Clinical characteristics and management of chronic spontaneous urticaria in patients refractory to H1-Antihistamines in Asia, Middle-East and Africa: Results from the AWARE-AMAC study

Abstract

Background: Chronic urticaria (CU) is a condition characterized by recurrent itchy hives and/or angioedema for ≥6 weeks. Most of the data about CU come from western countries with very little information available about CU in Asia, Africa, and the Middle East.

Methods: AWARE-AMAC is a 24-month prospective, observational, real-world, non-interventional study in patients aged ≥18 years from Asia, the Middle East, and Africa (AMAC) with CU refractory to H1-antihistamines (H1-AH). The main objective was to describe the real-world experience with CU, including clinical characteristics, presence of angioedema, treatment patterns (shifts between treatment classes and changes within a treatment class), investigator-assessed disease control, and the impact on quality of life. Subgroups of interest were type of CU at Baseline and treatment class (based on 2013 urticaria guidelines). There were no mandatory visits and diagnostic/monitoring procedures additional to routine practice, except the patient diary (7-day Urticaria Activity Score) and patient reported outcome assessments.

Results: The focus of the current manuscript is on patients with chronic spontaneous urticaria (CSU), who formed 98% of the sample. Patients were predominantly female (69.6% female, mean age ± SD 39.8 ± 13.29 years). Time since current diagnosis (Mean ± SD) was 28.6 ± 49.06 months. Amongst patients with CSU, 31.0% had comorbid chronic inducible urticaria (CINDU) and 46.4% had a history of angioedema. 91.9% received H1-AH therapy (±other treatments). The most frequently prescribed treatment classes at Baseline were any/combination of medications, not classified under the other 7 treatment classes, named "Others" (30.5%) followed by, omalizumab (OMA; 23.6%) and second-generation H1-AH monotherapy (sgAH; 15.1%). At Month 12, the most prescribed treatment classes (>15%) for patients were OMA (23.5%) and "Other" (21.3%); 19.7% received "No drug". At Month 24, OMA (22.5%), and "Other" (17.9%) were most frequently prescribed; 28.6% received "No drug". Overall, 79.5% of patients had some type of change in treatment. Over the study period, improvement in self-reported QoL increased, which was mirrored by better disease control.

Conclusion: In AMAC countries, the non-recommended "Other" treatment class played a major role in the initial management of CU patients. High usage of H1-AH (±other treatments) and OMA was observed. Treatment changes were observed in a majority of patients. Treatment escalation from sgAH was mostly via OMA. Improvement of disease control and QoL was achieved during the study period.

Trial registration: Observational study (NA).

Keywords: AMAC, Asia Middle East and Africa; CINDU, Chronic inducible urticarial; CSU, Chronic spontaneous urticarial; CU, Chronic urticaria; Chronic spontaneous urticaria; CsA, Cyclosporine A; DLQI, Dermatology Life Quality Index; Efficacy; GCP, Good Clinical Practice; H1-AH, H1-antihistamines; HRCU, H1-antihistamines refractory chronic urticarial; HRQoL, Health-related quality of life; MONT, Montelukast monotherapy, or in combination with any H1-AH; OMA, Omalizumab monotherapy, or in combination with any H1-AH, with or without steroids; Omalizumab; PRO, Patient-reported outcomes; PhyGA-VAS, Physician Global Assessment of disease control-visual analog scale; QoL, Quality of life; Quality of life; SD, Standard deviation; SGC, Systemic glucocorticosteroids monotherapy, or in combination with any H1-AH; Second-generation antihistamines; UAS7, 7-day Urticaria Activity Score; fgAH, First-generation antihistamines monotherapy, or in combination with sgAH; sgAH, Second-generation antihistamines monotherapy approved dose: once daily or as needed; sgAHUP, Updosed second-generation H1-AH.

Fig. 1

Pre-defined treatment classes analyzed in AWARE-AMAC study

Fig. 2

Urticaria-related Treatment Class during the Study. fgAH, first-generation H1-antihistamine; OMA, omalizumab; sgAH, second-generation H1-antihistamine (approved dose); sgAHUP, second-generation H1-antihistamine (up-dosed); SGC, systemic steroids; OTHER, any other medication or combination not classified under the other subgroup categories. During the study only 1% and 2% of patients were treated with cyclosporine and montelukast respectively (not displayed)

Fig. 3

a) UAS, b) PhyGA-VAS, and c) UAS7 in CSU patients at Month 12 and 24. Error bars represent the standard deviation in (a) and (b). The UAS7 assessment was optional and only conducted where the diary was available in the patient's local language. PhyGA-VAS, Visual Analog Scale Physician Global Assessment of disease control. For post-Baseline visits, only the results for patients with a value for both Baseline and the specific post-Baseline observation time-point are summarized

Fig. 4

Disease Status, Spontaneous Remission∗ and Recurrence of CSU∗∗ at Month 12 and 24. ∗ spontaneous remission, defined as complete remission of signs and symptoms of CU for a period longer than 6 months as collected in the eCRF. ∗∗ recurrence of disease, defined as those patients who achieved spontaneous remission before experiencing a recurrence of their symptoms or receiving treatment. Percentages (%) are based on the number of patients in the full analysis set with disease status available at the observation time-point of interest (m) for each respective group of interest