This is a decentralized study designed to describe the real-world effectiveness, safety, and patterns of use of dupilumab in patients with chronic spontaneous urticaria (CSU). This study will be conducted in the United States and will collect data available from participants' medical files, other items routinely collected during disease management in clinical practice, and patient-reported outcomes related to disease, work productivity, quality of life, and CSU-related hospitalizations.
Participation in this study is the patient's own choice and is entirely voluntary. The treating physician prescribes dupilumab treatment as part of routine care, independently of the study. Once the decision to prescribe dupilumab is made by the treating physician, patients can self-screen and will be contacted by the Virtual Research Coordination Center to determine potential study eligibility. Patients will be enrolled if they provide an informed consent and meet all inclusion criteria and none of the exclusion criteria.
The duration of the study for each participant is 24 months. All patients will be followed for 24 months or until death, loss to follow-up, or withdrawal, whichever occurs first.
Patients aged 12 years or older at the time of informed consent/assent.
Physician decision to treat the patient with dupilumab for chronic spontaneous urticaria (CSU) made prior to and independently of the patient's participation in the study.
Patient is able to understand and complete study-related questionnaires.
Patients and/or parent/legally authorized representative provide voluntary informed consent and/or assent to participate in the study before inclusion in the study.
Patients who have a contraindication to dupilumab according to the approved prescribing information label.
Any condition that the treating physician or virtual Investigator believes may interfere with the patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other comorbidities that can predictably prevent the patient from completing the schedule of assessments.
Patients currently participating in any interventional clinical trial.
Prior use of dupilumab within 6 months of the baseline assessment.
The study aims to enroll approximately 10% to 20% adolescents (that is, participants aged 12 to 17 years) of the total 400 participants. If the adolescent enrollment target is not met toward the end of the period, adult enrollment may be temporarily paused to allow more adolescents to enroll.
Cohort
Prospective
Dupilumab
DrugThis study will not administer any treatment, only observe the treatment as prescribed in real world clinical practice.
Summary of Sociodemographic Characteristics
Sociodemographic and clinical characteristics, including but not limited to month and year of birth, age, sex, race, ethnicity, IgE levels, employment status, height, weight, and smoking status will be collected.
Summary of Medical History of Chronic Spontaneous Urticaria (CSU)
Medical history of CSU, including but not limited to CSU status and CSU treatment history will be collected.
Summary of Type of Baseline Comorbidities
Type of baseline comorbidities including atopic and non-atopic will be collected.
Summary of Type of Concomitant Medication
Type of concomitant medication will be collected.
Change from Baseline in Disease Activity
Change from baseline in disease activity as assessed by Urticaria Activity Score over 7 days (UAS7) and Urticaria Control Test (UCT) scores.
Dupilumab Treatment Details: Summary of Participants who Achieve Response Thresholds
Summary of participants who achieve response thresholds, including onset of response, peak response, recapture response will be collected to evaluate the real-world long-term effectiveness of dupilumab for the treatment of CSU.
Dupilumab Treatment Details: Summary of Participants who Achieve Disease Control Thresholds
Summary of participants who achieve disease control thresholds will be collected to evaluate the real-world long-term effectiveness of dupilumab for the treatment of CSU.
Dupilumab Treatment Details: Durability of Response During and After Discontinuation of Dupilumab
Durability of response will be assessed by using Urticaria Activity Score over 7 days (UAS7). It is based on scoring wheals (hive severity score) and itch (itch severity score) separately on a scale of 0 (no signs/symptoms) to 3 (intense signs/symptoms) over 7 days. The final score is calculated by adding together the daily scores, which can range from 0 to 6, for 7 days. This results in a maximum total score of 42, and a minimum possible score of 0.
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Sanofi
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
