Adults with lupus nephritis (LN) who received obinutuzumab (Gazyva) plus standard of care therapy experienced significantly improved kidney function and fewer flares than those given a placebo plus standard of care.
Researchers conducted a post hoc analysis of the phase 2 NOBILITY study, a randomized trial in which 63 adults received 1000 mg of obinutuzumab or placebo by infusion on day 1 and at weeks 2, 24, and 26.
Outcomes were time to an unfavorable kidney outcome, defined by the first of any of the following events: treatment failure, doubling of serum creatinine, or death; researchers also measured LN flare outcomes including the first 30% and 40% declines in estimated glomerular filtration rate (eGFR) from baseline, chronic eGFR slope, and how many patients achieved complete renal response (CRR) on no more than 7.5 mg of prednisone.
Adding obinutuzumab to the treatment of patients with LN reduced the risk of the composite outcome by 60% and reduced the risk for LN flare by 57%.
The risk of first eGFR 30% and 40% decline was reduced by 80% and 91%, respectively, with obinutuzumab, and patients who took obinutuzumab had a significantly slower eGFR decline than with placebo (annualized eGFR slope advantage, 4.1 mL/min/1.73 m2 /year).
At 76 weeks (~1.5 years), 38% of patients receiving obinutuzumab achieved CRR on 7.5 mg or less of daily prednisone, compared with 16% of placebo patients, but this difference was not statistically significant at 104 weeks (2 years).
The total numbers of unfavorable kidney outcomes for obinutuzumab vs placebo were 12 vs 24 for treatment failure, 1 vs 6 for creatine doubling, and 1 vs 4 for death, respectively.
“By reducing flare risk, obinutuzumab should decrease the accumulation of chronic parenchymal kidney damage,” the authors write.
The study is to be presented at the American College of Rheumatology (ACR) 2023 Annual Meeting and was published online today in Arthritis & Rheumatology. The lead author was Brad H. Rovin, MD, of The Ohio State University in Columbus.
The analyses were post hoc and not prespecified, and the number of events was small, which prevented statistical confirmation, but the analyses are being repeated in an ongoing phase 3 study.
The study was supported by F. Hoffman-LaRoche. Rovin reported receiving personal fees from F. Hoffman-LaRoche during the conduct of the original trial. Several co-authors are F. Hoffman-LaRoche employees.
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