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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.

Background: There are no studies assesing whether patients with idiopathic anaphylaxis are a heterogenous population, Objective: A study has been carried out to assess whether clinical and functional differences (mast cell releasability) exist between two sub-types of Idiopathic Anaphylaxis (Generalized Idiopathic Anaphylaxis -IA-G- and Idiopathic Anaphylaxis with Angioedema -IA-A-)., Methods: Patients were selected from the Idiopathic Anaphylaxis (IA) patient population of Hospital General de Albacete (Albacete, Spain) and this data were collected between 1990 and 1995. This series is composed of 81 patients. In the interest of seeing whether an IA classification is warranted between IA-G and IA-A, a logistic regression model was constructed in order to know if differences exist between IA-G and IA-A. To evaluate mast cell releaseability in different groups (IA-G, IA-A, atopic patients, urticaria and healthy subjects) we analysed the log 10 wheal area produced by four consecutive concentrations of codeine (from 90 to 3,3 mg/ ml). In those patients with IA-G, the variable urticaria was controlled, but not in those with IA-A. A parallel line assay was used to study the differences arising among all groups. When the conditions of parallelism and linearity were not fulfilled, a Hotelling's T2 test was performed., Results: In the logistic regression equation total IgE, with an O.R. of 1.006 (95% C.I. 1.001-1.01) favoured the presence of IA-G; whereas the presence of urticaria did not favour the presence of IA-G, with an O.R. of 0.159 (95% C.I. 0.04-0.507). IA-G and IA-A patients showed a higher cutaneous reaction to codeine than atopic patients (p=0.005 and p=0.001 respectively). However, IA-G patients had a lower reaction to codeine than those patients with urticaria (p=0.048). No differences were observed among patients with IA-A and patients with urticaria, as was the case between IA-A and IA-G patients with respect to cutaneous response to codeine., Conclusion: Apparently, IA-G patients appear to be closely related to the presence of atopy, while IA-A patients are closely related to the presence of urticaria. Along with other unknown factors, an enhanced mast cell releaseability may explain these episodes of Idiopathic Anaphylaxis among atopic patients.