Biomaterial Database

A clinical exploratory study with itolizumab, an anti-CD6 monoclonal antibody, in patients with rheumatoid arthritis. 2012

Pedro C Rodriguez, and Roberto Torres-Moya, and Gil Reyes, and Claudino Molinero, and Dinorah Prada, and Ana M Lopez, and Isabel M Hernandez, and Maria V Hernandez, and Jose P Martinez, and Xochel Hernandez, and Angel Casaco, and Mayra Ramos, and Yisel Avila, and Yinet Barrese, and Enrique Montero, and Patricia Hernandez

Clinical Research Division, Center of Molecular Immunology, Havana, Cuba.

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.