Analytical and clinical evaluation of a new immunoassay for therapeutic drug monitoring of infliximab and adalimumab

Llinares-Tello, Francisca; Gallego, José; Soler, Gregorio Santos; Ramírez, Carlos Santos; Heredia, Esteban Salas; García, Juan Molina

doi:10.1515/cclm-2012-0050

Cited by 19 publications

(6 citation statements)

References 8 publications

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“…Drug-level analyses for all kits were carried out using a capture or sandwich ELISA, and ATI were measured using bridging ELISA (Lisa-Tracker and Promonitor), capture ELISA (Q-Inflixi) and RIA (Sanquin), as previously described. 21 – 24 The lower limit of quantification for IFX concentrations was 0.1, 0.03, 0.02 and 0.002 µg/ml for Lisa-Tracker, Promonitor, Q-Inflixi and Sanquin, respectively. The upper limit of quantification for IFX concentrations was 16, 14.4, 20 and 47 µg/ml for Lisa-Tracker, Promonitor, Q-Inflixi and Sanquin assays, respectively.…”

Section: Methodsmentioning

confidence: 99%

Reliability evaluation of four different assays for therapeutic drug monitoring of infliximab levels

Pérez

Fernández

Sánchez-Ramón

et al. 2018

Therap Adv Gastroenterol

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Background:The aim of this study was to evaluate reliability of four different assays for measuring infliximab trough levels and antibodies to infliximab (ATI).Methods:In this non-interventional, cross-sectional study including IBD patients, infliximab levels and ATI were measured using four different assays: Lisa-Tracker, Promonitor, Q-Inflixi and Sanquin. Reliability and agreement for infliximab levels was assessed using the intraclass correlation coefficient (ICC) and Bland–Altman plots. Qualitative agreement for infliximab (based on a pre-established target window of trough levels between 3 µg/ml and 7 µg/ml) and for ATI were estimated by Cohen’s kappa.Results:Serum samples of 84 IBD patients were evaluated for infliximab using the four assays. Reliability was ‘substantial’ between Lisa-Tracker versus Promonitor and ‘almost perfect’ between the remaining assay pairs, with ICCs [95% confidence interval (CI)] ranging from 0.93 (0.70–0.97) for Lisa-Tracker versus Promonitor to 0.97 (0.95–0.98) for Q-Inflixi versus Sanquin. Bland–Altman plots showed significant bias between assays except Promonitor versus Q-Inflixi, which had excellent agreement. The greatest differences in mean infliximab were found between Promonitor versus Lisa-Tracker (–0.91 µg/ml) and Lisa-Tracker versus Q-Inflixi (0.69 µg/ml). Qualitative agreement for infliximab was ‘almost perfect’ for Promonitor versus Q-Inflixi (kappa 0.84) and Q-Inflixi versus Sanquin (kappa 0.81), and ‘substantial’ for the remaining pairs. More than 10% of patients who had infliximab levels within the target interval by Lisa-Tracker had suboptimal concentrations (<3 µg/ml) with Promonitor and Q-Inflixi. Furthermore, 11% of patients within the target interval by Q-Inflixi had supra-optimal levels (>7 µg/ml) by Lisa-Tracker. In the remaining paired comparisons, fewer than 5% of patients were placed in different subgroups. Qualitative agreement for ATI fluctuated between ‘moderate’ and ‘almost perfect’.Conclusions:All four assays seem suitable for therapeutic drug monitoring of infliximab. Promonitor and Q-Inflixi had the best agreement, making those assays fully interchangeable. Systematic biases between Lisa-Tracker with Promonitor and Q-Inflixi suggest that these assays should not be interchanged during the follow up of an individual patient.

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Section: Methodsmentioning

confidence: 99%

Reliability evaluation of four different assays for therapeutic drug monitoring of infliximab levels

Pérez

Fernández

Sánchez-Ramón

et al. 2018

Therap Adv Gastroenterol

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“…Several assays and technologies have been approved for monitoring serum drug and antidrug level [50], but bridging ELISA seems to be the only method with the potential for routine adoption in a hospital clinical setting for patient monitoring [37, 43, 51, 52]. It has been demonstrated that antibodies against TNF antagonists are anti-idiotypic, therefore neutralizing by definition [53].…”

Section: Methodsmentioning

confidence: 99%

Monitoring Drug and Antidrug Levels: A Rational Approach in Rheumatoid Arthritis Patients Treated with Biologic Agents Who Experience Inadequate Response While Being on a Stable Biologic Treatment

Mazilu

Opriş

Gainaru

et al. 2014

BioMed Research International

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Clinical response in patients with rheumatoid arthritis (RA) treated with biologic agents can be influenced by their pharmacokinetics and immunogenicity. The present study evaluated the concordance between serum drug and antidrug levels as well as the clinical response in RA patients treated with biological agents who experience their first disease exacerbation while being on a stable biologic treatment. 154 RA patients treated with rituximab (RTX), infliximab (IFX), adalimumab (ADL), or etanercept (ETN) were included. DAS28, SDAI, and EULAR response were assessed at baseline and reevaluated at precise time intervals. At the time of their first sign of inadequate response, patients were tested for both serum drug level and antidrug antibodies level. At the next reevaluation, patients retreated with RTX that had detectable drug level had a better EULAR response (P = 0.038) with lower DAS28 and SDAI scores (P = 0.01 and P = 0.03). The same tendency was observed in patients treated with IFX and ETN regarding EULAR response (P = 0.002 and P = 0.023), DAS28 score (P = 0.002 and P = 0.003), and SDAI score (P = 0.001 and P = 0.026). Detectable biologic drug levels correlated with a better clinical response in patients experiencing their first RA inadequate response while being on a stable biologic treatment with RTX, IFX, and ETN.

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“…Those ranges were derived from clinical studies mainly in RA (and fewer in CD) 44,45 , including a study done by means of the Promonitor kit on 78 patients with RA for whom there were 612 blood samples. The drug level was measured by ELISA (Promonitor commercial kit of the Progenika Biopharma group) and expressed in microgram per milliliter (µg/ml).…”

Section: Methodsmentioning

confidence: 99%

Prevalence of TNF-α Blocker Immunogenicity in Psoriatic Arthritis

Zisapel

Zisman²,

Madar-Balakirski³

et al. 2014

J Rheumatol

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Analytical and clinical evaluation of a new immunoassay for therapeutic drug monitoring of infliximab and adalimumab

Cited by 19 publications

References 8 publications

Reliability evaluation of four different assays for therapeutic drug monitoring of infliximab levels

Reliability evaluation of four different assays for therapeutic drug monitoring of infliximab levels

Monitoring Drug and Antidrug Levels: A Rational Approach in Rheumatoid Arthritis Patients Treated with Biologic Agents Who Experience Inadequate Response While Being on a Stable Biologic Treatment

Prevalence of TNF-α Blocker Immunogenicity in Psoriatic Arthritis

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