1. Therapy Areas
  2. Dermatology
  3. I.ON Programme: Chronic spontaneous urticaria (CSU)
  4. About CSU
  5. AWARE clinical trial

AWARE clinical trial

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A UK subset of the worldwide, prospective, non-interventional AWARE (A World-wide Antihistamine-Refractory chronic urticaria patient Evaluation) study was conducted to provide data demonstrating the real-life burden of CU in the UK.1

The study assessed the treatment patterns, burden of disease and rates of healthcare resource utilisation in patients with CU who failed first-line H1 antihistamine treatment in the real-life clinical setting.1

The results of this UK subset of AWARE were published in Clinical and Experimental Dermatology in 2020.1

 

Study design1

 

csu-aware-study-design-chart

 

Assessments made throughout the 2-year follow up at different visits:1

  • Drug therapy
  • Satisfaction with current therapy (VAS)
  • Symptoms: Angioedema and hives
  • Healthcare use
  • Autologous serum skin test
  • PROs: QoL (DLQI and EQ-5D), disease activity (UAS7) and work productivity impairment (WPAI)

 

csu-map 

Findings

magnifying-glass-icon

UK data from AWARE revealed a high burden of disease in adult H1-AH (H1-antihistamine)-refractory patients with CU. CU impacted work productivity, activity, HR-QoL and contributed to high use of healthcare facilities.1

Compared with global data, UK patients were more likely to visit their GP, and were more likely to be lost to follow-up (72.1%).1

 

 

csu-aware-guide-thumb

AWARE has been summarised in a handy guide for quick reference and understanding.

Download

 

 

CU, chronic urticaria; CSU, chronic spontaneous urticaria; DLQI, Dermatology Quality of Life Index; EQ-5D, EuroQol five-dimensions instrument; GP, general practitioner; HRQoL, health-related quality of life; PROs, patient reported outcomes; QoL, quality of life; UAS7, 7-day Urticaria Activity Score; VAS, visual analogue scale; WPAI, work productivity and activity impairment.

Reference

  1. Savic S, et al. Clin Exp Dermatol 2020;45:1003–1010.
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UK | October 2021 | 146364
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