New Treatment for Lupus Nephritis Advances to Phase III

A possible new treatment for advanced lupus nephritis passes a phase two trial, according to a study presented at Kidney Week, the annual meeting of the American Society for Nephrology. The treatment, a CD20 antagonist called obinutuzumab, led to improvements in 41 percent of patients with lupus nephritis—a condition that affects one in 60 people with systemic lupus.

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Called NOBILITY, this was an 18-month randomized controlled study of the CD-20 antagonist obinutuzumab. Led by Brad Rovin, M.D., of The Ohio State University, the study documented a sustained benefit through week 104, which was approximately 18 months after the last infusion of obinutuzumab.

This study included lupus nephritis patients with severe disease marked by having diffuse lupus nephritis with more than 50 percent glomeruli. These patients, who were previously treated with mycophenolate and steroids, were randomized to either an treatment or placebo group.

Dr. Rovin reported that 41 percent of the treatment group and 23 percent of the placebo group met the primary endpoint of complete renal response at week 52 (P value 0.026). 54 percent of patients in the treatment group met the secondary endpoint of overall renal response and 56 percent had a modified complete renal response.

By week 76, 40 percent of patients in the treatment group achieved complete renal response as compared to 18 percent of placebo patients. The eGFR, or estimated glomerular filtration rate, was better in the treatment group by week 104 (+6.5 vs. -3.2 mL/min/1.73 m2, P = 0.018), and also in the urine protein/creatinine ratio (UPCR), anti-dsDNA, C3, and C4 tests. Serious adverse events were 25 percent in the treatment group as compared to 30 percent in the placebo group. Serious infections were eight percent for the treatment group (18 percent placebo) and there was one death in the treatment group (four in the placebo group).

With no unexpected safety events in trial participants, the treatment will go on to be evaluated in the phase three REGENCY trial for patients with lupus nephritis.

Other investigational therapies for lupus nephritis include belimumab, rituximab, voclosporin, atacicept, abetimus, and anticytokine therapies.

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REFERENCE

ABSTRACT: SU-OR31. "Two-Year Results from a Randomized, Controlled Study of Obinutuzumab for Proliferative Lupus Nephritis Session Information," American Society of Nephrology, Kidney Week, Oct. 25, 2020.