Hypothesis
Depleting B cells with rituximab, on top of mycophenolate and corticosteroids, would raise the renal response rate in class III or IV lupus nephritis.
What failed
Overall renal response at week 52 was 56.9% with rituximab vs 45.8% with placebo (P=0.18), across 144 patients — the primary endpoint was not met.
Broken assumption
Depleting B cells, and the serologic improvement that follows, improves renal outcomes in lupus nephritis within a year.
- Target engaged
- Yes
Why
The target was engaged: rituximab depleted peripheral CD19+ B cells in 71 of 72 patients and significantly improved C3, C4 and anti-dsDNA levels, but those serologic gains did not become better clinical renal outcomes at one year.
From the published paper: Rovin BH, Furie R, Latinis K, et al. (LUNAR). Arthritis Rheum, 2012 ↗