Efficacy and safety of abatacept in active primary Sjogren's syndrome: results of a phase III, randomised, placebo-controlled trial.

ABSTRACT:

Objectives

To evaluate efficacy and safety of abatacept in adults with active primary Sjögren's syndrome (pSS) in a phase III, randomised, double-blind, placebo-controlled trial.

Methods

Eligible patients (moderate-to-severe pSS [2016 ACR/European League Against Rheumatism (EULAR) criteria], EULAR Sjögren's Syndrome Disease Activity Index [ESSDAI] ≥5, anti-SS-related antigen A/anti-Ro antibody positive) received weekly subcutaneous abatacept 125 mg or placebo for 169 days followed by an open-label extension to day 365. Primary endpoint was mean change from baseline in ESSDAI at day 169. Key secondary endpoints were mean change from baseline in EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) and stimulated whole salivary flow (SWSF) at day 169. Other secondary clinic

SUBMITTER: Baer AN 

PROVIDER: S-EPMC7892395 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature