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Background: Omalizumab is not considered a disease-modifying drug and, accordingly, a large proportion of patients experience a relapse following withdrawal from treatment. Patients & methods:  A total of 42 patients who underwent at least one cycle of treatment with omalizumab were enrolled. Two groups of relapsed and not-relapsed subjects were compared. Then, patients were divided into subgroups. Results: Female patients relapse more frequently than male subjects. Patients who relapsed complained a long duration of disease, while patients who did not relapse had short a history of disease. Very early responders are thought to have a high recurrence rate. Basal IgE levels were increased in early responders and cholesterol levels were high in very early responders, who relapse following withdrawal from omalizumab. High D-dimer levels were observed in late responders. Conclusion: The identification of clinical and serological predictors will play a pivotal role in the future management of patients treated with omalizumab.

Background: Recent studies highlight that high levels of cytokines may precede the onset of many systemic autoimmune disorders and may also be related to chronic spontaneous urticaria (CSU) activity., Methods: Eight patients with CSU candidate to omalizumab therapy were enrolled. Four healthy controls were included with the purpose of comparing baseline cytokine levels. We evaluated serum levels of IFN-γ, IL-2, 4, 6, 8, and 10, TNF-α, and GM-CSF. For the patient group, venous blood samples were drawn at T0, T1 (1 week after first drug administration), T2 (after 3 months), T3 (after 6 months), and in case of relapse. Cytokine levels were measured using the human cytokines 8-plex kit. Disease activity and effect of therapy were calculated by means of Urticaria Activity Score 7., Results: Higher levels of IL-6 and IFN-γ were found in patients with CSU compared to those observed in the control group. Moreover, a common trend between these cytokines and the clinical history of disease could be hypothesized, with a decrease in levels of IFN-γ and IL-6 following remission of CSU with omalizumab treatment. Levels of other tested cytokines were similar between patients and healthy subjects., Conclusion: IFN-γ and IL-6 are proinflammatory cytokines that are strongly related to autoimmunity. Despite being limited by the small sample size, our data offer new insight into a better understanding of the pathogenesis of CSU and support the need for further investigations., (© 2020 The International Society of Dermatology.)