Long‐Term Efficacy and Safety of Ligelizumab as Re‐Treatment in Patients With Chronic Spontaneous Urticaria
Journal
Allergy
Journal Volume
81
Journal Issue
7
Start Page
2391-2402
ISSN
0105-4538
1398-9995
Date Issued
2025-12-08
Author(s)
Gimenez‐Arnau, Ana M.
Maurer, Marcus
Reich, Adam
Deleanu, Diana
Sussman, Gordon
Sanchez, Jorge
Brockow, Knut
Hayama, Koremasa
Hide, Michihiro
Denguezli, Mohamed
Meshkova, Raisa
Criado, Roberta F. J.
Saini, Sarbjit
Valle, Solange
Hua, Eva
Wang, Pengpeng
Burciu, Alis
Indermuehle, Isabelle
Varanasi, Vineeth
Joubert, Yolandi
Severin, Thomas
Patekar, Manmath
Abstract
Background: 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.
Methods: 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.
Results: 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.
Conclusion: 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.
Subjects
IgE
Phase 3b
anti‐IgE
chronic spontaneous urticaria
ligelizumab
Publisher
Wiley
Type
journal article