Sjögren's disease & overlap diseases
Repurposing leflunomide and hydroxychloroquine to treat Sjögren's disease (RepurpSS-II): a randomised, double-blind, placebo-controlled, phase 2b trial
Primary result · Change in ESSDAIResult — go to the resultMean difference −4.135 95% CI −6.558 to −1.709Authors' conclusion
This study supports previous findings that leflunomide in combination with hydroxychloroquine is an effective treatment for systemically active Sjögren's disease and was generally well tolerated.
Study context
- Population
- Adults aged 18–75 years with Sjögren's disease and ESSDAI of at least 5, University Medical Center Utrecht, The Netherlands43 (93%) female
- Participants
- 46 adults
- Comparison
- Leflunomide 20 mg plus HCQ 400 mg orally once a day vs placebo
- Leflunomide-hydroxychloroquinen = 21
- Placebon = 25reference
- Primary endpoint
- Between-group difference in change in ESSDAI from baseline to 24 weeks
- Follow-up
- 24 weeks
Methodological detailsdouble-blind, placebo-controlled, phase 2b, single-centre
- Double-blind
- Placebo-controlled
- Phase 2b
- Single-centre
Primary result
Change in ESSDAI
Mean difference
−4.135
95% CI −6.558 to −1.709
P = 0.0012
Leflunomide-hydroxychloroquinevs Placebo
mean difference −4.135 (95% CI −6.558 to −1.709); P = 0.0012
As reported in the abstract
Further findings
- No deaths during the study
Safety
Gastrointestinal discomfort (most common adverse event)
| Outcome | Leflunomide-hydroxychloroquine | Placebo |
|---|---|---|
| Serious adverse events | 1 events | — not stated in the abstract |
— not stated in the abstract
- Serious adverse events: probably unrelated to study medication (hospital admission for MI)
Adverse events overall
- Similar between groups
Original publication
Repurposing leflunomide and hydroxychloroquine to treat Sjögren's disease (RepurpSS-II): a randomised, double-blind, placebo-controlled, phase 2b trial. Lancet Rheumatol. Published 20 May 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →