Robust renal efficacy with obinutuzumab across key clinical criteria in lupus nephritis

In the phase 3 REGENCY trial, obinutuzumab demonstrated significant and consistent improvements in renal outcomes for patients with lupus nephritis (LN) at week 76. Benefits were seen regardless of the clinical endpoint definition used.

“Obinutuzumab is a humanised anti-CD20 monoclonal antibody, more potent than its predecessors," Prof. Richard Furie (Northwell Health, NY, USA) explained during his presentation [1]. LN remains a serious complication of systemic lupus erythematosus (SLE), often leading to irreversible kidney damage. In the REGENCY trial (NCT04221477), 271 participants with biopsy-confirmed active LN and meeting the American College of Rheumatology (ACR) classification criteria for SLE were included. The results showed that adding obinutuzumab to background therapy with mycophenolate mofetil and glucocorticoids significantly improved renal outcomes: 46.4% of participants receiving obinutuzumab achieved a complete renal response (CRR) versus 33.1% in the placebo group (95% CI 2.0–24.8; P=0.0232), at week 76.

Given the variations in CRR definitions across different LN trials, indirect comparisons between study results remain challenging. As Prof. Furie pointed out, the objective of this study was to evaluate the response rate in the REGENCY cohort using endpoints from other major LN trials, including BLISS-LN (NCT01639339) and AURORA-1 (NCT03021499).

Importantly, benefits remained consistent. Using the modified BLISS-LN CRR criteria, 48.7% of participants in the obinutuzumab group achieved response versus 33.1% in the placebo group (P=0.0084). Using the modified AURORA-1 definition, the CRR rates were 48.7% and 33.8%, respectively (P=0.0117).

Overall, the magnitude of benefit across all evaluated definitions ranged between 13% and 16%, supporting the broad applicability of obinutuzumab in LN treatment regimens.

Whilst cross-trial comparisons are challenging, the treatment benefit of obinutuzumab plus standard-of-care therapy appears robust. “REGENCY met its primary endpoint, and we had confirmation by borrowing and analysing metrics used in other studies,” concluded Prof. Furie.

1. Rovin BH, et al. Obinutuzumab demonstrates consistent benefit across numerous primary endpoint definitions using REGENCY study results of patients with active lupus nephritis. OP0006, EULAR 2025, 11–14 June, Barcelona, Spain.

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Posted on 8 August 2025