Infliximab and adalimumab concentrations and anti‐drug antibodies in inflammatory bowel disease control using New Zealand assays

Barclay, Murray L.; Karim, Shakir; Helms, Esther T. Johanna; Keating, Paula; Hock, Barry D.; Stamp, Lisa K.; Schultz, Michael

doi:10.1111/imj.14064

Cited by 10 publications

(5 citation statements)

References 19 publications

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“…1(A)). Applying the 2019‐determined therapeutic thresholds 1 of 5.1 mg/L on infliximab and 7.3 mg/L on adalimumab using our assays, then 46% (1762 of 3782) and 65% (1827 of 2809) of concentrations were below the threshold, respectively.…”

Section: Infliximab Adalimumab Totalmentioning

confidence: 95%

“…Therapeutic drug monitoring (TDM) of infliximab and adalimumab is recommended in several national guidelines for the treatment of inflammatory bowel disease 1–3 and now in rheumatological conditions 4 . TDM and dose adjustment of the antitumour necrosis factor (TNF) drugs are associated with improved patient outcomes and are cost‐effective 5 .…”

Section: Infliximab Adalimumab Totalmentioning

confidence: 99%

“…TDM and dose adjustment of the antitumour necrosis factor (TNF) drugs are associated with improved patient outcomes and are cost‐effective 5 . Reported thresholds for drug concentrations above which efficacy is improved vary from 3 to 5 mg/L for infliximab and 5 to 9 mg/L for adalimumab 1,6–9 . Prior to the introduction of the World Health Organization infliximab and adalimumab standards in 2019, the accuracy of measurement methods was variable.…”

Section: Infliximab Adalimumab Totalmentioning

confidence: 99%

“…5 Reported thresholds for drug concentrations above which efficacy is improved vary from 3 to 5 mg/L for infliximab and 5 to 9 mg/L for adalimumab. 1,[6][7][8][9] Prior to the introduction of the World Health Organization infliximab and adalimumab standards in 2019, the accuracy of measurement methods was variable. Assay-dependent target drug concentrations were recommended, and clinicians were advised to become familiar with a single assay and repeatedly monitor their patients with the same assay.…”

mentioning

confidence: 99%

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Four‐year review of New Zealand laboratory infliximab and adalimumab concentration results indicating potential for improved dosing

Keating,

Hock,

Smith

et al. 2023

Internal Medicine Journal

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A review of laboratory results across New Zealand for therapeutic drug monitoring (TDM) of infliximab and adalimumab concentrations and antidrug antibodies (ADAs) over 4 years was completed. Of 6591 results, the median serum concentration for infliximab was 5.7 mg/L and for adalimumab was 5.5 mg/L. Subtherapeutic drug concentrations (<7 mg/L) were measured in 54% of samples. Drug concentrations <2 mg/L were measured in 23% of samples, with ADAs detected in 51% of these. The high number of samples with subtherapeutic drug concentrations and common ADA detection is consistent with failing therapy but could also suggest that standard dosing is frequently too low for patients. These results reinforce the value of antitumour necrosis factor drug TDM in making decisions to adjust dosing or switch agents in patients taking infliximab and adalimumab.

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Section: Infliximab Adalimumab Totalmentioning

confidence: 95%

Section: Infliximab Adalimumab Totalmentioning

confidence: 99%

Section: Infliximab Adalimumab Totalmentioning

confidence: 99%

mentioning

confidence: 99%

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Four‐year review of New Zealand laboratory infliximab and adalimumab concentration results indicating potential for improved dosing

Keating,

Hock,

Smith

et al. 2023

Internal Medicine Journal

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“…Following ordinary meal times, lunch four hours submit dose and dinner 9 h publish dose, the release of the radioactive label from the dosage shape changed into measured in-vivo through γ-scintigraphy. In all cases (no matter feeding status), the label was launched at the goal site, both at the ileocecal junction, the ascending colon, the transverse colon or at the splenicor hepatic flexures 62 . No dosage forms released any of the labels inside the belly or small intestine, and no dosage shape failed to launch the label in-vivo.…”

Section: Pressure Controlled Drug Delivery System (Pcds)mentioning

confidence: 99%

Untitled

2021

IJPSR

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Inflammatory bowel diseases (IBD) are chronic and relapsing intestinal inflammatory conditions, hallmarked by a disturbance in the bidirectional interaction between gut and brain. IBD is Ulcerative colitis (UC) and Crohn's disease (CD). Conventional therapies are inadequate and are associated with several systemic side effects due to lack to localization of active moiety at the inflamed site. Treatment option range from small molecules to macromolecules (peptides, proteins and oligonucleotides) that target multiple therapeutic pathways, and dosed via injectable, oral or the rectal route for local bowel treatment. Conventional therapies are inadequate and are associated with several systemic side effects due to a lack of localization of active moiety at the inflamed site. But colonic drug targeting is a novel, potentially active area of research intended and focused on drug delivery for treating localized disease. Targeted drug delivery to the colon would ensure direct treatment at the disease site, lower dosing, and fewer systemic side effects. INTRODUCTION:Inflammatory bowel disease (IBD) is a persistent intestinal inflammatory disease with an unknown etiology. IBD is composed of two specific disease entities: Crohn's disorder (CD) and ulcerative colitis (UC). IBD has been idea to be idiopathic however has two fundamental attributable causes that include genetic and environmental factors. The gastrointestinal tract in which this ailment takes place is imperative to the immune system, and the innate and adaptive immune systems are balanced in complicated interactions with intestinal microbes underneath homeostatic conditions 1 .

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Appropriate Therapeutic Drug Monitoring of Biologic Agents for Patients With Inflammatory Bowel Diseases

Papamichael

Cheifetz

Melmed

et al. 2019

Clinical Gastroenterology and Hepatology

240

248

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BACKGROUND & AIMS: Therapeutic drug monitoring (TDM) is widely available for biologic therapies in patients with inflammatory bowel disease (IBD). We reviewed current data and provided expert opinion regarding the clinical utility of TDM for biologic therapies in IBD. METHODS: We used a modified Delphi method to establish consensus. A comprehensive literature review was performed regarding the use of TDM of biologic therapy in IBD and presented to international IBD specialists. Subsequently, 28 statements on the application of TDM in clinical practice were rated on a scale of 1 to 10 (1 [ strongly disagree and 10 [ strongly agree) by each of the panellists. Statements were accepted if 80% or more of the participants agreed with a score ‡7. The remaining statements were discussed and revised based on the available evidence followed by a second round of voting. RESULTS: The panel agreed on 24 (86%) statements. For anti-tumor necrosis factor (anti-TNF) therapies, proactive TDM was found to be appropriate after induction and at least once during maintenance therapy, but this was not the case for the other biologics. Reactive TDM was appropriate for all agents both for primary non-response and secondary loss of response. The panellists also agreed on several statements regarding TDM and appropriate drug and anti-drug antibody (ADA) concentration thresholds for biologics in specific clinical scenarios. CONCLUSION: Consensus was achieved towards the utility of TDM of biologics in IBD, particularly anti-TNF therapies. More data are needed especially on non-anti-TNF biologics to further define optimal drug concentration and ADA thresholds as these can vary depending on the therapeutic outcomes assessed.

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Infliximab and adalimumab concentrations and anti‐drug antibodies in inflammatory bowel disease control using New Zealand assays

Cited by 10 publications

References 19 publications

Four‐year review of New Zealand laboratory infliximab and adalimumab concentration results indicating potential for improved dosing

Four‐year review of New Zealand laboratory infliximab and adalimumab concentration results indicating potential for improved dosing

Untitled

Appropriate Therapeutic Drug Monitoring of Biologic Agents for Patients With Inflammatory Bowel Diseases

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