Patients and clinical data
We performed a prospective study comparing 68 patients with CHA and 63
patients with CSU-AE who were recruited in 6 hospitals across Spain. All
patients were older than 18 and provided signed informed consent to
participate in the study. Ethical approval was obtained in each of the
collaborating centers, and the study followed Good Clinical Practice
guidelines and the Helsinki Declaration.
The inclusion criterion to fulfill the diagnosis of CHA was the presence
of recurrent AE that responds to treatment with antihistamines,
corticosteroids, adrenaline or omalizumab. The exclusion criteria were
the presence of bradykinergic AEs, ACE inhibitor intake,
delayed-pressure AEs, vibratory AEs or edema induced by nonsteroidal
anti-inflammatory drugs (NSAIDs). All patients had normal C1INH, C1q, C3
and C4 protein levels and normal C1INH activity.
We collected demographic features, and the patients were requested to
complete validated patient-reported questionnaires. Disease activity was
determined by the following questionnaires: Angioedema Activity Score
for 7 consecutive days (AAS7) in both CHA and CSU-AE patients and
Urticaria Activity Score over 7 Days (UAS7) in CSU-AE patients. The AAS7
score was categorized into four score levels: no episodes (0), low
(1–6), moderate (7–18) and high (19–105).17 UAS7
was also divided into four score bands: no episodes (0), low (1–6),
moderate (7–27) and high (28–42).18 The impact on
quality of life was measured by the Angioedema Quality of Life (AE-QoL)
in CHA and CSU-AE patients and by the Chronic Urticaria Quality of Life
(CU-Q2oL) questionnaires in CSU-AE patients.
In addition, we collected blood and serologic parameters in the clinical
laboratories of each center: total serum IgE, blood cell counts, D-dimer
and C-reactive protein (CRP).