Biomarkers for Monitoring Treatment Response of Omalizumab in Patients with Chronic Urticaria

Abstract

Chronic urticaria (CU) is a debilitating skin disease affecting around 1% of the population. CU can be subdivided into chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU). Different pathophysiological mechanisms have been proposed to play a role in the development of CU, and these are also being investigated as potential biomarkers in the diagnosis and management of the disease. As of now the only assessment tools available for treatment response are patient reported outcomes (PROs). Although these tools are both validated and widely used, they leave a desire for more objective measurements. A biomarker is a broad subcategory of observations that can be used as an accurate, reproducible, and objective indicator of clinically relevant outcomes. This could be normal biological or pathogenic processes, or a response to an intervention or exposure, e.g., treatment response. Herein we provide an overview of biomarkers for CU, with a focus on prognostic biomarkers for treatment response to omalizumab, thereby potentially aiding physicians in personalizing treatments.

Omalizumab withdrawal outcomes in chronic spontaneous urticaria are linked with baseline IgE and eosinophil levels

“…Notably, a link between IgE and response to Oma was noted previously as low baseline IgE level was linked with a slower response to Oma, 25 , 26 which support the notion that low IgE may be a marker of a subgroup of CSU patient. This subgroup differs as on the one hand the mechanisms of initial response to Oma required a longer time to achieve response while on the other hand once remission is achieved, as seen in this study, their chances for successful withdrawal is higher.…”

Predicting the Speed of Response to Omalizumab in Chronic Spontaneous Urticaria

“…Several biomarkers have been investigated in previous studies for predicting the response to omalizumab, i.e., predicting response versus nonresponse [23]. Among these, a low baseline total IgE level was considered the strongest predictor for poor response, whereas the evidence is contradictory for IgG anti-TPO in the current literature [16,[23][24][25]. On the other hand, in a recent meta-analysis, high baseline total IgE levels were associated with a complete response to omalizumab [26].…”

“…Some studies defining early response in less than 3 months discussed this as a major limitation [21,22]. Several biomarkers have been investigated in previous studies for predicting the response to omalizumab, i.e., predicting response versus nonresponse [23]. Among these, a low baseline total IgE level was considered the strongest predictor for poor response, whereas the evidence is contradictory for IgG anti-TPO in the current literature [16,[23][24][25].…”

The Alarmin Triad—IL-25, IL-33, and TSLP—Serum Levels and Their Clinical Implications in Chronic Spontaneous Urticaria

“…The total UAS7 score is the sum of these daily assessments, with a maximum potential score of 42. The cumulative score categorizes CSU severity into three levels: mild (0-15), moderate (16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27), and severe (28)(29)(30)(31)(32)(33)(34)(35)(36)(37)(38)(39)(40)(41)(42), enabling a nuanced understanding of the disease's impact on the patient.…”

“…Currently, omalizumab is the only monoclonal antibody approved for CSU, yet there exists a subset of patients who do not respond adequately to this treatment [1,2,22]. This scenario underscores the pressing need for continued research into the mechanisms of treatment resistance and factors influencing treatment response in CSU [23][24][25]. The exploration of alternative therapeutic targets and the development of novel monoclonal antibodies are pivotal in addressing these challenges and improving patient outcomes.…”