ArticleClinical and experimental immunology2018
The anti-CD6 antibody itolizumab provides clinical benefit without lymphopenia in rheumatoid arthritis patients: results from a 6-month, open-label Phase I clinical trial.
Article in Clinical and experimental immunology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers, 1 of them a synthesis that pooled it.
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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.
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Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 31 citations in OpenAlex.
- Validation of GWAS-Identified Variants for Anti-TNF Drug Response in Rheumatoid Arthritis: A Meta-Analysis of Two Large Cohorts.Frontiers in immunology · 2021Pooled it
- A two-arm, randomized, controlled, multi-centric, open-label phase-2 study to evaluate the efficacy and safety of Itolizumab in moderate to severe ARDS patients due to COVID-19.Expert opinion on biological therapy · 2021Trial
- Anti-CD6 monoclonal antibody UMCD6 induces CD6 internalization, remodels costimulatory receptor availability, and modulates CD4Frontiers in immunology · 2026Article
- CD6 in Human Disease.Cells · 2025Review
- CD6 regulates CD4 T follicular helper cell differentiation and humoral immunity during murine coronavirus infection.Journal of virology · 2025Article
- Ambulatory Blood Pressure in Patients With Rheumatoid Arthritis: Association With Immune Activation.The Journal of rheumatology · 2024Article
- CD6 Regulates CD4 T Follicular Helper Cell Differentiation and Humoral Immunity During Murine Coronavirus Infection.bioRxiv : the preprint server for biology · 2024Article
- CD6 and Its Interacting Partners: Newcomers to the Block of Cancer Immunotherapies.International journal of molecular sciences · 2023Review
- Multi-omics analysis identifies IgG2b class-switching with ALCAM-CD6 co-stimulation in joint-draining lymph nodes during advanced inflammatory-erosive arthritis.Frontiers in immunology · 2023Article
- An Exploratory Study of Itolizumab on the Preservation of Beta Cell Function in Adults with Recent-Onset Type 1 Diabetes.Journal of clinical medicine · 2022Article
- Restoring the Balance between Pro-Inflammatory and Anti-Inflammatory Cytokines in the Treatment of Rheumatoid Arthritis: New Insights from Animal Models.Biomedicines · 2021Review
- Current and Emerging Targeted Therapies for Acute Graft-Versus-Host Disease.BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy · 2021Review
- An anti-CD6 monoclonal antibody (itolizumab) reduces circulating IL-6 in severe COVID-19 elderly patients.Immunity & ageing : I & A · 2020Article
- Failure of a T cell regulator: CD6 contributes to the aggravation of autoimmune inflammation.Cellular & molecular immunology · 2019Article
- CD6 expression has no effect on atherosclerosis in apolipoprotein E-deficient mice.BMC research notes · 2018Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
18 authors at 3 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Itolizumab is a humanized anti-CD6 monoclonal antibody (mAb) that has previously shown encouraging results, in terms of safety and positive clinical effects, in a 6-week monotherapy clinical trial conducted in rheumatoid arthritis (RA) patients. The current Phase I study evaluated the safety and clinical response for a longer treatment of 12 itolizumab intravenous doses in subjects with active RA despite previous disease-modifying anti-rheumatic drug (DMARD) therapy. Twenty-one subjects were enrolled into four dosage groups (0·1, 0·2, 0·4 and 0·8 mg/kg). Efficacy end-points including American College of Rheumatology (ACR)20, ACR50 and ACR70 response rates and disease activity score in 28 joints (DAS28) were monitored at baseline and at specific time-points during a 10-week follow-up period. Itolizumab was well tolerated up to the highest tested dose. No related serious adverse events were reported and most adverse events were mild. Remarkably, itolizumab treatment did not produce lymphopenia and, therefore, was not associated with infections. All patients achieved a clinical response (ACR20) at least once during the study. Eleven subjects (55%) achieved at least a 20% improvement in ACR just 1 week after the first itolizumab administration. The clinical response was observed from the beginning of the treatment and was sustained during 24 weeks. The efficacy profile of this 12-week treatment was similar to that of the previous study (6-week treatment). These results reinforce the safety profile of itolizumab and provide further evidence on the clinical benefit from the use of this anti-CD6 mAb in RA patients.
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