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https://www.readbyqxmd.com/read/28937551/frequency-of-severe-infusion-reactions-associated-with-outpatient-infusion-of-infliximab-without-premedications
#1
Stephanie Q Hutsell, May Wu, K T Park
In this report, we describe incremental changes, during a 2-year period at a single center with the administration of maintenance infliximab infusions. Given practice-driven changes consisting of 1-hour infusions and omission of premedications, we aimed to investigate if these changes contributed to severe infusion reactions. We reviewed approximately 900 infliximab infusions in a pediatric ambulatory infusion center from January 1, 2014, to December 31, 2015, for severe adverse reactions requiring either rescue epinephrine or a code blue or "rapid response" activation...
October 2017: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/28932268/therapeutic-drug-monitoring-of-ct-p13-a-comparison-of-four-different-immunoassays
#2
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
#3
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/28932193/safety-profile-of-anticancer-and-immune-modulating-biotech-drugs-used-in-a-real-world-setting-in-campania-region-italy-bio-cam-observational-study
#4
Cristina Scavone, Liberata Sportiello, Maria G Sullo, Carmen Ferrajolo, Rosanna Ruggiero, Maurizio Sessa, Pasquale M Berrino, Gabriella di Mauro, Liberato Berrino, Francesco Rossi, Concetta Rafaniello, Annalisa Capuano
Objectives: To investigate the occurrence of adverse events (AEs) in naïve patients receiving biotech drugs. Design: A prospective observational study. Setting: Onco-hematology, Hepato-gastroenterology, Rheumatology, Dermatology, and Neurology Units in Campania Region (Italy). Participants: 775 patients (53.81% female) with mean age 56.0 (SD 15.2). The mean follow-up/patient was 3.48 (95% confidence interval 3.13-3.84). Main outcome measures: We collected all AEs associated to biotech drugs, including serious infections and malignancies...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28928769/exclusive-enteral-nutrition-versus-infliximab-in-inducing-therapy-of-pediatric-crohn-s-disease
#5
Youyou Luo, Jindan Yu, Jingan Lou, Youhong Fang, Jie Chen
AIM: To compare the effectiveness of exclusive enteral nutrition (EEN) and infliximab (IFX) therapy in pediatric Crohn's disease (CD). METHODS: In a prospective study of children initiating EEN or infliximab therapy for CD, we compared clinical outcomes using the pediatric Crohn's disease activity index (PCDAI), growth improvement, endoscopic mucosal healing, and adverse effects. Data were measured at baseline and after 8 weeks of therapy. RESULTS: We enrolled 26 children with CD; of whom, 13 were treated with infliximab, 13 with EEN...
2017: Gastroenterology Research and Practice
https://www.readbyqxmd.com/read/28927869/what-have-we-learned-from-best
#6
Cornelia F Allaart, Iris M Markusse, Willem F Lems
BACKGROUND: How have the long term outcomes of RA improved in the last decade? METHODS: Patients with DMARD naïve RA were randomized to 4 treatment strategies: 1. sequential DMARD monotherapy, 2. step-up combination therapy, 3. initial combination therapy including prednisone or 4. including infliximab. Treatment-to-target was aimed at DAS≤2.4 (three-monthly calculations). Functional ability (HAQ), radiologic damage progression (Sharp/vanderHeijde Score) and overall survival were reported...
September 16, 2017: Clinical Immunology: the Official Journal of the Clinical Immunology Society
https://www.readbyqxmd.com/read/28922253/long-term-efficacy-safety-and-immunogenicity-of-biosimilar-infliximab-after-one-year-in-a-prospective-nationwide-cohort
#7
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)...
August 23, 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28921458/pharmacogenetics-and-pharmacogenomics-in-moderate-to-severe-psoriasis
#8
REVIEW
María C Ovejero-Benito, Ester Muñoz-Aceituno, Alejandra Reolid, Miriam Saiz-Rodríguez, Francisco Abad-Santos, Esteban Daudén
Pharmacogenetics is the study of variations in DNA sequence related to drug response. Moreover, the evolution of biotechnology and the sequencing of human DNA have allowed the creation of pharmacogenomics, a branch of genetics that analyzes human genes, the RNAs and proteins encoded by them, and the inter-and intra-individual variations in expression and function in relation to drug response. Pharmacogenetics and pharmacogenomics are being used to search for biomarkers that can predict response to systemic treatments, including those for moderate-to-severe psoriasis...
September 18, 2017: American Journal of Clinical Dermatology
https://www.readbyqxmd.com/read/28918934/reconstructive-microsurgical-approach-for-the-treatment-of-pyoderma-gangrenosum
#9
Karl Schwaiger, Elisabeth Russe, Hassan Kholosy, Michaela Hladik, Klemens Heinrich, Laurenz Weitgasser, Thomas Schoeller, Gottfried Wechselberger
INTRODUCTION: Pyoderma gangrenosum (PG) is a rare type of autoimmune disease that results in progressive ulcers with or without previous trauma. However, PG is not well understood to date, and its treatment therefore remains a challenge. Because of the disease's systemic characteristic and the unpredictability of the clinical course, no gold standard treatment is available, especially concerning the surgical procedures to treat pyodermic lesions. Often, PG is not recognized during routine clinical practice, and standard ulcer treatment (conservative wound care, debridement, skin grafting, and local flap coverage) is initiated; this induces an autoinflammatory response, resulting in disastrous ulcers, thereby making free flap coverage necessary...
August 16, 2017: Journal of Plastic, Reconstructive & Aesthetic Surgery: JPRAS
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
#10
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/28906316/secondary-loss-of-response-to-infliximab-in-pediatric-crohn-s-disease-does-it-matter-how-and-when-we-start
#11
Rishi Bolia, Jeremy Rosenbaum, Vered Schildkraut, Winita Hardikar, Mark Oliver, Donald Cameron, George Alex
OBJECTIVES: A significant proportion of children with Crohn's disease develop a secondary loss of response (LOR) to infliximab. Our aim was to study the impact of initial treatment strategies on secondary LOR. METHODS: We reviewed the medical records of children with Crohn's disease who received scheduled maintenance infliximab therapy for at least 12 months. We compared children who developed LOR with those who did not; with regards to their clinical and laboratory parameters, disease phenotype and treatment strategy before developing LOR...
September 12, 2017: Journal of Pediatric Gastroenterology and Nutrition
https://www.readbyqxmd.com/read/28906290/safety-considerations-with-the-use-of-corticosteroids-and-biologic-therapies-in-mild-to-moderate-ulcerative-colitis
#12
Raymond K Cross
BACKGROUND: The risk of corticosteroid-associated adverse events can limit the use of systemic corticosteroids. Oral, topically acting, second-generation corticosteroids that deliver drug to the site of inflammation, and biologic therapies, are effective treatment alternatives. The aim of this review was to evaluate the safety and tolerability of topically acting corticosteroids and biologic therapies versus oral systemic corticosteroids for ulcerative colitis (UC). METHODS: The PubMed database was searched for clinical and observational trials, systematic reviews, and case reports/series published between January 1950 and September 30, 2016...
October 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28905092/drug-induced-oral-lichenoid-reactions-a-real-clinical-entity-a-systematic-review
#13
REVIEW
Giulio Fortuna, Massimo Aria, Julie H Schiavo
PURPOSE: Drug-induced oral lichenoid reactions (DIOLRs) have been extensively reported in the literature, but the validity of the causality relationship between any drug and the oral lichenoid lesions (OLLs) still remains questionable. We sought to determine whether this causality relationship really exists, whether a resolution of the oral lesions upon withdrawal occurs, and what the most common alleged offending medications are. METHODS: Nine electronic databases from January 1966 to December 2016 were systematically searched to identify all relevant studies selected with specific inclusion criteria (a clinical and histopathological diagnosis of DIOLRs, and clearly statement on the systemic offending medication)...
September 13, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28903543/biosimilars-in-rheumatology-a-review-of-the-evidence-and-their-place-in-the-treatment-algorithm
#14
Hendrik Schulze-Koops, Alla Skapenko
Determining biosimilarity involves a comprehensive exercise with a focus on determining the comparability of the molecular characteristics and preclinical profile of the biosimilar and reference product, such that there is less need for extensive clinical testing to assure comparability of clinical outcomes. Three anti-TNF biosimilar agents are approved for patients with rheumatic diseases in the European Union. The infliximab (Remicade®) biosimilars CT-P13 (Remsima® and Inflectra®) and SB2 (Flixabi®) and the etanercept (Enbrel®) biosimilar SB4 (Benepali®) have shown close comparability to their reference medicinal products, having undergone extensive evaluations...
August 1, 2017: Rheumatology
https://www.readbyqxmd.com/read/28902041/switching-from-reference-infliximab-to-ct-p13-in-patients-with-inflammatory-bowel-disease-12-months-results
#15
Federico Argüelles-Arias, Maria Fernanda Guerra Veloz, Raul Perea Amarillo, Angel Vilches-Arenas, Luisa Castro Laria, Belen Maldonado Pérez, Dina Chaaro Benallal, Antonio Benítez Roldán, Vicente Merino, Gabriel Ramirez, Miguel Angel Calleja-Hernández, Angel Caunedo Álvarez, Manuel Romero Gómez
BACKGROUND: Biological agents, such as infliximab, have transformed the outcomes of patients with immune-mediated inflammatory diseases. The advent of biosimilar treatment options such as CT-P13 promises to improve the availability of biological therapy, yet real-world switching data are currently limited. Here, we assess the effectiveness and safety of switching to CT-P13 from infliximab reference product (RP) in patients with inflammatory bowel disease. MATERIALS AND METHODS: This was a prospective single-center observational study in patients with moderate to severe Crohn's disease (CD) and ulcerative colitis (UC)...
September 15, 2017: European Journal of Gastroenterology & Hepatology
https://www.readbyqxmd.com/read/28901727/retention-rates-of-adalimumab-etanercept-and-infliximab-as-first-line-biotherapy-agent-for-rheumatoid-arthritis-patients-in-daily-practice-auvergne-experience
#16
Martin Soubrier, Bruno Pereira, Thomas Frayssac, Angelique Fan, Marion Couderc, Sandrine Malochet-Guinamand, Sylvain Mathieu, Zuzana Tatar, Anne Tournadre, Jean-Jacques Dubost
OBJECTIVE: To compare, in real-life conditions, the retention rates of anti-tumor necrosis factor (anti-TNF) treatment (etanercept [ETN], adalimumab [ADA] and infliximab [IFX]) initiated as first-line biotherapy for rheumatoid arthritis (RA) and to evaluate, in case of failure, the switch to another anti-TNF or a non-anti-TNF biological. METHODS: Monocentric retrospective cohort including all patients with RA starting a first anti-TNF between 2001 and 2015. RESULTS: Among the 346 patients analyzed, 201 received ETN, 82 ADA and 63 IFX...
September 13, 2017: International Journal of Rheumatic Diseases
https://www.readbyqxmd.com/read/28900730/review-of-local-injection-of-anti-tnf-for-perianal-fistulising-crohn-s-disease
#17
REVIEW
Samuel O Adegbola, Kapil Sahnan, Philip J Tozer, Robin Ks Phillips, Omar D Faiz, Janindra Warusavitarne, Ailsa Hart
BACKGROUND: Perianal fistulising Crohn's disease (PFCD) affects a third of Crohn's disease patients and represents a disabling phenotype with poor outcome. The anti-tumour necrosis factor alpha (TNF) therapies have been shown to maintain clinical remission in a third of patients after 1 year of treatment. Maintenance therapy with systematic administration schedules confers greatest benefit, but exposes patients to risks/side effects of continued systemic use and led to consideration of local drug delivery (first described in 2000)...
September 12, 2017: International Journal of Colorectal Disease
https://www.readbyqxmd.com/read/28899741/small-bowel-stenosis-a-manifestation-of-chronic-graft-versus-host-disease-in-children
#18
Mickael Tordjman, Marie Ouachee, Arnaud Bonnard, Bogdana Tilea, Karima Yakouben, Jerome Viala, Michel Peuchmaur, Dominique Berrebi
Digestive graft versus host disease (GVHD) is a frequent complication after bone marrow transplantation (BMT), but small bowel obstruction is an extremely rare event. We present herein the first pediatric series of 4 cases of small bowel obstruction after BMT with detailed gross, histological data and their genetic status of the NOD2 gene. All patients had a history of severe acute GVHD treated by immunosuppressive agents and/or infliximab (in 3 cases). Acute or progressively worsening abdominal pain accompanied by small bowel occlusion occurred 5-16months after graft and CT-scan revealed multiple small intestinal stenosis...
September 9, 2017: Human Pathology
https://www.readbyqxmd.com/read/28898541/biologics-combined-with-conventional-systemic-agents-or-phototherapy-for-the-treatment-of-psoriasis-real-life-data-from-psonet-registries
#19
C I Busard, A D Cohen, P Wolf, S Gkalpakiotis, S Cazzaniga, R S Stern, B A Hutten, I Feldhamer, F Quehenberger, R Lichem, M Kojanova, E Adenubiova, A Addis, L Naldi, P I Spuls
BACKGROUND: Biologics have greatly improved psoriasis management. However, primary and secondary non-response to treatment requires innovative strategies to optimize outcomes. OBJECTIVE: To describe the use of combined treatment of biologics with conventional systemic agents or phototherapy in daily clinical practice. METHODS: We collected data on frequency of use, demographics, treatment characteristics and drug survival of biologics combined with conventional systemic agents or phototherapy in five PSONET registries...
September 12, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/28895664/the-severe-and-acute-complications-of-the-biologics-in-psoriasis
#20
Elias Oussedik, Nupur U Patel, Devin R Cash, Angela S Gupta, Steven R Feldman
Biologic therapies have revolutionized the approach to immune-mediated diseases such as psoriasis. Due to their favorable safety profiles and excellent efficacy, biologic agents are considered the gold-standard for moderate-to-severe psoriasis. The aim of this paper is to saliently review the severe and acute complications of the Food and Drug Administration (FDA) approved biologic agents for psoriasis. Reviewed agents include tumor necrosis factor alpha (TNF-alpha) inhibitors (etanercept, infliximab, and adalimumab), interleukin 12/23 inhibitors (ustekinumab), and interleukin 17 inhibitors (secukinumab and ixekizumab)...
September 12, 2017: Giornale Italiano di Dermatologia e Venereologia: Organo Ufficiale, Società Italiana di Dermatologia e Sifilografia
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