Trial reportRMD open2025
Efficacy and safety of iguratimod in patients with primary Sjögren's syndrome: a multicentre randomised controlled trial.
Trial report in RMD open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04981145 (The Efficacy and Safety of Iguratimod), which is not on this map. Cited by 3 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome: a Multi-center, Prospective, Open Study
Who cites it
3 citing papers in PubMed.
- Comparative Value of Traditional versus Novel Immune-Inflammatory Indices in Assessing Disease Activity of Sjögren's Disease: A Multicenter Cohort Study.Clinical rheumatology · 2026Article
- Review
- Histone lactylation: a metabolic-epigenetic bridge linking glycolysis to salivary gland fibrosis in Sjögren's disease.Frontiers in immunology · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
objectiveThis 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).
methodsEligible 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.
resultsA total of 78 pSS patients were randomised (40 in HCQ group, 38 in IGU group) and 66 patients (35 in HCQ group, 31 in IGU group) completed the 24-week research. SSRI-30 response rate, the primary endpoint, was numerically higher in the IGU group (57.9% vs 40.0%, p=0.114), but with no statistical significance. However, IGU demonstrated significantly higher response rates for key secondary endpoints including STAR (39.5% vs 15.0%, p=0.015) and ESSDAI (21.1% vs 5.0%, p=0.034) response rate. IGU also showed superior IgG reduction (p=0.046). Adverse events were more frequent with IGU (60.6% vs 37.8%) but were mostly mild.
conclusionIGU monotherapy demonstrated significant improvements in composite, systemic and serologic outcomes compared with HCQ in active pSS and was well-tolerated. These findings establish IGU as a promising therapeutic option for pSS, particularly in the subset of patients with hyperglobulinaemia. TRIAL REGISTRATION NUMBER: NCT04981145.
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