Sjögren's disease & overlap diseases
Efficacy and safety of nipocalimab in patients with moderate-to-severe Sjögren's disease (DAHLIAS): a randomised, phase 2, placebo-controlled, double-blind trial
Authors' conclusion
Fc receptor blockade by nipocalimab 15 mg/kg significantly improved clinical disease activity versus placebo and was safe and well tolerated in participants with moderate-to-severe, active Sjögren's disease.
Study context
- Population
- Participants with moderate-to-severe, active SjD (ClinESSDAI of at least 6), seropositive for anti-Ro IgG autoantibodies; 69 centres in France, Germany, Italy, Japan, the Netherlands, Poland, Portugal, Spain, Taiwan and the USA151 (93%) female
- Participants
- 163 participants
- Comparison
- IV nipocalimab 5 mg/kg or 15 mg/kg vs placebo every 2 weeks for 22 weeks
- Nipocalimab 5 mg/kgn = 53
- Nipocalimab 15 mg/kgn = 54
- Placebon = 56reference
- Primary endpoint
- Change from baseline in ClinESSDAI score
- Follow-up
- Week 24
Methodological detailsphase 2, double-blind, placebo-controlled, multicentre
- Phase 2
- Double-blind
- Placebo-controlled
- Multicentre
Primary result
As reported in the abstract
Change in ClinESSDAI score
Each group vs placeboLeast squares mean difference (90% CI)P value
Nipocalimab 15 mg/kg
−2.65(−4.03 to −1.28)
P = 0.0018Nipocalimab 5 mg/kg
−0.34(−1.71 to 1.03)
P = 0.68Safety
Adverse events and serious adverse events
- Safety profile of both doses comparable with placebo; generally similar rates of AEs and SAEs across groups
Original publication
Efficacy and safety of nipocalimab in patients with moderate-to-severe Sjögren's disease (DAHLIAS): a randomised, phase 2, placebo-controlled, double-blind trial. Lancet. Published 24 October 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →