Obinutuzumab or Tacrolimus in Primary Membranous Nephropathy - PubMed
3 hours ago
- #obinutuzumab
- #clinical trial
- #primary membranous nephropathy
- Obinutuzumab, a type II anti-CD20 antibody, was tested against tacrolimus for treating primary membranous nephropathy in a phase 3 trial involving 142 adults.
- At week 104, complete remission occurred in 37% of obinutuzumab patients versus 6% in tacrolimus, with a significant adjusted difference of 31 percentage points (95% CI, 18 to 44; P<0.001).
- Secondary endpoints including complete or partial remission at week 104 and complete remission at week 76 also favored obinutuzumab, but a sustained eGFR reduction did not show significant treatment effects.
- Safety profiles were similar: 22% in obinutuzumab and 19% in tacrolimus had grade 3 or higher adverse events, with serious adverse events at 17% and 14%, respectively.
- Infection rates were comparable, with obinutuzumab associated with infusion-related reactions, respiratory infections, and neutropenia; one death occurred in each group during escape therapy.
- The study concluded obinutuzumab is superior to tacrolimus for inducing complete remission in primary membranous nephropathy.