Lupus & antiphospholipid syndrome
Outcome of Patients With Lupus Nephritis Treated With an Anti‐CD40 Monoclonal Antibody According to Kidney Biopsy Features
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 = 0.04CRR, 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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