Biomarkers for Short-Term Omalizumab Response in Chronic Spontaneous Urticaria
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Background: Omalizumab, a monoclonal antibody targeting immunoglobulin E (IgE), is approved for adults and adolescents (12 years or older) with chronic spontaneous urticaria (CSU) that does not respond to high-dose antihistamines. In Korea, there is limited research on predictive biomarkers for omalizumab response in CSU patients. Objective: This retrospective, single-institution study aimed to identify clinical parameters predicting omalizumab response in Korean CSU patients. Methods: We analyzed records of CSU patients aged 19 or older starting omalizumab between January 2017 and October 2019. Omalizumab efficacy was assessed using the Urticaria Activity Score summed over 7 days (UAS7), categorized as well-controlled, mild, moderate, or severe. Ninety CSU patients participated in this study. Results: Among these, improvements in UAS7 categories from baseline to 12 weeks of treat- ment were observed in 78 patients, while 12 patients showed no significant efficacy. The present study identified potential biomarkers that could predict a patient’s response to omalizumab, including disease duration and total serum IgE levels (p=0.022, p=0.046). Notably, a significant correlation was observed between higher detection rates in multiple antigen simultaneous test (MAST) food testing and lower treatment responses (p=0.033). Conclusion: Shorter disease duration of CSU and elevated initial serum total IgE level may serve as potential predictive biomarkers for the responsiveness to omalizumab. Furthermore, a higher MAST food detection rate seemed to correlate with a less favorable treatment response, sug- gesting patients with a high MAST food detection rate might benefit from a food evaluation in addition to omalizumab treatment.
Abstract
Background: Omalizumab, a monoclonal antibody targeting immunoglobulin E (IgE), is approved for adults and adolescents (12 years or older) with chronic spontaneous urticaria (CSU) that does not respond to high-dose antihistamines. In Korea, there is limited research on predictive biomarkers for omalizumab response in CSU patients. Objective: This retrospective, single-institution study aimed to identify clinical parameters predicting omalizumab response in Korean CSU patients. Methods: We analyzed records of CSU patients aged 19 or older starting omalizumab between January 2017 and October 2019. Omalizumab efficacy was assessed using the Urticaria Activity Score summed over 7 days (UAS7), categorized as well-controlled, mild, moderate, or severe. Ninety CSU patients participated in this study. Results: Among these, improvements in UAS7 categories from baseline to 12 weeks of treat- ment were observed in 78 patients, while 12 patients showed no significant efficacy. The present study identified potential biomarkers that could predict a patient’s response to omalizumab, including disease duration and total serum IgE levels (p=0.022, p=0.046). Notably, a significant correlation was observed between higher detection rates in multiple antigen simultaneous test (MAST) food testing and lower treatment responses (p=0.033). Conclusion: Shorter disease duration of CSU and elevated initial serum total IgE level may serve as potential predictive biomarkers for the responsiveness to omalizumab. Furthermore, a higher MAST food detection rate seemed to correlate with a less favorable treatment response, sug- gesting patients with a high MAST food detection rate might benefit from a food evaluation in addition to omalizumab treatment.
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