Clinical trials have shown the efficacy of omalizumabs efficacy in refractory chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU), but real-life management strategies are lacking. To assess the long-term efficacy and safety of omalizumab, and to identify predictive factors and optimum dosage regimens. This was a prospective study of 13 patients (11 women, 2 men) with severe CSU [weekly urticaria activity score (UAS7) >28] resistant to anti-H1 antihistamines. Patients were started on omalizumab 150mg subcutaneously every 4weeks. Dose and interval between administrations were adjusted according to clinical response (189 administrations; treatment duration range 2-38months). Mean UAS7 was 36.3±5.4. Of the 13 patients, all had experienced angio-oedema, while in addition, 7 had delayed pressure urticaria (DPU) and 1 had solar urticaria (SU). After omalizumab treatment, 4 (30.8%) of the 13 patients had complete response (CR), and the remaining 8 (61.5%) had partial response. CR was achieved with a dose of 150mg every 4 (n=2 patients) or 5 (n=2)weeks. One of these patients remained disease-free after stopping treatment. Partial responses were achieved with 150mg every 4weeks (n=4) and with 300mg (n=4) at intervals of 5weeks (n=1), 4weeks (n=2) or 3weeks (n=1). Only one patient (7.7%) did not show significant improvement, despite a dose of 300mg every 4weeks. There were no significant differences in epidemiological, clinical and laboratory data between the different response groups. Only two adverse events were observed: one was mild headache and the other was severe angio-oedema and aggravation of urticaria within 6h of omalizumab administration. Omalizumab dose and interval between administrations could be individualized for long-term management of CSU.
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