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https://www.readbyqxmd.com/read/29045077/subjective-complaints-as-main-reason-for-biosimilar-discontinuation-after-open-label-transitioning-from-originator-to-biosimilar-infliximab
#1
Lieke Tweehuysen, Bart J F van den Bemt, Iris L van Ingen, Alphons J L de Jong, Willemijn H van der Laan, Frank H J van den Hoogen, Alfons A den Broeder
OBJECTIVE: To evaluate drug survival, effectiveness, pharmacokinetics, immunogenicity and safety after transitioning treatment from originator infliximab (Remicade(®) , REM) to biosimilar infliximab (CT-P13) in patients with rheumatoid arthritis, psoriatic arthritis or ankylosing spondylitis in daily practice. METHODS: 192 of 222 REM-treated patients agreed to transition to CT-P13 and were included in this multicenter prospective cohort study. Change in DAS28-CRP, BASDAI, CRP and (anti-) infliximab levels were assessed after six months and adverse events (AEs) were documented...
October 18, 2017: Arthritis & Rheumatology
https://www.readbyqxmd.com/read/29035182/induction-with-infliximab-and-a-plant-based-diet-as-first-line-ipf-therapy-for-crohn-disease-a-single-group-trial
#2
Mitsuro Chiba, Tsuyotoshi Tsuji, Kunio Nakane, Satoko Tsuda, Hajime Ishii, Hideo Ohno, Kenta Watanabe, Mai Ito, Masafumi Komatsu, Takeshi Sugawara
BACKGROUND: Approximately 30% of patients with Crohn disease (CD) are unresponsive to biologics. No previous study has focused on a plant-based diet in an induction phase of CD treatment. OBJECTIVE: To investigate the remission rate of infliximab combined with a plant-based diet as first-line (IPF) therapy for CD. METHODS: This was a prospective single-group trial conducted at tertiary hospitals. Subjects included consecutive adults with a new diagnosis (n = 26), children with a new diagnosis (n = 11), and relapsing adults (n = 9) with CD who were naïve to treatment with biologics...
2017: Permanente Journal
https://www.readbyqxmd.com/read/29023827/tnf%C3%AE-and-il-17a-are-differentially-expressed-in-psoriasis-like-vs-eczema-like-drug-reactions-to-tnf%C3%AE-antagonists
#3
C Deubelbeiss, A G A Kolios, L E French, N Yawalkar, W Kempf, K Kerl, B Meier, F Anzengruber, A A Navarini
BACKGROUND: Tumor necrosis factor α (TNFα) blocking drugs are in use for a wide range of autoimmune disorders. In up to 5% of patients, this class of drugs produces puzzling cutaneous side effects that are the subject of this investigation, namely psoriasiform and eczema-like skin inflammation. These side effects can occur after any time of treatment and regardless of the underlying disorders. The exact pathophysiology is as yet unknown. METHODS: 33 patients (19 female, average age 52 years) who had a cutaneous reaction to infliximab, adalimumab or etanercept were included...
October 10, 2017: Journal of Cutaneous Pathology
https://www.readbyqxmd.com/read/29022926/erratum-transmembrane-tnf-%C3%AE-density-but-not-soluble-tnf-%C3%AE-level-is-associated-with-primary-response-to-infliximab-in-inflammatory-bowel-disease
#4
Azade Amini Kadijani, Hamid Asadzadeh Aghdaei, Dario Sorrentino, Alireza Mirzaei, Shabnam Shahrokh, Hedieh Balaii, Vu Q Nguyen, Jessica L Mays, Mohammad Reza Zali
This corrects the article DOI: 10.1038/ctg.2017.44.
October 12, 2017: Clinical and Translational Gastroenterology
https://www.readbyqxmd.com/read/28993262/outcomes-7-years-after-infliximab-withdrawal-for-patients-with-crohn-s-disease-in-sustained-remission
#5
Catherine Reenaers, Jean-Yves Mary, Maria Nachury, Yoram Bouhnik, David Laharie, Matthieu Allez, Mathurin Fumery, Aurélien Amiot, Guillaume Savoye, Romain Altwegg, Martine Devos, Georgia Malamut, Arnaud Bourreille, Bernard Flourie, Philippe Marteau, Lucine Vuitton, Benoît Coffin, Stéphanie Viennot, Jérôme Lambert, Jean-Frédéric Colombel, Edouard Louis
BACKGROUND & AIMS: Little is known about long-term outcomes of patients with Crohn's disease (CD) after infliximab withdrawal. We aimed to describe the long-term outcomes of patients with CD in clinical remission after infliximab treatment was withdrawn. METHODS: We performed a retrospective analysis of data from the 115 patients included in the infliximab discontinuation in patients with CD in stable remission on combined therapy with anti-metabolites (STORI) study, performed at 20 centers in France and Belgium from March 2006 through December 2009...
October 6, 2017: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28983301/immunological-changes-in-blood-of-newborns-exposed-to-anti-tnf-%C3%AE-during-pregnancy
#6
Ana Esteve-Solé, Àngela Deyà-Martínez, Irene Teixidó, Elena Ricart, Macarena Gompertz, Maria Torradeflot, Noemí de Moner, Europa Azucena Gonzalez, Ana Maria Plaza-Martin, Jordi Yagüe, Manel Juan, Laia Alsina
BACKGROUND: Although anti-TNF-α monoclonal antibodies are considered safe during pregnancy, there are no studies on the development of the exposed-infant immune system. The objective was to study for the first time the impact of throughout pregnancy exposure to anti-TNF-α has an impact in the development of the infant's immune system, especially B cells and the IL-12/IFN-γ pathway. METHODS: Prospective study of infants born to mothers with inflammatory bowel disease treated throughout pregnancy with anti-TNF-α (adalimumab/infliximab)...
2017: Frontiers in Immunology
https://www.readbyqxmd.com/read/28976302/certolizumab-pegol-and-secukinumab-for-treating-active-psoriatic-arthritis-following-inadequate-response-to-disease-modifying-antirheumatic-drugs-a-systematic-review-and-economic-evaluation
#7
Mark Corbett, Fadi Chehadah, Mousumi Biswas, Thirimon Moe-Byrne, Stephen Palmer, Marta Soares, Matthew Walton, Melissa Harden, Pauline Ho, Nerys Woolacott, Laura Bojke
BACKGROUND: Several biologic therapies are approved by the National Institute for Health and Care Excellence (NICE) for psoriatic arthritis (PsA) patients who have had an inadequate response to two or more synthetic disease-modifying antirheumatic drugs (DMARDs). NICE does not specifically recommend switching from one biologic to another, and only ustekinumab (UST; STELARA(®), Janssen Pharmaceuticals, Inc., Horsham, PA, USA) is recommended after anti-tumour necrosis factor failure. Secukinumab (SEC; COSENTYX(®), Novartis International AG, Basel, Switzerland) and certolizumab pegol (CZP; CIMZIA(®), UCB Pharma, Brussels, Belgium) have not previously been appraised by NICE...
October 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/28970719/autoimmune-hepatitis-standard-treatment-and-systematic-review-of-alternative-treatments
#8
REVIEW
Benedetta Terziroli Beretta-Piccoli, Giorgina Mieli-Vergani, Diego Vergani
Autoimmune hepatitis is a rare chronic inflammatory liver disease, affecting all ages, characterised by elevated transaminase and immunoglobulin G levels, positive autoantibodies, interface hepatitis at liver histology and good response to immunosuppressive treatment. If untreated, it has a poor prognosis. The aim of this review is to summarize the evidence for standard treatment and to provide a systematic review on alternative treatments for adults and children. Standard treatment is based on steroids and azathioprine, and leads to disease remission in 80%-90% of patients...
September 7, 2017: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/28954041/importance-of-measuring-levels-of-infliximab-in-patients-treating-inflammatory-bowel-disease-in-a-brazilian-cohort
#9
Katia Cristina Kampa, Daphne Benatti Gonçalves Morsoletto, Marcela Rocha Loures, Alcindo Pissaia, Rodrigo Bremer Nones, Cláudia Alexandra Pontes Ivantes
BACKGROUND: Crohn's disease and ulcerative colitis are chronic inflammatory bowel diseases. In such pathologies, there is an increased production of alpha tumor necrosis factor (TNF-α). Patients, in whom the conventional immunosuppressant treatment fails, require the use of immunobiological therapy, such as anti-TNF-α, a monoclonal antibody. Infliximab is an anti-TNF-α drug, a chimerical immunoglobulin, with a murine component, which is responsible for the generation of immunogenicity against the drug and formation of anti-TNF-α antibodies...
September 21, 2017: Arquivos de Gastroenterologia
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
#10
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/28945636/distinct-thresholds-of-infliximab-trough-level-are-associated-with-different-therapeutic-outcomes-in-patients-with-inflammatory-bowel-disease-a-prospective-observational-study
#11
Xavier Roblin, Gilles Boschetti, Gérard Duru, Nicolas Williet, Emilie Deltedesco, Jean M Phelip, Laurent Peyrin-Biroulet, Stéphane Nancey, Bernard Flourié, Stéphane Paul
BACKGROUND: Several studies have reported a strong correlation between infliximab (IFX) trough levels (trough levels of infliximab [TLI]) and clinical remission (CR). We aimed to determine threshold values of TLI associated with the occurrence of CR, with or without normal inflammatory biomarkers, including serum C-reactive protein (CRP) and fecal calprotectin (fCal). METHODS: We included prospectively all consecutive patients with inflammatory bowel disease under IFX therapy (5 mg/kg every 8 wk) for at least 6 months...
November 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28939234/persistence-of-biologic-disease-modifying-antirheumatic-drugs-in-patients-with-rheumatoid-arthritis-an-analysis-of-the-south-korean-national-health-insurance-database
#12
Min-Young Lee, Ju-Young Shin, Sun-Young Park, Donguk Kim, Hoon-Suk Cha, Eui-Kyung Lee
OBJECTIVES: This study examined and compared the persistence of adalimumab, etanercept, infliximab, or abatacept as first- and subsequent-line treatment for rheumatoid arthritis in the South Korean clinical practice. METHODS: We conducted a retrospective cohort study with patients receiving adalimumab, etanercept, infliximab, or abatacept between July 1, 2009 and December 31, 2012, using the nationwide Korean National Health Insurance database. Patients who were receiving a newly initiated biologic treatment and those who switched from other biologic treatment were identified and classified into first- and subsequent-use cohorts, respectively...
August 31, 2017: Seminars in Arthritis and Rheumatism
https://www.readbyqxmd.com/read/28932267/clinical-performance-of-an-infliximab-rapid-quantification-assay
#13
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/28922253/long-term-efficacy-safety-and-immunogenicity-of-biosimilar-infliximab-after-one-year-in-a-prospective-nationwide-cohort
#14
Lorant Gonczi, Krisztina B Gecse, Zsuzsanna Vegh, Zsuzsanna Kurti, Mariann Rutka, Klaudia Farkas, Petra A Golovics, Barbara D Lovasz, Janos Banai, Laszlo Bene, Bea Gasztonyi, Tunde Kristof, Laszlo Lakatos, Pal Miheller, Ferenc Nagy, Karoly Palatka, Maria Papp, Arpad Patai, Agnes Salamon, Tamas Szamosi, Zoltan Szepes, Gabor T Toth, Aron Vincze, Balazs Szalay, Tamas Molnar, Peter L Lakatos
BACKGROUND: It has been previously shown that biosimilar infliximab CT-P13 is effective and safe in inducing remission in inflammatory bowel diseases. We report here the 1-year outcomes from a prospective nationwide inflammatory bowel disease cohort. METHODS: A prospective, nationwide, multicenter, observational cohort was designed to examine the efficacy and safety of CT-P13 in the induction and maintenance treatment of Crohn's disease (CD) and ulcerative colitis (UC)...
November 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28914262/transmembrane-tnf-%C3%AE-density-but-not-soluble-tnf-%C3%AE-level-is-associated-with-primary-response-to-infliximab-in-inflammatory-bowel-disease
#15
Azade Amini Kadijani, Hamid Asadzadeh Aghdaei, Dario Sorrentino, Alireza Mirzaei, Shabnam Shahrokh, Hedieh Balaii, Vu Q Nguyen, Jessica L Mays, Mohammad Reza Zali
OBJECTIVES: Anti-tumor necrosis factor (TNF)-α agents like Infliximab (IFX) are effective in the treatment of inflammatory bowel diseases (IBDs) and are widely used. However, a considerable number of patients do not respond or lose response to this therapy. Preliminary evidence suggests that transmembrane TNF-α (tmTNF-α) might be linked to response to IFX by promoting reverse signaling-induced apoptosis in inflammatory cells. The main aim of this study was the evaluation of this hypothesis in primary IFX non-responders...
September 14, 2017: Clinical and Translational Gastroenterology
https://www.readbyqxmd.com/read/28879645/pharmacokinetic-effects-of-antidrug-antibodies-occurring-in-healthy-subjects-after-a-single-dose-of-intravenous-infliximab
#16
Eli D Ehrenpreis
BACKGROUND: Infliximab pharmacokinetic studies have been performed in patients receiving chronic infliximab therapy. In these patients, infliximab antidrug antibodies (ADAs) increase infliximab clearance and decrease serum levels and drug efficacy. OBJECTIVE: This study analyzed the pharmacokinetic effect of infliximab ADAs in healthy subjects receiving a single dose of intravenous infliximab. METHODS: Data were obtained from a single-blind, parallel-group, single-dose study of healthy subjects receiving 5 mg/kg of intravenous SB2 (infliximab biosimilar), EU-sourced Remicade (EU-IFX) or US-sourced Remicade (US-IFX)...
September 6, 2017: Drugs in R&D
https://www.readbyqxmd.com/read/28879509/il26-modulates-cytokine-response-and-anti-tnf-consumption-in-crohn-s-disease-patients-with-bacterial-dna
#17
Paula Piñero, Oriol Juanola, Ana Gutiérrez, Pedro Zapater, Paula Giménez, Anna Steinert, Laura Sempere, José M González-Navajas, Jan H Niess, Rubén Francés
Interleukin IL26 supports killing of microbes and the innate sensing of bacterial-derived DNA (bactDNA). We evaluated the relationship between IL26 serum levels and bactDNA translocation in Crohn's disease (CD). We ran a prospective study on CD patients in remission. IL26 common polymorphisms, serum cytokines and complement protein, amplified-bactDNA, and anti-TNF-α were evaluated. In vitro PBMC analysis was performed. Three hundred and thirteen patients were included (mean CDAI: 83.6 ± 32.8; mean fecal calprotectin: 55...
September 6, 2017: Journal of Molecular Medicine: Official Organ of the "Gesellschaft Deutscher Naturforscher und Ärzte"
https://www.readbyqxmd.com/read/28876147/primary-and-secondary-nonresponse-to-infliximab-mechanisms-and-countermeasures
#18
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/28871936/xanthoma-like-skin-changes-in-an-elderly-woman-with-a-normal-lipid-profile
#19
Piotr Nockowski, Zdzisław Woźniak, Adam Reich, Joanna Maj
Dear Editor, An 83-year-old woman developed yellow-brownish infiltrates, nodules, and tumors mimicking xanthomas, mostly involving the periorbital and chest area within three months (Figure 1). She had no abnormalities in serum cholesterol or triglycerides levels. A detailed laboratory analysis revealed the presence of mild monoclonal gammopathy with a presence of immunoglobulin G (IgG) kappa light chains; however, according to hematologist consultation, it did not require medical intervention. Imaging assessment and ultrasound examination did not show any specific involvement of internal organs...
July 2017: Acta Dermatovenerologica Croatica: ADC
https://www.readbyqxmd.com/read/28865888/evolution-after-switching-to-biosimilar-infliximab-in-inflammatory-bowel-disease-patients-in-clinical-remission
#20
Lourdes Guerrero Puente, Eva Iglesias Flores, José Manuel Benítez, Rosario Medina Medina, Isabel Salgueiro Rodríguez, Patricia Aguilar Melero, Manuel Jesús Cárdenas Aranzana, Rafael González Fernández, Bárbara Manzanares Martin, Valle García-Sánchez
BACKGROUND AND AIM: The biosimilar of infliximab (CT-P13) has been approved for the same indications held by the infliximab reference product (Remicade(®)); however, there are few clinical data on switching in inflammatory bowel disease (IBD). The aim of this study was to assess the efficacy, safety, bioavailability profile and factors associated with relapse after switching to biosimilar infliximab in IBD patients in clinical remission. MATERIAL AND METHOD: Observational study with IBD patients treated with Remicade(®) for at least 6 months and in clinical remission for at least 3 months who switched to infliximab biosimilar...
August 30, 2017: Gastroenterología y Hepatología
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