Sjögren's disease & overlap diseases
Leflunomide/hydroxychloroquine combination therapy targets type I IFN-associated proteins in patients with Sjögren’s syndrome that show potential to predict and monitor clinical response
Authors' conclusion
LEF/HCQ combination therapy targets type-I IFN-associated proteins that are associated with strongly decreased B cell hyperactivity and disease activity.
Study context
- Population
- Patients with primary SjD (pSS)
- Participants
- 21 vs 8
- Comparison
- Leflunomide (LEF)/hydroxychloroquine (HCQ) vs placebo
- LEF/HCQn = 21
- Placebon = 8reference
- Primary endpoint
- Capacity of baseline expression and early changes (after 8 weeks) in IFN-associated biomarkers to predict treatment response at the clinical endpoint
- Follow-up
- 24 weeks
Methodological detailsplacebo-controlled, biomarker study, Blood drawn at baseline, 8, 16 and 24 weeks
- Placebo-controlled
- Biomarker study
- Blood drawn at baseline, 8, 16 and 24 weeks
Primary result
As reported in the abstract
Early (8-week) change in serum Galectin-9 predicting clinical response at 24 weeks
Early changes in serum Galectin-9 best predicted clinical response at 24 weeks (AUC)
0.90
Further findings
IFN-signatures in PBMC and whole blood · 24 weeks
- Decreased after LEF/HCQ treatment; changes only poorly correlated with changes in disease activity
Original publication
Leflunomide/hydroxychloroquine combination therapy targets type I IFN-associated proteins in patients with Sjögren’s syndrome that show potential to predict and monitor clinical response. RMD Open. Published 2 August 2023. doi:10. 1136/ rmdopen-2023-002979
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