Nipocalimab meets primary endpoint in Sjögren’s syndrome

In the DAHLIAS phase 2 trial, patients with Sjögren’s disease treated with nipocalimab demonstrated a significant reduction in Clinical EULAR Sjögren’s Syndrome Disease Activity Index (clinESSDAI) compared with placebo. These results support the further development of the drug.

“Sjögren’s disease is a chronic systemic autoimmune disease characterised by lymphocytic infiltrates of exocrine glandular tissues and secretion of autoantibodies,” Prof. Jacques-Eric Gottenberg (Strasbourg University Hospital, France) stated [1]. He underlined the high unmet need for treatment options for Sjögren’s disease since no specific drug has been approved so far.

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, randomised-controlled, phase 2 DAHLIAS trial (NCT04968912). The 163 adult participants were treated every 2 weeks 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-severe active primary Sjögren’s disease, represented by a clinESSDAI of ≥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 -6.40 versus -3.73 on placebo (P=0.002; see Figure). The 15 mg/kg regimen of nipocalimab also led to amelioration in a variety of secondary endpoints including Physician Global Assessment (PGA) of disease severity (P<0.001), change in ESSDAI score (P=0.012), Composite of Relevant Endpoints for Sjögren’s Syndrome (CRESS; P=0.001), and disease activity level (DAL; 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.

Figure: Primary endpoint: Change from baseline in clinESSDAI at week 24 [1]



CI, confidence interval; clinESSDAI, clinical EULAR Sjögren’s Syndrome Disease Activity Index; LS, least square; NS, not significant; SE, standard error; Q2W, every 2 weeks.

At least 1 adverse event was reported in 79.6% of the 15 mg/kg group and 62.5% on placebo. Serious adverse events occurred in 7.4% and 5.4%, respectively. There were no deaths and no opportunistic infections.

“These findings support the further clinical evaluation of nipocalimab, a new FcRn blocker, in Sjögren’s disease and other autoantibody-associated rheumatic diseases,” Prof. Gottenberg concluded.

1. Gottenberg J, et al. Efficacy and safety of nipocalimab, an anti-FcRn monoclonal antibody, in primary Sjogren’s disease: results from a phase 2, multicentre, randomised, placebo-controlled, double-blind study (DAHLIAS). LBA0010, EULAR 2024 Congress, 12–15 June, Vienna, Austria.

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Posted on 29 July 202429 July 2024