Obinutuzumab Promotes Renal Preservation in Lupus Nephritis

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TOPLINE:

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.

METHODOLOGY:

  • 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.

TAKEAWAY:

  • 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.

IN PRACTICE:

“By reducing flare risk, obinutuzumab should decrease the accumulation of chronic parenchymal kidney damage,” the authors write.

SOURCE:

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.

LIMITATIONS:

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.

DISCLOSURES:

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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