Improvement of patient outcomes following therapeutic optimization of chronic urticaria: two-year data from France as part of the international real-life AWARE study.

BACKGROUND: It is important to assess the burden of chronic urticaria (CU) with real-life studies. The AWARE study was performed in 36 countries over two years in CU patients resistant to H1-antihistamines. OBJECTIVES: To correlate patient-reported outcomes and available therapeutic options in CU patients. MATERIALS & METHODS: The AWARE study was a prospective, non-interventional, international study that included adult patients who have had H1-antihistamine-resistant CU for at least two months. The primary endpoints were the evolution of disease activity (UAS7), urticaria control (UCT), dermatological quality of life (DLQI) and treatment satisfaction (visual analogic scale) during a two-year follow-up. The data from French centres are reported. RESULTS: Ninety-two patients were included (mean age: 47.8 years; women: 70.7%; mean disease duration: 6.5 years; angioedema: 34.1%). The percentage of patients with CU treatment increased from 56.5% at inclusion to 86.0% after two years (for patients with non-sedative H1-antihistamines from 52.2% to 74.4%, and omalizumab from 2.2% to 25.6%). During the follow-up, the percentage of patients with UAS7 score <6 increased from 12.5% to 60.9%, and patients with well-controlled CU (UCT score >12) increased from 11.1% to 62.2%. The negative impact on quality of life (DLQI >10) decreased from 34.1% to 10.5%. The mean score of patient satisfaction for treatment increased from 4.6 to 7.6. CONCLUSION: The management of CU patients resistant to H1-antihistamines was not optimal at inclusion with uncontrolled disease, impaired quality of life and insufficient treatment. After a two-year follow-up, disease symptoms and quality of life improved, but the therapeutic management could be further optimized.

The burden of chronic urticaria: French baseline data from the international real-life AWARE study.

BACKGROUND: The AWARE study is an ongoing international study of patients with chronic urticaria refractory to H1-antihistamines. The aim of this study is to evaluate the burden of disease and the use of healthcare resources in real-life conditions. OBJECTIVES: To analyse the baseline data of French patients included in the AWARE study. MATERIALS & METHODS: AWARE is a prospective, non-interventional, international study that includes adult patients who have had chronic urticaria, refractory to at least one H1-antihistamine, for at least two months. RESULTS: Ninety-four patients (mean age: 47.9 years; 71.3% women) with chronic urticaria (50.0% spontaneous only, 9.6% inducible only, and 40.4% both) were included in French centres. The median duration from diagnosis was three years and angioedema was present in 31.5% of patients for the past six months. In 63.8% of cases, the patients received at least one treatment for urticaria (H1-antihistamine for 66.0%). Chronic urticaria was poorly controlled (UCT score <12) in 88.9% of patients and quality of life was severely impaired (mean DLQI score: 8.6). The use of healthcare resources was significant with frequent visits to general practitioners (80.8% of patients; mean: 8.1 visits). However, more than half of patients had not previously consulted a dermatologist. CONCLUSION: These baseline data of French patients in the AWARE study show that patients suffering from chronic urticaria, refractory to H1-antihistamines for a median of three years, are insufficiently treated and that their quality of life is impaired. Despite the significant use of healthcare resources, access to specialised consultations remains insufficient.