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adalimumab serum

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https://www.readbyqxmd.com/read/28066879/population-pharmacokinetics-and-immunogenicity-of-adalimumab-in-adult-patients-with-moderate-to-severe-hidradenitis-suppurativa
#1
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
#2
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
#3
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
#4
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
#5
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
#6
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...
November 13, 2016: 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
#7
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
#8
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...
November 21, 2016: AAPS Journal
https://www.readbyqxmd.com/read/27846745/a-disintegrin-and-metalloproteinase-adam-10-as-a-predictive-factor-for-tocilizumab-effectiveness-in-rheumatoid-arthritis
#9
Takeo Isozaki, Shinichiro Nishimi, Airi Nishimi, Mayu Saito, Yusuke Miwa, Yoichi Toyoshima, Katsunori Inagaki, Tsuyoshi Kasama
OBJECTIVES: A disintegrin and metalloproteinase (ADAM)-10 is expressed in rheumatoid arthritis (RA). In this study, we focused on ADAM-10 as a predictive factor for the treatment with biologics in RA. METHODS: The levels of ADAM-10 and fractalkine/CX3CL1 in RA and healthy controls serum were measured using enzyme-linked immunosorbent assays. Fifteen patients were treated with adalimumab (ADA), and 20 patients were treated with tocilizumab (TCZ). RESULTS: ADAM-10 positively correlated with fractalkine/CX3CL1 in the sera of RA patients and was presented at a significantly higher level compared to that in normal serum (487 ± 80 pg/ml and 85 ± 33 pg/ml, respectively, p < 0...
December 23, 2016: Modern Rheumatology
https://www.readbyqxmd.com/read/27845027/clinical-effectiveness-and-cost-effectiveness-of-use-of-therapeutic-monitoring-of-tumour-necrosis-factor-alpha-tnf-%C3%AE-inhibitors-lisa-tracker%C3%A2-enzyme-linked-immunosorbent-assay-elisa-kits-tnf-%C3%AE-blocker-elisa-kits-and-promonitor%C3%A2-elisa-kits-versus-standard-care
#10
Karoline Freeman, Martin Connock, Peter Auguste, Sian Taylor-Phillips, Hema Mistry, Deepson Shyangdan, Rachel Court, Ramesh Arasaradnam, Paul Sutcliffe, Aileen Clarke
BACKGROUND AND OBJECTIVES: Systematic reviews and economic modelling of clinical effectiveness and cost-effectiveness of therapeutic monitoring of tumour necrosis factor alpha (TNF-α) inhibitors [using LISA-TRACKER(®) enzyme-linked immunosorbent assay (ELISA) kits (Theradiag, Marne La Vallee, France, or Alpha Laboratories, Heriot, UK), TNF-α-Blocker ELISA kits (Immundiagnostik AG, Bensheim, Germany) and Promonitor(®) ELISA kits (Proteomika, Progenika Biopharma, Bizkaia, Spain)] versus standard care for Crohn's disease (CD)...
November 2016: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/27832822/sarcoidosis-presenting-as-granulomatous-myositis-in-a-16-year-old-adolescent
#11
Amir B Orandi, Eric Eutsler, Cole Ferguson, Andrew J White, Maleewan Kitcharoensakkul
BACKGROUND: Sarcoidosis is a multi-system disease characterized by the presence of non-caseating epithelioid granulomas in affected tissues, including skeletal muscle. These organized collections of immune cells have important pathophysiologic action including cytokine production leading to inflammation as well as enzymatic conversion of cholecalciferol to calcitriol via 1-α hydroxylase. There are limited reports of isolated granulomatous myositis causing hypercalcemia in pediatric patients...
November 10, 2016: Pediatric Rheumatology Online Journal
https://www.readbyqxmd.com/read/27774694/impact-of-adalimumab-treatment-on-cardiovascular-risk-biomarkers-in-psoriasis-results-of-a-pilot-study
#12
Spyridon Gkalpakiotis, Monika Arenbergerova, Petra Gkalpakioti, Jana Potockova, Petr Arenberger, Pavel Kraml
Psoriasis is a chronic systemic immune-mediated inflammatory dermatosis associated with several comorbidities. Psoriasis patients are at increased risk of developing cardiovascular diseases (CVD), namely, coronary heart disease, stroke or peripheral vascular disease, and psoriasis seems to be an independent cardiovascular risk factor. Antipsoriatic systemic therapy, especially anti-tumor necrosis factor (TNF)-α, seems to exert a beneficial effect on these comorbidities. The purpose of this study was: (i) to measure the level of cardiovascular serum markers in psoriasis patients in comparison with healthy volunteers; and (ii) to compare the serum level of the same markers in patients before and 3 months after adalimumab therapy...
October 24, 2016: Journal of Dermatology
https://www.readbyqxmd.com/read/27692527/adalimumab-for-treatment-of-noninfectious-uveitis-immunogenicity-and-clinical-relevance-of-measuring-serum-drug-levels-and-antidrug-antibodies
#13
Miguel Cordero-Coma, Sara Calleja-Antolín, Irene Garzo-García, Ana M Nuñez-Garnés, Carolina Álvarez-Castro, Manuel Franco-Benito, Jose G Ruiz de Morales
PURPOSE: To evaluate the rate of immunogenicity induced by adalimumab and its relationship with drug serum levels and clinical responses in patients with noninfectious uveitis. DESIGN: Prospective observational study. PARTICIPANTS: Consecutive patients from 1 referral center who initiated treatment with adalimumab for active noninfectious uveitis resistant to conventional therapy. METHODS: All patients received 40 mg adalimumab every other week...
December 2016: Ophthalmology
https://www.readbyqxmd.com/read/27683139/long-term-treatment-with-adalimumab-in-psoriatic-arthritis-serum-adalimumab-concentration-immunogenicity-and-the-link-with-clinical-response
#14
Maria Sole Chimenti, Paola Triggianese, Alessandra Narcisi, Barbara Marinari, Miriam Teoli, Sara Faleri, Annalisa Arcese, Roberto Perricone, Antonio Costanzo
OBJECTIVES: An observational study to evaluate the relationship between serum concentrations of adalimumab and disease activity in patients receiving long-term adalimumab treatment for psoriatic arthritis. METHODS: Serum adalimumab and adalimumab antidrug antibodies were quantified by enzyme linked immunosorbent assay. Disease activity was assessed using Disease Activity Score (44 joint measures). Serum C-reactive protein was quantified using standard methods. RESULTS: A total of 30 patients were recruited...
September 2016: Journal of International Medical Research
https://www.readbyqxmd.com/read/27682742/investigation-of-a-multi-biomarker-disease-activity-score-in-rheumatoid-arthritis-by-comparison-with-magnetic-resonance-imaging-computed-tomography-ultrasonography-and-radiography-parameters-of-inflammation-and-damage
#15
S Krabbe, R Bolce, C H Brahe, U M Døhn, B J Ejbjerg, M L Hetland, E H Sasso, D Chernoff, M S Hansen, L S Knudsen, A Hansen, O R Madsen, M Hasselquist, J Møller, M Østergaard
OBJECTIVES: To investigate the multi-biomarker disease activity (MBDA) score by comparison with imaging findings in an investigator-initiated rheumatoid arthritis (RA) trial (HURRAH trial, NCT00696059). METHOD: Fifty-two patients with established RA initiated adalimumab treatment and had magnetic resonance imaging (MRI), ultrasonography (US), computed tomography (CT), and radiography performed at weeks 0, 26, and 52. Serum samples were analysed using MBDA score assays and associations between clinical measures, MBDA score, and imaging findings were investigated...
September 28, 2016: Scandinavian Journal of Rheumatology
https://www.readbyqxmd.com/read/27616043/the-bispecific-antibody-aimed-at-the-vicious-circle-of-il-1%C3%AE-and-il-17a-is-beneficial-for-the-collagen-induced-rheumatoid-arthritis-of-mice-through-nf-%C3%AE%C2%BAb-signaling-pathway
#16
Qiang Wu, Yunxin Wang, Qiuying Wang, Dan Yu, Yuyang Wang, Liying Song, Zhihang Liu, Xianlong Ye, Pengfei Xu, Hongxue Cao, Deshan Li, Guiping Ren
Rheumatoid arthritis (RA) is a chronic, systemic and autoimmune disease with overexpression inflammation cytokines. The biological therapy targeting these inflammatory cytokines has been applied for the clinic. Drugs aimed at a single target are ineffective in some patients with RA. However, double-target and multi-target drugs have huge advantages in therapy. Interleukin-1β (IL-1β) and Interleukin-17A (IL-17A) are the keys to inflammatory factors in RA. The bispecific antibody(BsAb)against both human IL-1β and human IL-17A was formed and expressed in E...
September 8, 2016: Immunology Letters
https://www.readbyqxmd.com/read/27558398/can-baseline-serum-micrornas-predict-response-to-tnf-alpha-inhibitors-in-rheumatoid-arthritis
#17
Bart V J Cuppen, Marzia Rossato, Ruth D E Fritsch-Stork, Arno N Concepcion, Yolande Schenk, Johannes W J Bijlsma, Timothy R D J Radstake, Floris P J G Lafeber
BACKGROUND: In rheumatoid arthritis, prediction of response to TNF-alpha inhibitor (TNFi) treatment would be of clinical value. This study aims to discover miRNAs that predict response and aims to replicate results of two previous studies addressing this topic. METHODS: From the observational BiOCURA cohort, 40 adalimumab- (ADA) and 40 etanercept- (ETN) treated patients were selected to enter the discovery cohort and baseline serum profiling on 758 miRNAs was performed...
2016: Arthritis Research & Therapy
https://www.readbyqxmd.com/read/27545848/impact-of-immunogenicity-on-pharmacokinetics-efficacy-and-safety-of-adalimumab-in-adult-patients-with-moderate-to-severe-chronic-plaque-psoriasis
#18
N M Mostafa, A M Nader, P Noertersheuser, M Okun, W M Awni
BACKGROUND: Adalimumab is a tumour necrosis factor-alpha antibody approved for treatment of moderate to severe chronic plaque psoriasis. OBJECTIVE: To characterise population pharmacokinetics of adalimumab 40 mg every other week dosing regimen and impact of immunogenicity on pharmacokinetics, efficacy and safety in psoriasis patients. METHODS: Patients were enrolled in a Phase 3 study comprising a 16-week double-blind, placebo-controlled period, a 17-week open-label period for Week 16 Psoriasis Area and Severity Index (PASI) 75 responders, and a 19-week double-blind, placebo-controlled period for Week 33 PASI 75 responders...
August 22, 2016: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/27479756/improving-the-efficacy-and-safety-of-biologic-drugs-with-tolerogenic-nanoparticles
#19
Takashi K Kishimoto, Joseph D Ferrari, Robert A LaMothe, Pallavi N Kolte, Aaron P Griset, Conlin O'Neil, Victor Chan, Erica Browning, Aditi Chalishazar, William Kuhlman, Fen-Ni Fu, Nelly Viseux, David H Altreuter, Lloyd Johnston, Roberto A Maldonado
The development of antidrug antibodies (ADAs) is a common cause for the failure of biotherapeutic treatments and adverse hypersensitivity reactions. Here we demonstrate that poly(lactic-co-glycolic acid) (PLGA) nanoparticles carrying rapamycin, but not free rapamycin, are capable of inducing durable immunological tolerance to co-administered proteins that is characterized by the induction of tolerogenic dendritic cells, an increase in regulatory T cells, a reduction in B cell activation and germinal centre formation, and the inhibition of antigen-specific hypersensitivity reactions...
October 2016: Nature Nanotechnology
https://www.readbyqxmd.com/read/27474201/an-increase-in-serum-tumour-necrosis-factor-%C3%AE-during-anti-tumour-necrosis-factor-%C3%AE-therapy-for-crohn-s-disease-a-paradox-or-a-predictive-index
#20
Piotr Eder, Katarzyna Korybalska, Liliana Łykowska-Szuber, Kamila Stawczyk-Eder, Iwona Krela-Kaźmierczak, Joanna Łuczak, Natasza Czepulis, Krzysztof Linke, Janusz Witowski
BACKGROUND: Soluble tumour necrosis factor-α (sTNF-α) has been reported to increase in the course of anti-TNF-α therapy for rheumatoid and skin diseases. AIMS: To assess changes in sTNF-α and clinical efficacy of anti-TNF-α agents in Crohn's disease (CD). METHODS: Sixty-four patients on infliximab or adalimumab were analyzed. Clinical outcomes were assessed by using CD Activity Index after the induction therapy and at week 52. sTNF-α was measured before and after the induction therapy with high-sensitivity immunoassay...
October 2016: Digestive and Liver Disease
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