抄録
【Objective and Design】 Antibody-mediated rejection (ABMR) is one of the major causes of kidney graft failure, but the efficacy and safety of treatment with rituximab remain unclear. We conducted an open-label, non-randomized, multicenter Phase III study to evaluate the efficacy and safety of rituximab for ABMR treatment.
【Methods】 Rituximab 375 mg/m2 was administrated once or twice after steroid pulse therapy and optional plasma exchange in patients resulted in ABMR attributable to donor-specific antibodies (DSA) or anti-A/anti-B antibodies. Patients were aged 16 years or older and had a diagnosis of active or chronic active ABMR accompanied by worsening serum creatinine levels.
【Results】 Treatment was initiated immediately upon suspicion of ABMR, and 28 patients received rituximab. Efficacy was evaluated in 25 patients who were diagnosed with active (4 cases) or chronic active ABMR (21 cases) based on the Banff 2017 classification. The primary endpoint was the proportion of patients whose serum creatinine levels at 1 month after the rituximab administration (Day 1) showed improvement or remained stable, compared to the worst value during ABMR treatment to just before rituximab administration. In 19 out of 25 patients (76.0%, 95% confidence interval: 54.9; 90.6%), serum creatinine had improved or remained stable. There were no graft losses or patient deaths up to the final observation point, 6 months after the start of treatment. There were no serious adverse reactions related to rituximab.
【Conclusion】 Efficacy and tolerability were confirmed for rituximab after implementing steroid pulse therapy and optional plasma exchange for ABMR following kidney transplantation.
