Efficacy and safety of iguratimod in patients with primary Sjogren's syndrome: a multicentre randomised controlled trial.

ABSTRACT:

Objective

This multicentre randomised controlled trial aimed to compare the efficacy and safety of iguratimod (IGU) and hydroxychloroquine (HCQ) in patients with active primary Sjögren's syndrome (pSS).

Methods

Eligible pSS patients were randomised 1:1 to receive IGU (25 mg two times per day) or HCQ (0.2 g two times per day) for 24 weeks. The primary endpoint was the Sjögren's Syndrome Responder Index-30 (SSRI-30) response rate at week 24. Secondary endpoints included the Sjögren's Tool for Assessing Response (STAR), European Alliance of Associations for Rheumatology (EULAR) Sjögren's Syndrome Disease Activity Index (ESSDAI), EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) and biomarker changes.

Results

A total of 78 pSS patients were randomised (40 in HCQ gr

SUBMITTER: Chen X 

PROVIDER: S-EPMC12718576 | biostudies-literature | 2025 Dec

REPOSITORIES: biostudies-literature