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

Rodríguez, Pedro C.; Torres-Moya, Roberto; Reyes, Gil; Molinero, Claudino; Prada, Dinorah; López, Ana Marta; Hernández, Isabel Moreno; Hernández, M.V.; Martinez, Jose P.; Hernandez, Xochel; Casacó, Á.; Ramos, Mayra; Avila, Yisel; Barrese, Yinet; Montero, Enrique; Hernández, Patricia

doi:10.1016/j.rinim.2012.11.001

Cited by 38 publications

(61 citation statements)

References 46 publications

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“…Low immunogenicity of itolizumab has been demonstrated in previous studies, 33,35 including one in RA patients but only after 6 weeks of treatment. 33 Here, we assessed the generation of antiidiotypic antibodies against itolizumab after 12 weeks of treatment in the active group (itolizumab plus MTX).…”

Section: Itolizumab Administration Did Not Induce a Measurable Antiidmentioning

confidence: 70%

“…25,38,39 Itolizumab, an anti-CD6 mAb, has demonstrated clinical benefits, 33,40 as well as modulation of T cell proliferation and decrease of proinflammatory cytokine levels in psoriasis patients. 35 Studies have shown that itolizumab is not a T cell-depleting antibody when used as monotherapy both in Cuban RA 33 and psoriasis (unpublished data) patients. A small and transient decrease in ALC was, however, reported in an Indian study with psoriasis patients, 40 although no increase in infections was observed.…”

Section: Discussionmentioning

confidence: 99%

“…These results are consistent with our previous studies. 33,35 RA is a heterogeneous disorder where T cells contribute to disease development and chronicity. Here, we focused on the effect of the anti-CD6 mAb itolizumab on these cells.…”

Section: Discussionmentioning

confidence: 99%

“…33 Here, we assessed the generation of antiidiotypic antibodies against itolizumab after 12 weeks of treatment in the active group (itolizumab plus MTX). No antiidiotypic antibody response was detected in any of the evaluated patients (Fig.…”

Section: Itolizumab Administration Did Not Induce a Measurable Antiidmentioning

confidence: 99%

“…32 Moreover, itolizumab did not cause T cell depletion when used as monotherapy in RA patients. 33 In experiments in vitro with peripheral blood mononuclear cells (PBMC) from healthy donors, itolizumab reduced IFN-g, IL-6 and TNF production. 34 Recently, we found a significant decrease in T cell proliferation and reduction in circulating proinflammatory cytokine levels in psoriasis patients treated with itolizumab.…”

Section: Introductionmentioning

confidence: 99%

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Immunological evaluation of rheumatoid arthritis patients treated with itolizumab

Aira

Hernández

Prada³

et al. 2015

mAbs

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(2016) Immunological evaluation of rheumatoid arthritis patients treated with itolizumab, mAbs, 8:1, 187-195, DOI: 10.1080/19420862.2015 To link to this article: https://doi.org/10. 1080/19420862.2015 Rheumatoid arthritis is an autoimmune disease characterized by joint inflammation that affects approximately 1% of the general population. Itolizumab, a monoclonal antibody specific for the human CD6 molecule mainly expressed on T lymphocytes, has been shown to inhibit proliferation of T cells and proinflammatory cytokine production in psoriasis patients. We have now assessed the immunological effect of itolizumab in combination with methotrexate in rheumatoid arthritis by analyzing clinical samples taken from 30 patients enrolled in a clinical trial. T and B cell subpopulations were measured at different time points of the study. Plasma cytokine levels and anti-idiotypic antibody response to itolizumab were also evaluated. The combined treatment of itolizumab and methotrexate led to a reduction in the frequency of T cell subpopulations, and plasma levels of proinflammatory cytokines showed a significant decrease up to at least 12 weeks after treatment ended. No anti-idiotypic antibody response was detected. These results support the relevance of the CD6 molecule as a therapeutic target for the treatment of this disease.

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Section: Itolizumab Administration Did Not Induce a Measurable Antiidmentioning

confidence: 70%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Section: Itolizumab Administration Did Not Induce a Measurable Antiidmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Immunological evaluation of rheumatoid arthritis patients treated with itolizumab

Aira

Hernández

Prada³

et al. 2015

mAbs

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Itolizumab (Alzumab), Mogamulizumab (Poteligeo), and Tositumomab (Bexxar)

Dübel

2014

Handbook of Therapeutic Antibodies

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Itolizumab in combination with methotrexate modulates active rheumatoid arthritis: safety and efficacy from a phase 2, randomized, open-label, parallel-group, dose-ranging study

Chopra¹,

Chandrashekara²,

Iyer

et al. 2015

Clin Rheumatol

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The objective of this study was to assess the safety and efficacy of itolizumab with methotrexate in active rheumatoid arthritis (RA) patients who had inadequate response to methotrexate. In this open-label, phase 2 study, 70 patients fulfilling American College of Rheumatology (ACR) criteria and negative for latent tuberculosis were randomized to four arms: 0.2, 0.4, or 0.8 mg/kg itolizumab weekly combined with oral methotrexate, and methotrexate alone (2:2:2:1). Patients were treated for 12 weeks, followed by 12 weeks of methotrexate alone during follow-up. Twelve weeks of itolizumab therapy was well tolerated. Forty-four patients reported adverse events (AEs); except for six severe AEs, all others were mild or moderate. Infusion-related reactions mainly occurred after the first infusion, and none were reported after the 11th infusion. No serum anti-itolizumab antibodies were detected. In the full analysis set, all itolizumab doses showed evidence of efficacy. At 12 weeks, 50 % of the patients achieved ACR20, and 58.3 % moderate or good 28-joint count Disease Activity Score (DAS-28) response; at week 24, these responses were seen in 22 and 31 patients. Significant improvements were seen in Short Form-36 Health Survey and Health Assessment Questionnaire Disability Index scores. Overall, itolizumab in combination with methotrexate was well tolerated and efficacious in RA for 12 weeks, with efficacy persisting for the entire 24-week evaluation period. (Clinical Trial Registry of India, http://ctri.nic.in/Clinicaltrials/login.php , CTRI/2008/091/000295).

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

Cited by 38 publications

References 46 publications

Immunological evaluation of rheumatoid arthritis patients treated with itolizumab

Immunological evaluation of rheumatoid arthritis patients treated with itolizumab

Itolizumab (Alzumab), Mogamulizumab (Poteligeo), and Tositumomab (Bexxar)

Itolizumab in combination with methotrexate modulates active rheumatoid arthritis: safety and efficacy from a phase 2, randomized, open-label, parallel-group, dose-ranging study

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