A summary of the current knowledge of the role of sex in the action and efficacy of omalizumab is presented below:

Omalizumab is the first biologic therapy launched for asthma, its trials began with a smaller proportion of women and only the two most recent trials of omalizumab included an analysis by sex.

Although asthma symptoms improve following omalizumab treatment, the overall perception of asthma is significantly worse in females compared to males at a 12-month follow-up visit.

In the treatment of CSU, omalizumab may obtain a better response in women than in men.

There are no sex differences in the tolerability and safety of omalizumab.

A possible action of omalizumab on sex hormones, or indirectly on the downstream mechanisms mediated by them, can be hypothesized.