Efficacy of drug therapies in antihistamine refractory chronic spontaneous urticaria: Real life data

Mehmet Unsel

Department of Allergy and Immunology, Near East University, Faculty of Medicine, Nicosia, Cyprus

Abstract

Background: Omalizumab is a safe and effective treatment for antihistamine-refractory chronic spontaneous urticaria (CSU) but is insufficient in one-third of patients. For serious cases in which omalizumab is ineffective, cyclosporine or methotrexate may be preferred. Most drug trials in CSU have focused on omalizumab or cyclosporine monotherapy.
Objectives: This retrospective study evaluated responses to monotherapy or combined therapy and real-life data on the effectiveness and safety of omalizumab in antihistamine-refractory CSU.
Methods: A total of 133 patients who received omalizumab due to antihistamine-refractory CSU were evaluated in terms of 7-day urticaria activity score, total IgE, anti-thyroid peroxidase, C-reactive protein, skin prick test with aeroallergens and disease duration. Partial or nonresponders to omalizumab monotherapy were given antihistamine, omalizumab, cyclosporine, and methotrexate as combined or monotherapy.
Results: Ninety-eight (73.7%) of the 133 patients were female and the mean age was 40.7 ± 14.4 years; 70.6% of the patients received omalizumab monotherapy and the others received combined or non-omalizumab monotherapy. Omalizumab monotherapy was effective in 66.9% of the patients. Of those with complete response to omalizumab monotherapy, 65.4% had early recurrence after discontinuing treatment. Treatment response was significantly better in patients who had high total IgE (p = 0.001). Patients with longer disease duration had significantly higher likelihood of early recurrence (p = 0.035).
Conclusions: Omalizumab monotherapy was as effective in real life as in placebo-controlled trials. Omalizumab was well tolerated by all patients. Treatment responses were comparable in patients treated with combined therapy and those who received monotherapy.
Key words: Omalizumab, methotrexate, cyclosporine, treatment, chronic spontaneous urticaria, efficacy, safety