Elsevier

Results in Immunology

Volume 2, 2012, Pages 204-211
Results in Immunology

A clinical exploratory study with itolizumab, an anti-CD6 monoclonal antibody, in patients with rheumatoid arthritis

https://doi.org/10.1016/j.rinim.2012.11.001Get rights and content
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open access

Abstract

T cells are involved in the pathogenesis of rheumatoid arthritis (RA). CD6 is a co-stimulatory molecule, predominantly expressed on lymphocytes, that has been linked to autoreactive responses. The purpose of this study was to evaluate the safety, immunogenicity and preliminary efficacy of itolizumab, a humanized anti-CD6 monoclonal antibody, in patients with active rheumatoid arthritis. Fifteen patients were enrolled in a phase I, open-label, dose-finding study. Five cohorts of patients received a weekly antibody monotherapy with a dose-range from 0.1 to 0.8 mg/kg. Itolizumab showed a good safety profile, with no severe or serious adverse events reported so far. No signs or symptoms associated with immunosuppression were observed in the study. Objective clinical responses were achieved in more than 80% of patients after treatment completion, and these responses tend to be sustained afterwards. This clinical study constitutes the first evidence of the safety and positive clinical effect of a monotherapy using an anti-CD6 antibody in patients with rheumatoid arthritis.

Highlights

▸ Exploratory study to assess itolizumab in rheumatoid arthritis patients. ▸ Good safety profile, neither severe or serious adverse events, nor immunosuppression. ▸ Objective clinical response achieved in more than 80% of patients. ▸ Clinical response trends to be sustained after itolizumab withdrawal.

Keywords

Rheumatoid arthritis
Exploratory study
T lymphocyte
CD6

Abbreviations

ACR
American College of Rheumatology
AE
adverse events
CRP
C reactive protein
iv
intravenous
DMARD
disease-modifying antirheumatic drug
ESR
eritrosedimentation rate
mAbs
monoclonal antibodies
NSAIDs
nonsteroidal antiinflammatory drugs
RA
rheumatoid arthritis
RF
rheumatoid factor
SAE
serious adverse event.

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