Investigational Agents Show Benefit in Chronic Spontaneous Urticaria

Complete control of chronic spontaneous urticaria (CSU) is associated with improvements in key HRQoL measures, such as overall quality of life, sleep interference, activity interference and work impairment, while a marked decline in these improvements to quality of life is seen among patients with only a low level of CSU symptoms. Furthermore, data presented at the European Academy of Dermatology and Venereology (EADV) 30th Anniversary Congress, show higher rates of complete control with ligelizumab from Novartis than with Xolair® (omalizumab) or placebo.

At Week 12, the proportion of patients with CSU completely controlled was 44.1% with ligelizumab 72mg, 40.0% with ligelizumab 240mg, 23.5% with omalizumab, and 0.0% with placebo. 

Additionally, Phase 2b data for remibrutinib (LOU064), were also presented at the EADV Congress. Remibrutinib is a potentially best-in-class oral BTK inhibitor that demonstrated rapid and effective disease control in patients with inadequately controlled chronic spontaneous urticaria.

In the randomized, double-blind, placebo-controlled study remibrutinib was associated with a statistically significant dose-response compared to placebo with respect to change from baseline in UAS7 score at Week 4.

All remibrutinib doses provided significant improvements with respect to change from baseline in UAS7 at Week 4 and at Week 12 (p<0.0001 for all doses vs placebo) and demonstrated a 

rapid improvement as of Week 1. Compared with placebo, more patients receiving any remibrutinib dose achieved a complete control with absence of hives and itch (UAS7=0) or well-controlled disease (UAS7≤6) until Week 12 (end of treatment). Remibrutinib showed a favorable safety profile and good tolerability across the entire dose range tested, with no dose-dependent pattern.