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https://www.readbyqxmd.com/read/28318043/the-effects-of-pregnancy-on-the-pharmacokinetics-of-infliximab-and-adalimumab-in-inflammatory-bowel-disease
#1
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/28286562/golimumab-pharmacokinetics-in-ulcerative-colitis-a-literature-review
#2
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
https://www.readbyqxmd.com/read/28279855/anti-therapeutic-antibodies-and-their-clinical-impact-in-patients-treated-with-the-tnf-antagonist-adalimumab
#3
Isabelle Cludts, Francesca Romana Spinelli, Francesca Morello, Jason Hockley, Guido Valesini, Meenu Wadhwa
Patients treated with the TNF antagonist adalimumab develop anti-therapeutic antibodies (ATA), the prevalence of which varies depending on the assay used. Most assays are compromised due to the presence of adalimumab in the clinical samples. Our objective was to develop an antibody assay, applicable for clinical testing, which overcomes the limitation of therapeutic interference and to further determine the relationship between ATA development, adalimumab levels and disease activity in patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA) or ankylosing spondylitis (AS)...
March 6, 2017: Cytokine
https://www.readbyqxmd.com/read/28274164/impact-of-immunogenicity-on-response-to-anti-tnf-therapy-in-moderate-to-severe-plaque-psoriasis-results-of-the-predir-study
#4
Mariano Ara-Martín, Pedro Herranz Pinto, Dora Pascual-Salcedo
PURPOSE: This study was conducted to examine the relationship between loss of clinical response to anti-tumor necrosis factor (TNF) therapy and the production of anti-drug antibodies (ADAs) and the potential effects of biologic immunogenicity. MATERIALS AND METHODS: This observational, non-interventional, cross-sectional study included patients with moderate-to-severe plaque psoriasis and secondary failure of adalimumab, etanercept and infliximab who were seen in the clinical practice setting...
March 8, 2017: Journal of Dermatological Treatment
https://www.readbyqxmd.com/read/28230306/suppression-of-anti-drug-antibodies-to-infliximab-or-adalimumab-with-the-addition-of-an-immunomodulator-in-patients-with-inflammatory-bowel-disease
#5
A S Strik, G R van den Brink, C Ponsioen, R Mathot, M Löwenberg, G R D'Haens
BACKGROUND: Loss of response to anti-tumour necrosis factor (TNF) therapy in patients with inflammatory bowel disease (IBD) is often caused by anti-drug antibody formation with neutralisation of drug effect. Addition of an immunomodulator has been suggested to reduce immunogenicity, leading to regained response. AIM: To investigate whether addition of an immunomodulator to anti-TNF monotherapy could lead to anti-drug antibody suppression and regained clinical response in IBD patients...
February 23, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28172864/p365-serum-adalimumab-levels-predict-successful-remission-and-safe-de-intensification-in-inflammatory-bowel-disease-patients-in-clinical-practice
#6
M Aguas, V Bosό, B Navarro, M R Marqués-Miñana, G Bastida, B Beltrán, M Iborra, E Monte-Boquet, J L Poveda-Andrés, P Nos
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28172861/p283-quantum-blue%C3%A2-adalimumab-development-of-the-first-point-of-care-rapid-test-for-therapeutic-drug-monitoring-of-serum-adalimumab-levels
#7
F I Bantleon, S Kräuchi, T B Schuster, M Schneider, A Abel
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28172461/dop034-serum-adalimumab-concentration-3-months-after-surgery-is-correlated-with-endoscopic-recurrence-in-crohn-s-disease-patients-treated-with-adalimumab-for-prevention-of-postoperative-recurrence
#8
L Boivineau, J F Bourgaux, G Pineton de Chambrun, L Caillo, G Danan, J Boitard, J Liautard, F Guillon, R Altwegg
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28164321/dose-de-escalation-to-adalimumab-40-mg-every-3-weeks-in-patients-with-crohn-s-disease-a-nested-case-control-study
#9
S Van Steenbergen, S Bian, S Vermeire, G Van Assche, A Gils, M Ferrante
BACKGROUND: Data on dose de-escalation in patients with Crohn's disease (CD) are limited. AIM: To evaluate outcomes of dose de-escalation from adalimumab (ADM) every other week (EOW) to every three weeks (ETW). METHODS: We selected patients with CD receiving maintenance therapy with ADM 40 mg ETW with serum levels (SL) available before and after dose de-escalation. Sex- and age-matched controls continuing ADM 40 mg EOW were identified. Patient reported outcome, C-reactive protein (CRP) and serum albumin were collected...
February 6, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28148280/optimizing-adalimumab-treatment-in-psoriasis-with-concomitant-methotrexate-optimap-study-protocol-for-a-pragmatic-single-blinded-investigator-initiated-randomized-controlled-trial
#10
Celine Busard, Stef Menting, Sun-Jine van Bezooijen, Juul van den Reek, Barbara Hutten, Errol Prens, Elke de Jong, Martijn van Doorn, Phyllis Spuls
BACKGROUND: The introduction of anti-tumor necrosis factor medications has revolutionized the treatment of psoriasis with achievement of treatment goals (Psoriasis Area and Severity Index score 75, remission) that are not usually met with conventional systemics. Nevertheless, some patients continue to experience persistent disease activity or treatment failure over time. Strategies to optimize treatment outcomes include the use of concomitant methotrexate, which has demonstrated beneficial effects on pharmacokinetics and treatment efficacy in psoriasis and other inflammatory diseases...
February 2, 2017: Trials
https://www.readbyqxmd.com/read/28147368/combining-therapeutic-drug-monitoring-with-biosimilars-a-strategy-to-improve-the-efficacy-of-biologicals-for-treating-inflammatory-bowel-diseases-at-an-affordable-cost
#11
REVIEW
Ann Gils
BACKGROUND: Biologicals provide a tight disease control but not all patients respond favourably to treatment. Some patients do not respond at all (primary non-responders), while other patients respond initially but show loss of response over time (secondary non-responders). Drug concentrations in the serum of patients can be monitored and correlated with biological, clinical or endoscopic response. Therapeutic thresholds have been defined for infliximab and adalimumab. The European Medicines Agency has approved 3 biosimilars of infliximab and new biosimilars are waiting approval...
2017: Digestive Diseases
https://www.readbyqxmd.com/read/28145781/detection-of-adalimumab-and-antibodies-to-adalimumab-using-the-anser%C3%A2-ada-homogeneous-mobility-shift-assay
#12
David T Rubin, Snehal Naik, Venkateswarlu Kondragunta, Tharak Rao, Anjali Jain
OBJECTIVE: In 2013 a novel commercial test was launched (Anser ADA test, Prometheus Laboratories Inc.) for the assay of serum adalimumab (ADL) and antibodies-to-adalimumab (ATA). This study aims to understand clinical practice patterns used with ADL in a real-world cross-sectional population. METHODS: Wilcoxon rank sum test, and linear and logistic regression methods were applied in the statistical analysis to test hypotheses. The study design was observational and uncontrolled...
February 1, 2017: Current Medical Research and Opinion
https://www.readbyqxmd.com/read/28066879/population-pharmacokinetics-and-immunogenicity-of-adalimumab-in-adult-patients-with-moderate-to-severe-hidradenitis-suppurativa
#13
Ahmed Nader, Denise Beck, Peter Noertersheuser, David Williams, Nael Mostafa
INTRODUCTION: Hidradenitis suppurativa (HS) is a serious, debilitating, chronic inflammatory skin disease. Adalimumab is a fully human, immunoglobulin G1 monoclonal antibody specific for tumor necrosis factor-alpha recently approved for use in patients with HS. The aim of this study is to describe the population pharmacokinetics and immunogenicity of adalimumab in adult patients with HS. METHODS: Data from one phase II and two phase III studies were included in the analysis...
January 9, 2017: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27943384/determination-of-adalimumab-and-etanercept-trough-levels-and-drug-antibodies-in-long-term-psoriasis-treatment-a-single-centre-cohort-study
#14
J Manriquez, M Alsina-Gibert
BACKGROUND: An algorithm based on measurement of a serum tumour necrosis factor antagonists (anti-TNF) and antidrug antibodies (ADA) has been proposed previously to guide dose escalation or therapy switching in the early (i.e. the first months of) treatment of psoriasis by anti-TNF. In long-term treatment of responding patients with psoriasis, it is usual to empirically reduce standard doses of anti-TNF to reduce exposure while maintaining clinical response. The relationship between serum anti-TNF, ADA levels and clinical efficacy in long-term treated patients with psoriasis has not yet been determined, so the potential role of these parameters in guiding dose escalation in this scenario is unknown...
January 2017: Clinical and Experimental Dermatology
https://www.readbyqxmd.com/read/27940624/anti-adalimumab-antibodies-in-psoriasis-lack-of-clinical-utility-and-laboratory-evidence
#15
G Lombardi, S Perego, V Sansoni, M Diani, G Banfi, G Altomare
OBJECTIVE: Adalimumab has proven effective in psoriasis; however, secondary failure may result from the drug's immunogenicity. Prevalence data on the immunogenicity of biologicals, and of adalimumab in particular, are highly variable. We investigated the prevalence of anti-adalimumab antibodies and the association with clinical indexes and tumour necrosis factor α (TNFα) serum levels in psoriatic patients. DESIGN: Case-control, longitudinal. SETTING: Single centre...
December 9, 2016: BMJ Open
https://www.readbyqxmd.com/read/27939407/higher-body-mass-index-and-anti-drug-antibodies-predict-the-discontinuation-of-anti-tnf-agents-in-korean-patients-with-axial-spondyloarthritis
#16
Jiwon Hwang, Hye-Mi Kim, Hyemin Jeong, Jaejoon Lee, Joong Kyong Ahn, Eun-Mi Koh, Eun-Suk Kang, Hoon-Suk Cha
OBJECTIVE: The development of anti-drug antibodies (ADAbs) against tumor necrosis factor (TNF) inhibitors is a likely explanation for the failure of TNF-inhibitors in patients with spondyloarthritis (SpA). Our study determined the existence and clinical implications of ADAbs in axial SpA patients. METHODS: According to the Assessment of SpondyloArthritis International Society classification criteria for axial SpA, patients treated with adalimumab or infliximab were recruited consecutively...
November 15, 2016: Revista Brasileira de Reumatologia
https://www.readbyqxmd.com/read/27936119/anti-tnf-%C3%AE-drugs-differently-affect-the-tnf%C3%AE-stnfr-system-and-monocyte-subsets-in-patients-with-psoriasis
#17
Lara Gibellini, Sara De Biasi, Elena Bianchini, Regina Bartolomeo, Antonella Fabiano, Marco Manfredini, Federica Ferrari, Giuseppe Albertini, Tommaso Trenti, Milena Nasi, Marcello Pinti, Anna Iannone, Carlo Salvarani, Andrea Cossarizza, Giovanni Pellacani
TNF-α has a central role in the development and maintenance of psoriatic plaques, and its serum levels correlate with disease activity. Anti-TNF-α drugs are, however, ineffective in a relevant percentage of patients for reasons that are currently unknown. To understand whether the response to anti-TNF-α drugs is influenced by the production of anti-drug antibodies or by the modulation of the TNFα-TNFα receptor system, and to identify changes in monocyte phenotype and activity, we analysed 119 psoriatic patients who either responded or did not respond to different anti-TNF-α therapies (adalimumab, etanercept or infliximab), and measured plasma levels of TNF-α, TNF-α soluble receptors, drug and anti-drug antibodies...
2016: PloS One
https://www.readbyqxmd.com/read/27908311/obesity-decreases-clinical-efficacy-and-levels-of-adalimumab-in-patients-with-ankylosing-spondylitis
#18
José Rosas, Francisca Llinares-Tello, José Miguel Senabre-Gallego, Xavier Barber-Vallés, Gregorio Santos-Soler, Esteban Salas-Heredia, Ana Pons Bas, Catalina Cano Pérez, Mario García-Carrasco
OBJECTIVES: Obesity can be a factor that affects response to anti-TNF drugs. However, studies on patients with ankylosing spondylitis (AS) are rare. We aimed to determine whether obesity affects serum levels of adalimumab (ADL), and immunogenicity and clinical efficacy of the drug in patients with AS. METHODS: A cross-sectional study on 57 patients with axial AS receiving ADL was conducted. They received DMARD per standard of care at their rheumatologist's discretion...
January 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/27884074/lc-ms-ms-strategies-for-therapeutic-antibodies-and-investigation-into-the-quantitative-impact-of-antidrug-antibodies
#19
Matthew Ewles, Ranbir Mannu, Chris Fox, Johannes Stanta, Graeme Evans, Lee Goodwin, James Duffy, Len Bell, Sian Estdale, David Firth
AIM: We aimed to establish novel, high-throughput LC-MS/MS strategies for quantification of monoclonal antibodies in human serum and examine the potential impact of antidrug antibodies. METHODOLOGY: We present two strategies using a thermally stable immobilized trypsin. The first strategy uses whole serum digestion and the second introduces Protein G enrichment to improve the selectivity. The impact of anti-trastuzumab antibodies on the methods was tested. CONCLUSION: Whole serum digestion has been validated for trastuzumab (LLOQ 0...
December 2016: Bioanalysis
https://www.readbyqxmd.com/read/27873119/validation-of-a-drug-resistant-anti-adalimumab-antibody-assay-to-monitor-immunogenicity-in-the-presence-of-high-concentrations-of-adalimumab
#20
Sumin Bian, Marc Ferrante, Ann Gils
With respect to patient safety and long-term efficacy, immunogenicity of therapeutic antibodies remains an important issue. Pre-treatment of samples using either higher temperature or acidification in order to separate drug/anti-drug antibody complexes has been implemented in the traditional bridging assay and an in-house-developed affinity capture elution assay but only a limited drug tolerance was obtained. In this study, we aim to apply a drug-resistant anti-drug antibody assay to adalimumab through a combination of adalimumab/anti-adalimumab antibody complex precipitation and acid dissociation...
March 2017: AAPS Journal
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