Obinutuzumab for lupus nephritis prevents flares while preserving kidney function

In the treatment of patients with lupus nephritis, adding obinutuzumab to standard-of-care therapy is more efficacious than standard-of-care therapy alone in preventing flares and preserving kidney function, according to a study.

For the study, researchers conducted a post hoc analysis of the phase II NOBILITY trial. The population comprised 125 patients with lupus nephritis who had been randomized to treatment with obinutuzumab (n=63) or placebo in combination with mycophenolate mofetil and glucocorticoids.

Outcomes evaluated included time to unfavourable kidney outcome (a composite of treatment failure, doubling of serum creatinine, or death), lupus nephritis flare, first 30- and 40-percent declines in estimated glomerular filtration rate (eGFR) from baseline, and chronic eGFR slope during the trial. These outcomes were compared between the obinutuzumab and placebo groups. The number of patients who achieved complete renal response (CRR) on 7.5 mg or less per day of prednisone was also determined.

Treatment with obinutuzumab reduced the risk of developing the composite kidney outcome by 60 percent, the risk of flare by 57 percent, and the risks of first 30- or 40-percent eGFR decline by 80 percent and 91 percent, respectively.

Compared with the placebo group, the obinutuzumab group had a significantly slower eGFR decline, with an annualized eGFR slope advantage of 4.1 ml/min/1.73 m²/year (95 percent confidence interval, 0.14–8.08).

By week 76, 38 percent of patients in the obinutuzumab group versus 16 percent of those in the placebo group had achieved CRR while receiving not more than 7.5 mg per day of prednisone (p<0.01). This advantage with obinutuzumab disappeared at week 104, with the difference in CRR rates not reaching significance (38 percent vs 22 percent; p=0.06).