Clinical observation of 9 cases of rituximab followed by belimumab in the treatment of severe systemic lupus erythematosus

ZHAO Yuanxia; GAO Guanmin; LU Xiaojing; CHU Yaojuan; WANG Song; SHI Xiangfen; DU Shuzhang; ZHANG Xiaojian

doi:10.6039/j.issn.1001-0408.2023.07.15

您当前的位置：

首页 >

文章列表页 >

Clinical observation of 9 cases of rituximab followed by belimumab in the treatment of severe systemic lupus erythematosus

更新时间：2025-09-25

- Clinical observation of 9 cases of rituximab followed by belimumab in the treatment of severe systemic lupus erythematosus
- ZHONGGUO YAOFANG Vol. 34, Issue 7, Pages: 849-853(2023)
- 作者机构：
  
  1.郑州大学第一附属医院药学部，郑州　450052
  2.郑州大学第一附属医院风湿免疫科，郑州　450052
- 作者简介：
- 基金信息：
- DOI：10.6039/j.issn.1001-0408.2023.07.15
  CLC： R593.24;R969.3
- Received：26 November 2022，
  
  Revised：2022-12-29，
  
  Accepted：06 March 2023，
  
  Published：15 April 2023
- 稿件说明：
移动端阅览
赵院霞,高冠民,卢晓静,等.9例利妥昔单抗序贯贝利尤单抗治疗重症系统性红斑狼疮的临床观察[J].中国药房,2023,34(07):849-853.

ZHAO Yuanxia,GAO Guanmin,LU Xiaojing,et al.Clinical observation of 9 cases of rituximab followed by belimumab in the treatment of severe systemic lupus erythematosus[J].ZHONGGUO YAOFANG,2023,34(07):849-853.
赵院霞,高冠民,卢晓静,等.9例利妥昔单抗序贯贝利尤单抗治疗重症系统性红斑狼疮的临床观察[J].中国药房,2023,34(07):849-853. DOI： 10.6039/j.issn.1001-0408.2023.07.15.

ZHAO Yuanxia,GAO Guanmin,LU Xiaojing,et al.Clinical observation of 9 cases of rituximab followed by belimumab in the treatment of severe systemic lupus erythematosus[J].ZHONGGUO YAOFANG,2023,34(07):849-853. DOI： 10.6039/j.issn.1001-0408.2023.07.15.

摘要

目的

探讨利妥昔单抗（RTX）序贯贝利尤单抗（BLM）在重症系统性红斑狼疮（SSLE）患者中的临床疗效与安全性。

方法

纳入2020年10月至2021年6月郑州大学第一附属医院风湿免疫科使用RTX序贯BLM治疗6个月以上的SSLE患者9例，回顾性收集患者的基线临床资料，用药第0、4、12、24周的实验室检查结果和基础治疗情况。分析患者系统性红斑狼疮疾病活动度指数（SLEDAI）评分、糖皮质激素用量和血清学指标（补体C3、补体C4、血清白蛋白和24 h尿蛋白定量）水平；同时收集患者不良反应发生情况。

结果

9例患者均完成超过24周的RTX序贯BLM药物治疗，所有患者均有肾脏损伤，其中7例（77.8%）有肾脏病理学支持，3例（33.3%）合并血液系统损伤，2例（22.2%）合并神经系统损伤。治疗期间，随着治疗时间的延长，患者的SLEDAI评分、24 h尿蛋白定量、糖皮质激素用量均呈显著的下降趋势，最终下降至正常指标水平（

＜0.05）；血清白蛋白、补体C3、补体C4均呈显著的升高趋势，最终升高至正常指标水平（

＜0.05）。在治疗及随访过程中，1例患者出现带状疱疹，1例患者出现上呼吸道病毒感染，1例患者出现泌尿系统细菌感染，给予对症处理后均痊愈。

结论

RTX序贯BLM治疗SSLE，早期给予RTX能快速稳定病情，使患者临床症状明显减轻，特异性血清学指标逐步趋于正常；后续给予BLM可减少基础治疗药物的种类和用量；同时未增加不良反应。

Abstract

OBJECTIVE

To investigate the clinical efficacy and safety of rituximab （RTX） followed by belimumab （BLM） in patients with severe systemic lupus erythematosus（SSLE）.

METHODS

Nine SSLE patients， who were treated with RTX followed by BLM for more than 6 months in the Department of Rheumatology and Immunology of the First Affiliated Hospital of Zhengzhou University from October 2020 to June 2021， were enrolled. Baseline clinical data of patients， laboratory examination results and basic treatment status at weeks 0， 4， 12， and 24 of medication were collected retrospectively. The patients’ systemic lupus erythematosus disease activity index （SLEDAI） score， glucocorticoid dosage and serological indicators （complement C3， complement C4， serum albumin， and 24-hour urine protein quantification） level were analyzed. At the same time， the occurrence of adverse drug reaction was collected.

RESULTS

All 9 patients completed more than 24 weeks of RTX followed by BLM therapy. All patients suffered from renal impairment， of which 7 （77.8%） had renal pathology support， 3（33.3%） had blood system damage and 2 （22.2%） had nervous system damage. During treatment， with the prolongation of treatment time， the SLEDAI score， 24-hour urinary protein quantification， and glucocorticoid dosage of patients showed a significant downward trend， and ultimately decreased to the normal index level （

＜0.05）； serum albumin， complement C3 and complement C4 all showed a significant upward trend， eventually rose to the normal index level （

＜0.05）. During treatment and follow-up， 1 patient developed herpes zoster， 1 patient developed upper respiratory tract virus infection， and 1 patient developed urinary system bacterial infection. All patients recovered after symptomatic treatment.

CONCLUSIONS

In sequential use of RTX followed by BLM for SSLE， early administration of RTX can quickly stabilize the condition， significantly alleviate clinical symptoms， and gradually normalize specific serological indicators； subsequent administration of BLM can reduce the type and dosage of basic treatment drugs； there is no increase in the incidence of adverse drug reactions.

关键词

Keywords

references

KRAAIJ T ， KAMERLING S W A ， DE ROOIJ E N M ， et al . The NET-effect of combining rituximab with beli- mumab in severe systemic lupus erythematosus [J ] . J Autoimmun ， 2018 ， 91 ： 45 - 54 .

MERRILL J ， BUYON J ， FURIE R ， et al . Assessment of flares in lupus patients enrolled in a phase Ⅱ/Ⅲ study of rituximab （EXPLORER） [J ] . Lupus ， 2011 ， 20 （ 7 ）： 709 - 716 .

MERRILL J T ， NEUWELT C M ， WALLACE D J ， et al . Efficacy and safety of rituximab in moderately-to-severely active systemic lupus erythematosus：the randomized，double-blind，phase Ⅱ/Ⅲ systemic lupus erythematosus evaluation of rituximab trial [J ] . Arthritis Rheum ， 2010 ， 62 （ 1 ）： 222 - 233 .

ROVIN B H ， FURIE R ， LATINIS K ， et al . Efficacy and safety of rituximab in patients with active proliferative lupus nephritis：the lupus nephritis assessment with rituximab study [J ] . Arthritis Rheum ， 2012 ， 64 （ 4 ）： 1215 - 1226 .

FANOURIAKIS A ， KOSTOPOULOU M ， ALUNNO A ， et al . 2019 update of the EULAR recommendations for the management of systemic lupus erythematosus [J ] . Ann Rheum Dis ， 2019 ， 78 （ 6 ）： 736 - 745 .

GORDON C ， AMISSAH-ARTHUR M B ， GAYED M ， et al . The British Society for Rheumatology Guideline for the management of systemic lupus erythematosus in adults [J ] . Rheumatology （Oxford）， 2018 ， 57 （ 1 ）： e1 - e45 .

BAKER K P ， EDWARDS B M ， MAIN S H ， et al . Generation and characterization of LymphoStat-B，a human monoclonal antibody that antagonizes the bioactivities of B lymphocyte stimulator [J ] . Arthritis Rheum ， 2003 ， 48 （ 11 ）： 3253 - 3265 .

NAVARRA S V ， GUZMÁN R M ， GALLACHER A E ， et al . Efficacy and safety of belimumab in patients with active systemic lupus erythematosus：a randomised，placebo-controlled，phase 3 trial [J ] . Lancet ， 2011 ， 377 （ 9767 ）： 721 - 731 .

FURIE R ， PETRI M ， ZAMANI O ， et al . A phase Ⅲ，randomized，placebo-controlled study of belimumab，a monoclonal antibody that inhibits B lymphocyte stimulator，in patients with systemic lupus erythematosus [J ] . Arthritis Rheum ， 2011 ， 63 （ 12 ）： 3918 - 3930 .

CAMBRIDGE G ， ISENBERG D A ， EDWARDS J C ， et al . B cell depletion therapy in systemic lupus erythematosus：relationships among serum B lymphocyte stimulator levels，autoantibody profile and clinical response [J ] . Ann Rheum Dis ， 2008 ， 67 （ 7 ）： 1011 - 1016 .

GUALTIEROTTI R ， BORGHI M O ， GEROSA M ， et al . Successful sequential therapy with rituximab and belimumab in patients with active systemic lupus erythematosus：a case series [J ] . Clin Exp Rheumatol ， 2018 ， 36 （ 4 ）： 643 - 647 .

LIN W Y ， SESHASAYEE D ， LEE W P ， et al . Dual B cell immunotherapy is superior to individual anti-CD20 depletion or BAFF blockade in murine models of spontaneous or accelerated lupus [J ] . Arthritis Rheumatol ， 2015 ， 67 （ 1 ）： 215 - 224 .

SHIPA M ， EMBLETON-THIRSK A ， PARVAZ M ， et al . Effectiveness of belimumab after rituximab in systemic lupus erythematosus：a randomized controlled trial [J ] . Ann Intern Med ， 2021 ， 174 （ 12 ）： 1647 - 1657 .

TENG Y K O ， BRUCE I N ， DIAMOND B ， et al . Phase Ⅲ，multicentre，randomised，double-blind，placebo-controlled，104-week study of subcutaneous belimumab administered in combination with rituximab in adults with systemic lupus erythematosus （SLE）：bliss-BELIEVE study protocol [J ] . BMJ Open ， 2019 ， 9 （ 3 ）： e025687 .

DELBET J D ， LECLERC G ， ULINSKI T . Idiopathic nephrotic syndrome and rituximab：may we predict circula- ting B lymphocytes recovery [J ] . Pediatr Nephrol ， 2019 ， 34 （ 3 ）： 529 - 532 .

VAN DAM L S ， OSMANI Z ， KAMERLING S W A ， et al . A reverse translational study on the effect of rituximab，rituximab plus belimumab，or bortezomib on the humoral autoimmune response in SLE [J ] . Rheumatology （Oxford）， 2020 ， 59 （ 10 ）： 2734 - 2745 .

ATISHA-FREGOSO Y ， MALKIEL S ， HARRIS K M ， et al . Phase Ⅱ randomized trial of rituximab plus cyclophosphamide followed by belimumab for the treatment of lupus nephritis [J ] . Arthritis Rheumatol ， 2021 ， 73 （ 1 ）： 121 - 131 .

Views

257

下载量

CSCD

Alert me when the article has been cited

提交

Tools

Publicity Resources

Therapeutic efficacy and safety evaluation of weekly regimen versus intensive regimen of paclitaxel neoadjuvant chemotherapy in breast cancer

Network meta-analysis of first-line treatment of metastatic colorectal cancer with different chemotherapy combination regimens

Efficacy and safety of ruxolitinib in the treatment of myelofibrosis

Clinical evaluation of centrally procured generic and original esomeprazole for the treatment of acute non-variceal upper gastrointestinal bleeding

Effects of alirocumab combined with atorvastatin on clinical efficacy and safety in patients with acute coronary syndrome after PCI

Related Author

ZHAO Mingyue

ZHANG Yanhua

YANG Yang

ZHAO Rongsheng

ZHANG Xiaoqing

LIU Shuai

ZHANG Kai

JI Beibei

Related Institution

Dept. of Pharmacy， Third Hospital of Peking University

Dept. of Pharmacy Administration and Clinical Pharmacy， School of Pharmaceutical Sciences， Peking University

Dept. of Pharmacy， Peking University Cancer Hospital ＆ Beijing Institute for Cancer Research/Key Laboratory of Carcinogenesis and Translational Research （Ministry of Education）

Breast Cancer Prevention and Treatment Center，Peking University Cancer Hospital＆Beijing Institute for Cancer Research/Key Laboratory of Carcinogenesis and Translational Research （Ministry of Education）

Inner Mongolia Clinical Medical College， Inner Mongolia Medical University

⁰