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A Specialized Therapeutic Approach to Chronic Urticaria Refractory to H1-Antihistamines Improves Disease Burden: The Spanish AWARE Experience

Gimenez-Arnau A1, Bartra J2, Ferrer M3, Jauregui I4, Borbujo J5, Figueras I6, Muñoz-Bellido FJ7, Pedraz J8, Serra-Baldrich E9, Tejedor-Alonso MA10, Velasco M11, Terradas P12, Labrador M13

1Hospital del Mar, Barcelona, Spain
2Allergy Section, Pulmonology Department, Hospital Clínic, IDIBAPS, ARADyAL, Universitat de Barcelona, Barcelona, Spain
3Clínica Universidad de Navarra, ARADyAL, Pamplona, Spain
4Hospital Universitario Cruces, Vizcaya, Spain
5Hospital de Fuenlabrada, Madrid, Spain
6Hospital de Bellvitge, L’Hospitalet de Llobregat, Barcelona, Spain
7Complejo Asistencial Universitario de Salamanca, Salamanca, Spain
8Hospital Quirón, Pozuelo de Alarcón, Madrid, Spain
9Hospital de la Santa Creu i Sant Pau, Barcelona, Spain
10Fundación Hospital Alcorcón, Alcorcón, Madrid, Spain
11Hospital Arnau de Vilanova, Valencia, Spain
12Novartis Farmacéutica, Barcelona, Spain
13Hospital Vall d’Hebron, ARADyAL, Barcelona, Spain

J Investig Allergol Clin Immunol 2022; Vol 32(3) : 191-199
doi: 10.18176/jiaci.0661

Objective: During its first year, the AWARE study assessed disease activity, patient quality of life (QOL), and treatment patterns in chronic urticaria (CU) refractory to H1-antihistamines (H1-AH) in clinical practice.
Methods: We performed an observational, prospective (24 months), international, multicenter study. The inclusion criteria were age ≥18 years and H1-AH–refractory CU (>2 months). At each visit, patients completed questionnaires to assess disease burden (Urticaria Control Test [UCT]), disease activity (7 day-Urticaria Activity Score [UAS7]), and QOL (Dermatology Life Quality index [DLQI], Chronic Urticaria Quality of Life Questionnaire [CU-Q2oL], and Angioedema Quality of Life Questionnaire [AE-QoL]). We present data for Spain.
Results: The study population comprised 270 evaluable patients (73.3% female, mean [SD] age, 48.9 [14.7] years). At baseline, 89.3% were prescribed a CU treatment. After 1 year, first- and second-line treatments became less frequent and third-line treatments became more frequent. At baseline, 47.0% of patients experienced angioedema; at 1 year, this percentage had fallen to 11.8%. The mean (SD) AE-QoL score decreased from 45.2 (28.7) to 24.0 (25.8). The mean (SD) UCT score decreased from 7.0 (4.5) to 12.1 (4.1). According to UAS7, 38.2% of patients reported absence of wheals and itch in the previous 7 days at 1 year compared with 8.3% at baseline. The mean (SD) DLQI score decreased from 8.0 (7.4) to 2.8 (4.6). At the 1-year visit, the percentage of patients reporting a high or very high impact on QOL fell from 29.9% to 9.6%.
Conclusions: H1-AH–refractory CU in Spain is characterized by absence of control of symptoms and a considerable impact on QOL. Continuous follow-up of CU patients and third-line therapies reduce disease burden and improve patients’ QOL.

Key words: Chronic urticaria, Clinical practice, Spain, Quality of life, Angioedema, Urticaria

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