Department of Nephrology, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine, Tianjin, China.
National Clinical Research Center for Chinese Medicine Acupuncture and Moxibustion, Tianjin, China.
Ren Fail. 2024 Dec;46(2):2416605. doi: 10.1080/0886022X.2024.2416605. Epub 2024 Oct 23.
To evaluate the effectiveness and safety of different B cell-targeting biological agents combining with standard of care in patients with lupus nephritis (LN).
Comprehensive literature searches were conducted using PubMed, Embase, Web of Science, and Central in the Cochran Library, spanning from inception to May 20th, 2024. Randomized control trials (RCTs) comparing rituximab (RTX), belimumab, ocrelizumab, obinutuzumab, and anifrolumab in LN were selected. The primary outcomes of interest were related to complete renal remission (CRR), and partial renal remission (PRR). Additionally, we delved into safety outcomes, examining the occurrence of serious adverse events (SAEs), infections, and the discontinuation rates due to adverse events.
A total of 6 RCTs with 1150 patients applying various B cell-targeting biological agents were included. Notably, ranking probability based on the surface under the cumulative ranking curve (SUCRA) indicated that obinutuzumab (SUCRA 85.2%) has the highest potential superiority in improving CRR, followed by belimumab, ocrelizumab. Regarding the improvement in PRR, obinutuzumab (SUCRA 83.0%) has the highest potential superiority. In terms of safety, with a focus on SAEs, infections, and the discontinuation rates due to adverse events, the results were: SUCRA-based ranking indicated that RTX (SUCRA 74.1%) had the highest probability of postponing SAEs, followed by belimumab and obinutuzumab. Concerning infection reduction, anifrolumab (SUCRA 78.7%) had the highest potential superiority. Safety events monitoring infection occurred better with RTX than with standard therapy (OR = 3.57, 95% CI 1.02, 12.66) and were statistically different. For the discontinuation rates due to adverse events, RTX (SUCRA 88.6%) demonstrated the highest potential superiority.
Concerning the effectiveness and safety outcomes, obinutuzumab, belimumab, and RTX plus standard of care may be superior to the current standard therapy as treatments for LN. This study protocol has been registered with PROSPERO, with a registration number of CRD42024548522.
评估不同 B 细胞靶向生物制剂联合标准治疗在狼疮肾炎（LN）患者中的疗效和安全性。
全面检索 PubMed、Embase、Web of Science 和 Cochrane 图书馆中的 Central，检索时间截至 2024 年 5 月 20 日。纳入比较利妥昔单抗（RTX）、贝利尤单抗、奥克珠单抗、奥瑞珠单抗和阿尼鲁单抗治疗 LN 的随机对照试验（RCT）。主要疗效结局为完全肾脏缓解（CRR）和部分肾脏缓解（PRR）。此外，我们还研究了安全性结局，评估严重不良事件（SAE）、感染和因不良事件导致的停药率。
共纳入 6 项 RCT，纳入 1150 例应用不同 B 细胞靶向生物制剂的患者。基于排序概率的累积排序曲线下面积（SUCRA）表明，奥瑞珠单抗（SUCRA 85.2%）在改善 CRR 方面具有最高的潜在优势，其次是贝利尤单抗和奥克珠单抗。在改善 PRR 方面，奥瑞珠单抗（SUCRA 83.0%）具有最高的潜在优势。在安全性方面，重点关注 SAE、感染和因不良事件导致的停药率，结果显示：基于 SUCRA 的排序表明，RTX（SUCRA 74.1%）在推迟 SAE 方面具有最高的可能性，其次是贝利尤单抗和奥瑞珠单抗。在降低感染方面，阿尼鲁单抗（SUCRA 78.7%）具有最高的潜在优势。与标准治疗相比，RTX 更能有效监测感染相关的安全性事件（OR=3.57，95%CI 1.02，12.66），差异具有统计学意义。在因不良事件导致的停药率方面，RTX（SUCRA 88.6%）具有最高的潜在优势。
在疗效和安全性方面，奥瑞珠单抗、贝利尤单抗和 RTX 联合标准治疗可能优于当前的标准治疗，作为 LN 的治疗方法。本研究方案已在 PROSPERO 注册，注册号为 CRD42024548522。
