Obinutuzumab outperforms tacrolimus in primary membranous nephropathy

Among patients with primary membranous nephropathy, those treated with obinutuzumab are more likely to achieve complete remission than those treated with tacrolimus, according to the phase III MAJESTY trial.

A total of 142 adult patients with primary membranous nephropathy were randomly assigned to receive intravenous obinutuzumab or oral tacrolimus.

The primary endpoint of complete remission was defined as a urinary protein-to-creatinine ratio of ≤0.3 and a stable estimated glomerular filtration rate (eGFR) at week 104. Secondary endpoints included complete or partial remission at week 104, complete remission at week 76, a sustained reduction in the eGFR of ≥30 percent, duration of complete remission, and change in the Patient-Reported Outcomes Measurement Information System Fatigue T score from baseline to week 104. Safety was also evaluated.

At week 104, complete remission was achieved in 37 percent of obinutuzumab-treated patients vs 6 percent of those who received tacrolimus (adjusted difference, 31 percentage points, 95 percent confidence interval, 18–44; p<0.001). Similar results were observed for complete or partial remission at week 104 and complete remission at week 76.

No significant between-group difference was observed for the number of patients who showed sustained eGFR reduction.

In terms of safety, grade ≥3 adverse events (AEs) occurred in 22 percent of patients in the obinutuzumab group and 19 percent in the tacrolimus group. Serious AEs were reported in 17 percent and 14 percent, respectively. Infections occurred at a rate of 61 and 57 infections per 100 patient-years in the obinutuzumab and tacrolimus groups, respectively.

The most common adverse drug reactions in the obinutuzumab group were infusion-related reactions, respiratory tract infections, and neutropenia.

One patient in each group died during escape therapy.