Omalizumab in Chronic Urticaria: An Italian Survey

Abstract

Omalizumab is approved for use in chronic spontaneous urticaria (CSU); however, it is not approved for chronic inducible urticaria (CIndU). The aim of the present study was to assess the effectiveness of omalizumab in treating CSU and CIndU in Italy. This is a multicentre prospective observational real-life study involving patients with severe urticaria capable of undergoing omalizumab therapy. We enrolled 127 patients (59.1% females), ranging in age from 15 to 83 years, 69.3% had CSU alone, 26.8% had CSU and CIndU, and 3.9% had only CIndU (30.8% delayed pressure, 35.9% dermographic, 15.3% cholinergic, 12.8% cold, 5.1% aquagenic). After the first cycle of omalizumab (300 mg every 4 weeks for 24 weeks), 16 CSU patients and 10 patients (20.5%) with CIndU with or without CSU did not require a second cycle of omalizumab (300 mg every 4 weeks for 20 weeks). The patient with aquagenic urticaria achieved remission after the first cycle. None showed a lack of response to the second cycle of omalizumab. Omalizumab is a promising drug for both spontaneous and inducible chronic urticaria. Current evidence indicates that omalizumab may be approved also for CIndU.

From regulatory limitations to new opportunities: Real‐life experience on the effectiveness of short courses of omalizumab in the treatment of chronic idiopatic urticaria

“…In our study, in line with the literature (Damiani et al, ; Mandel et al, ; Nettis, ), clinical responses to the first, second, and third courses of omalizumab were similar. This characteristic is important because some patients are subject to relapses of moderate‐to‐severe degree after a course of treatment (mean disease‐free interval is about 2.5 months) and need periodic retreatment.…”

“…To the best of our knowledge, the time limit of 6 months for continuous treatment with omalizumab is defined only in Italian regulations. Thus, our data can be compared with those of studies performed by Italian authors (Bongiorno et al, ; Damiani et al, ; Mandel et al, ; Nettis, ; Romano et al, ). Romano et al reported a higher rate of complete resolution than in our study, but in a smaller population (6/9 patients, 67%), while Bongiorno et al reported, in a group of 18 patients, a 35.7% rate of complete resolution, followed by relapse within 1–4 months in all cases.…”

“…The reasons of the above differences are unknown. However, variability could be due, at least in part, to enrolment criteria: some authors studied CIU patients, while others included all types of spontaneous urticaria and even inducible urticaria, because omalizumab showed efficacy also in these forms of the disease (Arasi et al, ; Bongiorno et al, ; Damiani et al, ; Kaplan et al, ; Mandel et al, ; Nettis, ; Romano et al, ; Tharp et al, ).…”

Omalizumab in children and adolescents with chronic spontaneous urticaria: Case series and review of the literature

“…so-called chronic inducible urticaria, CindU), it is named chronic spontaneous urticaria (CSU), which may include auto-immune pathogenesis. 1 First line treatment is based on second-generation antihistamines (H 1 ), which can be increased up twofold to fourfold the standard dosage to reach clinical remission (ie, second line of treatment). 2 However, in some individuals, standard therapy with antihistamines is inadequate; therefore, these patients require alternative therapeutic approaches.…”

Successful Treatment of Chronic Spontaneous Urticaria Associated with Autoimmune Thyroiditis: Clinical Case

“…Следует заметить, что отдельного исследования по использованию омализумаба при ХСК у детей до 18 лет в мире не проводилось. Однако, есть данные реальной клинической практики, где подростки вместе со взрослыми пациентами с ХСК получали данную терапию [25]. В одном из последних метаанализов оценки эффективности и безопасности омализумаба при ХСК, в который были включены и исследования с подростками, показано, что эффек-тивность омализумаба была выше, чем в проведенных ранее плацебоконтролируемых рандомизированных исследованиях, и достигала 72% [26].…”