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infliximab pharmacokinetics

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https://www.readbyqxmd.com/read/29236229/model-based-therapeutic-drug-monitoring-of-infliximab-using-a-single-serum-trough-concentration
#1
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-on-treatment-intensification-in-patients-with-crohn-s-disease-who-lose-clinical-response
#2
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...
December 11, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29200097/external-evaluation-of-population-pharmacokinetic-models-of-infliximab-in-inflammatory-bowel-disease-patients
#3
Eugènia Santacana, Lorena Rodríguez-Alonso, Ariadna Padullés, Jordi Guardiola, Francisco Rodríguez-Moranta, Katja Serra, Jordi Bas, Francisco Morandeira, 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 IBD patients for dose individualization for Crohn's disease and ulcerative colitis in our clinical setting. METHODS: The authors collected 370 trough levels prospectively from 100 adult IBD patients who were undergoing IFX treatment between July 2013 and August 2016...
December 1, 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/29189133/risk-assessment-and-monitoring-of-antibody-responses-to-biosimilars-in-chronic-inflammatory-diseases
#4
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
#5
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
#6
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
#7
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
https://www.readbyqxmd.com/read/29045077/subjective-complaints-as-main-reason-for-biosimilar-discontinuation-after-open-label-transitioning-from-originator-to-biosimilar-infliximab
#8
Lieke Tweehuysen, Bart J F van den Bemt, Iris L van Ingen, Alphons J L de Jong, Willemijn H van der Laan, Frank H J van den Hoogen, Alfons A den Broeder
OBJECTIVE: To evaluate drug survival, effectiveness, pharmacokinetics, immunogenicity and safety after transitioning treatment from originator infliximab (Remicade(®) , REM) to biosimilar infliximab (CT-P13) in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis in daily practice. METHODS: 192 of 222 REM-treated patients agreed to transition to CT-P13 and were included in this multicenter prospective cohort study. Change in DAS28-CRP, BASDAI, CRP and (anti-) infliximab levels were assessed after six months and adverse events (AEs) were documented...
October 18, 2017: Arthritis & Rheumatology
https://www.readbyqxmd.com/read/28945638/tissue-drug-concentrations-of-anti-tumor-necrosis-factor-agents-are-associated-with-the-long-term-outcome-of-patients-with-crohn-s-disease
#9
Takeo Yoshihara, Shinichiro Shinzaki, Shoichiro Kawai, Hironobu Fujii, Shuko Iwatani, Toshio Yamaguchi, Manabu Araki, Satoshi Hiyama, Takahiro Inoue, Yoshito Hayashi, Kenji Watabe, Hideki Iijima, Tetsuo Takehara
BACKGROUND: Many reports indicate that a high-serum trough level of anti-tumor necrosis factor (TNF) agents is required for sustained remission in patients with Crohn's disease The pharmacokinetics of anti-TNF agents in inflamed intestinal tissue, however, is not well investigated. We investigated the association between the tissue concentration of anti-TNF agents and long-term disease outcome. METHODS: This was a prospective single-center study that enrolled 25 patients with Crohn's disease who were administered infliximab or adalimumab...
December 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28879645/pharmacokinetic-effects-of-antidrug-antibodies-occurring-in-healthy-subjects-after-a-single-dose-of-intravenous-infliximab
#10
Eli D Ehrenpreis
BACKGROUND: Infliximab pharmacokinetic studies have been performed in patients receiving chronic infliximab therapy. In these patients, infliximab antidrug antibodies (ADAs) increase infliximab clearance and decrease serum levels and drug efficacy. OBJECTIVE: This study analyzed the pharmacokinetic effect of infliximab ADAs in healthy subjects receiving a single dose of intravenous infliximab. METHODS: Data were obtained from a single-blind, parallel-group, single-dose study of healthy subjects receiving 5 mg/kg of intravenous SB2 (infliximab biosimilar), EU-sourced Remicade (EU-IFX) or US-sourced Remicade (US-IFX)...
December 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28803431/sb2-an-infliximab-biosimilar
#11
Yvette N Lamb, Lesley J Scott, Emma D Deeks
SB2 is a biosimilar of the reference anti-TNF-α antibody infliximab. In May 2015, it was approved in the EU for use in all indications for which reference infliximab is approved, including rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriatic arthritis and psoriasis. It is also approved in these indications in several other countries, including Korea, the USA and Australia. Characterization of SB2 in preclinical studies showed that it is similar to reference infliximab...
October 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28692448/the-use-of-biosimilars-in-paediatric-inflammatory-bowel-disease
#12
Maria Myrthe Elisabeth Jongsma, Arnold Vulto, Lissy de Ridder
PURPOSE OF REVIEW: After expiry of the patent of originator anti-tumor necrosis factor drug infliximab (Remicade), CT-P13 was in 2013 the first infliximab biosimilar to be approved by the European Medicine Agency (EMA) for the same indications as the reference drug, including paediatric inflammatory bowel disease (IBD). The approval was based on extrapolation, after extensive in-vitro studies and clinical experience in patients with ankylosing spondylitis and rheumatoid arthritis. The extrapolation of CT-P13 to IBD and to paediatric patients raised concerns among paediatric IBD specialists...
October 2017: Current Opinion in Pediatrics
https://www.readbyqxmd.com/read/28667429/long-term-clinical-outcomes-after-switching-from-remicade-%C3%A2-to-biosimilar-ct-p13-in-inflammatory-bowel-disease
#13
Lisa J T Smits, Anna Grelack, Lauranne A A P Derikx, Dirk J de Jong, Aura A J van Esch, Ronald S Boshuizen, Joost P H Drenth, Frank Hoentjen
BACKGROUND: Limited data are available on long-term clinical outcomes regarding the switch from Remicade(®) to the infliximab biosimilar CT-P13 in inflammatory bowel disease (IBD) patients. AIMS: To investigate long-term efficacy, safety, pharmacokinetic profile, and immunogenicity. METHODS: We performed a single-center prospective observational cohort study following an elective switch from Remicade(®) to CT-P13 in IBD patients. RESULTS: Eighty-three patients were included (57 Crohn's disease, 24 ulcerative colitis, and 2 IBD unclassified), and 68 patients completed one-year follow-up...
November 2017: Digestive Diseases and Sciences
https://www.readbyqxmd.com/read/28667384/effectiveness-and-safety-of-switching-from-innovator-infliximab-to-biosimilar-ct-p13-in-inflammatory-rheumatic-diseases-a-real-world-case-study
#14
Cristina Vergara-Dangond, Marina Sáez Belló, Mónica Climente Martí, Pilar Llopis Salvia, Juan José Alegre-Sancho
OBJECTIVE: CT-P13 is a biosimilar with comparable pharmacokinetics, efficacy and safety to its reference product (RP), infliximab. Studies have shown that switching from RP to CT-P13 does not reduce the effectiveness or safety of treatment. METHODS: In this retrospective real-world study, patients with inflammatory diseases treated with RP were switched to CT-P13 (n = 7) or continued on RP (n = 6). Clinical outcomes were compared between groups after four treatment cycles...
September 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28652703/ct-p13-design-development-and-place-in-therapy
#15
REVIEW
Tommaso Gabbani, Simona Deiana, Vito Annese
The introduction of biological agents has revolutionized the management of many life-threatening and debilitating immune-mediated diseases. Because of the high cost of biological drugs and their patent expiration, the market has opened to biosimilar agents, copy versions of the originators, which can lead to reduced health care expenditure and increase treatment access worldwide. CT-P13 is the first biosimilar of infliximab (IFX) and has been approved for the same indications as its originator drug. It obtained regulatory approval by the European Medicines Agency in September 2013 and by the US Food and Drug Administration in April 2016...
2017: Drug Design, Development and Therapy
https://www.readbyqxmd.com/read/28629912/calprotectin-and-the-magnitude-of-antibodies-to-infliximab-in-clinically-stable-ulcerative-colitis-patients-are-more-relevant-than-infliximab-trough-levels-and-pharmacokinetics-for-therapeutic-escalation
#16
Fernando Magro, Joana Afonso, Susana Lopes, Rosa Coelho, Raquel Gonçalves, Paulo Caldeira, Paula Lago, Helena Tavares de Sousa, Jaime Ramos, Ana Rita Gonçalves, Paula Ministro, Isadora Rosa, Ana Isabel Vieira, Patrícia Andrade, João-Bruno Soares, Diana Carvalho, Paula Sousa, Tânia Meira, Joanne Lopes, Joana Moleiro, Cláudia Camila Dias, Amílcar Falcão, Karel Geboes, Fatima Carneiro
Although infliximab (IFX) is an efficient therapy for ulcerative colitis (UC) patients, a considerably high rate of therapeutic failures still occurs. This study aimed at a better understanding of IFX pharmacokinetics and pharmacodynamics among clinically-asymptomatic UC patients. This was a multicentric and prospective study involving 65 UC patients in the maintenance phase of IFX therapy. There were no significant differences between patients with positive and negative clinical, endoscopic and histological outcomes concerning their IFX trough levels (TLs), area under the IFX concentration vs...
July 2017: EBioMedicine
https://www.readbyqxmd.com/read/28593609/therapeutic-drug-monitoring-tdm-as-a-tool-in-the-switch-from-infliximab-innovator-to-biosimilar-in-rheumatic-patients-results-of-a-12-month-observational-prospective-cohort-study
#17
E M H Schmitz, S Benoy-De Keuster, A J L Meier, V Scharnhorst, R A M Traksel, M A C Broeren, L J J Derijks
The objective of this study is to apply therapeutic drug monitoring (TDM) as an objective tool to monitor the switch from infliximab innovator (INX) to infliximab biosimilar (INB) in our diverse rheumatic cohort in daily clinical practice. All rheumatic patients on INX treatment (Remicade®) and ≥18 years were switched to INB (Inflectra®) as part of routine care, but in a controlled setting. Patients were monitored by taking blood samples just before the first infusion of INB (T1), and after the second (T2), fourth (T3), and seventh (T4) infusion of INB...
June 7, 2017: Clinical Rheumatology
https://www.readbyqxmd.com/read/28562666/quantitative-analysis-of-the-cd4-t-cell-response-to-therapeutic-antibodies-in-healthy-donors-using-a-novel-t-cell-pbmc-assay
#18
Heidi S Schultz, Stine Louise Reedtz-Runge, B Thomas Bäckström, Kasper Lamberth, Christian R Pedersen, Anne M Kvarnhammar
Many biopharmaceuticals (BPs) are known to be immunogenic in the clinic, which can result in modified pharmacokinetics, reduced efficacy, allergic reactions and anaphylaxis. During recent years, several technologies to predict immunogenicity have been introduced, but the predictive value is still considered low. Thus, there is an unmet medical need for optimization of such technologies. The generation of T cell dependent high affinity anti-drug antibodies plays a key role in clinical immunogenicity. This study aimed at developing and evaluating a novel in vitro T cell:PBMC assay for prediction of the immunogenicity potential of BPs...
2017: PloS One
https://www.readbyqxmd.com/read/28533919/combination-therapy-for-inflammatory-bowel-disease
#19
REVIEW
Keith S Sultan, Joshua C Berkowitz, Sundas Khan
Biologic therapies such as infliximab and adalimumab have become mainstays of treatment for inflammatory bowel disease. Early studies suggested that combination therapy (CT) with infliximab and an immunomodulator drug such as azathioprine may help optimize biologic pharmacokinetics, minimize immunogenicity, and improve outcomes. The landmark SONIC trial in Crohn's disease and the UC SUCCESS trial in ulcerative colitis demonstrated CT with infliximab and azathioprine to be superior to monotherapy with either agent alone at inducing clinical remission in treatment naïve patients with moderate to severe disease...
May 6, 2017: World Journal of Gastrointestinal Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28513424/a-review-of-six-methods-for-monitoring-infliximab-concentrations-and-antibodies-to-infliximab%C3%A2
#20
REVIEW
Fang Cao, Hailong Cao, Xiaocang Cao
Anti-TNF-α therapy, such as infliximab (IFX), has profoundly changed treatment to induce and maintain remission for inflammatory bowel diseases patients who do not respond to conventional therapies. Unfortunately, IFX, as a chimeric protein, is potentially immunogenic, and antibodies to infliximab (ATI) may interfere with the pharmacodynamics and pharmacokinetics of the drug, thus resulting in a loss of response for a substantial proportion of patients. The clinical efficacy of IFX is correlated with the levels of IFX and ATI...
July 2017: International Journal of Clinical Pharmacology and Therapeutics
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