title: A clinical exploratory study with itolizumab, an anti-CD6 monoclonal antibody, in patients with rheumatoid arthritis.
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.
authors.affiliation: Clinical Research Division, Center of Molecular Immunology, Havana, Cuba.
authors.forename: Pedro C
authors.initials: PC
authors.lastname: Rodriguez
authors.affiliation: National Service for Rheumatology, Havana, Cuba.
authors.forename: Roberto
authors.initials: R
authors.lastname: Torres-Moya
authors.affiliation: Rheumatology Service, Center of Surgical and Clinical Research, Havana, Cuba.
authors.forename: Gil
authors.initials: G
authors.lastname: Reyes
authors.affiliation: National Service for Rheumatology, Havana, Cuba.
authors.forename: Claudino
authors.initials: C
authors.lastname: Molinero
authors.affiliation: National Service for Rheumatology, Havana, Cuba.
authors.forename: Dinorah
authors.initials: D
authors.lastname: Prada
authors.affiliation: National Service for Rheumatology, Havana, Cuba.
authors.forename: Ana M
authors.initials: AM
authors.lastname: Lopez
authors.affiliation: National Service for Rheumatology, Havana, Cuba.
authors.forename: Isabel M
authors.initials: IM
authors.lastname: Hernandez
authors.affiliation: National Service for Rheumatology, Havana, Cuba.
authors.forename: Maria V
authors.initials: MV
authors.lastname: Hernandez
authors.affiliation: National Service for Rheumatology, Havana, Cuba.
authors.forename: Jose P
authors.initials: JP
authors.lastname: Martinez
authors.affiliation: Clinical Research Division, Center of Molecular Immunology, Havana, Cuba.
authors.forename: Xochel
authors.initials: X
authors.lastname: Hernandez
authors.affiliation: Clinical Research Division, Center of Molecular Immunology, Havana, Cuba.
authors.forename: Angel
authors.initials: A
authors.lastname: Casaco
authors.affiliation: Clinical Research Division, Center of Molecular Immunology, Havana, Cuba.
authors.forename: Mayra
authors.initials: M
authors.lastname: Ramos
authors.affiliation: National Coordinating Center of Clinical Trials, Havana, Cuba.
authors.forename: Yisel
authors.initials: Y
authors.lastname: Avila
authors.affiliation: National Coordinating Center of Clinical Trials, Havana, Cuba.
authors.forename: Yinet
authors.initials: Y
authors.lastname: Barrese
authors.affiliation: Experimental Immunotherapy Department, Center of Molecular Immunology, Havana, Cuba.
authors.forename: Enrique
authors.initials: E
authors.lastname: Montero
authors.affiliation: Clinical Research Division, Center of Molecular Immunology, Havana, Cuba.
authors.forename: Patricia
authors.initials: P
authors.lastname: Hernandez
keywords: ACR, American College of Rheumatology; AE, adverse events; CD6; CRP, C reactive protein; DMARD, disease-modifying antirheumatic drug; ESR, eritrosedimentation rate; Exploratory study; NSAIDs, nonsteroidal antiinflammatory drugs; RA, rheumatoid arthritis; RF, rheumatoid factor; Rheumatoid arthritis; SAE, serious adverse event.; T lymphocyte; iv, intravenous; mAbs, monoclonal antibodies