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Infliximab therapeutic drug monitoring

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https://www.readbyqxmd.com/read/29379609/protocol-for-a-multicentred-randomised-controlled-trial-investigating-the-use-of-personalised-golimumab-dosing-tailored-to-inflammatory-load-in-ulcerative-colitis-the-goal-arc-study-glm-dose-optimisation-to-adequate-levels-to-achieve-response-in-colitis-led
#1
Juliette Sheridan, Carol Ann Coe, Peter Doran, Laurence Egan, Garret Cullen, David Kevans, Jan Leyden, Marie Galligan, Aoibhlinn O'Toole, Jane McCarthy, Glen Doherty
Introduction: Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD), often leading to an impaired quality of life in affected patients. Current treatment modalities include antitumour necrosis factor (anti-TNF) monoclonal antibodies (mABs) including infliximab, adalimumab and golimumab (GLM). Several recent retrospective and prospective studies have demonstrated that fixed dosing schedules of anti-TNF agents often fails to consistently achieve adequate circulating therapeutic drug levels (DL) with consequent risk of immunogenicity treatment failure and potential risk of hospitalisation and colectomy in patients with UC...
2018: BMJ Open Gastroenterology
https://www.readbyqxmd.com/read/29361094/a-mobile-infliximab-dosing-calculator-for-therapy-optimization-in-inflammatory-bowel-disease
#2
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/29340807/long-term-outcome-of-infliximab-optimization-for-overcoming-immunogenicity-in-patients-with-inflammatory-bowel-disease
#3
Konstantinos Papamichael, Ravy K Vajravelu, Mark T Osterman, Adam S Cheifetz
BACKGROUND: Preliminary data suggest that treatment optimization can reverse immunogenicity and regain response in patients with IBD and secondary loss of response (SLR) to anti-TNF therapy due to antidrug antibodies. However, data regarding the long-term outcome of these patients are scarce. AIMS: We aimed to investigate drug retention in IBD patients of whom infliximab was optimized to overcome immunogenicity and variables associated with drug retention. METHODS: This was a retrospective, multicenter study of consecutive IBD patients with antibodies to infliximab (ATI), based on either proactive or reactive therapeutic drug monitoring, who underwent infliximab optimization (increasing dose, shortening interval, adding an immunomodulator, or combination) to overcome immunogenicity from September 2012 to July 2015; they were followed through December 2015...
January 16, 2018: Digestive Diseases and Sciences
https://www.readbyqxmd.com/read/29330783/clinical-pharmacokinetics-and-pharmacodynamics-of-infliximab-in-the-treatment-of-inflammatory-bowel-disease
#4
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/29317275/increasing-infliximab-dose-based-on-symptoms-biomarkers-and-serum-drug-concentrations-does-not-increase-clinical-endoscopic-or-corticosteroid-free-remission-in-patients-with-active-luminal-crohn-s-disease
#5
Geert D'Haens, Severine Vermeire, Guy Lambrecht, Filip Baert, Peter Bossuyt, Benjamin Pariente, Anthony Buisson, Yoram Bouhnik, Jérôme Filippi, Janneke Vander Woude, Philippe Van Hootegem, Jacques Moreau, Edouard Louis, Denis Franchimont, Martine De Vos, Fazia Mana, Laurent Peyrin-Biroulet, Hedia Brixi, Matthieu Allez, Philip Caenepeel, Alexandre Aubourg, Bas Oldenburg, Marieke Pierik, Ann Gils, Sylvie Chevret, David Laharie
BACKGROUND & AIMS: A combination of infliximab and immunomodulators is the most efficacious treatment for Crohn's disease (CD). Patients have the best outcomes when their serum concentrations of these drugs are above a determined therapeutic threshold. We performed a prospective, randomized trial to determine whether therapeutic drug monitoring (TDM) to maintain serum levels of infliximab above 3 μg/mL produced higher rates of clinical and endoscopic remission than adapting dose based only on symptoms...
January 6, 2018: Gastroenterology
https://www.readbyqxmd.com/read/29274766/infliximab-trough-levels-and-persistent-vs-transient-antibodies-measured-early-after-induction-predict-long-term-clinical-remission-in-patients-with-inflammatory-bowel-disease
#6
Giorgia Bodini, Edoardo G Giannini, Vincenzo Savarino, Lorenzo Del Nero, Sara Lo Pumo, Matteo Brunacci, Nicola De Bortoli, Anjali Jain, Salvatore Tolone, Edoardo Savarino
BACKGROUND: The use of therapeutic drug monitoring has been proposed as a useful tool in the management of patients with loss of response to biological therapy in patients with inflammatory bowel disease. AIMS: To evaluate whether early, post-induction anti-tumor necrosis factor trough levels and the presence of different types of anti-drug antibodies may impact long-term clinical remission in patients with inflammatory bowel disease. METHODS: We prospectively assessed anti-tumor necrosis factor trough levels and both persistent and transient anti-drug antibodies...
November 27, 2017: Digestive and Liver Disease
https://www.readbyqxmd.com/read/29236229/model-based-therapeutic-drug-monitoring-of-infliximab-using-a-single-serum-trough-concentration
#7
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/29210094/infliximab-trough-concentrations-during-maintenance-therapy-are-associated-with-endoscopic-and-histologic-healing-in-ulcerative-colitis
#8
K Papamichael, S Rakowsky, C Rivera, A S Cheifetz, M T Osterman
BACKGROUND: Endoscopic and histologic healing are emerging as new therapeutic goals in ulcerative colitis (UC), as these endpoints are associated with less relapse, hospitalization and colectomy. AIM: To investigate the association of serum infliximab trough concentrations during maintenance therapy with endoscopic or histologic healing in UC. METHODS: In this multi-center retrospective cohort study, we included consecutive patients with moderate-to-severe UC on infliximab maintenance therapy who had an endoscopic evaluation and underwent therapeutic drug monitoring within three months of the colonoscopy, between February 2008 and March 2016...
December 6, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29140939/infliximab-therapeutic-drug-monitoring-changes-clinical-decisions-in-a-virtual-biologics-clinic-for-inflammatory-bowel-disease
#9
Christian P Selinger, Marco V Lenti, Tanya Clark, Helen Rafferty, David Gracie, Alexander C Ford, Anthony OʼConnor, Tariq Ahmad, P John Hamlin
BACKGROUND: Virtual biologics clinics are often used to review patients with inflammatory bowel disease receiving biological therapy, with decisions whether to continue, switch, or stop therapy made based on review of symptoms, disease history, and investigations. We aimed to investigate whether therapeutic drug monitoring of infliximab (IFX) trough levels and anti-drug antibodies influences decision making within a virtual biologics clinic. METHODS: For all patients with inflammatory bowel disease receiving IFX maintenance therapy, 2 decisions were recorded in a preset format...
December 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/29027257/review-article-consensus-statements-on-therapeutic-drug-monitoring-of-anti-tumour-necrosis-factor-therapy-in-inflammatory-bowel-diseases
#10
REVIEW
N Mitrev, N Vande Casteele, C H Seow, J M Andrews, S J Connor, G T Moore, M Barclay, J Begun, R Bryant, W Chan, C Corte, S Ghaly, D A Lemberg, V Kariyawasam, P Lewindon, J Martin, R Mountifield, G Radford-Smith, P Slobodian, M Sparrow, C Toong, D van Langenberg, M G Ward, R W Leong
BACKGROUND: Therapeutic drug monitoring (TDM) in inflammatory bowel disease (IBD) patients receiving anti-tumour necrosis factor (TNF) agents can help optimise outcomes. Consensus statements based on current evidence will help the development of treatment guidelines. AIM: To develop evidence-based consensus statements for TDM-guided anti-TNF therapy in IBD. METHODS: A committee of 25 Australian and international experts was assembled. The initial draft statements were produced following a systematic literature search...
October 13, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28974885/defining-and-predicting-deep-remission-in-patients-with-perianal-fistulizing-crohn-s-disease-on-anti-tumor-necrosis-factor-therapy
#11
EDITORIAL
Konstantinos Papamichael, Adam S Cheifetz
Perianal fistulas can occur to up to one-third of patients with Crohn's disease (CD) leading to significant disabling disease and morbidity. Fistulising perianal CD treatment often necessitates a combined pharmacological and surgical approach. Anti-tumor necrosis factor (anti-TNF) therapy, particularly infliximab, has been shown to be very effective for both perianal and internal fistulising CD. Nevertheless, current data suggest that sustained remission and long-term complete fistula healing can be achieved in only 30% to 50% of patients...
September 14, 2017: World Journal of Gastroenterology: WJG
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
#12
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/28932268/therapeutic-drug-monitoring-of-ct-p13-a-comparison-of-four-different-immunoassays
#13
Joana Afonso, Helena Tavares de Sousa, Isadora Rosa, João Carvalho, Cláudia Camila Dias, Fernando Magro
BACKGROUND: The commercialization of CT-P13, an infliximab (IFX) biosimilar, has the potential to decrease health-related costs and enhance access to biological therapies. This study aimed to address the accuracy and inter-assay agreement of the CT-P13 quantification using four different assays initially developed to assess IFX. METHODS: The four different methods, one in-house method and three commercially available kits, were used to quantify exogenously-spiked samples and the sera from 185 inflammatory bowel disease (IBD) patients on CT-P13 therapy...
September 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/28932267/clinical-performance-of-an-infliximab-rapid-quantification-assay
#14
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, Tânia Meira, Patrícia Andrade, João-Bruno Soares, Diana Carvalho, Paula Sousa, Ana Isabel Vieira, Joanne Lopes, Cláudia Camila Dias, Karel Geboes, Fátima Carneiro
BACKGROUND: Therapeutic drug monitoring (TDM)-based algorithms can be used to guide infliximab (IFX) adjustments in inflammatory bowel disease (IBD) patients. This study aimed to explore a rapid IFX-quantification test from a clinical perspective. METHODS: This manuscript describes a prospective cohort study involving 110 ulcerative colitis (UC) patients on the maintenance phase of IFX. IFX trough levels were quantified using a rapid quantification assay and a commonly-used reference kit...
September 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/28876147/primary-and-secondary-nonresponse-to-infliximab-mechanisms-and-countermeasures
#15
REVIEW
Uni Wong, Raymond K Cross
Primary and secondary non-response to infliximab are common in patients with inflammatory bowel disease and remain a management challenge in clinical practice. Areas covered: This article describes the epidemiology, mechanisms and risk factors for primary and secondary nonresponse to infliximab in patients with inflammatory bowel disease. Data on proactive and reactive therapeutic drug monitoring are examined in this review. An algorithm for evaluation and management of non-response to infliximab is provided...
October 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28839908/utilisation-of-anti-tnf-levels-in-a-uk-tertiary-ibd-centre
#16
E L Johnston, B D Warner, J L Digby-Bell, N Unsworth, S Anderson, J D Sanderson, Z Arkir, P M Irving
OBJECTIVE: To ascertain how anti-tumour necrosis factor (TNF) drug and anti-drug antibody levels testing is used in a 'real-world' setting to optimise inflammatory bowel disease (IBD) treatment. DESIGN: Retrospective cohort study of prospectively collected patient data. SETTING: Tertiary IBD centre in London, UK. PATIENTS: All patients at Guy's and St Thomas' Hospitals on anti-TNF who had levels measured between the start of testing in 2012 and October 2014...
July 2017: Frontline Gastroenterology
https://www.readbyqxmd.com/read/28839870/use-of-anti-tnf-drug-levels-to-optimise-patient-management
#17
REVIEW
Konstantinos Papamichael, Adam S Cheifetz
Anti-tumour necrosis factor (TNF) therapies, such as infliximab, adalimumab, certolizumab pegol and golimumab, have been proven to be effective for the treatment of patients with Crohn's disease and ulcerative colitis. However, 10%-30% of patients with inflammatory bowel disease (IBD) show no initial clinical benefit to anti-TNF therapy (primary non-response), and over 50% after an initial favourable outcome will lose response over time (secondary loss of response (SLR)). Numerous recent studies in IBD have revealed an exposure-response relationship suggesting a positive correlation between high serum anti-TNF concentrations and favourable therapeutic outcomes including clinical, biomarker and endoscopic remission, whereas antidrug antibodies have been associated with SLR and infusion reactions...
October 2016: Frontline Gastroenterology
https://www.readbyqxmd.com/read/28828193/strategies-for-overcoming-anti-tumor-necrosis-factor-drug-antibodies-in-inflammatory-bowel-disease-case-series-and-review-of-literature
#18
EDITORIAL
Mansi M Kothari, Douglas L Nguyen, Nimisha K Parekh
Anti-tumor necrosis factor (TNF) biologics are currently amongst the most widely used and efficacious therapies for inflammatory bowel disease (IBD). The development of therapeutic drug monitoring for infliximab and adalimumab has allowed for measurement of drug levels and antidrug antibodies. This information can allow for manipulation of drug therapy and prediction of response. It has been shown that therapeutic anti-TNF drug levels are associated with maintenance of remission, and development of antidrug antibodies is predictive of loss of response...
August 6, 2017: World Journal of Gastrointestinal Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28743169/development-and-validation-of-an-optical-biosensor-for-rapid-monitoring-of-adalimumab-in-serum-of-patients-with-crohn-s-disease
#19
Sumin Bian, Jiadi Lu, Filip Delport, Séverine Vermeire, Dragana Spasic, Jeroen Lammertyn, Ann Gils
Therapeutic drug monitoring of adalimumab is recommended to improve therapeutic outcome in patients with Crohn's disease. Performing an ELISA requires a rather long time-to-result and the necessity of collecting multiple samples in order to decrease the cost per adalimumab determination. In this study, we aim to develop and validate a rapid assay suitable for measuring a single adalimumab serum sample using a fiber-optic surface plasmon resonance (FO-SPR) based sensor. Therefore, we have immobilized MA-ADM28B8 as capture antibody on a FO-probe and conjugated MA-ADM40D8 as detecting antibody to gold nanoparticles...
July 25, 2017: Drug Testing and Analysis
https://www.readbyqxmd.com/read/28710515/quantitative-lc-esi-srm-ms-of-antibody-biopharmaceuticals-use-of-a-homologous-antibody-as-an-internal-standard-and-three-step-method-development
#20
Fumio Osaki, Kenji Tabata, Tomoyuki Oe
Monoclonal antibody-based therapeutic agents (antibody drugs) have attracted considerable attention as a new type of drug. Concomitantly, the use of quantitative approaches for characterizing antibody drugs, such as liquid chromatography (LC)-mass spectrometry (MS), has increased. Generally, selective quantification of antibody drugs is done using unique peptides from variable regions (V H and V L) as surrogate peptides. Further, numerous internal standards (ISs) such as stable isotope-labeled (SIL)-intact proteins and SIL-surrogate peptides are used...
September 2017: Analytical and Bioanalytical Chemistry
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