PMID- 34423769
OWN - NLM
STAT- MEDLINE
DCOM- 20211117
LR  - 20211117
IS  - 0946-1965 (Print)
IS  - 0946-1965 (Linking)
VI  - 59
IP  - 11
DP  - 2021 Nov
TI  - An open-label, multiple-dose study to assess the preliminary pharmacokinetics, 
      pharmacodynamics, clinical activity, and safety of human mouse chimeric anti-CD22 
      monoclonal antibody (SM03) in patients with rheumatoid arthritis.
PG  - 691-704
LID - 10.5414/CP203907 [doi]
AB  - BACKGROUND: The pharmacokinetics, safety, and clinical activity of antibodies 
      targeting CD22 have been evaluated in systemic lupus erythematosus (SLE) and 
      non-Hodgkin lymphoma (NHL) patients, however, there have been no reports for the 
      rheumatoid arthritis (RA) population. SM03 is a novel chimeric IgG1 monoclonal 
      antibody which targets the B-cell-restricted antigen CD22. This is the first 
      study of the anti-CD22 antibody in RA patients. 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.
FAU - Zhao, Qian
AU  - Zhao Q
FAU - Chen, Xia
AU  - Chen X
FAU - Jiang, Ji
AU  - Jiang J
FAU - Li, Jing
AU  - Li J
FAU - Zhong, Wen
AU  - Zhong W
FAU - Han, Hongcan
AU  - Han H
FAU - Li, Zhengdong
AU  - Li Z
FAU - Leung, Shui-On
AU  - Leung SO
FAU - Zhang, Fengchun
AU  - Zhang F
FAU - Hu, Pei
AU  - Hu P
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PL  - Germany
TA  - Int J Clin Pharmacol Ther
JT  - International journal of clinical pharmacology and therapeutics
JID - 9423309
RN  - 0 (Antibodies, Monoclonal)
SB  - IM
MH  - Animals
MH  - Antibodies, Monoclonal/adverse effects
MH  - *Arthritis, Rheumatoid/drug therapy
MH  - Humans
MH  - Infusions, Intravenous
MH  - *Lupus Erythematosus, Systemic/drug therapy
MH  - Mice
MH  - Treatment Outcome
EDAT- 2021/08/24 06:00
MHDA- 2021/11/18 06:00
CRDT- 2021/08/23 08:48
PHST- 2021/10/12 00:00 [accepted]
PHST- 2021/08/24 06:00 [pubmed]
PHST- 2021/11/18 06:00 [medline]
PHST- 2021/08/23 08:48 [entrez]
AID - 188606 [pii]
AID - 10.5414/CP203907 [doi]
PST - ppublish
SO  - Int J Clin Pharmacol Ther. 2021 Nov;59(11):691-704. doi: 10.5414/CP203907.