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

Abstract

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 realworld 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.Maurer, Raap, Staubach, and Richter-Huhn equally contributed to this study.

Refractory Chronic Urticaria in Adults: Clinical Characterization and Predictors of Severity

“…This study re ects the resources allocated to diagnose and treat patients with refractory chronic urticaria and describes the real-life scenario and clinical management in an urticaria center in a tertiary hospital. Similar to other studies in Portugal and other countries (29,30,33,34), more than 70% of the patients were female and the median age was around 45 years old. CSU represented more than 55% of all cases of CU, however, a wide variability has been found (34)(35)(36).…”

“…In this study, 59.1% of the patients had papules at least once in the last 6 months, 16.1% reported at least 1 episode of angioedema, and 28.2% had moderate/high/very high impact on quality of life, namely due to pruritus, sleep disturbance and mental status disorders (29). Regarding control medications, 17.4% of the patietns were not following guideline recommended CU treatment (29). A similar AWARE study was conducted in Portugal and included 76 patients (30).…”

“…The prospective study AWARE (Germany) analyzed 1550 patients with H1 anti-histamine-refractory CSU in a 1-year non-interventional trial. In this study, 59.1% of the patients had papules at least once in the last 6 months, 16.1% reported at least 1 episode of angioedema, and 28.2% had moderate/high/very high impact on quality of life, namely due to pruritus, sleep disturbance and mental status disorders (29). Regarding control medications, 17.4% of the patietns were not following guideline recommended CU treatment (29).…”

“…Guideline recommended non-sedative H1-AH treatment was used in almost 91.0% of patients at enrollment (30). A total of 43.9% had moderate to severe urticaria, out of which 35.4% were medicated with third line therapy (omalizumab or cyclosporine), while 10.8% used oral corticosteroids, a lower percentage compared to the study performed in Germany (29).…”

The end of as required inhaled short‐acting bronchodilator for asthma?

“…In this issue of the Journal, Maurer et al have undertaken an observational study of real‐world antihistamine‐refractory chronic spontaneous urticaria (CSU) management in German adults . CSU continued to be uncontrolled in nearly half the participants after a year of follow‐up; quality of life similarly continued to be impaired.…”