Pharmacokinetics, Pharmacodynamics and Preliminary Observations for Clinical Activity and Safety of Multiple Doses of Human Mouse Chimeric Anti-CD22 Monoclonal Antibody (SM03) in Chinese Patients with Systemic Lupus Erythematosus

Zhao, Qian; Chen, Xia; Li, Jing; Jiang, Ji; Li, Mengtao; Zhong, Wen; Li, Zhengdong; Leung, Shui-on; Zhang, Fengchun; Hu, Pei

doi:10.1007/s40261-016-0426-7

Cited by 6 publications

(2 citation statements)

References 38 publications

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“…Generally, conventional immunosuppressive therapy, using either steroids or cytostatic drugs, is commonly used in many autoimmune diseases and partly inhibits autoantibody production ( 2 – 5 ). At present, several drugs that specifically target B cells or plasma cells are either in clinical use or under development and promise to be very efficient for the treatment of various autoimmune diseases ( 6 – 8 ). Among them are (I) monoclonal antibodies against CD19, CD20, and CD22 that can directly target multiple B cell subtypes, but not or only to a lesser extent mature antibody-secreting plasma cells, (II) inhibitors of B cell activating factor (BAFF) and A proliferation-inducing ligand (APRIL), two cytokines which are very important survival factors for B cells and plasma cells, respectively, and (III) velcade/bortezomib, a small molecule proteasome inhibitor that spares B cells but eliminates both short-lived and long-lived plasma cells ( 9 ).…”

Section: Introductionmentioning

confidence: 99%

Targeting B Cells and Plasma Cells in Autoimmune Diseases

2018

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Success with B cell depletion using rituximab has proven the concept that B lineage cells represent a valid target for the treatment of autoimmune diseases, and has promoted the development of other B cell targeting agents. Present data confirm that B cell depletion is beneficial in various autoimmune disorders and also show that it can worsen the disease course in some patients. These findings suggest that B lineage cells not only produce pathogenic autoantibodies, but also significantly contribute to the regulation of inflammation. In this review, we will discuss the multiple pro- and anti-inflammatory roles of B lineage cells play in autoimmune diseases, in the context of recent findings using B lineage targeting therapies.

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Section: Introductionmentioning

confidence: 99%

Targeting B Cells and Plasma Cells in Autoimmune Diseases

2018

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“…Novel immune-modulating drugs consisting of anifrolumab[ 55 ], sifalimumab[ 56 , 57 ], rontalizumab[ 58 ], epratuzumab[ 59 , 60 ], and SM03[ 61 ], all anti–interferon-α/receptor monoclonal antibodies, are currently in phase I and II clinical trials to treat patients resistant to conventional therapies[ 8 ]. Obinutuzumab[ 62 ], an anti-CD20 mAb for B cell depletion, is in phase II trials for proliferative LN.…”

Section: Discussionmentioning

confidence: 99%

Immunotherapies application in active stage of systemic lupus erythematosus in pregnancy: A case report and review of literature

Xiong¹,

Cao²,

Guan³

et al. 2020

WJCC

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BACKGROUND Pregnancy in the setting of systemic lupus erythematosus can worsen the condition from the stable to active stage, with quality of life and fertility desire being particular concerns. Pregnancy in the active stage of systemic lupus erythematosus (ASLE), although rare and complicated to manage, can be treated favorably with immunotherapies ifs used properly. Here we report such a success case. CASE SUMMARY A 31-year-old primigravida patient, diagnosed with SLE seven years ago, was induced ASLE after a cold at 21 + weeks. The patient’s vital signs on presentation were normal. Her laboratory exam was remarkable for significant proteinuria, liver and renal dysfunction, and low C3 and C4 levels. Infectious work-up was negative. The patient was diagnosed with ASLE. She was given immunosuppressive agents (methylprednisolone, gamma globulin and azathioprine etc .) and plasma adsorption therapy, monitoring blood pressure every 8 h, fetal heart rate twice a day, and liver and renal function at least twice a week. Successful maternal and fetal outcomes are presented here. CONCLUSION Child-bearing in ASLE has become more promising, even for this difficult case of ASLE with multiple organ damage. Thorough antepartum counseling, cautious maternal-fetal monitoring, and multi-organ function monitoring by multidisciplinary specialties are keys to favorable pregnancy outcomes.

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The 2018 pipeline of targeted therapies under clinical development for Systemic Lupus Erythematosus: a systematic review of trials

Felten

Dervovic

Chasset

et al. 2018

Autoimmunity Reviews

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Pharmacokinetics, Pharmacodynamics and Preliminary Observations for Clinical Activity and Safety of Multiple Doses of Human Mouse Chimeric Anti-CD22 Monoclonal Antibody (SM03) in Chinese Patients with Systemic Lupus Erythematosus

Abstract: Pharmacokinetic exposure increased in a lower-than-dose-proportional manner up to 900 mg. SM03 was well tolerated at doses ranging from 240 mg/m to 900 mg, with no new safety signals identified. SM03 has potential efficacy in Chinese patients with SLE.

Cited by 6 publications

References 38 publications

Targeting B Cells and Plasma Cells in Autoimmune Diseases

Targeting B Cells and Plasma Cells in Autoimmune Diseases

Immunotherapies application in active stage of systemic lupus erythematosus in pregnancy: A case report and review of literature

The 2018 pipeline of targeted therapies under clinical development for Systemic Lupus Erythematosus: a systematic review of trials

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