Safety and Efficacy of Obinutuzumab in Treating Lupus Nephritis: A Systematic Review

IF 2.7 4区医学 Q3 IMMUNOLOGY

Immunity, Inflammation and Disease Pub Date : 2026-04-13 DOI:10.1002/iid3.70439

Zainab Arif, Hafsa Ali, Erum Siddiqui, Shorrem Naeem, Mohammed Hammad Jaber Amin

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Abstract

Background

Lupus nephritis (LN) is a serious manifestation of systemic lupus erythematosus (SLE), often leading to end-stage renal disease. Despite current immunosuppressive therapies, complete renal remission remains limited. Obinutuzumab, a type II anti-CD20 monoclonal antibody, offers enhanced B-cell depletion compared to type I antibodies and may improve renal outcomes in LN. This systematic review evaluates the efficacy and safety of obinutuzumab in treating adult patients with proliferative LN.

Methods

This review was registered with PROSPERO (CRD420251074418) and conducted in accordance with the PRISMA guidelines. A comprehensive search of PubMed, Cochrane, Embase, Scopus, and clinical trial registries was conducted through June 2025. Eligible studies were randomized controlled trials (RCTs) comparing obinutuzumab vs. placebo in adult patients with biopsy-confirmed active LN. Primary outcomes included complete renal response (CRR), proteinuria, and estimated glomerular filtration rate (eGFR). Secondary outcomes included immunological markers and adverse events. Data were synthesized qualitatively due to the limited available trials.

Results

Two RCTs (REGENCY 2025 and NOBILITY 2022) with 396 patients met the inclusion criteria. Obinutuzumab significantly improved CRR (46.4% in REGENCY at week 76; 41% in NOBILITY at week 104) and reduced proteinuria (UPCR < 0.5 in 62% vs. 37% in controls). Improvements in eGFR, complement levels (C3 and C4), and anti-dsDNA titers were also noted. Adverse events occurred at similar rates across groups, although serious infections and infusion reactions were somewhat higher in one trial. No significant increase in mortality was observed.

Conclusion

Obinutuzumab appears to be a promising therapy for proliferative LN, offering enhanced renal response and immunological benefits. Its potential for long-term renal protection and steroid-sparing effects supports further investigation through large-scale comparative trials.

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Obinutuzumab治疗狼疮性肾炎的安全性和有效性：一项系统评价

狼疮性肾炎（LN）是系统性红斑狼疮（SLE）的一种严重表现，常导致终末期肾脏疾病。尽管目前有免疫抑制疗法，完全的肾脏缓解仍然有限。Obinutuzumab是一种II型抗cd20单克隆抗体，与I型抗体相比，可增强b细胞消耗，并可能改善LN患者的肾脏预后。本系统综述评估了obinutuzumab治疗成年增生性LN患者的有效性和安全性。方法本综述在PROSPERO注册（CRD420251074418），并按照PRISMA指南进行。到2025年6月，对PubMed、Cochrane、Embase、Scopus和临床试验注册进行了全面搜索。符合条件的研究是随机对照试验（rct），比较obinutuzumab和安慰剂在活检证实的活动性LN成人患者中的疗效。主要结局包括完全肾反应（CRR）、蛋白尿和估计的肾小球滤过率（eGFR）。次要结局包括免疫标志物和不良事件。由于可用试验有限，对数据进行了定性合成。结果2项随机对照试验（REGENCY 2025和贵族2022）396例患者符合纳入标准。Obinutuzumab显著提高了CRR （REGENCY组第76周为46.4%，贵族组第104周为41%）并降低了蛋白尿（62%组的UPCR为0.5，对照组为37%）。eGFR、补体水平（C3和C4）和抗dsdna滴度也有所改善。不同组的不良事件发生率相似，尽管在一项试验中严重感染和输液反应略高。未观察到死亡率显著增加。结论：Obinutuzumab似乎是一种有希望的治疗增生性LN的方法，提供增强的肾脏反应和免疫益处。其潜在的长期肾脏保护和类固醇节约效应支持通过大规模比较试验进一步研究。

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来源期刊

Immunity, Inflammation and Disease Medicine-Immunology and Allergy

CiteScore

3.60

自引率

0.00%

发文量

146

审稿时长

8 weeks

期刊介绍： Immunity, Inflammation and Disease is a peer-reviewed, open access, interdisciplinary journal providing rapid publication of research across the broad field of immunology. Immunity, Inflammation and Disease gives rapid consideration to papers in all areas of clinical and basic research. The journal is indexed in Medline and the Science Citation Index Expanded (part of Web of Science), among others. It welcomes original work that enhances the understanding of immunology in areas including: • cellular and molecular immunology • clinical immunology • allergy • immunochemistry • immunogenetics • immune signalling • immune development • imaging • mathematical modelling • autoimmunity • transplantation immunology • cancer immunology