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infliximab pharmacokinetics

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https://www.readbyqxmd.com/read/29623653/infliximab-pharmacokinetics-are-influenced-by-intravenous-immunoglobulin-administration-in-patients-with-kawasaki-disease
#1
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
#2
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...
March 29, 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
#3
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
#4
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
#5
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...
March 12, 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
#6
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
#7
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)...
February 15, 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
#8
B Gorovits, D J Baltrukonis, I Bhattacharya, M A Birchler, D Finco, D Sikkema, M S Vincent, S Lula, L Marshall, T P Hickling
OBJECTIVE: To examine the assay formats used to detect anti-drug antibodies (ADA) in clinical studies of the anti-TNF monoclonal antibodies adalimumab and infliximab in chronic inflammatory disease and their potential impact on pharmacokinetic and clinical outcomes. METHODS: Using findings of a recent systematic literature review of the immunogenicity of 11 biologic/biosimilar agents, we conducted an ancillary qualitative review of a subset of randomized controlled trials and observational studies of the monoclonal antibodies against anti-tumor necrosis 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
#9
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)...
January 30, 2018: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/29383030/immunogenicity-of-biologics-in-inflammatory-bowel-disease
#10
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
#11
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
#12
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
#13
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
#14
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
#15
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
#16
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
https://www.readbyqxmd.com/read/29189133/risk-assessment-and-monitoring-of-antibody-responses-to-biosimilars-in-chronic-inflammatory-diseases
#17
Iris Detrez, Ann Gils
BACKGROUND: The expiry of the patent of several leading biological medicinal products has led to a surge in the development of 'biosimilar' products. In contrast to generic small-molecule medicines, biosimilars are not identical to their reference medicinal products. METHODS: Full comparability in quality as well as in preclinical and clinical issues is required to register a biosimilar. Since immunogenicity is key for biological medicinal products, regulatory authorities in the European Union require antidrug antibody (ADA) responses to be evaluated and to be approached from a safety perspective...
November 29, 2017: Current Pharmaceutical Design
https://www.readbyqxmd.com/read/29172978/application-of-the-fda-biosimilar-extrapolation-framework-to-make-off-label-determinations
#18
Edward Li, Ernesto Lobaina
BACKGROUND: The FDA's extrapolation framework allows for a biosimilar to obtain licensure for indications that were not explicitly studied in the context of a clinical trial by extending conclusions from studies in 1 population to make inferences in other populations. Within routine clinical care, drugs and biologics are routinely used for medically accepted off-label indications. The appropriateness of these products for off-label indications are typically curated by compendia and guidelines, which have established processes and criteria for reviewing and evaluating the evidence to make such determinations...
December 2017: Journal of Managed Care & Specialty Pharmacy
https://www.readbyqxmd.com/read/29073159/body-mass-index-influences-infliximab-post-infusion-levels-and-correlates-with-prospective-loss-of-response-to-the-drug-in-a-cohort-of-inflammatory-bowel-disease-patients-under-maintenance-therapy-with-infliximab
#19
Franco Scaldaferri, Daria D'Ambrosio, Grainne Holleran, Andrea Poscia, Valentina Petito, Loris Lopetuso, Cristina Graziani, Lucrezia Laterza, Maria Teresa Pistone, Silvia Pecere, Diego Currò, Eleonora Gaetani, Alessandro Armuzzi, Alfredo Papa, Giovanni Cammarota, Antonio Gasbarrini
INTRODUCTION: Infliximab is an effective treatment for inflammatory bowel disease (IBD). Studies differ regarding the influence of body mass index (BMI) on the response to infliximab, with the majority of studies indicating that increased BMI may be associated with a poorer response to Infliximab. However, the pharmacokinetic mechanisms causing this have not yet been reported. AIMS: Examine the correlation between BMI/immunosuppressant use with clinical response, trough and post-infusion levels of infliximab, tumour necrosis factor-α(TNF-α) and anti-drug antibodies(ATI), and determine if these factors can predict future response...
2017: PloS One
https://www.readbyqxmd.com/read/29067885/a-review-article-on-biosimilar-infliximab-sb2-in-the-treatment-of-rheumatoid-arthritis
#20
Salvatore Bellinvia, Madiha Ashraf, Riccardo Polosa, Christopher Edwards
TNF inhibition has had a major impact as an approach for treating rheumatoid arthritis and a series of biologic agents directed against TNF have been developed for clinical use. Infliximab, a chimeric monoclonal antibody against soluble and membrane-bound TNF-α, was the biopharmaceutical to lead this 'biologics revolution'. However, with expiration of patent protection of the originator medicinal product, biosimilar versions of infliximab have been developed through biosimilarity studies and randomized controlled trials aiming to assess pharmacokinetic, pharmacodynamic and clinical equivalence to their originator (reference product) in patients with moderate-to-severe disease activity...
November 2017: Immunotherapy
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