Glomerular Renal Diseases, Nephrology Department, Fundació Puigvert, Cartagena 340-350, 08025, Barcelona, Spain.
Hospital Puerta de Hierro, Madrid, Spain.
BioDrugs. 2017 Jun;31(3):239-249. doi: 10.1007/s40259-017-0221-x.
Patients with difficult-to-treat idiopathic nephrotic syndrome (INS), steroid-dependent nephrotic syndrome (SDNS), or frequently relapsing nephrotic syndrome (FRNS) require long-term immunosuppressive therapy. Rituximab offers an alternative treatment for patients with disease that has not responded to multiple therapies.
Our objective was to determine the efficacy and safety of rituximab in adult patients with difficult-to-treat (SDNS or FRNS) INS.
We performed a retrospective multicenter study that included 50 adults with difficult-to-treat INS in six Spanish centers. All patients were treated with steroids in combination with another immunosuppressant: 28 patients received rituximab as the additional treatment (rituximab group), and the other 22 patients not treated with rituximab served as the control group.
Of the patients treated with rituximab, 23 (82%) experienced complete remission, 20 (71%) had no relapses after receiving rituximab, and 13 (46%) did not receive any immunosuppressant. Of those in the control group, 14 (63%) experienced complete remission, including eight without immunosuppressants (29%). The rituximab group experienced highly significant reductions in total number of relapses per year (p < 0.001), proteinuria (p = 0.03), steroid doses (p = 0.002), and tacrolimus doses (p = 0.001). Mean follow-up after rituximab was 31 ± 26 months (range 8-86). The need for steroids and other immunosuppressants to achieve sustained remission was lower in the rituximab group than in the control group.
Rituximab treatment was safe and well tolerated. It effectively reduced the incidence of relapses and need for maintenance immunosuppressive therapy in adults with difficult-to-treat INS.
对于难治性特发性肾病综合征（INS）、激素依赖性肾病综合征（SDNS）或频繁复发肾病综合征（FRNS）患者，需要长期免疫抑制治疗。利妥昔单抗为治疗多种治疗方法无效的疾病提供了另一种治疗选择。
我们旨在确定利妥昔单抗治疗成人难治性（SDNS 或 FRNS）INS 的疗效和安全性。
我们进行了一项回顾性多中心研究，纳入了西班牙 6 个中心的 50 例难治性 INS 成人患者。所有患者均接受了类固醇联合另一种免疫抑制剂治疗：28 例患者接受利妥昔单抗作为附加治疗（利妥昔单抗组），22 例未接受利妥昔单抗治疗的患者作为对照组。
接受利妥昔单抗治疗的患者中，23 例（82%）完全缓解，20 例（71%）利妥昔单抗治疗后无复发，13 例（46%）未接受任何免疫抑制剂治疗。对照组中，14 例（63%）完全缓解，包括 8 例未使用免疫抑制剂（29%）。利妥昔单抗组每年总复发次数（p<0.001）、蛋白尿（p=0.03）、类固醇剂量（p=0.002）和他克莫司剂量（p=0.001）均显著降低。利妥昔单抗治疗后平均随访 31±26 个月（范围 8-86）。与对照组相比，利妥昔单抗组需要类固醇和其他免疫抑制剂来维持缓解的需求更低。
利妥昔单抗治疗安全且耐受性良好。它有效降低了成人难治性 INS 患者的复发率和维持免疫抑制治疗的需求。
