Alemtuzumab for refractory primary systemic vasculitis-a randomised controlled dose ranging clinical trial of efficacy and safety (ALEVIATE).

ABSTRACT:

Background

Primary systemic vasculitis (PSV) is a heterogeneous group of autoimmune conditions. There is an unmet need for alternative therapies that lead to sustained remission in patients with refractory disease. Alemtuzumab, an anti-CD52 antibody, depletes lymphocytes for prolonged periods and, in retrospective studies, has induced sustained, treatment-free remissions in patients with refractory/relapsing vasculitis but has raised safety concerns of infection and secondary autoimmunity. This phase IIb clinical trial aimed to assess the efficacy and safety of alemtuzumab, at two different doses, in inducing remission in refractory vasculitis patients.

Methods

The ALEVIATE trial was a randomised, prospective, open-label, dose ranging clinical trial. Patients with refractory

SUBMITTER: Gopaluni S 

PROVIDER: S-EPMC8972754 | biostudies-literature | 2022 Apr

REPOSITORIES: biostudies-literature