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https://www.readbyqxmd.com/read/28425772/prediction-of-successful-dose-reduction-or-discontinuation-of-adalimumab-etanercept-or-infliximab-in-rheumatoid-arthritis-patients-using-serum-drug-levels-and-antidrug-antibody-measurement
#1
Cam Bouman, N van Herwaarden, Fhj van den Hoogen, A van der Maas, Bjf van den Bemt, A A den Broeder
BACKGROUND: To evaluate if TNF inhibitor serum drug levels (DL) or anti-drug antibodies (ADAb) can predict successful dose reduction (in patients with high DL) or discontinuation (in patients with no/low DL or ADAb) in rheumatoid arthritis (RA) patients. RESEARCH DESIGN AND METHODS: RA patients that were using adalimumab (n=42), etanercept (n=76) or infliximab (n=51) and were doing well, were tapered until discontinuation or flare (1-1.5 year follow up). Random timed DL for adalimumab and etanercept and trough DL for infliximab were measured before dose reduction: Receiver-Operator-Curves (ROC) analyses with optimal cut-off DL were determined...
April 20, 2017: Expert Opinion on Drug Metabolism & Toxicology
https://www.readbyqxmd.com/read/28417141/incidence-and-prevalence-of-psoriasis-in-denmark
#2
Alexander Egeberg, Lone Skov, Gunnar H Gislason, Jacob P Thyssen, Lotus Mallbris
The incidence and temporal trends of psoriasis in Denmark between 2003 and 2012 were examined. There was a female predominance ranging between 50.0% (2007) and 55.4% (2009), and the mean age at time of diagnosis was 47.7-58.7 years. A total of 126,055 patients with psoriasis (prevalence 2.2%) were identified. Incidence rates of psoriasis (per 100,000 person years) ranged from 107.5 in 2005 to a peak incidence of 199.5 in 2010. Incidence rates were higher for women, and patients aged 60-69 years, respectively...
April 18, 2017: Acta Dermato-venereologica
https://www.readbyqxmd.com/read/28412140/chronic-sleep-restriction-promotes-brain-inflammation-and-synapse-loss-and-potentiates-memory-impairment-induced-by-amyloid-%C3%AE-oligomers-in-mice
#3
Grasielle C Kincheski, Isabela S Valentim, Julia R Clarke, Danielle Cozachenco, Morgana T L Castelo-Branco, Angela M Ramos-Lobo, Vivian M B D Rumjanek, José Donato, Fernanda G De Felice, Sergio T Ferreira
It is increasingly recognized that sleep disturbances and Alzheimer's disease (AD) share a bidirectional relationship. AD patients exhibit sleep problems and alterations in the regulation of circadian rhythms; conversely, poor quality of sleep increases the risk of development of AD. The aim of the current study was to determine whether chronic sleep restriction potentiates the brain impact of amyloid-β oligomers (AβOs), toxins that build up in AD brains and are thought to underlie synapse damage and memory impairment...
April 13, 2017: Brain, Behavior, and Immunity
https://www.readbyqxmd.com/read/28411169/the-impact-of-immunogenicity-of-tnf%C3%AE-inhibitors-in-autoimmune-inflammatory-disease-a-systematic-review-and-meta-analysis
#4
REVIEW
Valentina Pecoraro, Elena De Santis, Alessandra Melegari, Tommaso Trenti
BACKGROUND: Monoclonal antibodies drugs directed against TNFα, TNFα inhibitors, are immunogenic, and consequent anti-drug antibodies (ADA) formation may decrease the functional drug concentration, resulting in a loss of response. We evaluated the impact of ADA on TNFα therapeutic response. METHODS: We considered studies enrolling adult patients affected by autoimmune inflammatory disease in therapy with TNFα inhibitors. We collected data about study and population characteristics, treatment dosage, determination of ADA and adverse events (AE)...
April 11, 2017: Autoimmunity Reviews
https://www.readbyqxmd.com/read/28401824/-biosimilar-registered-despite-the-netherlands-opposing-vote-greater-uncertainty-about-authorised-drugs-in-the-netherlands
#5
A G Vulto
On 1 April 2016 the Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on a new biological medicine, Flixabi®, a biosimilar to infliximab (Remicade®); however, in the appendix of the European Public Assessment Report (EPAR) it appeared that an important minority (14 of 33 votes) opposed this decision, among them the Netherlands representative. In an original article, the Dutch Medicines Board (CBG-MEB) explained the reason for this decision, but still allowed the drug on the market...
2017: Nederlands Tijdschrift Voor Geneeskunde
https://www.readbyqxmd.com/read/28400083/proposal-for-an-anti-tnf-exit-strategy-based-on-trough-serum-level
#6
Ulf Helwig, Frederik Lutter, Nadine Koppka, Stefan Schreiber
BACKGROUND AND AIMS: The aim of the study was to evaluate, if the strategy to stop anti-TNF treatment after determination of low trough serum levels and exclusion of inflammation is associated with lower relapse rates. METHODS: Since 2013 we followed an exit strategy in patients treated with anti-TNF treatment for inflammatory bowel disease based on trough serum levels. The relapse rates were observed prospectively, data analysis was performed in a retrospective manner of the collected clinical data...
April 8, 2017: Biologicals: Journal of the International Association of Biological Standardization
https://www.readbyqxmd.com/read/28393687/biosimilars-for-the-management-of-inflammatory-bowel-diseases-economic-considerations
#7
Laszlo Gulacsi, Marta Pentek, Fanni Rencz, Valentin Brodszky, Petra Baji, Zsuzsanna Vegh, Krisztina B Gecse, Silvio Danese, Laurent Peyrin-Biroulet, Peter L Lakatos
Biological drugs revolutionized the treatment of inflammatory bowel diseases (IBD) such as Crohn's disease and ulcerative colitis. However, not all clinically eligible patients have access to biologicals, due to significant costs and budget impact. Biosimilars are highly comparable to their originator product in terms of clinical efficacy and safety. Biosimilars are priced 15-75% lower than their reference product, which makes them a less costly alternative and is expected to offer better patients access to biologicals...
April 6, 2017: Current Medicinal Chemistry
https://www.readbyqxmd.com/read/28375831/the-effect-of-anti-tnf-treatment-on-osteoblastogenesis-in-ankylosing-spondylitis-the-number-of-circulating-osteoblast-lineage-cells-in-peripheral-blood-decreased-after-infliximab-therapy-in-patients-with-ankylosing-spondylitis
#8
Seong-Ryul Kwon, Kyong-Hee Jung, Mie-Jin Lim, Min-Jung Son, Byung Hyune Choi, Shin-Goo Park, Won Park
OBJECTIVES: The full effect of anti-TNF therapy on new bone formation is still in debate in spondylitis fields. We sought to obtain circulating osteoblast-lineage cells in peripheral blood from ankylosing spondylitis (AS) patients and healthy control subjects, and to evaluate the effect of before and after anti TNF-α therapy on osteoblastogenesis in patients with AS. METHODS: Sixteen male patients with AS slated for infliximab therapy and 19 controls were recruited...
March 31, 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/28370220/impact-of-anti-tumor-necrosis-factor-%C3%AE-agents-on-serum-levels-of-kl-6-and-surfactant-protein-d-in-patients-with-psoriasis
#9
Mitsuha Hayashi, Koichi Yanaba, Yoshinori Umezawa, Akihiko Asahina, Hidemi Nakagawa
We longitudinally examined the influence of anti-tumor necrosis factor (TNF)-α treatment on serum levels of KL-6 and surfactant protein-D (SP-D). The study group comprised 22 patients with psoriasis treated with infliximab or adalimumab and with no history of interstitial lung disease (ILD). KL-6 and SP-D levels were measured in serum samples. Twelve of the 22 patients (55%) showed at least a 20% increase in KL-6 levels compared with baseline. Of these 12 patients, none exhibited any signs of ILD on chest computed tomography and nine who showed an increase in KL-6 levels (75%) showed at least a 20% increase in SP-D levels...
March 31, 2017: Journal of Dermatology
https://www.readbyqxmd.com/read/28365979/a-multidimensional-analytical-comparison-of-remicade-and-the-biosimilar-remsima
#10
Karthik Pisupati, Yuwei Tian, Solomon Okbazghi, Alexander Benet, Rose Ackermann, Michael Ford, Sergei V Saveliev, Christopher M Hosfield, Marjeta Urh, Eric Carlson, Christopher Becker, Thomas J Tolbert, Steven P Schwendeman, Brandon T Ruotolo, Anna Schwendeman
In April 2016, the Food and Drug Administration approved the first biosimilar monoclonal antibody (mAb) - Inflectra/Remsima (Celltrion) based off the original product Remicade (infliximab, Janssen). Biosimilars promise significant cost savings for patients, but the unavoidable differences between innovator and copycat biologics raise questions regarding product interchangeability. In this study, Remicade and Remsima were examined by native mass spectrometry, ion mobility and quantitative peptide mapping. The levels of oxidation, deamidation and mutation of individual amino acids were remarkably similar...
April 1, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28362851/clinical-role-optimal-timing-and-frequency-of-serum-infliximab-and-anti-infliximab-antibody-level-measurements-in-patients-with-inflammatory-bowel-disease
#11
Renáta Bor, Klaudia Farkas, Anna Fábián, Anita Bálint, Ágnes Milassin, Mariann Rutka, Mária Matuz, Ferenc Nagy, Zoltán Szepes, Tamás Molnár
BACKGROUND: Serum infliximab (IFX) and antibody-to-infliximab (ATI) levels are objective parameters, that may have a great role in the therapeutic decisions during maintenance biological therapy. RESEARCH DESIGN AND METHODS: 48 inflammatory bowel disease patients receiving maintenance IFX therapy were prospectively enrolled and divided into adequate (complete remission N = 20) and inadequate responder (partial response, loss of response, dose escalation; N = 28) groups...
2017: PloS One
https://www.readbyqxmd.com/read/28356746/an-estimate-of-the-cost-of-administering-intravenous-biological-agents-in-spanish-day-hospitals
#12
Joan Miquel Nolla, Esperanza Martín, Pilar Llamas, Javier Manero, Arturo Rodríguez de la Serna, Manuel Francisco Fernández-Miera, Mercedes Rodríguez, José Manuel López, Alexandra Ivanova, Belén Aragón
OBJECTIVE: To estimate the unit costs of administering intravenous (IV) biological agents in day hospitals (DHs) in the Spanish National Health System. PATIENTS AND METHODS: Data were obtained from 188 patients with rheumatoid arthritis, collected from nine DHs, receiving one of the following IV therapies: infliximab (n=48), rituximab (n=38), abatacept (n=41), or tocilizumab (n=61). The fieldwork was carried out between March 2013 and March 2014. The following three groups of costs were considered: 1) structural costs, 2) material costs, and 3) staff costs...
2017: Therapeutics and Clinical Risk Management
https://www.readbyqxmd.com/read/28353200/asymptomatic-acute-hepatitis-e-in-a-female-patient-with-ulcerative-colitis
#13
Kazuyuki Suzuki, Ichiro Kumagai, Yuichi Yoshida, Akio Miyasaka, Yasuhiro Takikawa, Ryoichi Kamiya, Kouryo Kondo, Akinobu Kato, Toshimi Chiba, Hiroaki Okamoto
We present a 60-year-old female patient with asymptomatic acute hepatitis E that was fortuitously detected during the course of ulcerative colitis (UC). She was admitted to hospital on October 30, 2015. Endoscopy and histological examination of the colon showed typical findings of UC. All parameters of liver function tests were normal on this date. Combination therapy with oral prednisolone and mesalazine was started and intravenous administration of infliximab once every 8 weeks was added later. Her symptoms gradually improved after these treatments, and she was discharged on February 7, 2016...
March 28, 2017: Clinical Journal of Gastroenterology
https://www.readbyqxmd.com/read/28336735/risk-of-tuberculosis-in-patients-treated-with-tnf-%C3%AE-antagonists-a-systematic-review-and-meta-analysis-of-randomised-controlled-trials
#14
Zheng Zhang, Wei Fan, Gui Yang, Zhigao Xu, June Wang, Qingyuan Cheng, Mingxia Yu
OBJECTIVES: An increased risk of tuberculosis (TB) has been reported in patients treated with TNF-α antagonists, an issue that has been highlighted in a WHO black box warning. This review aimed to assess the risk of TB in patients undergoing TNF-α antagonists treatment. METHODS: A systematic literature search for randomised controlled trials (RCTs) was performed in MEDLINE, Embase and Cochrane library and studies selected for inclusion according to predefined criteria...
March 22, 2017: BMJ Open
https://www.readbyqxmd.com/read/28333755/treatment-persistence-for-infliximab-versus-adalimumab-in-crohn-s-disease-a-14-year-single-center-experience
#15
Pablo Olivera, Linda Thiriet, Amandine Luc, Cedric Baumann, Silvio Danese, Laurent Peyrin-Biroulet
BACKGROUND: Infliximab (IFX) and adalimumab (ADA) are widely used in the treatment of patients with Crohn's disease (CD). There are few published data on the treatment persistence of IFX and ADA in patients with CD. METHODS: We aimed to compare the persistence rates of IFX versus ADA as first- and second-line tumor necrosis factor antagonist (anti-TNF), to identify factors potentially associated with persistence, and to evaluate reasons for treatment withdrawal in CD patients...
March 16, 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28318043/the-effects-of-pregnancy-on-the-pharmacokinetics-of-infliximab-and-adalimumab-in-inflammatory-bowel-disease
#16
C H Seow, Y Leung, N Vande Casteele, E Ehteshami Afshar, D Tanyingoh, G Bindra, M J Stewart, P L Beck, G G Kaplan, S Ghosh, R Panaccione
BACKGROUND: Transplacental transfer of infliximab and adalimumab results in detectable drug levels in the cord blood and infant. AIM: To determine if pregnancy influenced the pharmacokinetics of anti-TNF agents in women with inflammatory bowel disease. METHODS: Twenty-five women from the University of Calgary inflammatory bowel disease(IBD) pregnancy clinic on maintenance infliximab or adalimumab were recruited prospectively with serum bio-banking performed each trimester...
March 20, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28300604/altered-activation-of-peripheral-cd8-t-cells-in-pediatric-crohn-s-disease
#17
Csaba Orbán, Dolóresz Szabó, Anna Bajnok, Barna Vásárhelyi, Tivadar Tulassay, András Arató, Gábor Veres, Gergely Toldi
AIM: Although Crohn's disease (CD) is an extensively investigated autoimmune condition, knowledge on early phase activation of lymphocytes, especially CD8+ Tc cells is scarce. Our aim was to investigate the calcium influx characteristics of CD8+ cells upon activation as well as the expression and function of Kv1.3 and IKCa1 lymphocyte potassium channels. METHODS: We took peripheral blood from 12 healthy controls, 23 CD children on conventional therapy and 6 severe CD children before and after infliximab therapy...
March 11, 2017: Immunology Letters
https://www.readbyqxmd.com/read/28293938/effectiveness-and-safety-of-infliximab-biosimilar-ct-p13-in-treating-ulcerative-colitis-a-real-life-experience-in-ibd-primary-centers
#18
Antonio Tursi, Leonardo Allegretta, Stefania Chiri, Nicola Della Valle, Walter Elisei, Giacomo Forti, Roberto Lorenzetti, Giammarco Mocci, Antonio Penna, Giuseppe Pranzo, Cristina Ricciardelli, Marcello Picchio
BACKGROUND: To assess the efficacy and safety of biosimilar infliximab (IFX) IFX CT-P13 in inducing and maintain remission in Ulcerative Colitis (UC) outpatients in Italian primary gastroenterology centers. METHODS: Patients were prospectively assessed at entry, after 8, 12, 24, 36, and therefore 52 weeks. Clinical activity was scored according to the Mayo score. The primary endpoint was reaching of clinical remission (Mayo score ≤2). Several secondary endpoints were clinical response to treatment, reaching of mucosal healing (MH), safety of the drug...
March 14, 2017: Minerva Gastroenterologica e Dietologica
https://www.readbyqxmd.com/read/28293096/clinical-correlations-of-infliximab-trough-levels-and-antibodies-to-infliximab-in-south-korean-patients-with-crohn-s-disease
#19
Eun Hye Oh, Dae-Hyun Ko, Hyungil Seo, Kiju Chang, Gwang-Un Kim, Eun Mi Song, Myeongsook Seo, Ho-Su Lee, Sung Wook Hwang, Dong-Hoon Yang, Byong Duk Ye, Jeong-Sik Byeon, Seung-Jae Myung, Suk-Kyun Yang, Sang Hyoung Park
AIM: To investigate the clinical implications of infliximab trough levels (IFX-TLs) and antibodies to infliximab (ATI) levels in Crohn's disease (CD) patients in Asian countries. METHODS: IFX-TL and ATI level were measured using prospectively collected samples obtained with informed consent from CD patients being treated at Asan Medical Center, South Korea. We analyzed the correlations between IFX-TLs/ATI levels and the clinical activity of CD (quiescent vs active disease) based on the CD activity index, C-reactive protein level, and physician's judgment of patients' clinical status at enrollment...
February 28, 2017: World Journal of Gastroenterology: WJG
https://www.readbyqxmd.com/read/28286562/golimumab-pharmacokinetics-in-ulcerative-colitis-a-literature-review
#20
REVIEW
Ines Harzallah, Josselin Rigaill, Nicolas Williet, Stephane Paul, Xavier Roblin
Golimumab (GLM) is the latest anti-tumor necrosis factor (TNF) that gained its marketing license. Thanks to the PURSUIT induction and maintenance trials, it was approved for the treatment of ulcerative colitis (UC) in 2013. The other anti-TNF drugs available are infliximab and adalimumab. These two drugs have validated algorithms concerning prescription and therapeutic drug monitoring (TDM) but little is known about GLM. The available data on GLM's exposure-response relationship in UC are from the PURSUIT trials and are recently published...
January 2017: Therapeutic Advances in Gastroenterology
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