Obinutuzumab shows robust efficacy across different renal endpoints in lupus nephritis

The addition of the anti-CD20 antibody obinutuzumab to standard-of-care therapy led to significantly higher renal response rates in patients with active lupus nephritis (LN) at 76 weeks across multiple endpoints.

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 ACR classification criteria for SLE were included. The results showed that adding obinutuzumab to a background of 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 variation in how CRR is defined across different LN trials, indirect comparisons between study results remain challenging. As Prof. Richard A. Furie (Northwell Health, NY, USA) pointed out, the objective of this study was to evaluate response rate in REGENCY using endpoints from other major LN trials, including BLISS-LN (NCT01639339) and AURORA-1 (NCT03021499).

Importantly, similar benefits were consistent. When applying 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 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 of CRR at week 76, 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 20 June 20258 August 2025