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A Specialized Therapeutic Approach to Chronic Urticaria Patient’s Refractory to H1-Antihistamines Improves the Burden of the Disease. 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
2Allergy Section, Pneumology Department, Hospital Clínic, IDIBAPS, ARADyAL, Universitat de Barcelona, Barcelona
3Clínica Universidad de Navarra, ARADyAL, Pamplona
4Hospital Universitario Cruces, Vizcaya
5Hospital de Fuenlabrada, Madrid
6Hospital de Bellvitge, L’Hospitalet de Llobregat, Barcelona
7Complejo Asistencial Universitario de Salamanca, Salamanca
8Hospital Quirón, Pozuelo de Alarcón, Madrid
9Hospital de la Santa Creu i Sant Pau, Barcelona
10Fundación Hospital Alcorcón, Alcorcón, Madrid
11Hospital Arnau de Vilanova, Valencia
12Novartis Farmacéutica, Barcelona
13Hospital Vall d’Hebron, ARADyAL, Barcelona

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

Objective: AWARE study assesses disease activity, patient’s quality of life (QoL) and treatment patterns in chronic urticaria (CU) patient’s refractory to H1-antihistamines (H1-AH) in clinical practice during the first year of the study.
Methods: Observational, prospective (24 months), international, multicenter study. Patients ≥18 years with H1-AH-refractory CU diagnosis (>2 months). At each visit, patients completed questionnaires to assess disease burden (Urticaria Control Test [UCT]), disease activity (7 day-Urticaria Activity Score [UAS7]), QoL (Dermatology Life Quality index [DLQI], Chronic Urticaria Quality of Life Questionnaire [CU-Q2oL], Angioedema Quality of Life [AE-QoL]). We present Spanish data.
Results: 270 evaluable patients included (73.3% female, mean age [SD] 48.9 [14.7] years). At baseline, 89.3% were prescribed a CU treatment. After 1-year, first/second line treatments tended to decrease and third line to increase. 47.0% patients experienced angioedema at baseline, being 11.8% at 1-year. Mean (SD) AE-QoL went from 45.2 (28.7) to 24.0 (25.8). Mean (SD) UCT went from 7.0 (4.5) to 12.1 (4.1). According to UAS7, 38.2% patients reported absence of wheals and itch in the last 7 days at 1-year versus 8.3% at baseline. Mean (SD) DLQI went from 8.0 (7.4) to 2.8 (4.6). At 1-year visit, the percentage of patients reporting high/very high QoL impact went from 29.9% to 9.6%.
Conclusions: Spanish H1-AH-refractory CU patients present a lack of symptomatology control with an important impact in their QoL. Continuous follow-up of chronic spontaneous urticaria patients and third line therapies have shown a tendency to reduce the burden of the disease and to improve patients’ QoL.

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

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