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Kidney Week

Abstract: SA-PO881

Post Hoc Analyses of Biomarkers Predictive of a Renal Response to Intravenous (IV) Belimumab (BEL) Plus Standard Therapy (ST) in Patients with Lupus Nephritis (LN)

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Trials

Authors

  • Rovin, Brad H., Ohio State University Wexner Medical Center, Columbus, Ohio, United States
  • Furie, Richard, Zucker School of Medicine at Hofstra/Northwell, Great Neck, New York, United States
  • Malvar, Ana, Hospital Fernandez, Buenos Aires, Argentina
  • Aranow, Cynthia, Feinstein Institutes for Medical Research, Manhasset, New York, United States
  • Pego-Reigosa, José M., Complexo Hospitalario Universitario de Vigo, Hospital Meixoeiro, Vigo, Spain
  • Zakharova, Elena, Moscow City Clinical Hospital n.a. S.P. Botkin, Moscow, Russian Federation
  • Schwarting, Andreas, University Center of Autoimmunity, Mainz, Germany
  • Jones-Leone, Angela Renne, GSK, Collegeville, Pennsylvania, United States
  • Gilbride, Jennifer A., GSK, Stevenage, Hertfordshire, United Kingdom
  • Ji, Beulah, GSK, Shanghai, China
  • Roth, David A., GSK, Collegeville, Pennsylvania, United States
  • Curtis, Paula S., GSK, Brentford, Middlesex, United Kingdom
  • van Maurik, André, GSK, Stevenage, Hertfordshire, United Kingdom
Background

In BLISS-LN (GSK BEL114054), a Phase 3 trial of adults with LN treated with BEL 10 mg/kg/month IV or placebo (PBO), + ST, BEL resulted in significantly more kidney responses (Primary Efficacy Renal Response [PERR] and Complete Renal Response [CRR]), and greater improvements in anti-dsDNA and anti-C1q autoantibodies and complement C3 and C4 levels than PBO over 104 weeks (wks). This post hoc analysis of BLISS-LN assessed the characteristics of patients with LN most likely to benefit from the addition of BEL to ST.

Methods

Post hoc logistic regression models tested the ability of potential baseline (BL) biomarker levels and biomarker level changes in the first 12 months of treatment to predict PERR and/or CRR at Wk 104.

Results

Overall, 446 patients were evaluated. High BL anti-C1q predicted a PERR with BEL and a CRR with PBO (Table). High BL levels of immunoglobulin (Ig)A and a decrease in IgA at Wk 8 with BEL were predictive of PERR, and high BL levels of naïve B cells were predictive of PERR and CRR to BEL. Low BL plasmablasts, and a decrease in IgA or IgM at Wk 24 predicted a PERR in both groups and a decrease in IgA at Wk 24 predicted CRR to BEL. A reduction in anti-C1q at Wk 52 and of uPCR at Wk 12 also predicted PERR and CRR in both groups. Changes in B-cell subsets were not predictive of a response in the BEL group.

Conclusion

High levels of IgA and naïve B cells at BEL initiation, as well as early reductions in IgA, predicted attainment of PERR and/or CRR for BEL but not PBO. Early reductions in uPCR predicted responses regardless of whether patients received BEL or PBO.

Funding

  • Commercial Support – GSK (GSK BEL114054; NCT01639339)