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Infliximab therapeutic drug monitoring

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https://www.readbyqxmd.com/read/29668893/therapeutic-drug-monitoring-guides-the-management-of-crohn-s-patients-with-secondary-loss-of-response-to-adalimumab
#1
Sophie Restellini, Che-Yung Chao, Peter L Lakatos, Achuthan Aruljothy, Haya Aziz, Omar Kherad, Alain Bitton, Gary Wild, Waqqas Afif, Talat Bessissow
Background: Managing loss of response (LOR) in Crohn's disase (CD) patients remains challenging. Compelling evidence supports therapeutic drug monitoring (TDM) to guide management in patients on infliximab, but data for other biologics are less robust. We aimed to asses if empiric dose escalation led to improved clinical outcome in addition to TDM-guided optimization in CD patients with LOR to adalimumab (ADA). Methods: Retrospective chart review of patients followed between 2014 and 2016 at McGill IBD Center with index TDM for LOR to ADA was performed...
April 13, 2018: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/29660428/the-kinetics-of-anti-drug-antibodies-drug-levels-and-clinical-outcomes-in-infliximab-exposed-patients-with-immuno-mediated-disorders
#2
Nencini Francesca, Vultaggio Alessandra, Pratesi Sara, Cammelli Daniele, Milla Monica, Fiori Ginevra, Bagnoli Siro, Prignano Francesca, Romagnani Sergio, Maggi Enrico, Matucci Andrea
BACKGROUND: Hypersensitivity reactions (HRs) and loss of response (LOR) to infliximab (IFX) are related to drug immunogenicity characterized by anti-drug antibodies (ADA). OBJECTIVE: To analyse the timing of ADA appearance, and its relationship with drug levels and clinical outcomes in IFX-treated patients with different diseases. METHODS: Samples were longitudinally collected before each infusion from 91 IFX-treated patients and were assayed for ADA and drug levels by ELISA and for IgE by CAP-system Clinical data were also monitored, regarding efficacy and safety of therapy...
April 13, 2018: Journal of Allergy and Clinical Immunology in Practice
https://www.readbyqxmd.com/read/29608486/simultaneous-quantification-of-adalimumab-and-infliximab-in-human-plasma-by-liquid-chromatography-tandem-mass-spectrometry
#3
Jean-François Jourdil, Benjamin Némoz, Elodie Gautier-Veyret, Charlotte Romero, Françoise Stanke-Labesque
BACKGROUND: Adalimumab (ADA) and infliximab (IFX) are therapeutic monoclonal antibodies (TMabs) targeting tumor necrosis factor-alpha (TNFα). They are used to treat inflammatory diseases. Clinical trials have suggested that therapeutic drug monitoring for ADA or IFX could improve treatment response and cost-effectiveness. However, ADA and IFX were quantified by ELISA in all these studies, and the discrepancies between the results obtained raise questions about their reliability.We describe here the validation of a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the simultaneous quantification of ADA and IFX in human samples...
March 30, 2018: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/29600948/intraarticular-infliximab-therapy-in-patients-with-juvenile-idiopathic-arthritis-the-role-of-musculoskeletal-ultrasound-and-disease-activity-scores-in-monitoring-therapy-response
#4
Mandica Vidovic, Lovro Lamot, Mirta Lamot, Miroslav Harjacek
OBJECTIVES: Juvenile idiopathic arthritis (JIA) is the most common chronic rheumatic disease in children, with heterogeneous clinical features. Although therapeutic options are wide and in the majority of children symptoms improve with the combination of non-steroidal anti-inflammatory and disease-modifying drugs, there are a number of patients who do not respond to conventional therapy and who do not meet the criteria for systemic biologics, namely anti TNF-alpha. Those patients are potential candidates for intraarticular therapy with biologics and in this report we present the results of intra-articular infliximab treatment in a series of patients diagnosed with oligoarticular subtype of JIA...
March 21, 2018: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/29590345/proactive-infliximab-monitoring-following-reactive-testing-is-associated-with-better-clinical-outcomes-than-reactive-testing-alone-in-patients-with-inflammatory-bowel-disease
#5
Konstantinos Papamichael, Ravy K Vajravelu, Byron P Vaughn, Mark T Osterman, Adam S Cheifetz
Background and aims: Reactive testing has emerged as the new standard of care for managing loss of response to infliximab in inflammatory bowel disease (IBD). Recent data suggest that proactive infliximab monitoring is associated with better therapeutic outcomes in IBD. Nevertheless, there are no data regarding the clinical utility of proactive infliximab monitoring after first reactive testing. We aimed to evaluate long-term outcomes of proactive infliximab monitoring following reactive testing compared to reactive testing alone in patients with IBD...
March 24, 2018: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/29589185/contemporary-management-of-ulcerative-colitis
#6
REVIEW
Rohini Vanga, Millie D Long
PURPOSE OF REVIEW: We discuss the newest evidence-based data on management of ulcerative colitis (UC). We emphasize risk-stratification, optimizing medical therapies, and surgical outcomes of UC. RECENT FINDINGS: Recent medical advances include introduction of novel agents for UC. Vedolizumab, an anti-adhesion molecule, has demonstrated efficacy in moderate to severe UC. Tofacitinib, a small molecule, has also demonstrated efficacy. Data on optimization of infliximab show the superiority of combination therapy with azathioprine over monotherapy with infliximab or azathioprine alone...
March 27, 2018: Current Gastroenterology Reports
https://www.readbyqxmd.com/read/29568735/outcomes-of-a-national-cohort-of-children-with-acute-severe-ulcerative-colitis
#7
Abisoye O Akintimehin, Ríoghnach Sinead O'Neill, Conor Ring, Tara Raftery, Séamus Hussey
Aim: All Irish children with ulcerative colitis (UC) attend the National Centre for Paediatric Gastroenterology at Our Lady's Children's Hospital, Crumlin. The aim of this study was to determine the outcomes of children with acute severe ulcerative colitis (ASC) and the impact of infliximab on these outcomes following its introduction for this indication in 2011. Methods: A retrospective chart review of all patients admitted with ASC between January 1, 2009 and December 31, 2015 was undertaken...
2018: Frontiers in Pediatrics
https://www.readbyqxmd.com/read/29492747/biosimilars-in-the-treatment-of-inflammatory-bowel-disease-supporting-evidence-in-2017
#8
REVIEW
Frank I Scott, Gary R Lichtenstein
PURPOSE OF REVIEW: Monoclonal antibodies targeting tumor necrosis factor-alpha, integrin molecules, and interleukin-12/23 have become backbone therapies for Crohn's disease and ulcerative colitis. While clinically effective, these biologic therapies come with significant expense, contributing to overall healthcare spending in the USA. Biosimilars have the potential to significantly reduce expenditures secondary to the use of biologic medications such as infliximab and adalimumab, though their complicated manufacturing process results in inherent differences in structure when compared to the originator compounds...
March 1, 2018: Current Treatment Options in Gastroenterology
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
#9
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
#10
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
#11
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
#12
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-and-corticosteroid-free-remission-in-patients-with-active-luminal-crohn-s-disease
#13
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...
April 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
#14
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
#15
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
#16
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...
February 2018: 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
#17
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
#18
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
#19
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
#20
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
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