Comparative Evaluation of 4 Commercially Available ELISA Kits for Measuring Adalimumab and Anti-adalimumab Antibodies

Sam, Melissa; Connor, Susan J.; Toong, Catherine

doi:10.1097/ftd.0000000000000795

Cited by 9 publications

(10 citation statements)

References 19 publications

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“…Limitations of the study include the potential variance in drug levels due to the use of ELISA kits from different sources for maternal infliximab and adalimumab levels. Previous studies 11‐14 and our own in‐house evaluation (unpublished) show similar levels across the different assay kits. Small differences would be unlikely to significantly influence the results as the majority of intrapartum levels were measured using the Q‐INFLIXI and Q‐ADA assays respectively.…”

Section: Discussionsupporting

confidence: 66%

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Infliximab, adalimumab and vedolizumab concentrations across pregnancy and vedolizumab concentrations in infants following intrauterine exposure

Flanagan¹,

Gibson

Wright³

et al. 2020

Aliment Pharmacol Ther

101

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Background: The impact of pregnancy on levels of biologic agents in patients with IBD is undefined and time to elimination in vedolizumab-exposed infants is unknown. Aims: To determine the effect of pregnancy on infliximab, adalimumab and vedolizumab levels and to study infant vedolizumab clearance Methods: In a prospective observational study, maternal drug levels were measured pre-conception, in each trimester, at delivery and postpartum. The association between drug levels and gestation in weeks was assessed using generalised estimating equation modelling. Infant vedolizumab levels were performed at birth (cord blood), 6 weeks and 3 months or until undetectable. Results: We included 50 IBD patients (23 on infliximab, 15 on adalimumab and 12 on vedolizumab) with at least two intrapartum observations, plus 5 patients on vedolizumab with only mother and baby samples at delivery. Modelling showed no change in adalimumab levels, an increase in infliximab levels of 0.16 (95% CI 0.08-0.24) µg/L/week (P < 0.001) and a decrease of 0.18 (95% CI: −0.33 to −0.02) µg/L/week (P = 0.03) for vedolizumab. In 17 mother-baby pairs, median infant vedolizumab levels at birth were lower than maternal levels (P < 0.05) with an infant:maternal ratio of 0.7 (IQR 0.5-0.9). Vedolizumab was undetectable between 15 and 16 weeks of age in all 12 infants completing follow-up testing. Conclusions: During pregnancy, adalimumab levels remain stable, while infliximab levels increase and vedolizumab levels decrease. However, the increments were small suggesting that intrapartum therapeutic drug monitoring and dose adjustment are not indicated. Unlike infliximab and adalimumab, infant vedolizumab levels are lower in cord blood than in mothers and appear to clear rapidly.

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Section: Discussionsupporting

confidence: 66%

“…A minority of samples were sent to external laboratories for quantitative analysis of anti‐TNF drug levels, where other commercially available ELISA (Promonitor [Grifols]) or Lisa‐Tracker (Theradiag) were used, among which good correlation has been reported 11‐14 …”

Section: Methodsmentioning

confidence: 99%

Infliximab, adalimumab and vedolizumab concentrations across pregnancy and vedolizumab concentrations in infants following intrauterine exposure

Flanagan¹,

Gibson

Wright³

et al. 2020

Aliment Pharmacol Ther

101

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“…TDM assays. Although commercially available assays typically correlate well, absolute drug concentrations can differ among assays or even the same type of assay (66)(67)(68)(69)(70)(71)(72)(73)(74)(75)(76)(77). This is very important because clinical decisions are typically based on drug concentration thresholds to target.…”

Section: General Considerations Regarding Tdmmentioning

confidence: 99%

A Comprehensive Literature Review and Expert Consensus Statement on Therapeutic Drug Monitoring of Biologics in Inflammatory Bowel Disease

et al. 2021

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Therapeutic drug monitoring (TDM) of biologics is a rapidly evolving field. We aimed to provide a consensus statement regarding the clinical utility of TDM for biologics in inflammatory bowel disease (IBD). A modified Delphi method was applied to develop consensus statements. A comprehensive literature review was performed regarding TDM of biologic therapies in IBD, and 45 statements were subsequently formulated on the potential application of TDM in IBD. The statements, along with literature, were then presented to a panel of 10 gastroenterologists with expertise in IBD and TDM who anonymously rated them on a scale of 1–10 (1 = strongly disagree and 10 = strongly agree). An expert consensus development meeting was held virtually to review, discuss, refine, and reformulate statements that did not meet criteria for agreement or that were ambiguous. During the meeting, additional statements were proposed. Panelists then confidentially revoted, and statements rated ≥7 by 80% or more of the participants were accepted. During the virtual meeting, 8 statements were reworded, 7 new statements were proposed, and 19 statements were rerated. Consensus was finally reached in 48/49 statements. The panel agreed that reactive TDM should be used for all biologics for both primary nonresponse and secondary loss of response. It was recommended that treatment discontinuation should not be considered for infliximab or adalimumab until a drug concentration of at least 10–15 μg/mL was achieved. Consensus was also achieved regarding the utility of proactive TDM for anti–tumor necrosis factor therapy. It was recommended to perform proactive TDM after induction and at least once during maintenance. Consensus was achieved in most cases regarding the utility of TDM of biologics in IBD, specifically for reactive and proactive TDM of anti–tumor necrosis factors.

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“…Various commercial assays used to measure anti-TNF-a drug concentrations and immunogenicity offer good correlation, facilitating more uniform therapeutic decisions among clinicians. [2][3][4][5][6][7][8][9][10][11][12] Vedolizumab, a humanized monoclonal immunoglobulin G1 antibody that targets a conformational epitope of the a 4 b 7 integrin heterodimer, is approved for the treatment of adult patients with moderately to severely active UC or CD. 13,14 Data on vedolizumab exposure-response highlight the potential benefit of TDM in patients with IBD.…”

Section: Introductionmentioning

confidence: 99%

“…Various commercial assays used to measure anti-TNF-α drug concentrations and immunogenicity offer good correlation, facilitating more uniform therapeutic decisions among clinicians. 2–12…”

Section: Introductionmentioning

confidence: 99%

Measuring Serum Vedolizumab and Vedolizumab Antibodies: Comparison of Commercial Assays with the Vedolizumab Clinical Development Assay

Casteele

Yang

Dobler

et al. 2023

Therapeutic Drug Monitoring

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Background: Vedolizumab (VDZ) is an anti-a 4 b 7 integrin monoclonal antibody approved for inflammatory bowel disease treatment. VDZ serum and antidrug antibody (ADA) concentrations may be used for treatment optimization. In this article, the results of 5 commercial assays (Grifols, Immundiagnostik, Progenika, Sanquin, and Theradiag) measuring VDZ concentration and ADA were compared with those of the reference assays used in VDZ clinical studies. Our findings will assist clinicians in interpreting commercial assay results in the context of VDZ clinical trial data.Methods: VDZ-treated patient samples were used to evaluate the agreement between commercial assays and the reference VDZ serum concentration assay, based on linear regression, Bland-Altman, and qualitative agreement analyses. VDZ ADAs were detected using qualitative assays. Specificity, selectivity, accuracy, and precision were assessed using serum samples from healthy donors or patients with IBD (VDZ serum concentration ,0.5 mcg/mL) spiked with VDZ, with/without other biologics (identical sample sets per assay).Results: All assays were specific and selective for VDZ. Overall, the commercial assay results for VDZ-spiked samples correlated well with those of the reference serum concentration assay (R 2 $ 0.98). Compared with the Immundiagnostik and Theradiag assays, the Grifols, Sanquin, and Progenika assays had the best reference assay agreement (based on regression analysis, Bland-Altman plots, and qualitative agreement [Cohen's kappa $0.92]). All immunogenicity assays detected VDZ ADAs; only the reference assay detected VDZ ADAs in the presence of 15 mcg/mL VDZ, advising caution with commercial ADA assays if VDZ is present.Conclusions: All 5 commercial assays are suitable for VDZ therapeutic monitoring and ADA testing. However, the absolute values from the reference assays and the different commercial assays were not comparable, indicating that the same assay must be used for repeated monitoring of VDZ serum concentrations.

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Comparative Evaluation of 4 Commercially Available ELISA Kits for Measuring Adalimumab and Anti-adalimumab Antibodies

Cited by 9 publications

References 19 publications

Infliximab, adalimumab and vedolizumab concentrations across pregnancy and vedolizumab concentrations in infants following intrauterine exposure

Infliximab, adalimumab and vedolizumab concentrations across pregnancy and vedolizumab concentrations in infants following intrauterine exposure

A Comprehensive Literature Review and Expert Consensus Statement on Therapeutic Drug Monitoring of Biologics in Inflammatory Bowel Disease

Measuring Serum Vedolizumab and Vedolizumab Antibodies: Comparison of Commercial Assays with the Vedolizumab Clinical Development Assay

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