Abstract

IntroductionIn Italy, the real-world evidence on the extent of adherence to guidelines and the benefits of recommended therapeutic medications and their impact on the quality of life (QoL) of H1-antihistamines (H1-AH) refractory chronic urticaria (CU) patients is limited. MethodsAWARE (A World-wide Antihistamine-Refractory chronic urticaria patient Evaluation) was a global prospective, non-interventional study of CU in real-world setting which included patients aged ≥18 years with a medically confirmed diagnosed of CU present for more than 2 months. In this study, the disease characteristics, pharmacological treatments and patient-reported outcomes (PROs) are reported. ResultsIn total, 159 patients from 24 study centres in Italy completed the study. At baseline, 221 (89.5%) and 8 (3.2%) patients had chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), respectively, while 18 (7.3%) patients had concomitant CSU and CIndU. For CSU patients, mean dermatology life quality index and CU quality of life questionnaire scores reduced to 3.0 ± 4.9 and 14.6 ± 18.6 at Month 24 from baseline scores of 7.5 ± 6.6 and 33.2 ± 19.5, respectively, indicating an improvement in QoL. This was reflected in their work-life as work productivity impairment reduced considerably after 2 years. Only 71.9% CSU patients had a prior treatment, while during the study, 96.8% of the patients were treated with a medication. At baseline, only 52.9% CSU patients reported nonsedating H1-antihistamines as first-line of treatment in prior medication, this increased to 89.6% during current medication. ConclusionThis study shows that CSU has a considerable socio-economic burden and an improvement in QoL can be achieved in CSU patients if an appropriate therapeutic path is followed.

Highlights

  • In Italy, the real-world evidence on the extent of adherence to guidelines and the benefits of recommended therapeutic medications and their impact on the quality of life (QoL) of H1-antihistamines (H1-AH) refractory chronic urticaria (CU) patients is limited

  • For chronic spontaneous urticaria (CSU) patients, mean dermatology life quality index and CU quality of life questionnaire scores reduced to 3.0 Æ 4.9 and 14.6 Æ 18.6 at Month 24 from baseline scores of 7.5 Æ 6.6 and 33.2 Æ 19.5, respectively, indicating an improvement in QoL

  • Only 52.9% CSU patients reported nonsedating H1-antihistamines as first-line of treatment in prior medication, this increased to 89.6% during current medication

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Summary

Introduction

In Italy, the real-world evidence on the extent of adherence to guidelines and the benefits of recommended therapeutic medications and their impact on the quality of life (QoL) of H1-antihistamines (H1-AH) refractory chronic urticaria (CU) patients is limited. Chronic urticaria (CU) is a common skin disorder that is associated with hives (wheals) and/or angioedema (swelling on the skin) for 6 weeks or more.[1,2,3] CU can be generally classified into chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU). While CSU includes the spontaneous appearance of hives (wheals), CIndU can be triggered by external or any unknown inducing factors.[2,4]. When compared to other skin diseases, the impact of CU is substantial due to associated symptoms that include itching, prominent red wheals, swellings in the deeper layers of the skin, and angioedema.[6] All this triggers a loss in work productivity, lack of sleep, high levels of anxiety, and psychological distress.[2,7]

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