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Abstract: SA-PO882

Outcome of Lupus Nephritis Patients Treated with a New Anti-CD40 Monoclonal Antibody According to Kidney Biopsy Features

Session Information

Category: Glomerular Diseases

  • 1402 Glomerular Diseases: Clinical, Outcomes, and Trials


  • Uzzo, Martina, Department of Medicine and Surgery, University of Milano-Bicocca, Monza, Italy
  • Schumacher, Helmut, Statistical Consultant, Ingelheim, Germany
  • Steffgen, Juergen, Boehringer Ingelheim International GmbH, Biberach, Germany
  • Deutschel, Simone, Boehringer Ingelheim International GmbH, Biberach, Germany
  • Jayne, David R.W., University of Cambridge Department of Medicine, Cambridge, Cambridgeshire, United Kingdom
  • Bajema, Ingeborg M., Department of Pathology and Medical Biology, University of Groningen, University Medical Center, Groningen, Netherlands

Lupus Nephritis (LN) is responsible for SLE-related mortality and morbidity. A phase II trial tested different doses of the anti-CD40 monoclonal antibody BI655064 as add-on therapy to the standard of care in class III or IV LN patients with active renal disease. A post-hoc analysis showed a potential benefit of the higher tested dosages (180mg/240mg) versus low dosage (120mg) and placebo. Monocytes constitutively express CD40. We investigated whether the efficacy of BI655064 was predicted by the presence of monocytes in the kidney biopsy.


101 renal biopsies of LN patients enrolled in the BI 655064 trial were scored centrally. eGFR and spot urine protein/urine creatinine ratio (UP/UC) were evaluated at every visit. Through a linear regression model (last available value vs. baseline), patients were divided according to their ‘’Better’’ or ‘’Worse’’ performance compared to the average. Biopsy parameters which differed between the two groups in the univariate analyses (p<0.1) were entered into a multivariate logistic regression model, and a routine model selection procedure (p<0.2) used to identify parameters predictive for proteinuria reduction or increase in eGFR (LN class IV vs III, Mesangial sclerosis, Lymphocytes, Microthrombi, Modified Chronicity index for UP/UC; Adhesions, Modified Activity index, Modified Chronicity index for eGFR). A logistic regression model adjusted for the same parameters was used to investigate whether the efficacy of BI655064 associated with the presence of renal monocytes.


A lower modified chronicity index was predictive of UP/UC improvement (P=0.032); eGFR tended to be higher with a lower modified chronicity and a higher modified activity index. A higher treatment dose (BI655064 180/240mg vs Placebo/BI655064 120mg) was associated with a greater proteinuria reduction when kidney biopsies contained glomerular monocytes (OR 3.72 (1.07–12.9), P=0.039). No substantial association between monocytes and eGFR change was detected.


In this post-hoc analysis, we showed that BI 655064 treatment in LN may improve the rate of proteinuria over time when monocytes are present in the biopsy, suggesting that specific renal biopsy characteristics could direct the choice of treatment for individual LN patients.


  • Commercial Support – Boehringer Ingelheim International GmbH, Biberach, Germany