Socio-economic burden and resource utilisation in Italian patients with chronic urticaria: 2-year data from the AWARE study

Abstract

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.

Methods: AWARE (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.

Results: In 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.

Conclusion: This 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.

Keywords: AWARE study; CIndU, chronic inducible urticaria; CSU, chronic spontaneous urticaria; CU, chronic urticaria; CU-Q2oL, CU quality of life questionnaire; Chronic spontaneous urticaria; DLQI, dermatology life quality index; GCP, good clinical practices; H1-AH, H1-antihistamines; Italy; PRO, patient-reported outcomes; QoL, quality of life; Resource utilisation; SD, standard deviation; Socio-economic burden; UAS7, weekly urticaria activity score; WPAI-CU, work productivity and activity impairment questionnaire; nsAH, non-sedating H1-AH; sAH, sedating H1-AH.

Fig. 1

Predefined observed treatment groups

Fig. 2

Prevalence of Wheals (2A) Angioedema (2B)UAS7 (2C) in patients with CSU over time. The number of subjects with available data at each visit varied because of the registry nature of AWARE.CSU, chronic spontaneous urticaria; n, number of patients; SD, standard deviation; UAS7; 7-day Urticaria activity score

Fig. 3

QoL of patients with CSU measured by DLQI (3A)CU-Q₂oL (3B) DLQI (3C) in categories. The number of subjects with available data at each visit varied because of the registry nature of AWARE. CU-Q₂oL, chronic urticaria quality of life questionnaire; DLQI, dermatology life quality index; n, number of patients; SD, standard deviation

Fig. 4

Treatment groups over the 2-year study period in patients diagnosed with CSU. CSU, chronic spontaneous urticaria; n, number of patients; nsAH, non-sedating antihistamines; sAH, sedating antihistamines

Fig. 5

Percentage of A. Total work productivity impairment B. Total activity impairment. The number of subjects with available data at each visit varied because of the registry nature of AWARE. n, number of patients; SD, standard deviation