Antihistamine‐resistant chronic spontaneous urticaria remains undertreated: 2‐year data from the AWARE study

• DOI: 10.1111/cea.13716
• Publication Date: 2020-07-31T20:40:05Z
• Authors: Marcus Maurer; Celia Costa; AnaMaria Gimenez ...; Gerard Guillet; Moises Labrador‐H...; Hilde Lapeere; Raisa Meshkova; Sinisa Savic; Nadine Chapman‐Rothe
• Keywords: Adult; Male; chronic spontaneous urticaria; Time Factors; Immunology; Drug Resistance; 610; Omalizumab; GUIDELINES; THERAPY; VALIDATION; urticaria; 03 medical and health sciences; OMALIZUMAB; 0302 clinical medicine; Cost of Illness; QUALITY-OF-LIFE; Anti-Allergic Agents; Medicine and Health Sciences; MANAGEMENT; Immunology and Allergy; Humans; Chronic Urticaria; Patient Reported Outcome Measures; Prospective Studies; Practice Patterns, Physicians'; angioedema; CHRONIC IDIOPATHIC/SPONTANEOUS URTICARIA; Middle Aged; 3. Good health; Europe; Hospitalization; REAL-LIFE; DEFINITION; quality of life; CLINICAL-PRACTICE; Practice Guidelines as Topic; Histamine H1 Antagonists; Quality of Life; Female; Guideline Adherence; 600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit

AbstractBackgroundReal‐world evidence describing the benefits of recommended therapies and their impact on the quality of life (QoL) of chronic urticaria (CU) patients is limited.ObjectiveTo investigate disease burden, current treatment schedule, and the use of clinical resources by patients with H1‐antihistamine‐refractory CU in Europe.MethodsAWARE (A World‐wide Antihistamine‐Refractory chronic urticaria patient Evaluation) is a global, prospective, non‐interventional study in the real‐world setting, sponsored by the manufacturer of omalizumab. Disease characteristics, pharmacological treatments, and health‐related QoL of patients (N = 2727) ≥18 years of age diagnosed with H1‐antihistamine‐refractory chronic spontaneous urticaria (without inducible urticaria) for >2 months are reported here.ResultsOf the 2727 patients included, 1232 (45.2%) and 1278 (46.9%) were successfully followed up for any assessment and for the key outcome, the urticaria control test (UCT) score, respectively, and patients with complete remission (14.1%) were excluded from analyses.The proportion of patients with uncontrolled CSU (UCT score <12) dropped from 78% (n/N = 1641/2104) at baseline to 28.7% (n/N = 269/936) after two years of participation in the AWARE study. In addition, the proportion of patients with no impact of CSU on their QoL (assessed by the Dermatological Life Quality Index) increased to 57% (n/N = 664/1164) from 18.7% (n/N = 491/2621) at baseline. Emergency room visits (2.4% [n/N = 7/296] vs 33.5% [n/N = 779/2322]) and hospital stays (1.7% [n/N = 5/296] vs 24.2% [n/N = 561/2322]) reduced at Month 24 vs baseline. Overall, 23.2% (n/N = 26/112) patients on non‐sedating H1‐antihistamines (nsAH) and 41.9% (n/N = 44/105) patients on up‐dosed nsAH had uncontrolled CSU (UCT <12) at Month 24. In omalizumab‐treated patients, 27.1% (n/N = 78/288) had uncontrolled CSU at Month 24.ConclusionThese data confirm improvements for most patients with CSU over a 2‐year follow‐up period. Further studies are needed to understand the differences between guideline recommendations and reported management.