Ghaith Noaiseh, MD: Nipocalimab Improves Disease Measures, Reduces Autoantibodies in Sjogren’s

Nipocalimab led to significant improvements compared with placebo inkey efficacy endpoints in people with Sjogren disease (SjD), supporting the mechanism of anti-neonatal Fc receptor (FcRn) monoclonal antibodies and reduction of IgG autoantibodies.

Data from the phase 2 DAHLIAS study, the first to evaluated an FcRn blocker in SjD, were presented at the American College of Rheumatology (ACR) Convergence 2024, held November 14-19 in Washington, DC.

“SjD is the underdog of autoimmune rheumatological disorders. Really, it's the disease that that attracted the least attention, I would argue, over the last 30-40, years, until recently, and often… many clinicians misdiagnose SjD and misclassify it, meaning that those patients are often [diagnosed with] lupus or rheumatoid arthritis, especially when they have certain blood testing when they show up to the doctor. So, we know that, and there's a lot of literature for that,” investigator Ghaith Noaiseh, MD, associate professor, Allergy, Clinical Immunology, and Rheumatology, University of Kansas Medical Center, told HCPLive® at the meeting.

Participants with moderate-to-severe SjD receiving 15 mg/kg nipocalimab (n = 54) met the primary endpoint of change from baseline in total Clinical European League Against Rheumatism SjD Activity Index score at week 24 compared with placebo (least squares mean difference, 2.65 [90% CI, –4.03 to –1.28]; P = .002) with similar favorable improvements in in Physician Global Assessment of Disease Severity and ESSDAI score, treatment response according to SjD Tool for Assessing Response, Composite of Relevant Endpoints for SjD, disease activity level response, and patient-reported outcomes. This group had a serious adverse event rate of 7.4% compared with 5.4% in the placebo group, no severe infections/infections were considered related to nipocalimab, and there were no deaths.

“Every time we lecture about SjD, we always highlight those points to clinicians who may not be aware of these dynamics, to try to bring more attention on their mind about the disease and how to diagnose it, and the challenges that we come across when we try to diagnose a given patient in a given scenario,” Noaiseh said.

Relevant disclosures for Noaiseh include Janssen and Novartis.

REFERENCE

Gottenberg JA, Sivils K, Campbell K, 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). Presented at: ACR Convergence 2024; November 14-19; Washington, DC. Abstract 2527.