Marcus Maurer1, Celia Costa2, AnaMaria Gimenez Arnau3, Gerard Guillet4, Moises Labrador-Horrillo5,6, Hilde Lapeere7, Raisa Meshkova8, Sinisa Savic9, Nadine Chapman-Rothe10. 1. Dermatological Allergology, Department of Dermatology, Venereology, and Allergology, Allergie-Centrum-Charité, Charité - Universitätsmedizin Berlin, Berlin, Germany. 2. Serviço de Imunoalergologia, Hospital de Santa Maria, Lisbon, Portugal. 3. Dermatology Department, Hospital del Mar, Parc de Salut Mar, IMIM, Universitat Autònoma de Barcelona, Barcelona, Spain. 4. Service de Dermato-allergologie, CHU Poitiers, Poitiers, France. 5. Allergy Section, Hospital Vall d'Hebron, Vall d'Hebron Research Institute (VHIR), Universitat Autònoma de Barcelona, Barcelona, Spain. 6. ARADyAL Research Network (RD16/0006/0020), Instituto de Salud Carlos III (ISCIII), Madrid, Spain. 7. Department of Dermatology, Ghent University Hospital, Ghent, Belgium. 8. Allergy and Clinical Immunology, Smolensk State Medical University, Smolensk, Russia. 9. National Institute for Health Research-Leeds Biomedical Research Centre, Leeds Institute of Rheumatic and Musculoskeletal Medicine, St James's University Hospital, Leeds, UK. 10. Novartis Pharma AG, Basel, Switzerland.
Abstract
BACKGROUND: 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. OBJECTIVE: To investigate disease burden, current treatment schedule, and the use of clinical resources by patients with H1 -antihistamine-refractory CU in Europe. METHODS: 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 H1 -antihistamine-refractory chronic spontaneous urticaria (without inducible urticaria) for >2 months are reported here. RESULTS: 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 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. CONCLUSION: 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.
BACKGROUND: 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. OBJECTIVE: To investigate disease burden, current treatment schedule, and the use of clinical resources by patients with H1 -antihistamine-refractory CU in Europe. METHODS: AWARE (A World-wide Antihistamine-Refractory chronic urticariapatient 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. RESULTS: 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 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. CONCLUSION: 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.
Authors: Pavel Kolkhir; Ana M Giménez-Arnau; Kanokvalai Kulthanan; Jonny Peter; Martin Metz; Marcus Maurer Journal: Nat Rev Dis Primers Date: 2022-09-15 Impact factor: 65.038
Authors: Emek Kocatürk; Indrashis Podder; Ana C Zenclussen; Alicja Kasperska Zajac; Daniel Elieh-Ali-Komi; Martin K Church; Marcus Maurer Journal: Front Allergy Date: 2022-07-07