Antihistamine‐resistant chronic spontaneous urticaria: 1‐year data from the AWARE study

Summary Background Previous reports indicate that patients with chronic spontaneous urticaria ( CSU ) are undertreated and that physicians show poor adherence to guideline recommendations. Awareness of CSU has improved in recent years, but it remains unclear if this has improved the management of these patients in clinical practice. Objective To describe disease burden, quality of life (QoL), and treatment patterns of patients with H 1 ‐antihistamine‐refractory CSU in Germany. Method A World‐wide Antihistamine‐Refractory chronic urticaria (CU) patient Evaluation ( AWARE ) is a global prospective, non‐interventional study of CU in the real‐world setting, supported by the manufacturer of omalizumab. Patients (18‐75 years) were included who had H 1 ‐antihistamine‐refractory CSU for ≥2 months. Disease characteristics, pharmacological treatments, and QoL (dermatology life quality index [ DLQI ], CU‐QoL questionnaire, and angioedema QoL questionnaire) are reported for patients enrolled in Germany. Results After 1 year in AWARE , CSU remained uncontrolled (urticaria control test [ UCT ] score <12) in 432 of 1032 (42.2%) patients. QoL impairment remained high after 1 year, with 28.2% of patients reporting that CSU had a moderate/very large/extremely large effect on the DLQI . Most patients did not receive guideline‐recommended treatments at the end of the 1‐year observation period. Changes in treatments were most evident at the first patient visit, with an increase in patients receiving omalizumab vs prior therapy from 8.5% to 21.4%, and a decrease in those receiving no treatment from 29.9% to 12.8%. These changes were associated with reduced hives, angioedema, UCT scores, and QoL scores at Month 3, but only modest improvements thereafter. Of 528 patients with uncontrolled CSU and who were eligible for treatment escalation, only 3% received up‐dosing of H 1 ‐antihistamines and only 5% were initiated on omalizumab during 1 year of treatment. Conclusions & Clinical Relevance This study highlights a significant discrepancy between recommendations for managing CSU in international guidelines, and in real‐world clinical practice in Germany.