Chronic urticaria treatment patterns and changes in quality of life: AWARE study 2-year results

Marcus Maurer; Ana Giménez-Arnau; Luis Felipe Ensina; Chia-Yu Chu; Xavier Jaumont; Paolo Tassinari

doi:10.1016/j.waojou.2020.100460

Chronic urticaria treatment patterns and changes in quality of life: AWARE study 2-year results

World Allergy Organ J. 2020 Sep 12;13(9):100460. doi: 10.1016/j.waojou.2020.100460. eCollection 2020 Sep.

Authors

Marcus Maurer¹, Ana Giménez-Arnau², Luis Felipe Ensina^{3

4}, Chia-Yu Chu⁵, Xavier Jaumont⁶, Paolo Tassinari⁶

Affiliations

¹ Dermatological Allergology, Allergie-Centrum-Charité, Department of Dermatology and Allergy, Charité -Universitätsmedizin Berlin, Germany.
² Dermatology Department, Hospital del Mar. IMIM, Universitat Autònoma, Barcelona, Spain.
³ CPAlpha Clinical Research Center, São Paulo, Brazil.
⁴ Hospital Sírio-Libanês, São Paulo, Brazil.
⁵ Department of Dermatology, National Taiwan University Hospital and National Taiwan University College of Medicine, Taipei, Taiwan.
⁶ Novartis Pharma AG, Basel, Switzerland.

Abstract

Background: A Worldwide Antihistamine-Refractory Chronic Urticaria (CU) patient Evaluation (AWARE) is a non-interventional, multicenter study including patients from Europe, Central and Latin America, Asia-Pacific, and the Middle East. AWARE describes real-world evidence for CU, including clinical characteristics, treatment patterns and the impact on quality of life.

Methods: Over the 2-year study, therapy changes, angioedema occurrence, and patient-reported outcomes (PROs) were recorded over 9 visits, including dermatology life quality index (DLQI) and 7-day urticaria activity score (UAS7). Data were stratified into subgroups: chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), or CSU + CIndU.

Results: Out of 4838 patients analyzed, 9.9% were receiving no treatment for their CU symptoms at baseline, and 20.4% were receiving first-line non-sedating H₁-antihistamine at approved doses. The predominant baseline therapy was up-dosed non-sedating H₁-antihistamines (25.5%). By Visit 2, omalizumab was the overall most commonly used therapy (29.6%), increasing to 30.1% by the end of the study. Baseline DLQI scores for patients with CSU, CIndU and CSU + CIndU were 8.3, 7.6 and 9.1, respectively; scores decreased over the study for CSU and CSU + CIndU patients, but fluctuated for CIndU patients. Baseline angioedema occurrence was higher in CSU and CSU + CIndU patients, reported in 45.4% and 45.5% of patients, respectively, compared to 17.0% in CIndU patients. By the final visit, angioedema had decreased to 11.9% and 11.2% for CSU and CSU + CIndU, respectively, and 9.6% for CIndU.

Conclusion: CU patients are undertreated at baseline; after entering the AWARE study, more patients received appropriate treatment. However, over two thirds are not escalated to third-line treatments.

Keywords: AMAC, Asia-Pacific and the Middle East; AWARE, A Worldwide Antihistamine-Refractory Chronic Urticaria patient Evaluation; Angioedema; CIndU, chronic inducible urticaria; CSU, chronic spontaneous urticaria; CU, chronic urticaria; DLQI, dermatology life quality index; Dermatology; LaCAN, Central and Latin America; PRO, patient-reported outcome; QoL, quality of life; Quality-of-life; SD, standard deviation; UAS7, 7-day urticaria activity score; Urticaria.