BACKGROUND: Chronic spontaneous/idiopathic urticaria (CSU/CIU) is defined as the spontaneous appearance of itchy hives, angioedema, or both that recur for 6 weeks or longer. CSU/CIU has a significant impact on patient's health related quality of life (HRQOL). However, there is little information on the clinical characteristics in patients with CSU/CIU refractory to H1-antihistamines.
OBJECTIVES: ASSURE-CSU, a non-interventional study evaluating the HRQOL, healthcare resource utilization, absence from work and productivity, aims to identify and quantify the humanistic and economic burden of illness in patients with CSU/CIU refractory to H1-antihistamines. Here we describe the clinical journey of patients enrolled in the ASSURE-CSU study in Canada.
METHODS: Patients with CSU/CIU refractory to H1-antihistamines, aged greater than or equal to 18 years, with disease persisting for more than 12 months were assessed. Data were collected via a retrospective medical chart review for the 12 months prior to enrollment and were analysed using descriptive statistics.
RESULTS: Overall, 99 patients were assessed. The mean (SD) age at enrollment was 50.8 (15.01) years, while the mean (SD) age at symptom onset was 42.9 (16.87) years, and at diagnosis was 45.8 (15.55) years. The majority of patients were female (78%) and Caucasian (81%), with a mean (SD) disease duration from diagnosis of 62.0 (81.91) months. An ICD-10 code was reported in only 11 (11.1%) medical record charts. Overall, data from the charts indicate that 50% of patients had concomitant angioedema. Of those, at the time of diagnosis, 41% presented with angioedema with 28% experiencing angioedema within the previous 12 months, with an annual mean (SD) of 12.4 (14.29) episodes. In terms of comorbidities, 16% had asthma, 14% had some form of auto-immune disease, 12% allergic rhinitis, and 12% had hypersensitivity to non-steroidal anti-inflammatory drugs. A small proportion of patients also presented with connective tissue disorders, atopic eczema. Overall, 16% had a history of allergic disease and 10% had a family history of allergic disease.
CONCLUSIONS: This Canadian-specific analysis from ASSURE-CSU suggests that patients with CSU/CIU refractory to H1-antihistamines are in majority women, who have experienced symptoms for approximately three years before diagnosis, with average disease duration of more than five years at time of enrollment. Approximately half of all patients presenting with CIU/CSU had concomitant angioedema. There were also a number of other co-morbidities reported in the medical charts with the majority being related to allergic diseases. Overall, these data highlight the extent of the burden of disease in patients with CSU/CIU refractory to H1-antihistamines, one which may be underestimated.
