Evidence map›Paper›PMID 24371585›Full record

ArticleResults in immunology2012

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

Pedro C Rodriguez, Roberto Torres-Moya, Gil Reyes, Claudino Molinero, Dinorah Prada, Ana M Lopez, Isabel M Hernandez, Maria V Hernandez, Jose P Martinez, Xochel Hernandez and 6 more

Open access · hybridAbstract read
In one paragraph

Article in Results in immunology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 29 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
29citing papers in PubMed, 2 pooled it
3.0field-weighted citation impact, top 9% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

29 citing papers in PubMed, 2 syntheses or guidelines pooled it, 45 citations in OpenAlex.

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  15. Approval of Itolizumab for COVID-19: A Premature Decision or Need of The Hour?BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2020
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors at 2 institutions in 1 country.

Pedro C RodriguezClinical Research Division, Center of Molecular Immunology, Havana, Cuba.
Roberto Torres-MoyaNational Service for Rheumatology, Havana, Cuba.
Gil ReyesRheumatology Service, Center of Surgical and Clinical Research, Havana, Cuba.
Claudino MolineroNational Service for Rheumatology, Havana, Cuba.
Dinorah PradaNational Service for Rheumatology, Havana, Cuba.
Ana M LopezNational Service for Rheumatology, Havana, Cuba.
Isabel M HernandezNational Service for Rheumatology, Havana, Cuba.
Maria V HernandezNational Service for Rheumatology, Havana, Cuba.
Jose P MartinezNational Service for Rheumatology, Havana, Cuba.
Xochel HernandezClinical Research Division, Center of Molecular Immunology, Havana, Cuba.
Angel CasacoClinical Research Division, Center of Molecular Immunology, Havana, Cuba.
Mayra RamosClinical Research Division, Center of Molecular Immunology, Havana, Cuba.
Yisel AvilaNational Coordinating Center of Clinical Trials, Havana, Cuba.
Yinet BarreseNational Coordinating Center of Clinical Trials, Havana, Cuba.
Enrique MonteroExperimental Immunotherapy Department, Center of Molecular Immunology, Havana, Cuba.
Patricia HernandezClinical Research Division, Center of Molecular Immunology, Havana, Cuba.
Center of Molecular Immunology (Cuba) · CUCuban Neuroscience Center · CU

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

ACR, American College of RheumatologyAE, adverse eventsCD6CRP, C reactive proteinDMARD, disease-modifying antirheumatic drugESR, eritrosedimentation rateExploratory studyiv, intravenousmAbs, monoclonal antibodiesNSAIDs, nonsteroidal antiinflammatory drugsRA, rheumatoid arthritisRF, rheumatoid factorRheumatoid arthritisSAE, serious adverse event.T lymphocyte

Identifiers

PMID24371585
PMCPMC3862386
OpenAlexW2110623161

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.