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infliximab pharmacokinetics

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https://www.readbyqxmd.com/read/29045077/subjective-complaints-as-main-reason-for-biosimilar-discontinuation-after-open-label-transitioning-from-originator-to-biosimilar-infliximab
#1
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
#2
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...
September 22, 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
#3
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)...
September 6, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28803431/sb2-an-infliximab-biosimilar
#4
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...
August 12, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28692448/the-use-of-biosimilars-in-paediatric-inflammatory-bowel-disease
#5
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
#6
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...
June 30, 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
#7
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...
June 30, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28652703/ct-p13-design-development-and-place-in-therapy
#8
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
#9
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
#10
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
#11
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
#12
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
#13
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
https://www.readbyqxmd.com/read/28498153/infliximab-trough-levels-at-induction-to-predict-treatment-failure-during-maintenance
#14
Claire Liefferinckx, Charlotte Minsart, Jean-François Toubeau, Anneline Cremer, Leila Amininejad, Eric Quertinmont, Jacques Devière, Ann Gils, André van Gossum, Denis Franchimont
BACKGROUND: Infliximab (IFX) is indicated for the treatment of inflammatory bowel diseases (IBD). Nevertheless, loss of response (LOR) to IFX is reported in up to 10% to 30% of patients within the first year of treatment. Our objective was to evaluate the impact of the pharmacokinetics of IFX at induction on treatment failure. METHODS: This is a longitudinal cohort study on 269 patients with IBD treated with IFX in a single center. A total of 2331 blood samples were prospectively collected from 2007 until March 2015 with a retrospective analysis of clinical data...
August 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28471911/application-of-population-pharmacokinetic-modeling-for-individualized-infliximab-dosing-strategies-in-crohn-s-disease
#15
Adam Frymoyer, Daniël R Hoekman, Travis L Piester, Tim G de Meij, Thalia Z Hummel, Marc A Benninga, Angelika Kindermann, K T Park
OBJECTIVES: The pharmacokinetics of infliximab are highly variable in children with Crohn's disease (CD), and a one-size-fits-all approach to dosing is inadequate. Model-based drug dosing can help individualize dosing strategies. We evaluated the predictive performance and clinical utility of a published population pharmacokinetic model of infliximab in children with CD. METHODS: Within a cohort of 34 children with CD who had infliximab trough concentrations measured, the pharmacokinetics of each patient was estimated in NONMEM® using a published population pharmacokinetic model...
May 3, 2017: Journal of Pediatric Gastroenterology and Nutrition
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
#16
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
#17
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-recombinant-tumor-necrosis-factor-%C3%AE-in-plasma-using-minimal-physiologically-based-pharmacokinetic-models
#18
Xi Chen, Debra C DuBois, Richard R Almon, William J Jusko
The soluble cytokine tumor necrosis factor-α (TNF-α) is an important target for many therapeutic proteins used in the treatment of rheumatoid arthritis. Biologics targeting TNF-α exert their pharmacologic effects through binding and neutralizing this cytokine and preventing it from binding to its cell surface receptors. The magnitude of their pharmacologic effects directly corresponds to the extent and duration of free TNF-α suppression. However, endogenous TNF-α is of low abundance, so it is quite challenging to assess the free TNF-α suppression experimentally...
July 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
#19
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...
August 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28363434/switching-biologics-in-the-treatment-of-psoriatic-arthritis
#20
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...
August 2017: Seminars in Arthritis and Rheumatism
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