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adalimumab serum

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https://www.readbyqxmd.com/read/28708805/serum-adalimumab-levels-predict-successful-remission-and-safe-deintensification-in-inflammatory-bowel-disease-patients-in-clinical-practice
#1
Mariam Aguas Peris, Virginia Bosó, Belén Navarro, Maria R Marqués-Miñana, Guillermo Bastida, Belén Beltrán, Marisa Iborra, Esteban Sáez-González, Emilio Monte-Boquet, Jose L Poveda-Andrés, Pilar Nos
BACKGROUND: Little is known about the association between the pharmacokinetic features of adalimumab (ADL) and disease outcome in patients with inflammatory bowel disease (IBD). AIMS: To assess the association between random serum ADL levels and clinical or biochemical remission with clinical decision making in daily practice according to these levels; and to determine the cutoff value for successful dose reduction in patients with IBD treated with ADL. METHODS: We conducted a prospective observational study of patients with IBD who received long-term maintenance therapy with ADL...
August 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28675520/a-randomized-phase-i-comparative-pharmacokinetic-study-comparing-sb5-with-reference-adalimumab-in-healthy-volunteers
#2
D Shin, Y Lee, H Kim, T Körnicke, R Fuhr
WHAT IS KNOWN AND OBJECTIVE: SB5 is a biosimilar to the reference adalimumab (ADL) currently in development. The primary study objective was to demonstrate pharmacokinetic (PK) equivalence of SB5 to European Union-sourced adalimumab (EU-ADL), and United States-sourced adalimumab (US-ADL) in healthy subjects. Safety, tolerability and immunogenicity were also assessed as secondary objectives. METHODS: In this phase I, single-blind trial, 189 healthy volunteers were randomized to a single 40 mg dose of SB5, EU-ADL or US-ADL and PK was evaluated for 71 days afterwards...
July 3, 2017: Journal of Clinical Pharmacy and Therapeutics
https://www.readbyqxmd.com/read/28657729/a-generic-hplc-method-for-absolute-quantification-of-oxidation-in-monoclonal-antibodies-and-fc-fusion-proteins-using-uv-and-ms-detection
#3
Christof Regl, Therese Wohlschlager, Johann Holzmann, Christian G Huber
Oxidation of biopharmaceuticals may affect their bioactivity, serum half-life, and (bio)chemical stability. The Fc domain of IgG monoclonal antibodies (mAbs) contains two methionine residues which are susceptible to oxidation. Here, we present a middle-down approach employing the cysteine protease IdeS under reducing conditions to obtain three mAb subunits of approximately 25 kDa: Fc/2, Fd' and LC. These subunits were separated by ion-pair reversed-phase high-performance liquid chromatography (IP-RP-HPLC) and detected by UV-spectroscopy as well as Orbitrap mass spectrometry (MS), as well as MS upon all-ion fragmentation (AIF-MS)...
June 28, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28632883/importance-of-immunogenicity-testing-for-cost-effective-management-of-psoriasis-patients-treated-with-adalimumab
#4
Fernando Mota, Esmeralda Neves, José Carlos Oliveira, Manuela Selores, Tiago Torres
INTRODUCTION: Up to 30% of patients treated with anti-tumor necrosis factor drugs do not respond adequately, and up to 50% lose response over time. Immunogenicity is now known to be one of the main causes of this loss of response. METHODS: Serum levels of adalimumab and anti-drug antibodies (ADAs) were measured in 19 patients with psoriasis. RESULTS: Eighty-nine percent of the patients were responders (Psoriasis Area Severity Index (PASI) > 75) and 11% were partial responders (PASI 50-75)...
June 2017: Acta Dermatovenerologica Alpina, Panonica, et Adriatica
https://www.readbyqxmd.com/read/28604127/correlation-between-trough-serum-levels-of-adalimumab-and-absolute-pasi-score-in-a-series-of-patients-with-psoriasis
#5
J M Carrascosa Carrilllo, M Toro Montecinos, F Ballescá López, A Teniente Serra, E Martínez Cáceres, C Ferrándiz
BACKGROUND: The possibility of monitoring serum drug levels has opened the door to optimizing biologic therapy. To consolidate this advance, it is imperative to demonstrate an adequate correlation between serum drug levels and clinical course. OBJECTIVES: To investigate whether a correlation exists between adalimumab levels and clinical response measured as absolute PASI. METHODS: In a prospective cohort study, we enrolled 51 patients with psoriasis treated with adalimumab for at least 16 weeks...
June 12, 2017: Journal of Dermatological Treatment
https://www.readbyqxmd.com/read/28570371/prolongation-of-biologic-dosing-intervals-in-patients-with-stable-psoriasis-a-feasibility-study
#6
Ji S van Bezooijen, Martijn B A van Doorn, Marco W J Schreurs, Birgit C P Koch, Henk Te Velthuis, Errol P Prens, Teun van Gelder
BACKGROUND: Biologics are usually licensed according to the "one dose fits all" principle. It is therefore suspected that a significant number of patients with psoriasis are overtreated. However, evidence for successful dose reduction of biologics in psoriasis is scarce. The aim of this study was to investigate whether the dosing interval of 3 biologics, adalimumab, etanercept, or ustekinumab could be prolonged successfully in patients with plaque psoriasis. METHODS: In a prospective exploratory cohort study, 59 patients with psoriasis on maintenance treatment with adalimumab, etanercept, or ustekinumab were included...
August 2017: Therapeutic Drug Monitoring
https://www.readbyqxmd.com/read/28565826/transcriptional-profiling-of-leukocytes-from-rheumatoid-arthritis-patients-before-and-after-anti-tumor-necrosis-factor-therapy-a-comparison-of-anti-nuclear-antibody-positive-and-negative-subsets
#7
Laurie S Davis, Andreas M Reimold
Anti-nuclear antibodies (ANAs) may be induced in patients with rheumatoid arthritis (RA) receiving anti-tumor necrosis factor (TNF) therapy with TNF inhibitors (TNFi), etanercept, infliximab or adalimumab. In the present study, 11 patients who were TNFi drug naive were started on TNFi at a time of high disease activity. Of these, all cases were positive for rheumatoid factor and 9 cases tested were positive for anti-citrullinated peptide (anti-CCP) antibodies prior to TNFi treatment. Peripheral blood mononuclear cells (PBMCs) and serum were collected from all patients before and after TNFi therapy...
May 2017: Experimental and Therapeutic Medicine
https://www.readbyqxmd.com/read/28560470/cost-per-response-for-abatacept-versus-adalimumab-in-rheumatoid-arthritis-by-acpa-subgroups-in-germany-italy-spain-us-and-canada
#8
Laure Weijers, Christoph Baerwald, Francesco S Mennini, José M Rodríguez-Heredia, Martin J Bergman, Denis Choquette, Kirsten H Herrmann, Giulia Attinà, Carmela Nappi, Silvia Jimenez Merino, Chad Patel, Mondher Mtibaa, Jason Foo
Rheumatoid arthritis (RA) is a chronic inflammatory disorder leading to disability and reduced quality of life. Effective treatment with biologic DMARDs poses a significant economic burden. The Abatacept versus Adalimumab Comparison in Biologic-Naïve RA Subjects with Background Methotrexate (AMPLE) trial was a head-to-head, randomized study comparing abatacept in serum anti-citrullinated protein antibody (ACPA)-positive patients, with increasing efficacy across ACPA quartile levels. The aim of this study was to evaluate the cost per response accrued using abatacept versus adalimumab in ACPA-positive and ACPA-negative patients with RA from the health care perspective in Germany, Italy, Spain, the US and Canada...
July 2017: Rheumatology International
https://www.readbyqxmd.com/read/28537934/alternative-treatments-for-chronic-spontaneous-urticaria-beyond-the-guideline-algorithm
#9
Gino A Vena, Marcus Maurer, Nicoletta Cassano, Torsten Zuberbier
PURPOSE OF REVIEW: The international EAACI/GALEN/EDF/WAO guideline suggests a stepwise approach for the therapeutic management of chronic spontaneous urticaria (CSU), outlined in an algorithm. The aim of this article is to summarize and review the evidence available on alternative treatment options for CSU outside of this algorithm. RECENT FINDINGS: Although CSU is a common disease, there are a limited number of high-quality studies, and only antihistamines and omalizumab are licensed for its treatment...
August 2017: Current Opinion in Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/28537863/severe-pellagra-masked-by-concurrent-plaque-psoriasis-a-case-report-of-a-hidden-diagnosis
#10
Elizabeth A Wang, Jason Kao, Michelle Y Cheng, Chelsea Ma, Soneet Dhillon, Thomas Konia, Emanual Maverakis, Cindy J Chambers
Despite characteristic features, psoriasis can mimic other dermatologic conditions, such as seborrheic dermatitis, lichen simplex chronicus, and certain nutritional deficiencies such as pellagra. We present a patient with a longstanding history of severe plaque psoriasis who presented with disfiguring scaly plaques involving greater than 80% body surface area. The patient's disease was minimally responsive to multiple therapies. Repeat punch biopsies demonstrated parakeratosis, psoriasiform hyperplasia, and dilated blood vessels consistent with psoriasis...
May 15, 2017: Dermatology Online Journal
https://www.readbyqxmd.com/read/28507492/long-term-treatment-of-chronic-plaque-psoriasis-with-biological-drugs-can-control-platelet-activation-targeting-the-bridge-between-inflammation-and-atherothrombosis
#11
Bartłomiej Kwiek, Joanna Narbutt, Anna Sysa-Jędrzejowska, Andrzej Langner, Aleksandra Lesiak
INTRODUCTION: Platelet activation is elevated in moderate to severe psoriasis, and the reduction in platelet activation during short-term treatment has already been demonstrated. Soluble P-selectin is a well-established marker of platelet activation. AIM: To show whether the long-term treatment of psoriasis with biological drugs can reduce elevated platelet activation. MATERIAL AND METHODS: An observational study of 27 patients with chronic plaque psoriasis, treated with infliximab, adalimumab, etanercept, or ustekinumab for up to 12 months was conducted...
April 2017: Postȩpy Dermatologii i Alergologii
https://www.readbyqxmd.com/read/28489469/significant-se-selectin-levels-reduction-after-6-months-of-anti-tnf-%C3%AE-therapy-in-non-diabetic-patients-with-moderate-to-severe-psoriasis
#12
Fernanda Genre, Susana Armesto, Alfonso Corrales, Raquel López-Mejías, Sara Remuzgo-Martínez, Trinitario Pina, Begoña Ubilla, Verónica Mijares, José Luis Martín-Varillas, Javier Rueda-Gotor, Virginia Portilla, Trinidad Dierssen-Sotos, Marcos Antonio González-López, María Del Carmen González-Vela, Ricardo Blanco, Javier Llorca, José Luis Hernández, Miguel Ángel González-Gay
PURPOSE: Psoriasis patients have high risk of atherosclerosis, characterized by endothelial dysfunction. We aimed to study the association of the endothelial activation biomarkers monocyte chemoattractant protein 1 (MCP-1), soluble (s) E-selectin and P-selectin with disease activity and severity in psoriasis patients treated with anti-TNF-α therapy. Also, to evaluate the relationship of metabolic syndrome features with these biomarkers and the effect of anti-TNF-α therapy on these molecules...
May 31, 2017: Journal of Dermatological Treatment
https://www.readbyqxmd.com/read/28481014/infliximab-and-adalimumab-drug-levels-in-crohn-s-disease-contrasting-associations-with-disease-activity-and-influencing-factors
#13
M G Ward, B Warner, N Unsworth, S-W Chuah, C Brownclarke, S Shieh, M Parkes, J D Sanderson, Z Arkir, J Reynolds, P R Gibson, P M Irving
BACKGROUND: Discriminative drug level thresholds for disease activity endpoints in patients with Crohn's disease. have been consistently demonstrated with infliximab, but not adalimumab. AIMS: To identify threshold concentrations for infliximab and adalimumab in Crohn's disease according to different disease endpoints, and factors that influence drug levels. METHODS: We performed a cross-sectional service evaluation of patients receiving maintenance infliximab or adalimumab for Crohn's disease...
July 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28474834/editorial-variability-in-adalimumab-trough-and-peak-serum-concentrations
#14
EDITORIAL
N Vande Casteele, A Gils
No abstract text is available yet for this article.
June 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28474825/editorial-variability-in-adalimumab-trough-and-peak-serum-concentrations-authors-reply
#15
EDITORIAL
M G Ward, P R Gibson, M P Sparrow
No abstract text is available yet for this article.
June 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28463029/high-rate-of-improvement-in-serum-matrix-metalloproteinase-3-levels-at-4-weeks-predicts-remission-at-52-weeks-in-ra-patients-treated-with-adalimumab
#16
Yosuke Hattori, Toshihisa Kojima, Atsushi Kaneko, Daihei Kida, Yuji Hirano, Takayoshi Fujibayashi, Yuichiro Yabe, Takeshi Oguchi, Yasuhide Kanayama, Hiroyuki Miyake, Takefumi Kato, Hideki Takagi, Masatoshi Hayashi, Takayasu Ito, Tomone Shioura, Nobunori Takahashi, Hisato Ishikawa, Koji Funahashi, Naoki Ishiguro
OBJECTIVE: This study aimed to determine whether serum matrix metalloproteinase-3 (MMP-3) levels can predict remission in rheumatoid arthritis (RA) patients treated with adalimumab (ADA). METHODS: Subjects were 114 RA patients continuously treated with ADA for 52 weeks. Predictive factors at baseline and 4 weeks after initiation of ADA therapy for the achievement of remission (28-point count Disease Activity Score-CRP (DAS28-CRP) < 2.3) at 52 weeks were evaluated by multivariate logistic regression analysis...
May 2, 2017: Modern Rheumatology
https://www.readbyqxmd.com/read/28448562/the-impact-of-anti-drug-antibodies-on-drug-concentrations-and-clinical-outcomes-in-rheumatoid-arthritis-patients-treated-with-adalimumab-etanercept-or-infliximab-results-from-a-multinational-real-world-clinical-practice-non-interventional-study
#17
Robert J Moots, Ricardo M Xavier, Chi Chiu Mok, Mahboob U Rahman, Wen-Chan Tsai, Mustafa H Al-Maini, Karel Pavelka, Ehab Mahgoub, Sameer Kotak, Joan Korth-Bradley, Ron Pedersen, Linda Mele, Qi Shen, Bonnie Vlahos
OBJECTIVE: To assess the incidence of anti-drug antibodies (ADA) in patients with rheumatoid arthritis (RA) treated with the TNF inhibitors etanercept (ETN), adalimumab (ADL), or infliximab (IFX), and determine the potential relationship with trough drug concentration, efficacy, and patient-reported outcomes. METHODS: This multi-national, non-interventional, cross-sectional study (NCT01981473) enrolled adult patients with RA treated continuously for 6-24 months with ETN, ADL, or IFX...
2017: PloS One
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
#18
RANDOMIZED CONTROLLED TRIAL
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)...
June 2017: Expert Opinion on Drug Metabolism & Toxicology
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
#19
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)...
June 2017: Autoimmunity Reviews
https://www.readbyqxmd.com/read/28400083/proposal-for-an-anti-tnf-exit-strategy-based-on-trough-serum-level
#20
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
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