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infliximab pharmacokinetics

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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
#1
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...
November 19, 2016: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/27739011/magnitude-of-increased-infliximab-clearance-imposed-by-anti-infliximab-antibodies-in-crohn-s-disease-is-determined-by-their-concentration
#2
Helena Edlund, Casper Steenholdt, Mark A Ainsworth, Eva Goebgen, Jørn Brynskov, Ole Ø Thomsen, Wilhelm Huisinga, Charlotte Kloft
Antibodies (Abs) against infliximab (IFX) increase IFX clearance and can result in treatment failure and acute hypersensitivity reactions. However, interpretation of their clinical value is complicated by individual differences in Ab responses and methods used for quantification. The increase in IFX clearance imposed by anti-IFX Abs has generally been evaluated using a binary classification, i.e., positive or negative. This analysis aimed to investigate if anti-IFX Ab concentrations provide a more adequate prediction of alterations in clearance...
October 13, 2016: AAPS Journal
https://www.readbyqxmd.com/read/27739008/pharmacokinetic-dashboard-recommended-dosing-is-different-than-standard-of-care-dosing-in-infliximab-treated-pediatric-ibd-patients
#3
Marla C Dubinsky, Becky L Phan, Namita Singh, Shervin Rabizadeh, Diane R Mould
Standard of care (SOC; combination of 5-10 mg/kg and an interval every 6-8 weeks) dosing of infliximab (IFX) is associated with significant loss of response. Dashboards using covariates that influence IFX pharmacokinetics (PK) may be a more precise way of optimizing anti-TNF dosing. We tested a prototype dashboard to compare forecasted dosing regimens with actual administered regimens and SOC. Fifty IBD patients completing IFX induction were monitored during maintenance (weeks 14-54). Clinical and laboratory data were collected at each infusion; serum was analyzed for IFX concentrations and anti-drug antibodies (ADA) at weeks 14 and 54 (Prometheus Labs, San Diego)...
October 13, 2016: AAPS Journal
https://www.readbyqxmd.com/read/27737604/biology-of-anti-tnf-agents-in-immune-mediated-inflammatory-diseases-therapeutic-implications
#4
Roger A Levy, Renato Guzman, Gilberto Castañeda-Hernández, Manuel Martinez-Vazquez, Guilherme Damian, Carlos Cara
Biologics are increasingly being used to modify the course of immune-mediated inflammatory diseases. Some main agents are monoclonal antibodies and a fusion-protein that target TNF. This group includes adalimumab, infliximab, certolizumab pegol, golimumab and etanercept. Although the efficacy of anti-TNFs is supported by numerous randomized clinical trials, their pharmacokinetics depend on many factors, in particular immunogenicity, which can cause marked and rapid clearance and a consequent decrease in efficacy...
October 14, 2016: Immunotherapy
https://www.readbyqxmd.com/read/27711946/-biosimilars-in-inflammatory-bowel-disease
#5
B Siegmund, R Atreya, B Bokemeyer, W Kruis, J Mudter, C Sander, S Schreiber, W Reindl, S Zeissig, T Kucharzik
After the expiry date of the patent protection for Infliximab in 2013, the biosimilar CT‑P13 was approved for indications in Crohn's disease and ulcerative colitis in adults as well as in children. The approval has been based on two randomized clinical studies indicating equivalence for the biosimilar with regard to pharmacokinetics, efficacy, as well as side-effects. The clinical experience since, in addition to multiple non-randomized studies, indicate a comparable efficacy and immunogenicity of the Infliximab biosimilar CT-P13 in inflammatory bowel disease...
October 6, 2016: Zeitschrift Für Gastroenterologie
https://www.readbyqxmd.com/read/27650650/infliximab-biosimilar-ct-p13-infliximab-dyyb-a-review-in-autoimmune-inflammatory-diseases
#6
Hannah A Blair, Emma D Deeks
Infliximab biosimilar (CT-P13/infliximab-dyyb; Remsima(®), Inflectra(®)) is approved in several countries for use in all indications for which reference infliximab (Remicade(®)) is approved, including rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis, psoriasis, Crohn's disease, and ulcerative colitis. Clinical data contributing to the EU approval of infliximab biosimilar were obtained from two pivotal double-blind clinical trials in patients with AS (PLANETAS) or RA (PLANETRA)...
October 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/27589009/the-underlying-inflammatory-chronic-disease-influences-infliximab-pharmacokinetics
#7
Christophe Passot, Denis Mulleman, Theodora Bejan-Angoulvant, Alexandre Aubourg, Stephanie Willot, Thierry Lecomte, Laurence Picon, Philippe Goupille, Gilles Paintaud, David Ternant
Infliximab is an anti-tumor necrosis factor monoclonal antibody approved in chronic inflammatory diseases such as rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn's disease (CD) and ulcerative colitis (UC). Infliximab pharmacokinetics is variable between patients, but influence of the underlying disease was never assessed. This study aimed at assessing this influence using a cohort of patients monitored in a single center and with the same assay. Infliximab trough concentrations were determined on samples collected between weeks 0 and 22 after treatment initiation in 218 patients treated for RA, PsA, AS, CD or UC...
October 2016: MAbs
https://www.readbyqxmd.com/read/27449503/safety-efficacy-and-immunogenicity-of-switching-from-innovator-to-biosimilar-infliximab-in-patients-with-spondyloarthritis-a-6-month-real-life-observational-study
#8
Maurizio Benucci, Francesca Li Gobbi, Francesca Bandinelli, Arianna Damiani, Maria Infantino, Valentina Grossi, Mariangela Manfredi, Simone Parisi, Enrico Fusaro, Alberto Batticciotto, Piercarlo Sarzi-Puttini, Fabiola Atzeni, Francesca Meacci
Biosimilar infliximab (INX) was recently approved by the European Medicine Agency for the treatment of rheumatoid arthritis, ankylosing spondylitis (AS), Crohn's disease, ulcerative colitis, psoriatic arthritis (PsA), and psoriasis on the grounds that its pharmacokinetics, safety, and efficacy were comparable to those of innovator INX. The aim of this study was to investigate the real-life efficacy, safety, and immunogenicity of switching from innovator to biosimilar INX in patients with spondyloarthritis (SpA)...
July 23, 2016: Immunologic Research
https://www.readbyqxmd.com/read/27438459/pharmacokinetics-interactions-of-monoclonal-antibodies
#9
REVIEW
Nicola Ferri, Stefano Bellosta, Ludovico Baldessin, Donatella Boccia, Giorgi Racagni, Alberto Corsini
The clearance of therapeutic monoclonal antibodies (mAbs) typically does not involve cytochrome P450 (CYP450)-mediated metabolism or interaction with cell membrane transporters, therefore the pharmacokinetics interactions of mAbs and small molecule drugs are limited. However, a drug may affect the clearance of mAbs through the modulation of immune response (e.g., methotrexate reduces the clearance of infliximab, adalimumab, and golimumab, possibly due to methotrexate's inhibitory effect on the formation of antibodies against the mAbs)...
September 2016: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/27310969/infliximab-therapy-for-intestinal-neurological-and-vascular-involvement-in-behcet-disease-efficacy-safety-and-pharmacokinetics-in-a-multicenter-prospective-open-label-single-arm-phase-3-study
#10
Toshifumi Hibi, Shunsei Hirohata, Hirotoshi Kikuchi, Ukihide Tateishi, Noriko Sato, Kunihiko Ozaki, Kazuoki Kondo, Yoshiaki Ishigatsubo
Behçet disease (BD) is a multisystem disease associated with a poor prognosis in cases of gastrointestinal, neurological, or vascular involvement. We conducted a multicenter, prospective, open-label, single-arm phase 3 study to determine the efficacy, safety, and pharmacokinetics of infliximab (IFX) in BD patients with these serious complications who had displayed poor response or intolerance to conventional therapy.IFX at 5 mg/kg was administered to 18 patients (11 intestinal BD, 3 neurological BD [NBD], and 4 vascular BD [VBD]) at weeks 0, 2, and 6 and every 8 weeks thereafter until week 46...
June 2016: Medicine (Baltimore)
https://www.readbyqxmd.com/read/27299733/a-multicenter-open-label-long-term-study-of-three-year-infliximab-administration-in-japanese-patients-with-ankylosing-spondylitis
#11
Shigeto Kobayashi, Toru Yoshinari
OBJECTIVE: To investigate the efficacy, safety, and pharmacokinetics of infliximab (IFX) in Japanese patients with active ankylosing spondylitis (AS). METHODS: In this multicenter open-label study, IFX was infused at 5 mg/kg to 33 Japanese patients with active AS using or intolerable to non-steroidal anti-inflammatory drugs (NSAIDs) at Weeks 0, 2, and 6, and then every six weeks for approximately three years (mean: 149.5 weeks). RESULTS: Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 24 (primary endpoint) was 97...
June 14, 2016: Modern Rheumatology
https://www.readbyqxmd.com/read/27240112/maintenance-therapy-options-for-ulcerative-colitis
#12
María Chaparro, Javier P Gisbert
INTRODUCTION: Medical therapy is the cornerstone of the management of ulcerative colitis (UC) and the goal of the treatment is the induction and maintenance of remission. AREAS COVERED: Mesalamine is the first line treatment in patients with mild to moderate UC. Despite having different formulations available, clinically significant differences in pharmacokinetics and exposure to these drugs have not been observed. Evidence supporting the efficacy of azathioprine and mercaptopurine for maintaining remission is UC patients come from both observational cohorts and clinical trials...
July 2016: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/27215364/biosimilars-in-inflammatory-bowel-disease-facts-and-fears-of-extrapolation
#13
Shomron Ben-Horin, Niels Vande Casteele, Stefan Schreiber, Peter Laszlo Lakatos
Biologic drugs such as infliximab and other anti-tumor necrosis factor monoclonal antibodies have transformed the treatment of immune-mediated inflammatory conditions such as Crohn's disease and ulcerative colitis (collectively known as inflammatory bowel disease [IBD]). However, the complex manufacturing processes involved in producing these drugs mean their use in clinical practice is expensive. Recent or impending expiration of patents for several biologics has led to development of biosimilar versions of these drugs, with the aim of providing substantial cost savings and increased accessibility to treatment...
May 21, 2016: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/27162107/pharmacology-and-metabolism-of-infliximab-biosimilars-a-new-treatment-option-in-inflammatory-bowel-diseases
#14
REVIEW
Marcin Włodarczyk, Jakub Fichna, Aleksandra Sobolewska-Włodarczyk
Biological therapy with monoclonal antibodies to tumor necrosis factor alpha (TNF-α) was shown in large clinical trials to be effective in inducing and maintaining clinical remission in patients with moderate to severe Crohn's disease (CD) and ulcerative colitis (UC). Infliximab, the first anti-TNF-α biologic drug, has significantly improved inflammatory bowel disease (IBD) treatment outcomes by preventing structural damage progression, thereby reducing complications and the need for surgery and hospitalization...
August 2016: Pharmacological Reports: PR
https://www.readbyqxmd.com/read/27100432/circulating-cytokines-and-cytokine-receptors-in-infliximab-treatment-failure-due-to-tnf-%C3%AE-independent-crohn-disease
#15
RANDOMIZED CONTROLLED TRIAL
Casper Steenholdt, Mehmet Coskun, Sine Buhl, Klaus Bendtzen, Mark A Ainsworth, Jørn Brynskov, Ole H Nielsen
The inflammatory response at infliximab (IFX) treatment failure due to tumor necrosis factor (TNF)-α-independent Crohn disease activity is unknown. This is an exploratory, hypothesis-generating study based on samples collected in a clinical trial among patients failing conventional IFX dosages and treated with an intensified IFX regimen for 12 weeks. Patients with clinical response at week 12, as defined by a reduction of Crohn disease activity index by ≥70, were considered to suffer from nonimmune pharmacokinetic (PK) treatment failure (n = 18), and nonresponders had a presumed pharmacodynamic (PD) failure due to non-TNF-driven disease (n = 8)...
April 2016: Medicine (Baltimore)
https://www.readbyqxmd.com/read/27095751/clinical-outcomes-following-a-switch-from-remicade%C3%A2-to-the-biosimilar-ct-p13-in-inflammatory-bowel-disease-patients-a-prospective-observational-cohort-study
#16
Lisa J T Smits, Lauranne A A P Derikx, Dirk J de Jong, Ronald S Boshuizen, Aura A J van Esch, Joost P H Drenth, Frank Hoentjen
BACKGROUND AND AIMS: The biosimilar of Remicade®, CT-P13, recently entered the European market. Clinical data on switching from Remicade® to CT-P13 in inflammatory bowel disease [IBD] are scarce. We aimed to prospectively investigate efficacy, safety, pharmacokinetic profile, and immunogenicity following a switch from Remicade® to CT-P13 in IBD patients. METHODS: Remicade®-treated IBD patients at the Radboud university medical centre who switched to CT-P13 were included in this prospective observational cohort study...
April 19, 2016: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/27091119/induction-infliximab-levels-among-patients-with-acute-severe-ulcerative-colitis-compared-with-patients-with-moderately-severe-ulcerative-colitis
#17
B Ungar, Y Mazor, R Weisshof, H Yanai, Y Ron, I Goren, A Waizbard, M Yavzori, E Fudim, O Picard, R Loebstein, U Kopylov, I Dotan, Y Chowers, R Eliakim, S Ben-Horin
BACKGROUND: Infliximab is effective as salvage therapy for patients with steroid refractory acute severe ulcerative colitis (UC). Although current data suggest that the pharmacokinetics of infliximab are influenced by inflammatory burden in patients with acute severe UC, data comparing infliximab trough levels in patients with acute severe UC vs. moderately severe UC are scarce. AIM: To compare infliximab trough and anti-infliximab antibody levels at a standard fixed time-point during induction between patients with acute severe and moderately severe UC...
June 2016: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/26978723/thiopurine-metabolism-in-the-era-of-combotherapy
#18
Xavier Roblin, Nicolas Williet, Laurent Peyrin-Biroulet
6-thioguanine nucleotides levels are associated with clinical remission in patients with inflammatory bowel disease (IBD) on thiopurine monotherapy. Recently, few studies investigated the interaction between thiopurine metabolism and anti-tumor necrosis factor therapy among patients with IBD on combotherapy. Two studies demonstrated that infliximab therapy increases 6-thioguanine nucleotides level, while such effect could not be observed with adalimumab. Three studies showed that a Delta mean corpuscular volume >7 and high 6-thioguanine nucleotides levels are associated with favorable outcomes, i...
June 2016: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/26952037/bioavailability-safety-and-immunogenicity-of-biosimilar-infliximab-bow015-compared-to-reference-infliximab
#19
RANDOMIZED CONTROLLED TRIAL
John Lambert, Michael Wyand, Cheryl Lassen, Lucy Shneyer, Elizabeth Thomson, Alastair Knight, Joerg Willers, Jonathan Kay
OBJECTIVES: To compare the single-dose pharmacokinetics (PK), safety, and immunogenicity of the biosimilar infliximab (BOW015) to reference infliximab (rIFX) in healthy volunteers and to establish bioequivalence. METHODS: In this randomized, double-blind, parallel-group, single-dose study, subjects received either BOW015 or rIFX. Both drugs were administered as a single IV 5 mg/kg dose over 2 hours on day 1. PK sampling occurred 10 times over 3 days and during safety and immunogenicity follow-up on day 4 and 1, 2, 3, 5, 7, 9, and 12 weeks after the infusion...
April 2016: International Journal of Clinical Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/26951254/the-regulation-of-biosimilars-in-latin-america
#20
Ricardo Garcia, Denizar Vianna Araujo
This article summarizes the regulatory scenario on biological medications in Latin America focusing on comparability studies, extrapolation of indications, interchangeability and pharmacovigilance issues. In the case of comparability studies, what is being discussed is the possibility of decreasing the clinical trials requirement, but that the molecule should be well characterized in the studies of pharmacokinetics and pharmacodynamics. With the worldwide-level approval of the first monoclonal antibody biosimilar, infliximab, extrapolation of indications are being discussed, since the behavior of the Latin America regulatory agencies has been different with regard to such issue...
March 2016: Current Rheumatology Reports
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