Long-Term Efficacy and Safety of Remibrutinib in Patients With Chronic Spontaneous Urticaria in the Phase 3 REMIX-1 and REMIX-2 Studies

https://www.urticariaknowledgecenter.novartis.com/EAACI/presentations/2024/Files/1_EAACI_2024_REMIX_Wk_52_LB_Oral_presentation.pdf

Late ORAL Abstract Session on Clinical Trials (L-OAS-CT 01) Clinical Trials, Friday 31 May 2024, 16:45-18:15 CET

Martin Metz, Ana Giménez-Arnau, Michihiro Hide, Vipul Jain, Abdallah Khemis, Mark Lebwohl, Michael Palumbo, Sarbjit Saini, Ekin Şavk, Gordon Sussman, Robert Szalewski, Irena Walecka Herniczek, Hugh Windom, Sibylle Haemmerle, Karine Lheritier, Paula G. P. Machado, El-Djouher Martzloff, Noriko Seko, Pengpeng Wang, Artem Zharkov, Marcus Maurer

Introduction

Remibrutinib is a novel, highly selective, oral BTK inhibitor • Despite treatment with standard-dose second-generation H1-AHs, >50% of patients with CSU remain symptomatic

• Updosing of second-generation H1-AHs, up to 4X the standard dose, provides no or only partial relief in 75% of these patients

• In the phase 3 REMIX-1 and REMIX-2a studies, remibrutinib demonstrated statistically significant superiority in both primary endpoint scenarios (UAS7 and ISS7/HSS7 at week 12) vs placebo in patients with CSU remaining symptomatic with second-generation H1-AHs

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