Antibody treatment demonstrates potential in lupus kidney disease

New Phase III data has demonstrated the potential benefit of the monoclonal antibody obinutuzumab to treat lupus nephritis. This therapy is already approved for B cell malignancies.

The REGENCY Phase III clinical trial evaluated 271 adults with active lupus nephritis, a severe complication of lupus that inhibits kidney function. Participants were randomised to receive either obinutuzumab plus mycophenolate mofetil and glucocorticoids as standard therapy, or a placebo plus standard therapy.

A significantly greater percentage of patients given obinutuzumab attained complete renal response at week 76 (46.4 percent), compared to 33.1 percent of individuals with lupus nephritis who were given placebo treatment.

Furthermore, the researchers observed a complete renal response at week 76 in more patients in the obinutuzumab group compared to the placebo group, in those given a daily prednisone dose of 7.5mg per day or less between weeks 64 and 76.

Therefore, the biologic treatment enabled a clinically meaningful improvement in kidney function, according to the study findings published in The New England Journal of Medicine.

Potential of the antibody as a new treatment for lupus nephritis

“These findings represent a major step forward in the treatment of lupus nephritis,” explained Dr Furie, Chief of the Division of Rheumatology at Northwell Health, US. “Obinutuzumab, a well-known and easy-to-obtain drug, could potentially offer new hope for patients living with this challenging condition.”

The new Phase III trial results provide “new hope for patients with lupus nephritis, a condition where effective treatments are desperately needed,” remarked Dr Kevin Tracey, President and CEO of the Feinstein Institutes and Karches Family Distinguished Chair in Medical Research. “This clinical trial result reveals that obinutuzumab can improve short-term outcomes while further data is being collected to determine the long-term impact the drug has on kidney health.”