Words by GOLD newsdesk
New trial results from Roche could reshape the treatment of lupus nephritis, a life-threatening complication of lupus that has long lacked effective options. The Phase 3 REGENCY study showed that nearly half of patients treated with Roche’s obinutuzumab plus standard therapy achieved a complete renal response, compared with a third of patients on standard therapy alone – a significant improvement.
The findings, presented at the World Congress of Nephrology 2025, are being reviewed by regulators, including the FDA and European Medicines Agency. If approved, Roche’s drug could offer a much-needed alternative for a condition that disproportionately affects younger women, particularly women of colour.
Talking in a press release, Dr Levi Garraway, Chief Medical Officer, Roche, said: “The fact that nearly half of lupus nephritis patients achieved a complete renal response, together with clinically meaningful benefits observed consistently across subgroups, indicates superior disease control with [obinutuzumab] compared to standard treatment alone.”
Lupus nephritis affects around 1.7 million people globally, and despite existing treatments, up to a third of patients develop end-stage kidney disease within a decade, leaving dialysis or transplant as the only options. The REGENCY trial builds on earlier research suggesting that obinutuzumab, a B-cell targeting therapy, could be more effective than the current standard of care.
Dr Richard Furie, Chief of the Division of Rheumatology, Northwell Health, said: “It is gratifying to see that patients who received obinutuzumab were not only more likely to achieve the desired outcome but were able to taper corticosteroids at the same time.”
While obinutuzumab safety profile was consistent with its established use in haematology-oncology, further analysis is ongoing. If regulators greenlight its use for lupus nephritis, it could mark a major step forward in addressing a condition that has long been difficult to treat.
