A Specialized Therapeutic Approach to Chronic Urticaria Patient's Refractory to H1-Antihistamines Improves the Burden of the Disease. The Spanish AWARE Experience.

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.