FcRn Blocker Nipocalimab Improves Disease Activity in Sjögren’s Disease

Nov 25, 2024

Photo Credit: Helivideo

Patients with moderate-to-severe active Sjögren’s disease who received nipocalimab in the phase 2 DAHLIAS study experienced improvements in disease activity scores at 24 weeks, and the drug was well-tolerated. These results establish proof-of-concept for nipocalimab in Sjögren’s disease.

DAHLIAS (NCT04968912) is the first study of a neonatal Fc receptor (FcRn) blocker in primary Sjögren’s disease¹. Dr. Ghaith Noaiseh, MD, from the University of Kansas Medical Center, in Kansas, explained that trial participants had moderate-to-severe active disease (total Clinical EULAR Sjögren’s Syndrome Disease Activity Index [clinESSDAI] ≥6) and were seropositive for anti-Ro60/anti-Ro52 IgG antibodies. The 163 randomly assigned participants had a mean age of 48 years, 92% were women, and their mean clinESSDAI score was 9.9. The patients received intravenous nipocalimab 5 mg/kg (n=53), 15 mg/kg (n=54), or placebo (n=56) every 2 weeks through week 22, plus standard-of-care. The primary endpoint was a change from baseline in clinESSDAI score at week 24.

The primary endpoint was met in the high-dose nipocalimab group. The mean change from baseline in clinESSDAI score at week 24 in this group was -6.40 versus -3.74 on placebo (P=0.002). The result in the nipocalimab 5 mg/kg group was -4.08. Dr. Noaiseh added that for most secondary and exploratory endpoints numerical improvements were observed, underscoring the effectiveness of nipocalimab 15 mg/kg. These endpoints included changes in Physician Global Assessment (PhGA), ESSDAI score, and EULAR Sjögren’s Syndrome Patient-Reported Index (ESSPRI). Biomarker results were presented as a separate poster².

Nipocalimab was generally well tolerated, without any major safety signals, said Dr. Noaiseh. Serious AEs were reported in 7.5%, 7.4%, and 5.4% of the participants in the nipocalimab 5 mg/kg, 15 mg/kg, and placebo groups, respectively. There was no clear correlation between severe infections and IgG nadir.

Medical writing support was provided by Michiel Tent

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Teresa Sellinger

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REFERENCES & ADDITIONAL READING

Gottenberg J-E, et al. Efficacy and safety of nipocalimab, an anti-FcRn monoclonal antibody, in primary Sjogren’s disease: results from a phase 2, multicenter, randomized, placebo-controlled, double-blind study (DAHLIAS). Abstract 2527, ACR Convergence 2024, 14–19 November, Washington DC, USA.
Sivils K, et al. Pharmacodynamic effects of nipocalimab on disease biomarkers in patients with moderate-to-severe active Sjögren’s disease: results from a multicenter, randomized, double-blinded, placebo-controlled phase 2 study. Abstract 2294, ACR Convergence 2024, 14–19 November, Washington DC, USA.