**7. Conclusions**

The introduction of anti-IgE antibodies in urticaria management has been representing a milestone in the treatment of H1-antihistamine refractory patients.









 *Clinical Efficacy of Anti-IgE Antibodies in Phase II and III randomised controlled trials of Chronic Urticaria.*

**Table**

**2.**

The results of the anti-IgE antibodies on CU in phase II and III randomised controlled trials [49, 50, 53, 54, 94, 112, 130–137] were summarized in **Table 2**.

Omalizumab 300 mg every 4 weeks, as add-on therapy, has demonstrated effective and safe in most, but not all, patients with CSU and there is evidence that this holds true for angioedema and CIndU. However, additional studies, using registries, real life settings and controlled trials should investigate personalized dosages and administration intervals, based on e. g. body mass index, UAS7 results, and on the identification of biomarkers able to predict changes in disease activity in response to therapy, for the development of tailored treatment algorithms to be used in clinical practice.

Current data of ligelizumab, being the next-generation anti-IgE antibody that is one-step ahead in clinical trials, are very promising and it has the potential to be a valid alternative for CSU patients unresponsive to omalizumab. If the phase III trial program confirms the superiority of ligelizumab compared to omalizumab, there is hope that symptoms might be controlled in all patients with CSU.

There are no licensed treatment options for CIndU and, therefore, recommended treatment is similar to CSU. However, off-label use of omalizumab has shown to be less effective compared to in CSU. Results from randomized controlled trials of ligelizumab for CIndU seem to be highly encouraging.

It will be intersting to see whether next-generation anti-IgE therapies are effective in CSU, CIndU and angioedema. The mechanism of action of the various anti-IgE approaches should be further elucidated in order to optimize the treatment of CU patients and its better understanding might enable targeted therapy in the near future.

### **Acknowledgements**

The chapter was funded by Novartis Farma S.p.A.

### **Author contributions**

All authors made substantive intellectual contributions to the published chapter, and each author listed on the publication has seen and approved the submission of the chapter.

### **Funding**

Honorarium, grant, or other form of payment was not given to anyone of the authors to produce the chapter.

### **Conflict of interest**

The authors declare that they have no competing interests.

### **Nomenclature**


