Safety and efficacy of subcutaneous ianalumab (VAY736) in patients with primary Sjögren's syndrome: a randomised, double-blind, placebo-controlled, phase 2b dose-finding trial

摘要

Background:Sjögren's syndrome is an autoimmune disease characterised by dry eyes and mouth,systemic features,and reduced quality of life.There are no disease-modifying treatments.A new biologic,ianalumab(VAY736),with two modes of suppressing B cells,has previously shown preliminary efficacy.This dose-finding trial aimed to assess the safety and efficacy of different subcutaneous doses of ianalumab in patients with moderate to severe primary Sjögren's syndrome.