Immunogenicity, adalimumab levels and clinical response in ankylosing spondylitis patients during 24 weeks of follow-up

Kneepkens, E.; Wei, James Cheng‐Chung; Nurmohamed, Michael T.; Yeo, Kai-Jieh; Chen, C Y; Horst-Bruinsma, Irene E van der; Kleij, Desirée van der; Rispens, Theo; Wolbink, Gertjan; Krieckaert, C.

doi:10.1136/annrheumdis-2013-204185

Cited by 74 publications

(57 citation statements)

References 30 publications

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“…60,61 This response can occur even when patients are treated with fully human mAbs. [62][63][64] Anti-drug antibodies to the 5 anti-TNF agents approved to treat RA patients have been measured. In the case of adalimumab, a fully human antibody, immunogenicity has been linked with a lack of clinical response.…”

Section: Discussionmentioning

confidence: 99%

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: Discussionmentioning

confidence: 99%

Immunological evaluation of rheumatoid arthritis patients treated with itolizumab

Aira

Hernández

Prada³

et al. 2015

mAbs

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“…Anti-drug Ab are generally reported as detected in up to one third of RA and about 25% of SpA patients [2,[30][31][32][33]. Chimericdrugs (mouse-human), such as IFX, have a greater likelihood of inducing anti-drug Abs production compared to fully human antibodies [34,35].…”

Section: Discussionmentioning

confidence: 99%

“…In a third of cases such drugs are ineffective and this is due to primary treatment failure (drug inefficacy or serious side effects) or secondary treatment failure (drug loss of efficacy after initial good response). It has been shown that serum levels of ADA, ETN and IFX correlate with the clinical response in RA, while in ankylosing spondylitis (AS) data are controversial [1][2][3][4]. Similarly, anti-drug Ab levels inversely correlate with drugs levels and therapeutic response [4][5][6].…”

Section: Introductionmentioning

confidence: 99%

Biologic therapies in rheumatic diseases: drug and anti-drug antibody levels and clinical efficacy

Lombardi¹,

Bernardoni²,

Bertolucci³

et al. 2017

J Autoimmun Cell Response

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Background: The aim of this study was to evaluate the relevance of drug and anti-drug antibody detection in the clinical management of patients with rheumatoid arthritis (RA) and spondyloarthropaties (SpA) in treatment with anti-tumor necrosis factor alpha (TNFα) biologics. Methods and results:The study included 192 adult consecutive patients treated for at least 6 months with adalimumab (ADA) or etanercept (ETN) or infliximab (IFX); patients underwent clinical observations in the Rheumatologic Unit of 5 Hospitals in Tuscany. Their demographic and clinical characteristics to calculate DAS28 and BASDAI scores were collected. Drug levels and anti-drug antibodies (anti-drug Ab) were evaluated immediately before drug injection or infusion. A total of 192 patients were studied: 62 receiving IFX, 64 ADA, and 66 ETN with a mean age of 57 years (range 18-86 years); the study group was composed of 51% women. Forty percent of the patients were affected by RA, 60% by SpA. Altogether, 81% of patients demonstrated therapeutic drug levels. Anti-drug Ab were found in 19% of patients taking IFX, 10% taking ETN and 5% taking ADA. No significant correlation was found between anti-drug Ab presence and low drug levels, between anti-drug Ab and high DAS28 and BASDAI scores, as well as between low drug levels and high DAS28 and BASDAI scores. Conclusions: Low drug levels were found in 19% of the rheumatic patients and there were not correlations with presence of anti-drug Ab or patient's clinical status.

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“…Одновре-менное назначение иммуносупрессантов снижает имму-ногенность ингибиторов ФНОα [4][5][6][7]. Однако при АС синтетические иммуносупрессоры неэффективны, и вли-яние приема метотрексата (МТ) на эффект ИНФ не дока-зано [8]. При АС выработка АТ к ИНФ ассоциируется со снижением его концентрации в сыворотке крови, потерей эффекта терапии и более высоким риском развития инфу-зионных реакций.…”

Section: Investigation Of a Role Of The Immunogenicity Of Infliximab unclassified

“…Однако в настоящее время нет стандартизированного подхода к определению уровня препарата в сыворотке крови и мониторингу нейтрализую-щих АТ, что существенно затрудняет их оценку и может приводить к ошибочным результатам [25]. При изучении результатов терапии АДА у больных АС было выявлено, что клинический эффект зависит от концентрации препа-рата и формирования АТ к нему, что требует проведения соответствующего мониторинга с целью оптимизации ле-чения [8]. F.B.…”

Section: таблицаunclassified

Investigation of a Role of the Immunogenicity of Infliximab in the Therapy of Ankylosing Spondylitis

Румянцева¹,

Бочкова²,

Урумова³

et al. 2016

rsp

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Immunogenicity, adalimumab levels and clinical response in ankylosing spondylitis patients during 24 weeks of follow-up

Abstract: Adalimumab levels are related to clinical response in AS patients measured with ASDAS and are influenced by ADAb detectable with an ABT.

Cited by 74 publications

References 30 publications

Immunological evaluation of rheumatoid arthritis patients treated with itolizumab

Immunological evaluation of rheumatoid arthritis patients treated with itolizumab

Biologic therapies in rheumatic diseases: drug and anti-drug antibody levels and clinical efficacy

Investigation of a Role of the Immunogenicity of Infliximab in the Therapy of Ankylosing Spondylitis

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