Background and importance Omalizumab is a monoclonal antibody directed against immunoglobulin-E and used in patients with antihistaminic refractory chronic idiopathic urticaria (CIU). Real-life data on the long-term effectiveness of omalizumab could provide relevant information for healthcare professionals.
Aim and objectives To evaluate the long-term effectiveness of omalizumab in CIU in clinical practice.
Material and methods Descriptive retrospective study was developed. All patients on treatment with omalizumab between October 2020 and June 2021 were included. Digital clinical history and Farmatools application were used to collect the following variables: gender, age, previous therapy, duration of treatment, regimen with omalizumab and baseline Urticaria Activity Score during a 7-day period (UAS7). Effectiveness endpoint was measured using UAS7 at 6, 30 and 60 months. No response to treatment (NR) was defined by UAS7 >15. Mild disease (MD) was defined as UAS7 = 7–15. Adequate disease control (DC) presented UAS7 ≤6. Total response (TR) was considered as UAS7 = 0. Patients with NR and omalizumab therapy suspension in a certain month were considered as NR in the following months.
Results Forty-seven patients were included in the study: 23.4% of patients were male and 76.6% were female. Median age was 45 (11–76) years. All patients had previously received H1 antihistamines and 72.3% were treated with corticosteroids. Median duration of treatment with omalizumab was 18 (11–56) months. Omalizumab regimens were as follows: 19.1% of patients were treated with 150 mg/28 days, 78.7% received 300 mg/28 days and 2.2% were treated with 450 mg/28 days. All patients presented NR at baseline, with UAS7 >15. Effectiveness data for UAS7 at 6 months were: 5.7% of patients presented NR, 14.3% MD, 5.7% DC and 74.3% TR. Effectiveness evaluations of UAS7 at 30 months: 6.7% of patients had NR, 6.7% MD, 40% DC and 46.6% TR. Effectiveness assessments of UAS7 at 60 months were: 28.6% of patients had NR, no patients presented MD, 28.6% DC and 42.8% TR.
Conclusion and relevance Omalizumab showed long-term effectiveness in CIU patients, maintaining almost half of the patients with TR and almost one-third of patients with DC at 60 months.
References and/or acknowledgements None
Conflict of interest No conflict of interest
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