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Infliximab therapeutic drug monitoring

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https://www.readbyqxmd.com/read/29027257/review-article-consensus-statements-on-therapeutic-drug-monitoring-of-anti-tumour-necrosis-factor-therapy-in-inflammatory-bowel-diseases
#1
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
#2
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
#3
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/28932268/therapeutic-drug-monitoring-of-ct-p13-a-comparison-of-four-different-immunoassays
#4
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
#5
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
#6
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
#7
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
#8
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
#9
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
#10
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
#11
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...
July 14, 2017: Analytical and Bioanalytical Chemistry
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
#12
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/28561325/assays-for-infliximab-drug-levels-and-antibodies-a%C3%A2-matter-of-scales-and-categories
#13
COMPARATIVE STUDY
L I Bader, S M Solberg, S H Kaada, N Bolstad, D J Warren, S Gavasso, C G Gjesdal, C A Vedeler
Immunogenicity is a frequent cause of secondary non-response to tumour necrosis factor (TNF) inhibitors. Drug level measurement and detection of antidrug antibodies have been shown to be cost effective and clinically relevant, and a large number of assays are available for these purposes. It is, however, difficult to compare assays and translate results into clinical meaningful information due to different methodological approaches and a lack of assay standardization. We have analysed infliximab drug levels and antidrug antibodies in 107 patient samples using enzyme-linked immunoassays (ELISA), immunofluorometric assays (IFMA) and reporter-gene assays (RGA)...
September 2017: Scandinavian Journal of Immunology
https://www.readbyqxmd.com/read/28513424/a-review-of-six-methods-for-monitoring-infliximab-concentrations-and-antibodies-to-infliximab%C3%A2
#14
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/28498155/therapeutic-drug-monitoring-to-guide-infliximab-dose-adjustment-is-associated-with-better-endoscopic-outcomes-than-clinical-decision-making-alone-in-active-inflammatory-bowel-disease
#15
Orlaith B Kelly, Sarah Oʼ Donnell, Joanne M Stempak, A Hillary Steinhart, Mark S Silverberg
BACKGROUND: Adequate infliximab (IFX) levels are associated with favorable outcomes in inflammatory bowel disease. Using therapeutic drug monitoring (TDM) to guide dosing is cost effective and associated with clinical improvement, but effect on endoscopic outcomes remains unclear. METHODS: Primary responders to IFX who underwent dose escalation (2008-2014) were reviewed. Patients with active endoscopic disease were included. Two cohorts were examined: TDM-based decision to escalate (TDM) and clinical decision (non-TDM)...
July 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28472597/golimumab-for-the-treatment-of-ulcerative-colitis
#16
Mathurin Flamant, Stephane Paul, Xavier Roblin
Tumor necrosis factor antagonists have revolutionized the therapeutic management of inflammatory bowel disease. Infliximab and adalimumab were the first biological agents used to induce and maintain remission in ulcerative colitis. More recently, a third tumor necrosis factor antagonist, golimumab, was approved, extending the therapeutic approach for moderate-to-severe ulcerative colitis. Areas covered: In this review, the authors review the literature on the efficacy and safety of golimumab in the context of other anti-TNF agents used in the treatment of this disease...
July 2017: Expert Opinion on Biological Therapy
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/28374338/therapeutic-drug-monitoring-of-golimumab-in-the-treatment-of-ulcerative-colitis
#18
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/28370040/editorial-infliximab-trough-cut-off-for-perianal-crohn-s-disease-another-piece-of-the-therapeutic-drug-monitoring-guided-infliximab-dosing-puzzle
#19
EDITORIAL
N Mitrev, V Kariyawasam, R W Leong
No abstract text is available yet for this article.
May 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28365486/improved-long-term-outcomes-of-patients-with-inflammatory-bowel-disease-receiving-proactive-compared-with-reactive-monitoring-of-serum-concentrations-of-infliximab
#20
Konstantinos Papamichael, Karen A Chachu, Ravy K Vajravelu, Byron P Vaughn, Josephine Ni, Mark T Osterman, Adam S Cheifetz
BACKGROUND & AIMS: Monitoring serum concentrations of tumor necrosis factor antagonists in patients receiving these drugs as treatment for inflammatory bowel disease (IBD), also called therapeutic drug monitoring, is performed either after patient loss of response (reactive drug monitoring) or in patients in clinical remission in which the drug is titrated to a target concentration (proactive drug monitoring). We compared long-term outcomes of patients with IBD undergoing proactive vs reactive monitoring of serum concentrations of infliximab...
October 2017: Clinical Gastroenterology and Hepatology
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