A Gimenez-Arnau1, J Bartra2, M Ferrer3, I Jauregui4, J Borbujo5, I Figueras6, F J Muñoz-Bellido7, J Pedraz8, E Serra-Baldrich9, M A Tejedor-Alonso10, M Velasco11, P Terradas12, M Labrador13. 1. Hospital del Mar, Barcelona, Spain. 2. Allergy Section, Pulmonology Department, Hospital Clínic, IDIBAPS, ARADyAL, Universitat de Barcelona, Barcelona, Spain. 3. Clínica Universidad de Navarra, ARADyAL, Pamplona, Spain. 4. Hospital Universitario Cruces, Vizcaya, Spain. 5. Hospital de Fuenlabrada, Madrid, Spain. 6. Hospital de Bellvitge, L'Hospitalet de Llobregat, Barcelona, Spain. 7. Complejo Asistencial Universitario de Salamanca, Salamanca, Spain. 8. Hospital Quirón, Pozuelo de Alarcón, Madrid, Spain. 9. Hospital de la Santa Creu i Sant Pau, Barcelona, Spain. 10. Fundación Hospital Alcorcón, Alcorcón, Madrid, Spain. 11. Hospital Arnau de Vilanova, Valencia, Spain. 12. Novartis Farmacéutica, Barcelona, Spain. 13. Hospital Vall d'Hebron, ARADyAL, Barcelona, Spain.
Abstract
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%. CONCLUSION: 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.
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%. CONCLUSION: 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.
Authors: Maria Maddalena Sirufo; Enrica Maria Bassino; Francesca De Pietro; Lia Ginaldi; Massimo De Martinis Journal: Int J Immunopathol Pharmacol Date: 2021 Jan-Dec Impact factor: 3.219