Sjögren's disease & overlap diseases
Efgartigimod in Sjögren’s disease: a phase 2, randomised, placebo-controlled, parallel-group, double-blinded, proof-of-concept study (RHO)
Primary result · CRESS response on ≥3 itemsResult — go to the resultTreatment difference 34.4%Authors' conclusion
Data from the RHO study support proof of concept for efgartigimod in SjD.
Study context
- Population
- Adults with Sjögren's disease (SjD)31 in efficacy analysis
- Participants
- 34 adults
- Comparison
- Efgartigimod intravenous (IV) 10 mg/kg once weekly for 24 weeks vs placebo
- Efgartigimodn = 23
- Placebon = 11reference
- Primary endpoint
- Proportion of CRESS responders on ≥3 of 5 items (systemic disease activity, patient-reported symptoms, tear and salivary gland function, serology)
- Follow-up
- Week 24
Methodological detailsphase 2, proof-of-concept, double-blinded, placebo-controlled, multicentre, parallel-group, 2:1 randomisation, no formal statistical hypothesis tested
- Phase 2
- Proof-of-concept
- Double-blinded
- Placebo-controlled
- Multicentre
- Parallel-group
- 2:1 randomisation
- No formal statistical hypothesis tested
Primary result
CRESS response on ≥3 items
Treatment difference
34.4%
By group
As reported in the abstract
Secondary outcomes
cSTAR score ≥5 · week 24 · numerically higher
Safety
Treatment-emergent adverse events
- Treatment-emergent adverse events: all grade 1 or 2 in severity
Original publication
Efgartigimod in Sjögren’s disease: a phase 2, randomised, placebo-controlled, parallel-group, double-blinded, proof-of-concept study (RHO). Ann Rheum Dis. Published 16 April 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →