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infliximab pharmacokinetics

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https://www.readbyqxmd.com/read/28449228/azathioprine-dose-reduction-in-inflammatory-bowel-disease-patients-on-combination-therapy-an-open-label-prospective-and-randomised-clinical-trial
#1
X Roblin, G Boschetti, N Williet, S Nancey, H Marotte, A Berger, J M Phelip, L Peyrin-Biroulet, J F Colombel, E Del Tedesco, S Paul, B Flourie
BACKGROUND: Infliximab (IFX) combined with azathioprine (AZA) is more effective than IFX monotherapy in inflammatory bowel disease (IBD). AIM: To identify the AZA optimal dose that is required for efficacy when receiving combination therapy. METHODS: Patients with IBD in durable remission on combination therapy were enrolled in a 1-year, open-label, prospective trial after randomisation into three groups: AZA steady (2-2.5 mg/kg/day, n=28) vs AZA down (dose was halved 1-1...
April 27, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28444562/infliximab-maintenance-dosing-in-inflammatory-bowel-disease-an-example-for-in-silico-assessment-of-adaptive-dosing-strategies
#2
Jessica Wojciechowski, Richard N Upton, Diane R Mould, Michael D Wiese, David J R Foster
Infliximab is an anti-tumour necrosis factor alpha monoclonal antibody used to treat inflammatory diseases. Many patients fail during induction and others respond initially but relapse during maintenance therapy. Although anti-drug antibodies (ADA) are associated with some clinical failures, there is evidence that some failures may be due to subtherapeutic exposure. Adapting doses based on clinical outcomes and trough concentrations can improve response and reduce the proportion that develop ADA, but identification of appropriate doses in the presence of time-varying patient factors is complicated...
April 25, 2017: AAPS Journal
https://www.readbyqxmd.com/read/28411280/interrelationships-between-infliximab-and-rhtnf-%C3%AE-in-plasma-using-minimal-physiologically-based-pharmacokinetic-mpbpk-models
#3
Xi Chen, Debra C DuBois, Richard R Almon, William J Jusko
The soluble cytokine TNF-α is an important target for many therapeutic proteins used in the treatment of rheumatoid arthritis (RA). Biologics targeting TNF-α exert their pharmacological effects through binding and neutralizing this cytokine and preventing it from binding to its cell surface receptors. The magnitude of their pharmacological effects directly corresponds to the extent and duration of free TNF-α suppression. However, endogenous TNF-α is of low abundance and therefore it is quite challenging to assess the free TNF-α suppression experimentally...
April 14, 2017: Drug Metabolism and Disposition: the Biological Fate of Chemicals
https://www.readbyqxmd.com/read/28374338/therapeutic-drug-monitoring-of-golimumab-in-the-treatment-of-ulcerative-colitis
#4
REVIEW
Niels Vande Casteele, Reena Khanna
Ulcerative colitis (UC) is a relapsing-remitting chronic inflammatory disorder affecting the mucosal surface in a continuous manner from the rectum through part of, or the entire, colon. Patients with severe disease and those who become refractory or intolerant to corticosteroids and/or immunosuppressants, require treatment with biologic agents that target tumor necrosis factor-α (TNF). Golimumab, a fully human monoclonal antibody, is the latest TNF antagonist to get approved for the treatment of moderate-to-severe UC...
April 3, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28363434/switching-biologics-in-the-treatment-of-psoriatic-arthritis
#5
REVIEW
Joseph F Merola, Benjamin Lockshin, Elinor A Mody
OBJECTIVE: Psoriatic arthritis (PsA) is a heterogeneous inflammatory disorder that requires targeted treatment based on clinical manifestations, symptom severity, comorbidities, and other factors. Moderate or severe peripheral arthritis symptoms are typically treated with disease-modifying antirheumatic drugs (DMARDs) or biologic DMARDs (bDMARDs), and early and aggressive treatment is recommended in order to prevent permanent damage. Although rheumatologists are now able to choose between several bDMARDs for PsA that have different chemical structures, pharmacokinetic properties, dosing regimens, immunogenicity, safety profiles, and mechanisms of action, there is a lack of typical patient profiles or detailed treatment algorithms that can be followed when patients require alterations in their therapeutic regimens...
February 8, 2017: Seminars in Arthritis and Rheumatism
https://www.readbyqxmd.com/read/28318043/the-effects-of-pregnancy-on-the-pharmacokinetics-of-infliximab-and-adalimumab-in-inflammatory-bowel-disease
#6
C H Seow, Y Leung, N Vande Casteele, E Ehteshami Afshar, D Tanyingoh, G Bindra, M J Stewart, P L Beck, G G Kaplan, S Ghosh, R Panaccione
BACKGROUND: Transplacental transfer of infliximab and adalimumab results in detectable drug levels in the cord blood and infant. AIM: To determine if pregnancy influenced the pharmacokinetics of anti-TNF agents in women with inflammatory bowel disease. METHODS: Twenty-five women from the University of Calgary inflammatory bowel disease(IBD) pregnancy clinic on maintenance infliximab or adalimumab were recruited prospectively with serum bio-banking performed each trimester...
May 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28286562/golimumab-pharmacokinetics-in-ulcerative-colitis-a-literature-review
#7
REVIEW
Ines Harzallah, Josselin Rigaill, Nicolas Williet, Stephane Paul, Xavier Roblin
Golimumab (GLM) is the latest anti-tumor necrosis factor (TNF) that gained its marketing license. Thanks to the PURSUIT induction and maintenance trials, it was approved for the treatment of ulcerative colitis (UC) in 2013. The other anti-TNF drugs available are infliximab and adalimumab. These two drugs have validated algorithms concerning prescription and therapeutic drug monitoring (TDM) but little is known about GLM. The available data on GLM's exposure-response relationship in UC are from the PURSUIT trials and are recently published...
January 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/28280299/a-practical-guide-about-biosimilar-data-for-health-care-providers-treating-inflammatory-diseases
#8
REVIEW
Joseph Markenson, Daniel F Alvarez, Ira Jacobs, Carol Kirchhoff
To make informed decisions about the safety, efficacy, and clinical utility of a biosimilar, health care providers should understand the types and be able to analyze data generated from a biosimilar development program. This article reviews the biosimilar guidelines, the biosimilar development process to provide education and context about biosimilarity, and uses examples from infliximab biosimilars to review the terminology and potential types of analyses that may be used to compare potential biosimilars to the originator biologic...
2017: Biologics: Targets & Therapy
https://www.readbyqxmd.com/read/28209290/efficacy-safety-and-pharmacokinetics-of-biosimilars-of-anti-tumor-necrosis-factor-%C3%AE-agents-in-rheumatic-diseases-a-systematic-review-and-meta-analysis
#9
REVIEW
Yuga Komaki, Akihiro Yamada, Fukiko Komaki, Praneeth Kudaravalli, Dejan Micic, Akio Ido, Atsushi Sakuraba
OBJECTIVE: To evaluate the efficacy and safety of biosimilars of anti-tumor necrosis factor (TNF)-α agents compared to their reference agents in immune mediated diseases. METHODS: Electronic databases were searched for randomized controlled trials (RCTs) assessing the efficacy and safety of biosimilars of anti-TNF-α agents compared to their reference agents in patients with various immune mediated diseases. The outcomes were the rates of clinical response and adverse events among patients treated with biosimilars compared to their reference agents...
February 13, 2017: Journal of Autoimmunity
https://www.readbyqxmd.com/read/28197743/the-impact-of-therapeutic-antibodies-on-the-management-of-digestive-diseases-history-current-practice-and-future-directions
#10
EDITORIAL
M Anthony Sofia, David T Rubin
The development of therapeutic antibodies represents a revolutionary change in medical therapy for digestive diseases. Beginning with the initial studies that confirmed the pathogenicity of cytokines in inflammatory bowel disease, the development and application of therapeutic antibodies brought challenges and insights into their potential and optimal use. Infliximab was the first biological drug approved for use in Crohn's disease and ulcerative colitis. The lessons learned from infliximab include the importance of immunogenicity and the influence of pharmacokinetics on disease response and outcomes...
February 14, 2017: Digestive Diseases and Sciences
https://www.readbyqxmd.com/read/28195852/a-real-life-population-pharmacokinetic-study-reveals-factors-associated-with-clearance-and-immunogenicity-of-infliximab-in-inflammatory-bowel-disease
#11
Johannan F Brandse, Diane Mould, Oscar Smeekes, Yaël Ashruf, Sabine Kuin, Anne Strik, Gijs R van den Brink, Geert R DʼHaens
BACKGROUND: Several factors influencing the pharmacokinetics of infliximab (IFX) in inflammatory bowel disease (IBD) have been identified. We studied the impact of patient, disease, and treatment characteristics on clearance and immunogenicity of IFX in a real-world patient-with-IBD cohort. METHODS: Serum concentrations of IFX and antibodies to IFX (ATIs) were measured in patients with IBD at a single center using an enzyme-linked immunosorbent assay and radioimmunoassay...
April 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28188909/extensive-preclinical-evaluation-of-an-infliximab-biosimilar-candidate
#12
M A Velasco-Velázquez, N Salinas-Jazmín, E Hisaki-Itaya, L Cobos-Puc, W Xolalpa, G González, A Tenorio-Calvo, N Piña-Lara, L C Juárez-Bayardo, L F Flores-Ortiz, E Medina-Rivero, N O Pérez, S M Pérez-Tapia
Infliximab is therapeutic monoclonal antibody (mAb) against TNF-α employed in the treatment of immunoinflammatory diseases. The development of biosimilar mAbs is a global strategy to increase drug accessibility and reduce therapy-associated costs. Herein we compared key physicochemical characteristics and biological activities produced by infliximab and infliximab-Probiomed in order to identify functionally relevant differences between the mAbs. Binding of infliximab-Probiomed to TNF-α was specific and had kinetics comparable to that of the reference product...
February 7, 2017: European Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/28174940/dop032-hydrocortisone-premedication-withdrawal-in-patients-on-stable-infliximab-maintenance-clinical-and-pharmacokinetic-outcomes
#13
M-L Tran-Minh, M Maillet, C Auzolle, M Simon, A L Cathala, T Aparicio, C Baudry, J Bonnet, N Lourenco, P Houze, J-M Gornet, M Allez
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28172877/p393-evaluation-of-pharmacokinetic-profiles-of-sb2-as-a-biosimilar-of-reference-infliximab
#14
D Shin, J W Kang, S Park, Y Lee, S Lee
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28125553/o-005-combination-therapy-with-methotrexate-does-not-change-infliximab-pharmacokinetics-in-children-with-inflammatory-bowel-disease
#15
Valentina Shakhnovich, Leon Van Haandel, Mara Becker, Ryan Funk
BACKGROUND: There remains a question of equipoise regarding the use of anti-TNF-α agent (e.g., infliximab) monotherapy versus combination therapy with immunomodulators (e.g., methotrexate), for the treatment of pediatric Inflammatory Bowel Disease (IBD). The aim of this prospective cross-sectional study was to assess the impact of methotrexate (MTX) on infliximab (IFX) pharmacokinetics (i.e., serum trough levels) and infliximab antibody (anti-IFX) formation in children with IBD. METHODS: Forty-one children with IBD (9-21 yr of age), receiving maintenance IFX infusions as part of their standard-of-medical-care, had serum IFX and anti-IFX concentrations assessed via an established NF-kB luciferase gene-reporter assay (ARUP Laboratories)...
February 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28125552/o-004-application-of-population-pharmacokinetic-modeling-to-develop-individualized-infliximab-dosing-strategies-in-pediatric-crohn-s-disease
#16
Adam Frymoyer, Daniel Hoekman, Tim de Meij, Thalia Hummel, Marc Benninga, Angelika Kindermann, Travis Piester, K T Park
BACKGROUND: Adequate infliximab (IFX) exposure is critical when treating Crohn's disease (CD), and trough concentrations <3 μg/mL are associated with loss of response. However, the pharmacokinetics of IFX are highly variable in children with CD, and this has made IFX dosing challenging in this population. Model-based drug dosing offers the potential for developing individualized dosing strategies. The objective of the current study was to evaluate the predictive performance and clinical utility of a previously published population pharmacokinetic model of IFX when applied to children with CD...
February 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28095262/biosimilars-in-inflammatory-bowel-disease-accumulating-clinical-evidence
#17
REVIEW
Sean McConachie, Sheila M Wilhelm, Pramodini B Kale-Pradhan
Biologic antagonists to tumor necrosis factor alpha (TNF- α) are effective medications and have become well established in the treatment of both Crohn's disease and ulcerative colitis. Biosimilar medications, which are medications deemed to be equivalent to reference biologic products in terms of clinical effectiveness, safety, pharmacokinetic analysis, and immunogenicity, have now been approved in inflammatory bowel diseases (IBD) based on indication exploration from clinical data in alternate disease states...
April 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28078646/mucosal-healing-in-ulcerative-colitis-a-comprehensive-review
#18
REVIEW
Pedro Boal Carvalho, José Cotter
Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by periods of remission and periods of relapse. Patients often present with symptoms such as rectal bleeding, diarrhea and weight loss, and may require hospitalization and even colectomy. Long-term complications of UC include decreased quality of life and productivity and an increased risk of colorectal cancer. Mucosal healing (MH) has gained progressive importance in the management of UC patients. In this article, we review the endoscopic findings that define both mucosal injury and MH, and the strengths and limitations of the scoring systems currently available in clinical practice...
February 2017: Drugs
https://www.readbyqxmd.com/read/28074618/review-article-dose-optimisation-of-infliximab-for-acute-severe-ulcerative-colitis
#19
REVIEW
P Hindryckx, G Novak, N Vande Casteele, D Laukens, C Parker, L M Shackelton, N Narula, R Khanna, P Dulai, B G Levesque, W J Sandborn, G D'Haens, B G Feagan, V Jairath
BACKGROUND: Although optimal medical management of acute severe ulcerative colitis (UC) is ill-defined, infliximab has become a standard of care. Accumulating evidence suggests an increased rate of infliximab clearance in patients with acute severe UC and a reduced colectomy rate with an intensified infliximab induction regimen. AIM: To assess the strength of the current evidence for the relationship between infliximab pharmacokinetics, dosing strategies and disease behaviour in patients with acute severe UC...
January 11, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/27876365/midyear-commentary-on-trends-in-drug-delivery-and-clinical-translational-medicine-growth-in-biosimilar-complex-injectable-drug-formulation-products-within-evolving-collaborative-regulatory-interagency-fda-ftc-and-doj-practices-and-enforcement
#20
Rodney J Y Ho
Before the 2009 Biologics Price Competition and Innovation Act that enabled the U.S. Federal Drug Administration (FDA) to create the 351(k) Biologic License Application-an abbreviated biosimilar approval process, FDA approved follow-on biomolecule products such as beta-interferon, glucagon, hyaluronidase, and somatropin (human growth hormone) under varying and evolving rules. With the 351(k) Biologic License Application biosimilar approval process in place, currently, there are 4 (licensed in 2015-2016) biosimilars available, namely Neupogen (filgrastim; $1 B/y), Humira (adalumumab; $14...
February 2017: Journal of Pharmaceutical Sciences
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