Safety profile of anifrolumab in patients with active SLE: an integrated analysis of phase II and III trials.

ABSTRACT:

Objective

In phase II and III trials, anifrolumab, a human monoclonal antibody that binds type I interferon receptor subunit 1, has shown efficacy in adults with moderate to severe SLE. We evaluated the safety and tolerability of anifrolumab using data pooled from these trials to more precisely estimate the rate and severity of adverse events (AEs).

Methods

Data were pooled from patients receiving monthly intravenous anifrolumab 300 mg or placebo in MUSE, TULIP-1 and TULIP-2. Key safety endpoints included percentages and exposure-adjusted incidence rates (EAIRs) of patients who experienced AEs, serious AEs (SAEs), AEs leading to discontinuation and AEs of special interest.

Results

During treatment, 86.9% of patients receiving anifrolumab 300 mg (n=459) experienced AEs

SUBMITTER: Tummala R 

PROVIDER: S-EPMC7893670 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature