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

  • Marcus Maurer
    Dermatological Allergology Department of Dermatology, Venereology, and Allergology Allergie‐Centrum‐Charité Charité ‐ Universitätsmedizin Berlin Berlin Germany
  • Celia Costa
    Serviço de Imunoalergologia Hospital de Santa Maria Lisbon Portugal
  • AnaMaria Gimenez Arnau
    Dermatology Department, Hospital del Mar Parc de Salut Mar IMIM Universitat Autònoma de Barcelona Barcelona Spain
  • Gerard Guillet
    Service de Dermato‐allergologie CHU Poitiers Poitiers France
  • Moises Labrador‐Horrillo
    Allergy Section Hospital Vall d'Hebron Vall d'Hebron Research Institute (VHIR) Universitat Autònoma de Barcelona Barcelona Spain
  • Hilde Lapeere
    Department of Dermatology Ghent University Hospital Ghent Belgium
  • Raisa Meshkova
    Allergy and Clinical Immunology Smolensk State Medical University Smolensk Russia
  • Sinisa Savic
    National Institute for Health Research‐Leeds Biomedical Research Centre Leeds Institute of Rheumatic and Musculoskeletal Medicine St James's University Hospital Leeds UK
  • Nadine Chapman‐Rothe
    Novartis Pharma AG Basel Switzerland

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<jats:title>Abstract</jats:title><jats:sec><jats:title>Background</jats:title><jats:p>Real‐world evidence describing the benefits of recommended therapies and their impact on the quality of life (QoL) of chronic urticaria (CU) patients is limited.</jats:p></jats:sec><jats:sec><jats:title>Objective</jats:title><jats:p>To investigate disease burden, current treatment schedule, and the use of clinical resources by patients with H<jats:sub>1</jats:sub>‐antihistamine‐refractory CU in Europe.</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>AWARE (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 H<jats:sub>1</jats:sub>‐antihistamine‐refractory chronic spontaneous urticaria (without inducible urticaria) for >2 months are reported here.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of 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 H<jats:sub>1</jats:sub>‐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.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>These 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.</jats:p></jats:sec>

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