perceived the improvements in symptoms triggered by a provocation test at study visits to be aligned with changes they noticed in their everyday life. For most participants, an improvement of 1 to 3 points on the weekly Urticaria Symptoms Daily Diary symptom item scores, a 1- or 2-category change on a Patient Global Impression of Severity, and “a little better” or “a lot better” on a Patient Global Impression of Change item represented meaningful improvement.
CONCLUSIONS: Symptom improvement can have meaningful and important benefits on the lives and wellbeing of people affected by CIndU. Heterogeneity in symptom experience highlights the importance of assessing the MBS when evaluating the effectiveness of new treatments. Symptom improvement following a provocation test is perceived as reflecting real-world experiences.
METHODS: The trial was a multinational, phase 3, basket study of remibrutinib in participants with CIndU inadequately controlled by H1-antihistamines. Optional, semi-structured interviews were conducted with 74 participants with symptomatic dermographism (n=12), cold urticaria (n=26), and cholinergic urticaria (n=36) in Argentina, Canada, France, Germany, Spain, and the United States. Interviews were conducted after the 24-week double-blind, placebo-controlled treatment period and analysed using thematic analysis methods.
RESULTS: Interview participants reported pre-trial experiences of hives (100.0%), itch (98.6%), burning (85.1%), and pain (55.4%), which caused physical discomfort, disruption to daily activities and sleep, and emotional distress. Itch was most often the most bothersome symptom (MBS) (72.2%), although burning (16.7%) and pain (8.3%) were also identified. Most participants (92.6%) who reported improvements in their symptoms, described meaningful benefits in their daily functioning, sleep, and emotional well-being. Participants perceived the improvements in symptoms triggered by a provocation test at study visits to be aligned with changes they noticed in their everyday life. For most participants, an improvement of 1 to 3 points on the weekly Urticaria Symptoms Daily Diary symptom item scores, a 1- or 2-category change on a Patient Global Impression of Severity, and “a little better” or “a lot better” on a Patient Global Impression of Change item represented meaningful improvement.
CONCLUSIONS: Symptom improvement can have meaningful and important benefits on the lives and wellbeing of people affected by CIndU. Heterogeneity in symptom experience highlights the importance of assessing the MBS when evaluating the effectiveness of new treatments. Symptom improvement following a provocation test is perceived as reflecting real-world experiences.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
PT15
Topic
Clinical Outcomes, Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas, Sensory System Disorders (Ear, Eye, Dental, Skin)