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adalimumab serum

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https://www.readbyqxmd.com/read/28884856/significance-of-measurement-of-serum-trough-level-and-anti-drug-antibody-of-adalimumab-as-personalised-pharmacokinetics-in-patients-with-crohn-s-disease-a%C3%A2-subanalysis-of-the-diamond-trial
#1
H Nakase, S Motoya, T Matsumoto, K Watanabe, T Hisamatsu, N Yoshimura, T Ishida, S Kato, T Nakagawa, M Esaki, M Nagahori, T Matsui, Y Naito, T Kanai, Y Suzuki, M Nojima, M Watanabe, T Hibi
BACKGROUND: Significance of monitoring adalimumab trough levels and anti-adalimumab antibodies (AAA) for disease outcome in Crohn's disease (CD) patients remained unclear. AIM: To evaluate the association of adalimumab trough levels and AAA at week 26 with clinical remission at week 52, the effect of azathiopurine on AAA and factors influencing trough levels in CD patients in the DIAMOND trial. METHODS: We performed this study using adalimumab trough levels, AAA at week 26 and 6-thioguanine nucleotide (TGN) in red blood cells at week 12...
September 8, 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28884797/sapho-syndrome-associated-with-hidradenitis-suppurativa-and-pyoderma-gangrenosum-successfully-treated-with-adalimumab-and-methotrexate-a-case-report-and-review-of-the-literature
#2
REVIEW
Dunja A Vekic, Jane Woods, Peter Lin, Geoffrey D Cains
SAPHO (synovitis, acne, pustulosis, hyperostosis, and osteitis) syndrome is a rare inflammatory condition describing the combination of skin, bone, and joint manifestations that has a heterogeneous presentation. We report a case of severe SAPHO syndrome in association with hidradenitis suppurativa and pyoderma gangrenosum in a 27-year-old male. The patient had an initial migratory arthritis affecting the knees, ankles, metacarpophalangeal joints, proximal interphalangeal joints, wrists, shoulder, and lower back, which progressed to a persistent arthritis and swelling at the sternum, shoulders, wrists, hands, feet, and lower back...
September 7, 2017: International Journal of Dermatology
https://www.readbyqxmd.com/read/28870657/use-of-biologic-therapy-by-pregnant-women-with-inflammatory-bowel-disease-does-not-affect-infant-response-to-vaccines
#3
Dawn B Beaulieu, Ashwin N Ananthakrishnan, Christopher Martin, Russell D Cohen, Sunanda V Kane, Uma Mahadevan
BACKGROUND & AIMS: In women with inflammatory bowel diseases (IBD), exposure to immunomodulator or biologic therapy has not been associated with adverse events during pregnancy or outcomes of newborns. We investigated whether exposure of patients to these agents during pregnancy affects serologic responses to vaccines in newborns. METHODS: We collected data from the Pregnancy in IBD and Neonatal Outcomes registry, which records outcomes of pregnant women with diagnosis of IBD receiving care at multiple centers in the United States, from 2007 - 2016...
September 1, 2017: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28857255/efficacy-of-a-concomitant-elemental-diet-to-reduce-the-loss-of-response-to-adalimumab-in-patients-with-intractable-crohn-s-disease
#4
Naoko Sugita, Kenji Watanabe, Noriko Kamata, Tomomi Yukawa, Koji Otani, Shuhei Hosomi, Yasuaki Nagami, Fumio Tanaka, Koichi Taira, Hirokazu Yamagami, Tetsuya Tanigawa, Masatsugu Shiba, Toshio Watanabe, Kazunari Tominaga, Daijiro Kabata, Ayumi Shintani, Tetsuo Arakawa, Yasuhiro Fujiwara
BACKGROUND AND AIM: Secondary loss of response to adalimumab (ADA-LOR) commonly occurs in patients with Crohn's disease (CD) treated with ADA. We evaluated the efficacy of concomitant elemental diet (ED) therapy to reduce ADA-LOR in adult CD patients. METHODS: Patients were divided into either an ED (≥900 kcal/day) or a non-ED group (<900 kcal/day). Cumulative non-ADA-LOR rates were compared between groups. The effects of ED intake to reduce ADA-LOR was also assessed in anti-tumor necrosis factor-alpha (TNFα) naïve and infliximab (IFX)-intolerant or refractory CD patients...
August 30, 2017: Journal of Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28839870/use-of-anti-tnf-drug-levels-to-optimise-patient-management
#5
REVIEW
Konstantinos Papamichael, Adam S Cheifetz
Anti-tumour necrosis factor (TNF) therapies, such as infliximab, adalimumab, certolizumab pegol and golimumab, have been proven to be effective for the treatment of patients with Crohn's disease and ulcerative colitis. However, 10%-30% of patients with inflammatory bowel disease (IBD) show no initial clinical benefit to anti-TNF therapy (primary non-response), and over 50% after an initial favourable outcome will lose response over time (secondary loss of response (SLR)). Numerous recent studies in IBD have revealed an exposure-response relationship suggesting a positive correlation between high serum anti-TNF concentrations and favourable therapeutic outcomes including clinical, biomarker and endoscopic remission, whereas antidrug antibodies have been associated with SLR and infusion reactions...
October 2016: Frontline Gastroenterology
https://www.readbyqxmd.com/read/28822031/advances-in-the-management-of-thyroid-eye-diseases-an-overview
#6
REVIEW
Rashmi Kumari, Bhawesh Chandra Saha
INTRODUCTION: Thyroid eye disease (TED) remains a notorious ailment for both patients and the treating ophthalmologists. Recent years have witnessed considerable research in the immunopathogenic mechanism of TED that has resulted in an expansion and modification of the available management options. AIM: Purpose of this review is to summarise the advances in the management of thyroid ophthalmopathy. MATERIAL AND METHOD: A thorough literature search and of the past 10 years web search with words Thyroid ophthalmopathy, recent, advances...
August 18, 2017: International Ophthalmology
https://www.readbyqxmd.com/read/28791718/dried-blood-spots-from-finger-prick-facilitate-therapeutic-drug-monitoring-of-adalimumab-and-anti-adalimumab-in-patients-with-inflammatory-diseases
#7
Eva L Kneepkens, Mieke F Pouw, Gerrit Jan Wolbink, Tiny Schaap, Michael T Nurmohamed, Annick de Vries, Theo Rispens, Karien Bloem
AIMS: Development of a self-sampling method for therapeutic drug monitoring (TDM) of biologicals will enhance TDM implementation in routine care and pharmacokinetic knowledge. The aim of this study was to compare adalimumab and anti-adalimumab antibody (ADA) concentration measurements in dried blood spots (DBS) obtained from finger prick with measurements in serum obtained via venepuncture, from patients with rheumatic inflammatory diseases. METHODS: In this cross-sectional study, 161 consecutive patients were included...
August 9, 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28743358/higher-body-mass-index-and-anti-drug-antibodies-predict-the-discontinuation-of-anti-tnf-agents-in-korean-patients-with-axial-spondyloarthritis
#8
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 against tumor necrosis factor inhibitors is a likely explanation for the failure of TNF-inhibitors in patients with spondyloarthritis. Our study determined the existence and clinical implications of ADAbs in axial spondyloarthritis patients. METHODS: According to the Assessment of SpondyloArthritis International Society classification criteria for axial spondyloarthritis, patients treated with adalimumab or infliximab were recruited consecutively...
July 2017: Revista Brasileira de Reumatologia
https://www.readbyqxmd.com/read/28743169/development-and-validation-of-an-optical-biosensor-for-rapid-monitoring-of-adalimumab-in-serum-of-patients-with-crohn-s-disease
#9
Sumin Bian, Jiadi Lu, Filip Delport, Séverine Vermeire, Dragana Spasic, Jeroen Lammertyn, Ann Gils
Therapeutic drug monitoring of adalimumab is recommended to improve therapeutic outcome in patients with Crohn's disease. Performing an ELISA requires a rather long time-to-result and the necessity of collecting multiple samples in order to decrease the cost per adalimumab determination. In this study, we aim to develop and validate a rapid assay suitable for measuring a single adalimumab serum sample using a fiber-optic surface plasmon resonance (FO-SPR) based sensor. Therefore, we have immobilized MA-ADM28B8 as capture antibody on a FO-probe and conjugated MA-ADM40D8 as detecting antibody to gold nanoparticles...
July 25, 2017: Drug Testing and Analysis
https://www.readbyqxmd.com/read/28708805/serum-adalimumab-levels-predict-successful-remission-and-safe-deintensification-in-inflammatory-bowel-disease-patients-in-clinical-practice
#10
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
#11
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
#12
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)...
July 25, 2017: Analytical Chemistry
https://www.readbyqxmd.com/read/28632883/importance-of-immunogenicity-testing-for-cost-effective-management-of-psoriasis-patients-treated-with-adalimumab
#13
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
#14
J M Carrascosa, M Toro Montecinos, F Ballescá, A Teniente Serra, E Martínez Cáceres, C Ferrándiz
BACKGROUND: The possibility of monitoring serum drug levels has opened the door to optimising 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 s...
July 6, 2017: Journal of Dermatological Treatment
https://www.readbyqxmd.com/read/28570371/prolongation-of-biologic-dosing-intervals-in-patients-with-stable-psoriasis-a-feasibility-study
#15
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
#16
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
#17
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
#18
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
#19
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
#20
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
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