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infliximab pharmacokinetics

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https://www.readbyqxmd.com/read/29901557/association-between-infliximab-drug-and-antibody-levels-and-therapy-outcome-in-pediatric-inflammatory-bowel-diseases
#1
Bella Ungar, Yoav Glidai, Miri Yavzori, Orit Picard, Ella Fudim, Avishay Lahad, Yael Haberman, Dror S Shouval, Ilana Weintraub, Rami Eliakim, Shomron Ben-Horin, Batia Weiss
OBJECTIVES: While infliximab pharmacokinetics are associated with therapy outcome in adult IBD population, limited data is available in pediatric patients. We aimed to define the relationship between Infliximab trough and antibodies' levels (IFX-TL, ATI) and clinical, biomarker remission. METHODS: IFX-TL and ATI were routinely obtained between 2011-2017. Associations with clinical and inflammatory (C-reactive protein, CRP) end-points were studied throughout the first year of infliximab therapy...
June 12, 2018: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/29788058/modeling-immunization-to-infliximab-in-children-with-crohn-s-disease-using-population-pharmacokinetics-a-pilot-study
#2
Antoine Petitcollin, Oriane Leuret, Camille Tron, Florian Lemaitre, Marie-Clémence Verdier, Gilles Paintaud, Guillaume Bouguen, Stéphanie Willot, Eric Bellissant, David Ternant
Background: Antidrug antibodies (ADAs) dramatically increase infliximab clearance and are responsible for underexposure to the drug, leading to treatment failure. This pilot study aimed at developing a population pharmacokinetic model to detect and describe an early increase in infliximab clearance due to ADA. Methods: Twenty children with Crohn's disease (CD) were followed for 1 year or until treatment failure. Infliximab trough concentration, ADA, C-reactive protein (CRP), and Paediatric Crohn's Disease Activity Index (PCDAI) were recorded at each visit...
May 18, 2018: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/29665045/high-body-mass-index-is-associated-with-increased-risk-of-treatment-failure-and-surgery-in-biologic-treated-patients-with-ulcerative-colitis
#3
S Kurnool, N H Nguyen, J Proudfoot, P S Dulai, B S Boland, N Vande Casteele, E Evans, E L Grunvald, A Zarrinpar, W J Sandborn, S Singh
BACKGROUND: Though pharmacokinetic studies suggest accelerated biologic drug clearance with increasing body weight, evidence of obesity's impact on clinical outcomes in biologic-treated patients with ulcerative colitis (UC) is inconsistent. AIM: To evaluate the impact of obesity on real world response to biological therapy in patients with UC. METHODS: In a single-centre retrospective cohort study between 2011-2016 of biologic-treated patients with UC, we evaluated treatment response by baseline body mass index (BMI)...
June 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29659758/accelerated-clearance-of-infliximab-is-associated-with-treatment-failure-in-patients-with-corticosteroid-refractory-acute-ulcerative-colitis
#4
David Kevans, Sanjay Murthy, Diane R Mould, Mark S Silverberg
Background and Aims: A significant proportion of patients with corticosteroid-refractory acute ulcerative colitis [UC] fail therapy. We aimed to assess the pharmacokinetics [PK] of infliximab [IFX] in patients with corticosteroid-refractory acute UC and determine the association between induction IFX PK and short- and long-term therapy outcome. Methods: A population PK model was developed using data from 51 patients with UC [n = 42] and Crohn's disease [n = 9]. A subset of patients [n = 36] with acute corticosteroid-refractory UC (median Mayo score 11 [range 8-12]; 33 of 36 hospitalized; median corticosteroid dose at study entry 50mg prednisolone equivalent IV/oral) commencing IFX were studied to assess further correlations between PK from the first induction dose and therapy outcomes...
May 25, 2018: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/29623653/infliximab-pharmacokinetics-are-influenced-by-intravenous-immunoglobulin-administration-in-patients-with-kawasaki-disease
#5
Niels Vande Casteele, Jun Oyamada, Chisato Shimizu, Brookie M Best, Edmund V Capparelli, Adriana H Tremoulet, Jane C Burns
BACKGROUND: Infliximab, a monoclonal antibody directed against tumor necrosis factor-α, is being evaluated as adjunctive therapy to intravenous immunoglobulin (IVIG) for treatment of young children with acute Kawasaki disease (KD). OBJECTIVE: The aim of this study was to develop a population pharmacokinetic (PopPK) model for infliximab in children with KD, and to evaluate the impact of covariates on infliximab disposition. Specifically, we wanted to investigate the effect of body weight and IVIG administration on PK parameters...
April 5, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29606564/serum-concentrations-after-switching-from-originator-infliximab-to-the-biosimilar-ct-p13-in-patients-with-quiescent-inflammatory-bowel-disease-secure-an-open-label-multicentre-phase-4-non-inferiority-trial
#6
Anne S Strik, Wim van de Vrie, Joanne P J Bloemsaat-Minekus, Michael Nurmohamed, Peter J J Bossuyt, Alexander Bodelier, Theo Rispens, Yvonne J B van Megen, Geert R D'Haens
BACKGROUND: Biological treatment of chronic inflammatory diseases has improved patient outcomes but increased health-care costs. Switching patients from originator infliximab to a biosimilar can reduce costs, but prospective data about pharmacokinetics and potential immunogenicity are scarce. We aimed to show that infliximab serum concentrations with biosimilar CT-P13 are non-inferior to those with originator infliximab after switching from originator infliximab in patients with inflammatory bowel disease...
June 2018: Lancet. Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/29541870/a-minimal-physiologically-based-pharmacokinetic-model-with-a-nested-endosome-compartment-for-novel-engineered-antibodies
#7
Dongfen Yuan, Frederik Rode, Yanguang Cao
We proposed here a minimal physiologically based pharmacokinetic (mPBPK) model for a group of novel engineered antibodies in mice and humans. These antibodies are designed with altered binding properties of their Fc domain with neonatal Fc receptor (FcRn) or the Fab domain with their cognate targets (recycling antibodies) in acidic endosomes. To enable simulations of such binding features in the change of antibody pharmacokinetics and its target suppression, we nested an endothelial endosome compartment in parallel with plasma compartment based on our previously established mPBPK model...
March 14, 2018: AAPS Journal
https://www.readbyqxmd.com/read/29518978/structural-biology-of-the-tnf%C3%AE-antagonists-used-in-the-treatment-of-rheumatoid-arthritis
#8
REVIEW
Heejin Lim, Sang Hyung Lee, Hyun Tae Lee, Jee Un Lee, Ji Young Son, Woori Shin, Yong-Seok Heo
The binding of the tumor necrosis factor α (TNFα) to its cognate receptor initiates many immune and inflammatory processes. The drugs, etanercept (Enbrel® ), infliximab (Remicade® ), adalimumab (Humira® ), certolizumab-pegol (Cimzia® ), and golimumab (Simponi® ), are anti-TNFα agents. These drugs block TNFα from interacting with its receptors and have enabled the development of breakthrough therapies for the treatment of several autoimmune inflammatory diseases, including rheumatoid arthritis, Crohn's disease, and psoriatic arthritis...
March 7, 2018: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/29504427/a-randomized-study-comparing-the-pharmacokinetics-of-the-potential-biosimilar-pf-06438179-gp1111-with-remicade%C3%A2-infliximab-in-healthy-subjects-reflections-b537-01
#9
Ramesh Palaparthy, Chandrasekhar Udata, Steven Y Hua, Donghua Yin, Chun-Hua Cai, Stephanie Salts, Muhammad I Rehman, Joseph McClellan, Xu Meng
BACKGROUND: To demonstrate pharmacokinetic (PK) similarity of PF-06438179/GP1111, a potential biosimilar to Remicade®, to Remicade® sourced from European Union (infliximab-EU) and United States (infliximab-US), and of infliximab-EU to infliximab-US. METHODS: In this phase I, parallel-group, three-arm trial, healthy adult subjects were randomized to receive a single 10-mg/kg intravenous infusion of PF-06438179/GP1111, infliximab-EU, or infliximab-US. PK, and safety and immunogenicity evaluations were performed over 8 and 12 weeks, respectively...
April 2018: Expert Review of Clinical Immunology
https://www.readbyqxmd.com/read/29446128/editorial-restoring-therapeutic-infliximab-drug-levels-in-patients-with-loss-of-response-pharmacokinetics-and-anti-drug-antibodies-as-useful-guidance-tools
#10
EDITORIAL
S Ben-Horin
No abstract text is available yet for this article.
March 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29446098/safety-efficacy-and-pharmacokinetics-of-vedolizumab-in-patients-with-simultaneous-exposure-to-an-anti-tumour-necrosis-factor
#11
S Ben-Horin, B Ungar, U Kopylov, A Lahat, M Yavzori, E Fudim, O Picard, Y Peled, R Eliakim, E Del Tedesco, S Paul, X Roblin
BACKGROUND: Data on combination-biologic treatment in (IBD) are still scant. AIM: To explore outcomes of patients co-exposed to anti-TNF and vedolizumab. METHODS: Patients starting vedolizumab having measurable anti-TNF levels after recently stopping adalimumab/infliximab ('VDZ-aTNF' group), were compared with control vedolizumab patients in a retrospective 1:2 matched case-control study. RESULTS: Seventy-five patients were included (25 VDZ-aTNF, 50 VDZ)...
April 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29431871/immunoassay-methods-used-in-clinical-studies-for-the-detection-of-anti-drug-antibodies-to-adalimumab-and-infliximab
#12
B Gorovits, D J Baltrukonis, I Bhattacharya, M A Birchler, D Finco, D Sikkema, M S Vincent, S Lula, L Marshall, T P Hickling
We examined the assay formats used to detect anti-drug antibodies (ADA) in clinical studies of the anti-tumour necrosis factor (TNF) monoclonal antibodies adalimumab and infliximab in chronic inflammatory disease and their potential impact on pharmacokinetic and clinical outcomes. Using findings of a recent systematic literature review of the immunogenicity of 11 biological/biosimilar agents, we conducted an ancillary qualitative review of a subset of randomized controlled trials and observational studies of the monoclonal antibodies against anti-TNF factor adalimumab and infliximab...
February 12, 2018: Clinical and Experimental Immunology
https://www.readbyqxmd.com/read/29390113/long-term-outcomes-after-switching-to-ct-p13-in-pediatric-onset-inflammatory-bowel-disease-a-single-center-prospective-observational-study
#13
Ben Kang, Yoon Lee, Kiwuk Lee, Young Ok Choi, Yon Ho Choe
Background: The relatively high cost and patent expiry of infliximab, an anti-tumor necrosis factor monoclonal antibody used in inflammatory bowel disease (IBD), has led to the development of biosimilar versions of the reference product (RP). This study investigated the long-term efficacy, safety, pharmacokinetics, and immunogenicity of CT-P13 after switching from infliximab RP in pediatric-onset IBD patients. Methods: In this prospective observational study, patients with pediatric-onset IBD receiving maintenance infliximab RP were followed for 1 year after continuing infliximab RP (RP maintenance group) or switching to CT-P13 (CT-P13 switch group)...
February 15, 2018: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/29383030/immunogenicity-of-biologics-in-inflammatory-bowel-disease
#14
Séverine Vermeire, Ann Gils, Paola Accossato, Sadiq Lula, Amy Marren
Crohn's disease and ulcerative colitis are chronic inflammatory disorders of the gastrointestinal tract. Treatment options include biologic therapies; however, a proportion of patients lose response to biologics, partly due to the formation of anti-drug antibodies (ADAbs). Concomitant immunosuppressive agents reduce the development of ADAbs. This review article aims to assess the immunogenicity of biologic therapies and their clinical implications. A comprehensive literature search was conducted for articles published January 2009 to August 2015 reporting immunogenicity to adalimumab (ADM), certolizumab pegol (CZP), golimumab, infliximab (IFX), ustekinumab, and vedolizumab in inflammatory bowel disease (IBD)...
2018: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/29381220/prediction-of-individual-serum-infliximab-concentrations-in-inflammatory-bowel-disease-by-a-bayesian-dashboard-system
#15
Alexander Eser, Christian Primas, Sieglinde Reinisch, Harald Vogelsang, Gottfried Novacek, Diane R Mould, Walter Reinisch
Despite a robust exposure-response relationship of infliximab in inflammatory bowel disease (IBD), attempts to adjust dosing to individually predicted serum concentrations of infliximab (SICs) are lacking. Compared with labor-intensive conventional software for pharmacokinetic (PK) modeling (eg, NONMEM) dashboards are easy-to-use programs incorporating complex Bayesian statistics to determine individual pharmacokinetics. We evaluated various infliximab detection assays and the number of samples needed to precisely forecast individual SICs using a Bayesian dashboard...
January 30, 2018: Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/29361094/a-mobile-infliximab-dosing-calculator-for-therapy-optimization-in-inflammatory-bowel-disease
#16
Travis Piester, Adam Frymoyer, Megan Christofferson, Helen Yu, Dorsey Bass, K T Park
Background: Inadequate infliximab (IFX) drug exposure remains a clinical challenge and leads to high loss of response rates and therapy failure in inflammatory bowel disease (IBD). We aimed to determine the feasibility and pilot effectiveness of a novel, web-based, mobile IFX dosing calculator (mIDC) for therapy optimization. Methods: We developed an mIDC leveraging the known clinical variables of C-reative protein (CRP), albumin, patient's weight, disease activity indices, calprotectin, drug trough levels, and antibodies to IFX that significantly affect pharmacokinetics and/or outcomes...
January 18, 2018: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/29330783/clinical-pharmacokinetics-and-pharmacodynamics-of-infliximab-in-the-treatment-of-inflammatory-bowel-disease
#17
REVIEW
Amy Hemperly, Niels Vande Casteele
Infliximab was the first monoclonal antibody to be approved for the treatment of pediatric and adult patients with moderately to severely active Crohn's disease (CD) and ulcerative colitis (UC). It has been shown to induce and maintain both clinical remission and mucosal healing in pediatric and adult patients with inflammatory bowel disease (IBD) who are unresponsive or refractory to conventional therapies. The administration of infliximab is weight-based and the drug is administered intravenously. The volume of distribution of infliximab is low and at steady state ranges from 4...
January 12, 2018: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29236229/model-based-therapeutic-drug-monitoring-of-infliximab-using-a-single-serum-trough-concentration
#18
David Ternant, Christophe Passot, Alexandre Aubourg, Philippe Goupille, Céline Desvignes, Laurence Picon, Thierry Lecomte, Denis Mulleman, Gilles Paintaud
BACKGROUND AND OBJECTIVES: The pharmacokinetics of infliximab are highly variable and influence clinical response in chronic inflammatory diseases. The goal of this study was to build a Bayesian model allowing predictions of upcoming infliximab concentrations and dosing regimen adjustment, using only one concentration measurement and information regarding the last infliximab infusion. METHODS: This retrospective study was based on data from 218 patients treated with infliximab in Tours University Hospital who were randomly assigned to learning (two-thirds) or validation (one-third) data subsets...
December 13, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/29226370/anti-infliximab-antibody-concentrations-can-guide-treatment-intensification-in-patients-with-crohn-s-disease-who-lose-clinical-response
#19
E Dreesen, T Van Stappen, V Ballet, M Peeters, G Compernolle, S Tops, K Van Steen, G Van Assche, M Ferrante, S Vermeire, A Gils
BACKGROUND: The presence of antibodies towards infliximab (ATI) is associated with lower infliximab (IFX) trough concentrations and loss of response. IFX treatment intensification is effective for restoring response in most, but not all patients with Crohn's disease (CD). AIM: To compare outcome, pharmacokinetics and immunogenicity of treatment intensification strategies in patients with CD who lost clinical response to IFX. METHODS: A retrospective cohort study was conducted, including 103 patients with CD who lost clinical response during IFX maintenance therapy and therefore received a double dose IFX (10 mg/kg) and/or a next infusion after a shortened interval...
February 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29200097/external-evaluation-of-population-pharmacokinetic-models-of-infliximab-in-patients-with-inflammatory-bowel-disease
#20
Eugènia Santacana, Lorena Rodríguez-Alonso, Ariadna Padullés, Jordi Guardiola, Francisco Rodríguez-Moranta, Katja Serra, Jordi Bas, Francisco Morandeira Biology, Helena Colom, Núria Padullés
BACKGROUND: Infliximab (IFX) trough levels vary markedly between patients with inflammatory bowel disease (IBD), which is important for clinical response. The aim of this study was to evaluate the performance of previously developed population pharmacokinetic models in patients with IBD for dose individualization for Crohn disease (CD) and ulcerative colitis in our clinical setting. METHODS: The authors collected 370 trough levels prospectively from 100 adult patients with IBD who were undergoing IFX treatment between July 2013 and August 2016...
February 2018: Therapeutic Drug Monitoring
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