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

RMD OpenPublished Secondary analysis of the RepurpSS-I randomised trial

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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