Lupus & antiphospholipid syndrome

Outcome of Patients With Lupus Nephritis Treated With an Anti‐CD40 Monoclonal Antibody According to Kidney Biopsy Features

Arthritis RheumatolPublished Post hoc analysis of a phase 2 randomised trial of BI 655064

Authors' conclusion

In LN kidney biopsy samples with glomerular monocytes, high-dose BI 655064 treatment improved proteinuria at 52 weeks and resulted in a higher CRR compared to biopsy samples without glomerular monocytes.

Study context

Population
Patients with active class III or IV lupus nephritis (LN) enrolled in the BI 655,064 phase 2 trial, with centrally scored renal biopsies
Participants
101 renal biopsies
Comparison
Higher-dose BI 655064 (180 or 240 mg) vs low dose (120 mg) or placebo, by presence or absence of glomerular monocytes
Primary endpoint
Better vs worse performance than cohort average in eGFR, UP/UC and complete renal response (CRR), by glomerular monocytes
Follow-up
52 weeks
Methodological detailscentral biopsy scoring, mixed model for repeated measurements, logistic regression adjusted for potential confounders
  • Central biopsy scoring
  • Mixed model for repeated measurements
  • Logistic regression adjusted for potential confounders

Primary result

As reported in the abstract

BI 655064 180 or 240 mg vs BI 655064 120 mg or placeboOdds ratio (95% CI)P value
UP/UC, glomerular monocytes present
3.66(1.09–12.3)
P = 0.04
CRR, glomerular monocytes present
4.58(1.24–16.9)
P = 0.02
Trend toward improved estimated glomerular filtration rate (eGFR) with glomerular monocytes present
P = 0.08

Original publication

Outcome of Patients With Lupus Nephritis Treated With an Anti‐CD40 Monoclonal Antibody According to Kidney Biopsy Features. Arthritis Rheumatol. Published 28 January 2025. doi:10.1002/art.43076

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