Nipocalimab, an anti-FcRn monoclonal antibody, in participants with moderate to severe active rheumatoid arthritis and inadequate response or intolerance to anti-TNF therapy: results from the phase 2a IRIS-RA study
Authors' conclusion
Despite not achieving statistical significance in the primary endpoint, nipocalimab showed consistent, numerical efficacy benefits in participants with moderate to severe active RA, with greater benefit observed for participants with a higher baseline ACPA.
Study context
- Population
- Participants with moderate to severe active rheumatoid arthritis (RA), seropositive for anticitrullinated protein antibodies (ACPA) or RF, with inadequate response or intolerance to ≥1 TNFi
- Participants
- 53 participants
- Comparison
- Nipocalimab 15 mg/kg IV every 2 weeks vs placebo, Weeks 0 to 10
- Nipocalimabn = 33
- Placebon = 20reference
- Primary endpoint
- Change from baseline in DAS28-CRP
- Follow-up
- Week 12
Methodological detailsphase 2a, placebo-controlled
- Phase 2a
- Placebo-controlled
Primary result
As reported in the abstract
Change from baseline in DAS28-CRP, least squares mean
Nipocalimab
−1.03
least squares mean · 95% CI −1.66–-0.40
Placebo
−0.58
least squares mean · 95% CI −1.24–0.07
Secondary outcomes
Secondary efficacy outcomes and patient-reported outcomes (PROs)
- Numerically higher improvements in all secondary efficacy outcomes and PROs with nipocalimab
Serum IgG, ACPA, circulating immune complexes and inflammatory markers
- Nipocalimab significantly and reversibly reduced serum IgG, ACPA and circulating immune complex levels but not serum inflammatory markers, including CRP
ACPA reduction and baseline ACPA vs clinical response
- ACPA reduction associated with DAS28-CRP remission and ACR50 response rate; higher baseline ACPA had greater clinical improvement
Safety
Serious adverse events · through Week 18
- Serious adverse events in participants (burn infection, infusion-related reaction and DVT)
- 3
Original publication
Nipocalimab, an anti-FcRn monoclonal antibody, in participants with moderate to severe active rheumatoid arthritis and inadequate response or intolerance to anti-TNF therapy: results from the phase 2a IRIS-RA study. RMD Open. Published 28 June 2024. doi:10.
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