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Infliximab therapeutic drug monitoring

Laura Martelli, Pablo Olivera, Xavier Roblin, Alain Attar, Laurent Peyrin-Biroulet
BACKGROUND: Therapeutic drug monitoring (TDM) of anti-TNF is increasingly used to manage inflammatory bowel diseases (IBD) and rheumatoid arthritis (RA). The cost-effectiveness of this strategy is debated. METHODS: All studies comparing the cost-effectiveness of a TDM-based strategy and an empirical dose management of anti-TNF in IBD or RA were screened. Studies were identified through the MEDLINE electronic database (up to July 2016), and annual international meeting abstracts were also manually reviewed...
September 24, 2016: Journal of Gastroenterology
B Hernández-Breijo, M Chaparro, D Cano-Martínez, I Guerra, M Iborra, J L Cabriada, L Bujanda, C Taxonera, V García-Sánchez, I Marín-Jiménez, M Barreiro-de Acosta, I Vera, M D Martín-Arranz, F Mesonero, L Sempere, F Gomollón, J Hinojosa, J P Gisbert, L G Guijarro
BACKGROUND: The availability of a quantitative method to measure anti-infliximab (IFX) antibodies (ATI) would facilitate the implementation of therapeutic drug monitoring in clinical decision-making. Our aim was to standardize the homogeneous mobility shift assay (HMSA) used in the measure of ATI levels. METHODS: In this prospective longitudinal multicenter study, 50 IFX-treated Crohn's disease (CD) patients were followed up for 54weeks. During this period 360 human serum samples were analysed...
September 21, 2016: Biochemical Pharmacology
Anuj Singhal, Darshan Bhakuni, Vishal Marwaha, Vivek Hande, Garvit Bagga
INTRODUCTION: Ankylosing Spondylitis (AS) with non-steroidal anti-inflammatory drug (NSAID) therapeutic failure is treated with biologics. AIM: To compare the clinical outcomes of different biologics for Asian Indian patients with AS who have NSAID therapeutic failure. MATERIALS AND METHODS: Thirty-five AS patients with NSAID failure were administered Etanercept (n=15) (50mg SQ, weekly) or Infliximab (n=20) (5mg/kg IV every 2(nd) month) based on patient convenience or physician discretion as per 2015 ACR/SAA/SPARTAN recommendations...
July 2016: Journal of Clinical and Diagnostic Research: JCDR
Joseph C Marini, Jocelyn Sendecki, Freddy Cornillie, John W Popp, Shawn Black, Marion Blank, Ann Gils, Thomas Van Stappen, Dörte Hamann, Theo Rispens, Lina Thérien, Kelly Chun, Gopi Shankar
Monitoring infliximab (IFX) concentrations and antibodies-to-IFX (ATI) titers during inflammatory bowel disease treatment may allow more informed decisions in assessing exposure/response and determining appropriate dosing. To aid in interpreting results from different commercial tests in the context of Janssen's published Remicade® results, the reliability of Janssen's IFX and ATI assays was compared with commercial assays from KU Leuven, Sanquin, Dynacare, and LabCorp. Test results were independently reported to Janssen...
September 6, 2016: AAPS Journal
Jacqueline Jossen, Marla Dubinsky
PURPOSE OF REVIEW: There are an expanding number of therapies available to treat pediatric inflammatory bowel disease (IBD). As pediatric gastroenterologists attempt to achieve complete intestinal mucosal healing for their patients, it has become more important to gain an understanding of how to maximize the efficacy of our medications while minimizing their toxicities. We aim to provide an overview of therapeutic drug monitoring in IBD with an emphasis on the biologic therapies (antitumor necrosis factor and anti-integrin monoclonal antibodies)...
October 2016: Current Opinion in Pediatrics
Monique Wei Meng Lee, Susan Connor, Watson Ng, Catherine Mei-Ling Toong
The monitoring of infliximab drug levels aids in the management of several autoimmune diseases, notably inflammatory bowel disease. Several commercial kits are now available and approved by the Therapeutic Goods Administration (TGA) for the measurement of infliximab levels, but there have been limited verification or comparison studies to date. Finding an assay that most accurately measures infliximab is essential for optimal drug titration and patient management. We performed this study to compare the performance of the Grifols Promonitor, Theradiag Lisatracker and R-Biopharm Ridascreen enzyme linked immunosorbent assay (ELISA) kits...
October 2016: Pathology
Filipa Silva-Ferreira, Joana Afonso, Pedro Pinto-Lopes, Fernando Magro
BACKGROUND: Immunogenicity to therapeutic proteins has been linked to loss of response by a large percentage of patients taking anti-tumor necrosis factor-alpha agents. Drug monitoring can be extremely useful, allowing physicians to adjust the therapeutic scheme individually. This article aims to systematically review the published data with respect to cutoff levels of infliximab (IFX) and adalimumab (ADA) and relate them to the methodology adopted for quantification of IFX and ADA levels and clinical outcomes...
September 2016: Inflammatory Bowel Diseases
J Afonso, S Lopes, R Gonçalves, P Caldeira, P Lago, H Tavares de Sousa, J Ramos, A R Gonçalves, P Ministro, I Rosa, A I Vieira, C C Dias, F Magro
BACKGROUND: Therapeutic drug monitoring is a powerful strategy known to improve the clinical outcomes and to optimise the healthcare resources in the treatment of autoimmune diseases. Currently, most of the methods commercially available for the quantification of infliximab (IFX) are ELISA-based, with a turnaround time of approximately 8 h, and delaying the target dosage adjustment to the following infusion. AIM: To validate the first point-of-care IFX quantification device available in the market - the Quantum Blue Infliximab assay (Buhlmann, Schonenbuch, Switzerland) - by comparing it with two well-established methods...
October 2016: Alimentary Pharmacology & Therapeutics
T Billiet, I Cleynen, V Ballet, M Ferrante, G Van Assche, A Gils, S Vermeire
BACKGROUND: The long-term efficacy of infliximab in patients with Crohn's disease is suboptimal. AIM: To study prognostic factors for real-life long-term effcacy of infliximab in Crohn's disease. METHODS: All consecutive Crohn's disease patients treated with infliximab at a tertiary centre were retrospectively analysed. Only patients who received scheduled infliximab maintenance treatment were considered. Patient- and disease-related factors were used to identify independent predictors of infliximab failure-free survival using Cox proportional hazards regression...
October 2016: Alimentary Pharmacology & Therapeutics
F Boufidou, C Nikolaou
Mounting data of evidence that have emerged during the last twenty years, point towards the existence of an inflammatory mechanism underlying the pathophysiology of depressive disorder. These data have inspired a number of clinical studies characterized by the administration of inflammatory response altering medication in addition to conventional medication in depressive disorder patients. The drugs were either Non Steroid Anti-inflammatory Drugs (NSAIDs) or Tumor Necrosis Factor-alpha (TNFa) inhibitors and were selected among those that are already in use for various diseases related to the immune system...
April 2016: Psychiatrikē, Psychiatriki
Da Woon Sim, Kyung Hee Park, Hye Jung Park, Young Woong Son, Sang Chul Lee, Jung-Won Park, Jae-Hyun Lee
PURPOSE: The use of monoclonal antibodies (mAbs) is increasing in various clinical fields. Although mAb safety must be demonstrated prior to approval, targeted pharmacovigilance is essential for the recognition and assessment of adverse reactions. The purpose of this study was to identify the major clinical features of adverse reactions to mAbs in Korea. METHODS: Spontaneous reports of adverse reactions attributed to 18 mAbs from January 2005 to December 2014 were extracted from the Korea Adverse Event Reporting System...
June 30, 2016: Pharmacoepidemiology and Drug Safety
Mohsin El Amrani, Marcel P H van den Broek, Camiel Göbel, Erik M van Maarseveen
The therapeutic monoclonal antibody Infliximab (IFX) is a widely used drug for the treatment of several inflammatory autoimmune diseases. However, approximately 10% of patients develop anti-infliximab antibodies (ATIs) rendering the treatment ineffective. Early detection of underexposure to unbound IFX would result in a timely switch of therapy which could aid in the treatment of this disease. Streptavidin coated 96 well plates were used to capture biotinylated-tumor necrosis factor -alpha (b-TNF-α), which in turn was used to selectively extract the active form of IFX in human serum...
July 8, 2016: Journal of Chromatography. A
Giorgia Bodini, Edoardo G Giannini, Vincenzo Savarino, Lorenzo Del Nero, Gaia Pellegatta, Costanza De Maria, Isabella Baldissarro, Edoardo Savarino
OBJECTIVE: Few data are available on the relevance of adalimumab (ADA) trough serum levels and anti-ADA antibodies (AAA) during long-term follow-up of patients with Crohn's Disease (CD), and their association with disease outcome. In this study, our aim was to assess ADA trough serum levels and the presence of AAA according to disease activity and clinical response during long-term follow-up in a series of patients with CD treated with ADA monotherapy. MATERIAL AND METHODS: We prospectively evaluated 23 consecutive, infliximab-naïve CD patients who achieved clinical remission/response after induction and were in maintenance treatment with ADA, and who were followed-up for at least 72 weeks...
September 2016: Scandinavian Journal of Gastroenterology
Ji S van Bezooijen, Birgit C P Koch, Martijn B A van Doorn, Errol P Prens, Teun van Gelder, Marco W J Schreurs
BACKGROUND: To optimize treatment of inflammatory diseases, interest in the measurement of anti-tumor necrosis factor alpha (anti-TNFα) serum drug concentrations is increasing. Preferably, assays for the detection of these drugs should be compared using the same reference material. In this study, 2 commercially available enzyme-linked immunosorbent assays (ELISAs) and a commercially available bioassay for the determination of anti-TNFα drugs are compared. METHODS: Serum samples from infliximab-, adalimumab-, and etanercept-treated patients, control samples from ustekinumab-treated patients, and healthy donors were obtained...
August 2016: Therapeutic Drug Monitoring
M Begoña Ruiz-Argüello, Ainara Maguregui, Ainhoa Ruiz Del Agua, Dora Pascual-Salcedo, Ana Martínez-Feito, Teresa Jurado, Chamaida Plasencia, Alejandro Balsa, Francisca Llinares-Tello, José Rosas, Nerea Torres, Antonio Martínez, Daniel Nagore
OBJECTIVES: The aim of this study was to determine whether antibodies to infliximab (IFX) in Remicade-treated patients cross-react with the biosimilar CT-P13. METHODS: 250 consecutive patients with rheumatic diseases under Remicade and 77 controls were retrospectively selected for the study. Anti-IFX antibodies at drug through levels were measured in parallel with three different bridging ELISA assays: Promonitor-ANTI-IFX kit, which uses Remicade to detect antibodies, and two more assays that use either Inflectra or Remsima with the same format...
September 2016: Annals of the Rheumatic Diseases
Ann Gils, Thomas Van Stappen, Erwin Dreesen, Ruth Storme, Séverine Vermeire, Paul J Declerck
BACKGROUND: The availability of an infliximab ELISA for measuring the originator drug Remicade and its biosimilars, such as Remsima and Inflectra (CT-P13), would facilitate the implementation of therapeutic drug monitoring of biosimilars and enhance the extrapolation of treatment stratification algorithms established for Remicade. A universal calibrator for all anti-infliximab antibody bridging assays allows harmonization of anti-drug antibody titers. METHODS: A panel of 55 mouse monoclonal antibodies raised against Remicade, including MA-IFX6B7 and MA-IFX10F9, were evaluated for their reactivity toward the biosimilars using a sandwich-type ELISA and surface plasmon resonance...
April 2016: Inflammatory Bowel Diseases
Rosita Saraceno, Sergio Chimenti, Luca Bianchi, Monika Fida, Annunziata Dattola, Francesca Specchio, Andrea Chiricozzi
UNLABELLED: The therapeutic paradigm in psoriasis includes antitumor necrosis alpha agents that have been proved effective and safe as long-term therapy. Recently, it has been described a correlation between the use of biologic agents and the occurrence of monoclonal gammopathies, which are haematological conditions characterized by clonal plasma cells proliferation producing a monoclonal immunoglobulin that accumulates in the blood. OBJECTIVE: The aim of this study is to detect electrophoretic abnormalities in psoriatic patients undergoing treatment with infliximab...
February 2016: Journal of Drugs in Dermatology: JDD
Eugènia Santacana Juncosa, Ariadna Padullés Zamora, Helena Colom Codina, Lorena Rodríguez Alonso, Jordi Guardiola Capo, Jordi Bas Minguet, Núria Padullés Zamora
No abstract text is available yet for this article.
February 2016: Revista Española de Enfermedades Digestivas
Konstantinos Papamichael, Gerassimos J Mantzaris, Laurent Peyrin-Biroulet
INTRODUCTION: Anti-tumor necrosis factor-alpha (TNF-α) therapy has revolutionized the medical treatment of Crohn's disease (CD). Nevertheless, anti-TNF-α therapy has been associated with serious adverse events (SAE) raising safety concerns. This review focuses on the safety profile of anti-TNF-α agents in CD. AREAS COVERED: We performed a literature search until August 2015 to collect safety data on infliximab, adalimumab and certolizumab pegol monotherapy or combined with immunomodulators (IMM)...
2016: Expert Opinion on Drug Safety
D Seah, P De Cruz
BACKGROUND: Acute severe ulcerative colitis (ASUC) is a life-threatening condition for which optimal management strategies remain ill-defined. AIM: To review the evidence regarding the natural history, diagnosis, monitoring and treatment of ASUC to inform an evidence-based approach to management. METHODS: Relevant articles addressing the management of ASUC were identified from a search of MEDLINE, the Cochrane Library and conference proceedings...
February 2016: Alimentary Pharmacology & Therapeutics
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