Renal response to obinutuzumab does not differ by the timing of peripheral B-cell recovery in patients with proliferative class 3/4 lupus nephritis, investigators reported at the 60th annual European Renal Association Congress.

Obinutuzumab is a humanized type II anti-CD20 monoclonal antibody that depletes peripheral B cells. The original NOBILITY trial demonstrated renal response to intravenous obinutuzumab (1000 mg) as add-on therapy to standard of care mycophenolate immunosuppression: C3 and C4 levels increased, anti-dsDNA decreased, eGFR increased, and urinary protein to creatinine ratio (UPCR) decreased compared with placebo plus standard of care.

This post hoc analysis included 51 of the 63 original patients receiving obinutuzumab on day 1 and weeks 2, 24, and 26. Of these 51 patients, 3 recovered B cells before redosing at week 26, another 37 patients recovered B cells within 93 weeks of the last dose, and 11 patients still had not recovered by 93 weeks.

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Renal response rates at week 104 were similar among patients who recovered B cells within 93 weeks and those who recovered later or still had not recovered, Dario Roccatello, MD, PhD, of S. Giovanni Bosco Hospital and University of Turin in Turin, Italy, reported on behalf of his team.

Obinutuzumab treatment did not increase rates of serious adverse events, serious infections, or deaths compared with placebo, Dr Roccatello reported.

These results are limited by the small sample size.

Patients with an eGFR less than 30 or more than half of glomeruli with sclerosis were excluded from the trial.

“The phase 3 REGENCY study will provide further information on the relationship between duration of B-cell depletion and obinutuzumab efficacy and safety,” Dr Roccatello concluded in an oral presentation.

Disclosure: This research was supported by F. Hoffmann-La Roche Ltd. Please see the original reference for a full list of disclosures.


Roccatello D, Vital E, Black D, et al. B-cell recovery in a randomized controlled trial of B-cell depletion with obinutuzumab for the treatment of proliferative lupus nephritis (NOBILITY). Presented at: ERA 2023 Congress; June 15-18; Milan, Italy. Presentation 3280.