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infliximab level

Wael El-Matary, Thomas D Walters, Hien Q Huynh, Jennifer deBruyn, David R Mack, Kevan Jacobson, Mary E Sherlock, Peter Church, Eytan Wine, Matthew W Carroll, Eric I Benchimol, Sally Lawrence, Anne M Griffiths
Background: There is some evidence in adults that higher serum infliximab (IFX) levels are needed to adequately treat fistulizing perianal Crohn's disease (CD). However, data in children are lacking. We aimed to determine postinduction serum trough IFX levels that are associated with healing of fistulizing perianal CD (PCD) at week 24. Methods: In a multicenter inception cohort study, consecutive children younger than age 17 years with fistulizing perianal CD treated with IFX between April 2014 and June 2017 who had serum trough IFX titers measured before the fourth infusion were included...
June 15, 2018: Inflammatory Bowel Diseases
Bella Ungar, Yoav Glidai, Miri Yavzori, Orit Picard, Ella Fudim, Avishay Lahad, Yael Haberman, Dror S Shouval, Ilana Weintraub, Rami Eliakim, Shomron Ben-Horin, Batia Weiss
OBJECTIVES: While infliximab pharmacokinetics are associated with therapy outcome in adult IBD population, limited data is available in pediatric patients. We aimed to define the relationship between Infliximab trough and antibodies' levels (IFX-TL, ATI) and clinical, biomarker remission. METHODS: IFX-TL and ATI were routinely obtained between 2011-2017. Associations with clinical and inflammatory (C-reactive protein, CRP) end-points were studied throughout the first year of infliximab therapy...
June 12, 2018: Journal of Pediatric Gastroenterology and Nutrition
Minh Vu Chuong Nguyen, Athan Baillet, Xavier Romand, Candice Trocmé, Anaïs Courtier, Hubert Marotte, Thierry Thomas, Martin Soubrier, Pierre Miossec, Jacques Tébib, Laurent Grange, Bertrand Toussaint, Thierry Lequerré, Olivier Vittecoq, Philippe Gaudin
OBJECTIVES: Tumour necrosis factor-alpha inhibitors (TNFi) are effective treatments for Rheumatoid Arthritis (RA). Responses to treatment are barely predictable. As these treatments are costly and may induce a number of side effects, we aimed at identifying a panel of protein biomarkers that could be used to predict clinical response to TNFi for RA patients. METHODS: Baseline blood levels of C-reactive protein, platelet factor 4, apolipoprotein A1, prealbumin, α1-antitrypsin, haptoglobin, S100A8/A9 and S100A12 proteins in bDMARD naive patients at the time of TNFi treatment initiation were assessed in a multicentric prospective French cohort...
June 6, 2018: Joint, Bone, Spine: Revue du Rhumatisme
Bella Ungar, Tal Engel, Doron Yablecovitch, Adi Lahat, Alon Lang, Benjamin Avidan, Ofir Har-Noy, Dan Carter, Nina Levhar, Limor Selinger, Sandra Neuman, Ola Haj Natour, Miri Yavzori, Ella Fudim, Orit Picard, Uri Kopylov, Yehuda Chowers, Timna Naftali, Efrat Broide, Eyal Shachar, Rami Eliakim, Shomron Ben-Horin
OBJECTIVES: Adalimumab is usually self-injected at home, making prospective serial-sampling studies challenging and scarce. This has led to a gap in knowledge about evolution of anti-adalimumab antibodies (AAAs) over time and its correlation with clinical and inflammatory outcomes. METHODS: A program for home visits by physicians at induction, every 3 months and at event of relapse, was established prospectively for Crohn's disease (CD) patients. At each visit, patients' clinical scores were determined and sera were obtained for C-reactive protein, drug, and AAA levels...
June 5, 2018: American Journal of Gastroenterology
Jukyung Kang, Karthik Pisupati, Alexander Benet, Brandon T Ruotolo, Steven P Schwendeman, Anna Schwendeman
Structural and functional differences between REMICADE and its two FDA-approved biosimilars appear to have clinical implications. We suggest a personalized biosimilar substitution approach based on prescribed indication, biosimilar afucosylation level, and a patient's FCGR3A polymorphism. We also advocate for establishing glycosylation variation limits for biosimilar approvals.
May 31, 2018: Trends in Biotechnology
Luisa Guidi, Daniela Pugliese, Tommaso Panici Tonucci, Alexandra Berrino, Barbara Tolusso, Michele Basile, Laura Cantoro, Paola Balestrieri, Fortunata Civitelli, Lorenzo Bertani, Manuela Marzo, Carla Felice, Elisa Gremese, Francesco Costa, Franca Viola, Michele Cicala, Anna Kohn, Antonio Gasbarrini, Gian Lodovico Rapaccini, Matteo Ruggeri, Alessandro Armuzzi
Background: Empirical dose intensification and therapeutic drug monitoring (TDM) of infliximab (IFX) trough levels (ITL) and antibody (ATI) assays are recognised approaches for managing the loss of response (LoR) in inflammatory bowel disease (IBD) patients. Aim: To compare these two interventions in a clinical setting, in terms of effectiveness and cost savings. Methods: Consecutive IBD patients, experiencing LoR, were clinically managed according to a TDM algorithm...
May 31, 2018: Journal of Crohn's & Colitis
Felicia M Bloemendaal, Pim J Koelink, Karin A van Schie, Theo Rispens, Charlotte P Peters, Christianne J Buskens, Jarmila D van der Bilt, Willem A Bemelman, Hannelie Korf, João G Sabino, Cyriel Y Ponsioen, Anje A Te Velde, Geert R A M D'Haens, Gijs R van den Brink, Manon E Wildenberg
Background and Aims: We have recently shown that the mode of action of IgG1 anti-TNF antibodies in inflammatory bowel disease (IBD) requires Fcγ-receptor (FcR) engagement on macrophages. Here we examine the effect of Fcγ-receptor signaling by anti-TNF on macrophage IL-12/IL-23 secretion. Methods: Cytokine production by human inflammatory macrophages was assessed at the level of RNA and or protein. TNF-anti-TNF immune complex formation was determined by size-exclusion chromatography and signaling visualized by immunofluorescence...
May 30, 2018: Journal of Crohn's & Colitis
J German Sanchez-Hernandez, Noemi Rebollo, Fernando Muñoz, Ana Martin-Suarez, Maria Victoria Calvo
BACKGROUND: Tumour necrosis factor inhibitor (TNFi) therapy has drastically changed the management of chronic inflammatory diseases (CID). Some important drawbacks that can cause loss of response during treatment with these drugs are related to their large individual variability, the disease burden and the formation of anti-drug-antibodies (ADA) that increase its clearance. Therapeutic drug monitoring (TDM) of these drugs is not yet recommended by all scientific societies, and if so, only in patients with inflammatory symptoms...
January 1, 2018: Annals of Clinical Biochemistry
Nanping Xiao, Fenghua Liu, Guangxi Zhou, Mingming Sun, Fengfu Ai, Zhanju Liu
Objective Dietary antigens are common luminal antigens in the gastrointestinal tract and have been considered to contribute to the pathogenesis of inflammatory bowel disease (IBD). We analyzed the levels of food-specific IgGs against a variety of dietary antigens, explored the clinical relevance of food allergy to the pathogenesis of IBD, and investigated whether or not infliximab (IFX) treatment could regulate the immune responses induced by dietary antigens. Methods A total of 301 IBD patients, including 201 patients with Crohn's disease (CD) and 100 patients with ulcerative colitis (UC), were recruited, and their serum food-specific IgGs against 14 food antigens were detected by a semi-quantitative enzyme linked immunosorbent assay (ELISA)...
May 18, 2018: Internal Medicine
Shannon L Kanis, Alison de Lima, Cokkie van der Ent, Dimitris Rizopoulos, C Janneke van der Woude
Background and Aims: Pregnancy guidelines for women with Inflammatory Bowel Disease (IBD) provide recommendations regarding anti-TNF cessation during pregnancy, in order to limit fetal exposure. Although infliximab (IFX) leads to higher anti-TNF concentrations in cord blood than adalimumab (ADA), recommendations are similar. We aimed to demonstrate the effect of anti-TNF cessation during pregnancy on fetal exposure, for IFX and ADA separately. Methods: We conducted a prospective single center cohort study...
May 15, 2018: Journal of Crohn's & Colitis
Ray K Boyapati, Joana Torres, Carolina Palmela, Claire E Parker, Orli M Silverberg, Sonam D Upadhyaya, Tran M Nguyen, Jean-Frédéric Colombel
BACKGROUND: Crohn's disease (CD) is a chronic, relapsing and remitting disease of the gastrointestinal tract that can cause significant morbidity and disability. Current treatment guidelines recommend early intervention with immunosuppressant or biological therapy in high-risk patients with a severe disease phenotype at presentation. The feasibility of therapeutic de-escalation once remission is achieved is a commonly encountered question in clinical practice, driven by patient and clinician concerns regarding safety, adverse events, cost and national regulations...
May 12, 2018: Cochrane Database of Systematic Reviews
Akihiro Koga, Toshiyuki Matsui, Noritaka Takatsu, Yasumichi Takada, Masahiro Kishi, Yutaka Yano, Takahiro Beppu, Yoichiro Ono, Kazeo Ninomiya, Fumihito Hirai, Takashi Nagahama, Takashi Hisabe, Yasuhiro Takaki, Kenshi Yao, Hirotsugu Imaeda, Akira Andoh
Background/Aims: Decreased trough levels of infliximab (TLI) and antibodies to infliximab (ATI) are associated with loss of response (LOR) in Crohn's disease. Two prospective studies were conducted to determine whether TLI or ATI better correlates with LOR (Study 1), and whether TLI could become a predictor of mucosal healing (MH) (Study 2). Methods: Study 1 was conducted in 108 patients, including those with LOR and remission to compare ATI and TLI in discriminating the 2 conditions based on receiver operating characteristic (ROC) curve analyses...
April 2018: Intestinal Research
Hideto Kameda
As of February 2018, 5 originator TNF inhibitors(infliximab, etanercept, adalimumab, golimumab and certolizumab pegol)and biosimilar agents of infliximab and etanercept are available for rheumatoid arthritis(RA)in Japan. The effectiveness of TNF inhibitors considerably improves with concomitant methotrexate regardless of their immunogenicity. The Japan College of Rheumatology guideline for TNF inhibitor use in RA has been updated in March 2017 according to recent evidences. During the remission induction phase, maintenance of drug trough level above effective blood concentration is paramount, while the tapering and withdrawal of TNF inhibitors may be considered after achieving sustained remission...
2018: Clinical Calcium
Alessandra Vultaggio, Francesca Nencini, Alessia Carraresi, Sara Pratesi, Robert Movérare, Camilla Eriksson, Lennart Venemalm, Enrico Maggi, Andrea Matucci
BACKGROUND: Infliximab (IFX) carries potential risk of immunogenicity with the production of anti-drug antibodies (ADA). ADA may belong to different isotypes and are usually measured by ELISA bridging assay. This test is not designed to detect IgG4 antibodies. The aim was to measure IgG4 anti-IFX antibodies in a cohort of IFX-treated patients and to evaluate their relationship with ADA and their clinical impact. METHODS: ADA were detected by using a bridging ELISA in the serum of 222 treated patients with different clinical outcomes to IFX...
May 2, 2018: Allergy
Konstantinos Papamichael, Shana Rakowsky, Claudio Rivera, Adam S Cheifetz, Mark T Osterman
Background and aim: Objective and more rigorous therapeutic outcomes are emerging as novel targets in Crohn's disease (CD). We investigated the association between maintenance serum infliximab trough concentrations and biochemical, endoscopic, or histologic remission in CD. Methods: This retrospective multicenter study involved consecutive CD patients treated with infliximab who had a serum C-reactive protein (CRP) measured within 1 week or endoscopic evaluation within 12 weeks of therapeutic drug monitoring between January 2010 and June 2016...
April 28, 2018: Inflammatory Bowel Diseases
Lisa Yue Chi, Naamah Levy Zitomersky, Enju Liu, Sophia Tollefson, Julia Bender-Stern, Snehal Naik, Scott Snapper, Athos Bousvaros
Goal: The aim of this study was to evaluate the effect of combination therapy with methotrexate or 6-mercaptopurine on infliximab levels (IFXL) and antibodies to infliximab (ATI). Background: Infliximab (IFX) is a highly effective therapy for inflammatory bowel disease (IBD). Unfortunately, 25%-50% of patients will lose response to IFX. Loss of response is correlated with low IFXL and ATI formation which accelerates drug clearance. Combination therapy is thought to decrease ATI formation...
April 26, 2018: Inflammatory Bowel Diseases
Eirini Theodoraki, Eleni Orfanoudaki, Kalliopi Foteinogiannopoulou, Ioannis E Koutroubakis
Background: Both muscle-related complaints and elevated serum creatine kinase (CK) levels have been reported in patients with inflammatory bowel disease (IBD) treated with infliximab (IFX), mainly as case reports. The aim of this study was to investigate the effect of IFX therapy on serum CK levels in a cohort of Greek IBD patients. Methods: Demographic, clinical (including muscle complaints), and laboratory data of consecutive IBD patients undergoing IFX treatment and a matched control group of IBD patients without any use of biological treatment were retrospectively analyzed...
May 18, 2018: Inflammatory Bowel Diseases
Kristin E Burke, Hamed Khalili, John J Garber, Talin Haritunians, Dermot P B McGovern, Ramnik J Xavier, Ashwin N Ananthakrishnan
Background: Despite a high nonresponse rate, predictors of response to anti-tumor necrosis factor (anti-TNF) therapy in ulcerative colitis (UC) remain limited. We aim to determine clinical and genetic predictors of primary nonresponse (PNR) and durable response (DR) to anti-TNF therapy in a large prospective UC cohort. Methods: Using the Illumina Immunochip, candidate polymorphisms associated with clinical outcomes of PNR and DR were separately evaluated and combined into weighted genetic risk scores...
April 30, 2018: Inflammatory Bowel Diseases
Tomer Greener, Boyko Kabakchiev, A Hillary Steinhart, Mark S Silverberg
Background: Patients requiring optimization of therapy for suboptimal response and/or targeting more robust outcomes may eventually reach high serum levels. Data evaluating the relationship between infliximab concentration and toxicity are limited. The aim of this study was to evaluate the frequency of adverse events (AEs) in inflammatory bowel disease (IBD) patients with infliximab higher-range (HR) and lower-range (LR) trough levels. Methods: We performed a retrospective analysis of 180 patients with at least 1 measurement of serum infliximab from 2012 to 2016...
April 25, 2018: Inflammatory Bowel Diseases
Olena Yakymenko, Ida Schoultz, Elisabeth Gullberg, Magnus Ström, Sven Almer, Conny Wallon, Arthur Wang, Åsa V Keita, Barry J Campbell, Derek M McKay, Johan D Söderholm
OBJECTIVE: Infliximab is important in the therapeutic arsenal of Crohn's disease (CD). However, its effect on mucosal barrier function is not fully understood. Adherent-invasive Escherichia coli (AIEC) are important in CD pathophysiology, but the transmucosal uptake routes are partly unknown. We investigated effects of infliximab on uptake of colon-specific AIEC HM427 across CD colonic mucosa. MATERIALS AND METHODS: Endoscopic biopsies from non-inflamed colon of seven patients with CD, before and after two infliximab infusions, and eight non-inflammation controls, were mounted in Ussing chambers...
April 24, 2018: Scandinavian Journal of Gastroenterology
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