Team: Obinutuzumab’s Got Game
***NOTE: This team was originally based on the phase II study results. In February of 2025, the phase III results of the REGENCY trial was published in the New England Journal of Medicine (click for link).
Authors: University of Michigan Fellowship Program
- Annie Carlton, MD, PhD, rheumatology fellow, University of Michigan
- Rocio Bautista Sanchez, MD, rheumatology fellow, University of Michigan
- Rishika Chin, MBBS, rheumatology fellow, University of Michigan
- Lauren He, MD, rheumatology fellow, University of Michigan
- Arati Kelekar, MBBS, rheumatology fellow, University of Michigan
- Marianne Kerski, MD, rheumatology fellow, University of Michigan
- Yasmin Khader, MD, rheumatology fellow, University of Michigan
- David Riccardi, MD, rheumatology fellow, University of Michigan
Team Overview:
Picture this: a 30-year-old female patient with systemic lupus erythematosus (SLE) and lupus nephritis (LN) on hydroxychloroquine, mycophenolate, and a stubborn prednisone requirement with persistent proteinuria despite your best efforts. What do you do next?
Obinutuzumab is an anti-CD20 monoclonal antibody with greater antibody-dependent cellular toxicity than traditional B cell depleting agents. In this double-blinded, placebo-controlled trial, adults with SLE and class III or IV LN with proteinuria (UPCR >1, eGFR≥30) who were treated with obinutuzumab were more likely to achieve complete renal response defined by UPCR<0.5, normal Cr (within 15% of baseline), and inactive sediment. Importantly, the greatest benefit was seen in those with baseline UPC>3 and class IV LN. Secondary outcomes were also impressive with greater improvement in eGFR, less rescue therapies, and rapid sustained depletion of CD19 cells in the obinutuzumab group. There were similar numbers of adverse events in both groups.
For a disease that has been described as far back as the 13th century, there has been a stagnant arsenal of medications in the rheumatologist’s toolbox for decades. Obinutuzumab reflects an exciting movement in SLE research today to expand therapeutic targets. This trial specifically includes patients we are most concerned about – those with marked kidney disease. While CAR-T is an innovative topic, it is not something that you pull from your bench to tag in when the game is on the line today. For that reason, we think the NOBILITY trial with obinutuzumab is the most important article for patients and providers.
***NOTE: The team overview above refers to the phase II study results. In February of 2025, the phase III results of the REGENCY trial was published in the New England Journal of Medicine (click for link).
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