538 Correlation Between Adalimumab Serum Levels and Remission After the Induction Phase in Crohn's Disease Patients

Chaparro, María; Guerra, Iván; Iborra, Marisa; Nuño, Jose Luis Cabriada; Bujanda, Luís; Taxonera, Carlos; García–Sánchez, Valle; Marín-Jiménez, Ignacio; Acosta, Manuel Barreiro‐de; Vera, Isabel; Arranz, María Dolores Martín; Hernández-Breijo, Borja; Mesonero, Francisco; Sempere, Laura; Nieto, Yolanda Ber; Hinojosa, Joaquín; Ramas, Mercedes; Bermejo, Fernando; Beltrán, Belén; Rodríguez–Lago, Iago; Mendoza, Juan L.; Aguilar-Melero, Patricia; Menchén, Luis; Ferreiro, Rocío; Gómez, Isabel Blázquez; García, Beatriz; Guijarro, Luis G.; Linares, Pablo M.; Gisbert, Javier P.

doi:10.1016/s0016-5085(15)30370-x

Cited by 4 publications

(3 citation statements)

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“…In addition to looking at the range of reported concentration thresholds in IBD, the relationships between concentration thresholds and the observed concentrations in IBD patients who achieved the clinical end points used to define the concentration thresholds were explored. For IBD patients, reported minimum concentration thresholds across biologics were about 70% of the mean concentrations in patients who achieved the desired outcomes to therapy (Figure 3), 29,33,35,39,40,43,44,[46][47][48][49][52][53][54][55] which is close to the average concentration in the overall population receiving the prescribed dose regimen. 28,39,48,52,55 Although this is no substitute for thorough exposure-response analyses, the data support the view that targeting the population mean or median exposure may generally result in efficacious concentrations for biologics in IBD.…”

Section: Target Concentration In Tdmmentioning

confidence: 89%

“…Most of the studies dealt with infliximab and adalimumab, and less data were available for other biologics. Figure 2 shows the ranges of reported trough concentration thresholds for the biologic therapies approved for IBD from published literature, including infliximab, [28][29][30][31][32][33][34][35][36][37][38][39][40][41] adalimumab, [42][43][44][45][46][47][48][49][50][51] golimumab, 52 ustekinumab, 53 and vedolizumab. 54,55 A tabulated list is provided in Supplemental Table S1.…”

Section: Target Concentration In Tdmmentioning

confidence: 99%

“…However, the trough concentration thresholds across indications for adalimumab did not follow the same pattern ( Figure 4b). [42][43][44][45][46][47][48][49][50][51]69,[71][72][73] It was expected that the relationships in terms of concentration thresholds across indications found for marketed IBD biologics may help predict or establish similar relationships for future investigational agents when there is a lack of data. However, the difference shown between infliximab and adalimumab suggests that more research needs to be conducted in this field in order to establish these relationships and to determine what relationships can or cannot be extrapolated to new biologics.…”

Section: Target Concentration In Tdmmentioning

confidence: 99%

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Therapeutic Drug Monitoring of Biologics for Inflammatory Bowel Disease: An Answer to Optimized Treatment?

Hoseyni

Zhou

2018

The Journal of Clinical Pharma

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Therapeutic drug monitoring (TDM), or the measurement of drug concentrations in blood and antidrug antibodies, for biologic therapies used to treat inflammatory bowel disease (IBD) is an area of growing interest within the IBD community. When there is a definable relationship between drug concentration and clinical effect, blood concentration of biologics (and antidrug antibodies assessment) could be used to predict patient response and to titrate the biologics to maximize therapeutic benefit. This dose individualization has been proven to be more efficacious and cost-effective than empiric dose adjustment and can better guide therapeutic decisions regarding therapy withdrawal or switch. Appropriate implementation and interpretation of drug concentration measurement in TDM are essential to ensure full clinical benefit. Factors that need to be considered include sources of variability, timing of blood sampling, dosing history, analytical performance, immunogenicity, comedications, and clinical status of the patients. Desired target concentrations for biologics used in IBD have not been clearly determined yet. Published concentration thresholds differed widely for a given biologic, indicating a lack of consistent information. Factors other than drug concentration that may contribute to the dose-response variation are largely missing in the current TDM setting. A target range is likely preferable to a single value for TDM of biologics in IBD, and additional prospective research needs to be conducted in order to establish these ranges. Moving forward, TDM may be combined with pharmacodynamic end points and modeling and simulation tools for improved therapeutic benefit in IBD.

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Section: Target Concentration In Tdmmentioning

confidence: 89%

Section: Target Concentration In Tdmmentioning

confidence: 99%

Section: Target Concentration In Tdmmentioning

confidence: 99%

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Therapeutic Drug Monitoring of Biologics for Inflammatory Bowel Disease: An Answer to Optimized Treatment?

Hoseyni

Zhou

2018

The Journal of Clinical Pharma

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American Gastroenterological Association Institute Technical Review on the Role of Therapeutic Drug Monitoring in the Management of Inflammatory Bowel Diseases

et al. 2017

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Therapeutic drug monitoring (TDM), which involves measurement of drug or active metabolite levels and anti-drug antibodies, is a promising strategy that can be used to optimize inflammatory bowel disease therapeutics. It is based on the premise that there is a relationship between drug exposure and outcomes, and that considerable inter-individual variability exists in how patients metabolize the drug (pharmacokinetics) and the magnitude and duration of response to therapy (pharmacodynamics). Therefore, the American Gastroenterological Association has prioritized clinical guidelines on the role of TDM in the management of inflammatory bowel disease. To inform these clinical guidelines, this technical review was developed in accordance with the GRADE (Grading of Recommendations Assessment, Development, and Evaluation) framework for interventional and prognostic studies, and focused on the application of TDM for biologic therapy, specifically anti-tumor necrosis factor-α agents, and for thiopurines. Focused questions address the benefits and risks of a strategy of reactive TDM (in patients with active inflammatory bowel disease) to guide treatment changes compared with empiric treatment changes, and the benefits and risks of a strategy of routine proactive TDM (during routine clinical care in patients with quiescent disease) compared with no routine TDM. Additionally, the review addresses the benefits and risks of routine measurement of thiopurine methyltransferase enzyme activity or genotype before starting thiopurine therapy compared with empiric weight-based dosing and explores the performance of different trough drug concentrations for anti-tumor necrosis factor agents and thiopurines to inform clinical decision making when applying TDM in a reactive setting. Due to a paucity of data, this review does not address the role of TDM for more recently approved biologic agents, such as vedolizumab or ustekinumab.

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American Gastroenterological Association Institute Guideline on Therapeutic Drug Monitoring in Inflammatory Bowel Disease

et al. 2017

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538 Correlation Between Adalimumab Serum Levels and Remission After the Induction Phase in Crohn's Disease Patients

Cited by 4 publications

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Therapeutic Drug Monitoring of Biologics for Inflammatory Bowel Disease: An Answer to Optimized Treatment?

Therapeutic Drug Monitoring of Biologics for Inflammatory Bowel Disease: An Answer to Optimized Treatment?

American Gastroenterological Association Institute Technical Review on the Role of Therapeutic Drug Monitoring in the Management of Inflammatory Bowel Diseases

American Gastroenterological Association Institute Guideline on Therapeutic Drug Monitoring in Inflammatory Bowel Disease

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