Abstract
OBJECTIVE: This study aimed to evaluate the efficacy and safety of obinutuzumab, a novel anti-CD20 monoclonal antibody, in patients with primary membranous nephropathy (pMN). METHODS: Fifty-five patients with pMN treated with obinutuzumab were respectively enrolled in this study. Clinical and immunological response, renal function and adverse events were assessed throughout the follow-up period between patients receiving obinutuzumab as initial therapy and alternative therapy. RESULTS: The study included 40 patients receiving obinutuzumab as an alternative therapy, and 15 patients receiving it as an initial therapy. During a follow up of 13.0(10.0, 18.0) months after obinutuzumab treatment, 23/25(92.0%) patients achieved immunological remission. 46/55(83.6%) patients achieved clinical remission (including 40.0% of PR and 43.6% of CR), with significantly reduced proteinuria and increased serum albumin. Patients with obinutuzumab as either the initial or alternative treatment showed similar clinical response (85.0 vs. 80.0%, P=0.692). 13 out of 18 patients (72.2%) with impaired kidney function (eGFR <60 mL/min/1.73 m²) also showed significant response to obinutuzumab, along with eGFR increasing from 35.3 to 47.6 mL/min/1.73m². Furthermore, obinutuzumab also had a comparable efficiency in patients without response to previous rituximab treatment and patients with negative anti-PLA2R antibody. More patients in the initial therapy group had infusion-related reactions (33.3 vs. 15.0%, P=0.149), while severe infections were all occurred in the alternative therapy group, particularly those with a history of long-term immunosuppressive therapy. CONCLUSIONS: Obinutuzumab, used as both initial and alternative therapy, can induce significant clinical response in patients with pMN, implying its potentially promising therapeutic effect on pMN.