Abstract | BACKGROUND: OBJECTIVES: This study was designed to preliminarily evaluate the pharmacokinetics, pharmacodynamics, safety, and clinical activity profiles of the anti-CD22 monoclonal antibody SM03 in Chinese patients with active RA. MATERIALS AND METHODS: This study was an open phase I study in 8 RA patients. Eligible patients received two 600 mg doses of SM03 administered through intravenous infusions given 2 weeks apart and were monitored over an 84-day observation period for pharmacokinetics, pharmacodynamics, immunogenicity, safety, and clinical responses. RESULTS: After multiple doses of SM03, the maximum serum concentration of SM03 was reached within 2 - 4 hours. Mean elimination half-life was 16 days (range: 13 - 22 days). Half of the patients responded according to ACR and DAS28 assessments, and CD19+ B lymphocyte counts decreased. Upper respiratory tract infections and headaches were the most common adverse events (AEs). No drug-related serious AEs were reported. CONCLUSION: This study is the first to report on the preliminary pharmacokinetics, pharmacodynamics, clinical activity, and safety of SM03 in RA patients. All AEs were mild or moderate in severity. SM03 showed potential efficacy in RA patients.
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Authors | Qian Zhao, Xia Chen, Ji Jiang, Jing Li, Wen Zhong, Hongcan Han, Zhengdong Li, Shui-On Leung, Fengchun Zhang, Pei Hu |
Journal | International journal of clinical pharmacology and therapeutics
(Int J Clin Pharmacol Ther)
Vol. 59
Issue 11
Pg. 691-704
(Nov 2021)
ISSN: 0946-1965 [Print] Germany |
PMID | 34423769
(Publication Type: Clinical Trial, Phase I, Journal Article)
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Chemical References |
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Topics |
- Animals
- Antibodies, Monoclonal
(adverse effects)
- Arthritis, Rheumatoid
(drug therapy)
- Humans
- Infusions, Intravenous
- Lupus Erythematosus, Systemic
(drug therapy)
- Mice
- Treatment Outcome
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