Session Information
Session Type: Poster Session C
Session Time: 10:30AM-12:30PM
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 IgG levels. In the IRIS-RA study (NCT04991753), participants with rheumatoid arthritis received nipocalimab 15 mg/kg or placebo intravenously every 2 weeks for 10 weeks. Here, we assessed the impact of nipocalimab on pre-existing clinically relevant anti-vaccine antibodies and on the humoral response to Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) challenge in IRIS-RA participants.
Methods: Serum IgG antibody levels against tetanus toxoid (TT) and varicella zoster virus (VZV) were measured at baseline and post-treatment in available biomarker samples (nipocalimab: n=33; placebo: n=20). In participants with documented SARS-CoV-2 vaccination or infection during the study, antibodies against different epitopes of SARS-CoV-2 were measured.
Results: Nipocalimab reduced pre-existing anti-TT and anti-VZV antibodies by 65% and 61% at Week 12, similar to total IgG reduction (observed median pre-dose/minimal reduction: 62%) and consistent with mechanism of action of nipocalimab. Anti-TT and anti-VZV antibody levels returned to baseline by Week 18, 8 weeks post-last dose. The majority of participants treated with nipocalimab who were immune to TT and VZV at baseline maintained protective antibody levels during and post-treatment. Participants receiving SARS-CoV-2 vaccination during nipocalimab treatment (n=3) elicited a humoral response for anti-spike antibodies, while participants with SARS-CoV-2 infection during nipocalimab treatment (n=4) had increased levels of anti-spike and anti-nucleocapsid antibodies.
Conclusion: Findings suggest that the majority of nipocalimab-treated patients remained protected for TT and VZV, that nipocalimab did not impact humoral responses to SARS-CoV-2 infection or vaccination, and that nipocalimab-treated patients may be able to follow recommended vaccination schedules as appropriate.
Disclosures: F. Yu: Janssen, 3, Johnson & Johnson, 11; E. Myshkin: Janssen Research & Development, LLC, 3, Johnson & Johnson, 11; C. Bobadilla Mendez: Janssen Research & Development, LLC, 3, Johnson & Johnson, 11; M. Cossu: Janssen Research & Development, LLC, 3, Johnson & Johnson, 11; K. Fei: Janssen, 3, Johnson & Johnson, 11; Q. Wang: Janssen, 3, Johnson and Johnson, 11; M. Loza: Janssen, 3, Johnson & Johnson, 11; D. Dimitrova: Janssen Research & Development, LLC, 3, Johnson & Johnson, 11; S. Gao: Janssen Research & Development, LLC, 3, Johnson & Johnson, 11.
To cite this abstract in AMA style:
Yu F, Myshkin E, Bobadilla Mendez C, Cossu M, Fei K, Wang Q, Loza M, Dimitrova D, Gao S. Post-Hoc Analysis of Clinically Relevant Anti-Vaccine Antibodies in Participants with Rheumatoid Arthritis Treated with Nipocalimab [abstract]. Arthritis Rheumatol. 2024; 76 (suppl 9). https://acrabstracts.org/abstract/post-hoc-analysis-of-clinically-relevant-anti-vaccine-antibodies-in-participants-with-rheumatoid-arthritis-treated-with-nipocalimab/. Accessed .« Back to ACR Convergence 2024
ACR Meeting Abstracts - https://acrabstracts.org/abstract/post-hoc-analysis-of-clinically-relevant-anti-vaccine-antibodies-in-participants-with-rheumatoid-arthritis-treated-with-nipocalimab/