Long-Term Efficacy and Safety of Ligelizumab as Re-Treatment in Patients With Chronic Spontaneous Urticaria.

Abstract

Chronic spontaneous urticaria (CSU) is a debilitating skin condition affecting approximately 1% of the global population, characterized by recurrent wheals, angioedema, or both for over 6 weeks without identifiable external triggers. This Phase 3b multicentre, double-blinded followed by open-label extension study evaluated the long-term efficacy and safety of ligelizumab re-treatment in patients with CSU who rolled over from previous studies. Patients from the PEARL-1 or PEARL-2 Phase 3 trials (re-treatment subpopulation) received blinded re-treatment with ligelizumab 72 mg or 120 mg every 4 weeks for 12 weeks, followed by open-label ligelizumab 120 mg up to Week 104. Patients from a Phase 3 open-label Japanese study or a Phase 2 pediatric study received open-label ligelizumab 120 mg throughout. Primary and key secondary efficacy endpoints were assessed at Week 12 in the re-treatment subpopulation; safety was evaluated throughout. In the overall ligelizumab re-treatment subpopulation, 53.5% and 57.5% of patients treated with ligelizumab 72 mg and 120 mg, respectively, achieved weekly urticaria activity score (UAS7) of ≤ 6 at Week 12. Re-treatment efficacy was demonstrated in both treatment arms, across all secondary endpoints, maintained up to Week 52. Re-treatment efficacy in the overall trial population showed similar trends to those in the re-treatment subpopulation. The safety profile of ligelizumab showed no new or unexpected safety signals compared with the known safety profile of ligelizumab. Long-term and re-treatment with ligelizumab was well tolerated and efficacious in patients with CSU, aligning with the short-term outcomes observed in the Phase 3 PEARL studies.