Efficacy and Safety of Nipocalimab in Sjögren’s Disease: Phase 2 Trial Results

Jul 16, 2024

Photo Credit: Tunatura

Nipocalimab showed a significant decrease in Clinical European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index.

Nipocalimab met its primary endpoint in the phase 2 DAHLIAS trial on Sjögren’s disease, showing a significant decrease in Clinical European League Against Rheumatism Sjögren’s Syndrome Disease Activity Index (clinESSDAI) compared with placebo.

Nipocalimab is an anti-neonatal Fc receptor (FcRn) monoclonal antibody that diminishes the circulating IgG and IgG autoantibody levels. Its efficacy and safety were evaluated in the multicentre, randomized-controlled, phase 2 DAHLIAS trial (NCT04968912).¹ The 163 adult participants were treated bi-weekly with placebo or nipocalimab at 5 or 15 mg/kg plus standard-of-care through 22 weeks.

All participants were seropositive for anti-Ro60 and/or anti-Ro52 IgG antibodies. They suffered from moderate-to-severely active primary Sjögren’s disease, represented by a clinESSDAI of at least 6. They had a median age of 48 years, and over 90% were women. The primary endpoint of change in clinESSDAI was assessed at week 24, while safety follow-up continued to week 30.

At week 24, a significant difference in clinESSDAI was detected on the higher dose of nipocalimab with a change from baseline in a least square mean of -6.4 versus -3.73 on placebo (P=0.002). The 15 mg/kg regimen of nipocalimab also led to ameliorations in a variety of secondary endpoints like Physician Global Assessment of Disease Severity (P<0.001), change in ESSDAI score (P=0.012), Composite of Relevant Endpoints for Sjogren’s Syndrome (P=0.001), and disease activity level (P=0.046). Overall, significant differences were not determined for the lower dose of the study drug. Nipocalimab increased the unstimulated whole salivary flow rate by 32% compared with 16% in the placebo group.

At least one adverse event was reported in 79.6% of the 15 mg/kg group and 62.5% on placebo. Serious adverse events were found in 7.4% and 5.4%, respectively. There were no deaths, opportunistic infections, or severe hypoalbuminemia.

“These findings support the further clinical evaluation of nipocalimab, a new FcRn blocker, in Sjögren’s disease and other autoantibody-associated rheumatic diseases,” noted Jacques-Eric Gottenberg, MD, in conclusion of his talk.