The clinical response to omalizumab in CSU patients is linked to and predicted by IgE levels and their change

Abstract

Background

Omalizumab is an effective and well-tolerated treatment for chronic spontaneous urticaria (CSU). Markers and predictors of response are largely unknown, but needed to optimize omalizumab treatment. Omalizumab targets IgE, and IgE levels may be linked to the effects of treatment. We evaluated if response rates to treatment with omalizumab in patients with CSU are linked to their baseline IgE levels, their IgE levels after omalizumab treatment, and the ratio of on treatment IgE and baseline IgE levels.

Methods

CSU patients (n=113) were treated with omalizumab 300 mg/4 weeks for 12 weeks, when their treatment responses, i.e. no, partial, or complete response, were assessed by use of the urticaria activity score, physician and patient visual analog scale, and treatment effectiveness score. Total IgE levels were measured before treatment (bIgE) with omalizumab and 4 weeks thereafter (w4IgE).

Results

Non-responders to omalizumab had significantly lower bIgE levels (17.9IU/ml, 17.0-55.0IU/ml) than partial responders (82.0IU/ml, 46.2-126.5IU/ml, p=0.008) and complete responders (73.7IU/ml, 19.45-153.8IU/ml, p=0.032). Non-responders also had lower w4IgE levels and lower ratios of w4IgE/bIgE levels than partial and complete responders (p<0.001). Non-response to omalizumab was best predicted by patients' w4IgE/bIgE ratios, significantly better than by bIgE levels (p=0.016).

Conclusions

In CSU, total IgE levels and their change predict the response to treatment with omalizumab. The assessment of pre- and post-treatment IgE levels and their ratio may help to improve the management of CSU in patients who require omalizumab treatment.

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