Sjögren's disease & overlap diseases
Efficacy and safety of iguratimod in patients with primary Sjögren’s syndrome: a multicentre randomised controlled trial
Authors' conclusion
IGU monotherapy demonstrated significant improvements in composite, systemic and serologic outcomes compared with HCQ in active pSS and was well-tolerated.
Study context
- Population
- Patients with active primary Sjögren's syndrome (pSS)66 completed
- Participants
- 78 patients
- Comparison
- Iguratimod (IGU) 25 mg twice daily vs hydroxychloroquine (HCQ) 0.2 g twice daily for 24 weeks
- IGUn = 38
- HCQn = 40reference
- Primary endpoint
- SSRI-30 response rate
- Follow-up
- Week 24
Methodological detailsmulticentre, 1:1 randomisation
- Multicentre
- 1:1 randomisation
Primary result
As reported in the abstract
P = 0.114
Secondary outcomes
STAR response rate
P = 0.015
ESSDAI response rate
P = 0.034
- IgG reduction · superior IgG reduction with IGU
- P = 0.046
Safety
Adverse events · mostly mild
Original publication
Efficacy and safety of iguratimod in patients with primary Sjögren’s syndrome: a multicentre randomised controlled trial. RMD Open. Published 21 December 2025. doi:10.
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