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

Clin Exp Allergy. 2020 Oct;50(10):1166-1175. doi: 10.1111/cea.13716. Epub 2020 Sep 3.

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.

Keywords: angioedema; chronic spontaneous urticaria; quality of life; urticaria.

Publication types

  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anti-Allergic Agents / therapeutic use
  • Chronic Urticaria / diagnosis
  • Chronic Urticaria / drug therapy*
  • Chronic Urticaria / immunology
  • Cost of Illness
  • Drug Resistance*
  • Europe
  • Female
  • Guideline Adherence / trends
  • Histamine H1 Antagonists / adverse effects
  • Histamine H1 Antagonists / therapeutic use*
  • Hospitalization
  • Humans
  • Male
  • Middle Aged
  • Omalizumab / therapeutic use
  • Patient Reported Outcome Measures
  • Practice Guidelines as Topic
  • Practice Patterns, Physicians' / trends*
  • Prospective Studies
  • Quality of Life
  • Time Factors
  • Treatment Outcome

Substances

  • Anti-Allergic Agents
  • Histamine H1 Antagonists
  • Omalizumab