2297: Clinically Relevant Anti-Vaccine and Virus Antibodies in Patients with Sjogren’s Disease Treated with Nipocalimab: Post-Hoc Analysis of the DAHLIAS Study

Background/Purpose: Nipocalimab is a fully human, high affinity, aglycosylated, effectorless IgG1 monoclonal antibody designed to selectively block neonatal fragment crystallizable receptor (FcRn), thereby lowering serum IgG levels. Results from a randomized, open-label vaccine study in healthy volunteers suggest that nipocalimab does not impact the development of IgG responses to T-cell–dependent/–independent vaccines.¹ In the DAHLIAS study (NCT04968912), participants with moderate to severe Sjögren's Disease received nipocalimab 5 mg/kg, 15 mg/kg, or placebo intravenously every 2 weeks for 22 weeks; 15 mg/kg nipocalimab treatment led to significant improvement over placebo in ClinESSDAI (Clinical European League Against Rheumatism Sjögren's Syndrome Disease Activity Index) at 24 weeks and was well-tolerated.² Here, we assessed the impact of nipocalimab on pre-existing clinically relevant anti-vaccine antibodies against tetanus toxoid (TT), varicella zoster virus (VZV), and Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) spike protein and on the humoral response to SARS-CoV-2 vaccination or infection in DAHLIAS participants.

Methods: Serum IgG antibody levels against TT and VZV were measured at baseline and post-treatment samples in a subset of participants. In participants with documented SARS-CoV-2 vaccination or infection during the study, antibodies against different epitopes of SARS-CoV-2 were measured. Participants with available samples were included in the analysis.

Results: Nipocalimab reduced pre-existing anti-TT and anti-VZV antibodies to a similar extent as total IgG (observed median pre-dose/minimal reduction: ~61%), consistent with its mechanism of action. Anti-TT and anti-VZV antibody levels returned to baseline by Week 30, 8 weeks post-last dose. All participants receiving SARS-CoV-2 vaccination in the 15 mg/kg nipocalimab group (n=2) elicited a humoral response as indicated by increases in anti-spike antibodies, while all participants with SARS-CoV-2 acute infection in the 15 mg/kg nipocalimab group (n=3, 2 mild and 1 moderate, all recovered) had increased levels of anti-spike and anti-nucleocapsid antibodies.

Conclusion: In nipocalimab-treated participants, preexisting anti-TT and anti-VZV antibodies followed a similar pattern as total IgG, consistent with its mechanism of action. Additionally, nipocalimab did not prevent humoral responses to SARS-CoV-2 infection or vaccination in participants with Sjögren's Disease in the DAHLIAS study. These observations suggest that patients treated with nipocalimab can follow recommended vaccination schedules concomitant with nipocalimab treatment as appropriate.

1. Cossu M, et al. Hum Vaccin Immunother. 2025;21(1):2491269.


2. Gottenburg J, et al. Arthritis Rheumatol. 2024;76(suppl 9).