ArticleClinical drug investigation2016
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.
Article in Clinical drug investigation, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed, 7 citations in OpenAlex.
- Immunotherapies application in active stage of systemic lupus erythematosus in pregnancy: A case report and review of literature.World journal of clinical cases · 2020Article
- Targeting B Cells and Plasma Cells in Autoimmune Diseases.Frontiers in immunology · 2018Review
Corrections and comments
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Authors and funding
10 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND AND
objectivesSM03 is a novel recombinant, human/mouse chimeric immunoglobulin G1 monoclonal antibody directed against the CD22 antigen on human B lymphocytes. This was the first study to investigate the pharmacokinetics, pharmacodynamics, immunogenicity, safety and clinical activity of SM03 in patients with systemic lupus erythematosus (SLE).
methodsThis study was an open, multiple-centre, parallel-group, multiple-ascending-dose, phase I study in 29 SLE patients. Pharmacokinetic assessment was conducted in 22 of these patients. Eligible patients received multiple intravenous infusions of SM03 for 4 weeks (240 mg/m
resultsAfter multiple-dose SM03, the maximal serum concentration of SM03 was reached within 3-7 h. The mean elimination half-life was 15 days. The average accumulation ratios of the area under the time-concentration curve and the maximum concentration after the fourth administration of SM03 were 2.0 and 1.5. CD19
conclusionPharmacokinetic exposure increased in a lower-than-dose-proportional manner up to 900 mg. SM03 was well tolerated at doses ranging from 240 mg/m
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.