Nipocalimab and certolizumab combination therapy in participants with active rheumatoid arthritis despite prior treatment with advanced therapies: results from the phase 2a DAISY-RA study
Authors' conclusion
Combination therapy of nipocalimab with certolizumab showed a similar outcome in the primary endpoint and secondary endpoints compared with certolizumab monotherapy in participants with active RA.
Study context
- Population
- Participants with active rheumatoid arthritis (RA) despite treatment with advanced therapies
- Participants
- 103 participants
- Comparison
- Nipocalimab plus certolizumab combination therapy vs certolizumab monotherapy
- Combination therapyn = 62
- Monotherapyn = 41reference
- Primary endpoint
- Change from baseline in DAS28-CRP
- Follow-up
- Week 12
Methodological detailsphase 2a
- Phase 2a
Primary result
As reported in the abstract
- Primary endpoint similar between groups
- Combination therapy vs Monotherapy: P = 0.822
Secondary outcomes
Secondary endpoints (ACR50, DAS28-CRP <2.6, DAS28-CRP ≤3.2) · week 12
- Similar between groups, although numerically higher proportions with combination therapy vs monotherapy achieved ACR50, DAS28-CRP <2.6 and DAS28-CRP ≤3.2
Pharmacokinetics and pharmacodynamics
- Nipocalimab with certolizumab showed nonlinear pharmacokinetics with accelerated clearance and substantially, reversibly reduced serum IgG, including ACPA levels
Safety
Serious adverse events
Parts of this Brief are withheld: the automatic checks could not confirm them against the abstract.
Original publication
Nipocalimab and certolizumab combination therapy in participants with active rheumatoid arthritis despite prior treatment with advanced therapies: results from the phase 2a DAISY-RA study. RMD Open. Published 4 March 2026. doi:10.
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