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adalimumab serum

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https://www.readbyqxmd.com/read/29133475/response-to-comment-on-l-ami-et-al-titled-successful-reduction-of-overexposure-in-patients-with-rheumatoid-arthritis-with-high-serum-adalimumab-concentrations-an-open-label-non-inferiority-randomised-clinical-trial-by-den-broeder-et-al
#1
Merel J l'Ami, Charlotte L M Krieckaert, Michael T Nurmohamed, Ronald F van Vollenhoven, Theo Rispens, Maarten Boers, Gerrit Jan Wolbink
No abstract text is available yet for this article.
November 13, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/29104875/a-novel-system-for-the-quantification-of-the-adcc-activity-of-therapeutic-antibodies
#2
Christophe Lallemand, Feifei Liang, Flore Staub, Maud Simansour, Benoit Vallette, Lue Huang, Rosa Ferrando-Miguel, Michael G Tovey
Novel ADCC effector cells expressing the V-variant or F-variant of FcγRIIIa (CD16a) and firefly luciferase under the control of a chimeric promoter incorporating recognition sequences for the principal transcription factors involved in FcγRIIIa signal transduction, together with novel target cells overexpressing a constant high level of the specific antigen recognized by rituximab, trastuzumab, cetuximab, infliximab, adalimumab, or etanercept, confer improved sensitivity, specificity, and dynamic range in an ADCC assay relative to effector cells expressing a NFAT-regulated reporter gene and wild-type target cells...
2017: Journal of Immunology Research
https://www.readbyqxmd.com/read/29057561/pre-clinical-results-in-pig-to-non-human-primate-islet-xenotransplantation-using-anti-cd40-antibody-2c10r4-based-immunosuppression
#3
Jun-Seop Shin, Jong-Min Kim, Byoung-Hoon Min, Il Hee Yoon, Hyun Je Kim, Jung-Sik Kim, Yong-Hee Kim, Seong-Jun Kang, Jiyeon Kim, Hee-Jung Kang, Dong-Gyun Lim, Eung-Soo Hwang, Jongwon Ha, Sang-Joon Kim, Wan Beom Park, Chung-Gyu Park
BACKGROUND: Islet transplantation is an effective therapy for selected patients with type 1 diabetes with labile glycemic control and hypoglycemic unawareness, but donor organs are limited. Islet xenotransplantation using porcine islets will potentially solve this problem. Although successful proof of concept studies using clinically inapplicable anti-CD154 monoclonal antibody (mAb) in pig-to-non-human primate (NHP) islet xenotransplantation has been demonstrated by several groups worldwide, potentially clinically applicable anti-CD40 (2C10R4) mAb-based studies have not been reported...
October 22, 2017: Xenotransplantation
https://www.readbyqxmd.com/read/29043871/a-review-of-sarilumab-for-the-treatment-of-rheumatoid-arthritis
#4
Eun Bong Lee
Rheumatoid arthritis (RA) is a chronic systemic inflammatory disease predominantly affecting the peripheral diarthrodial joints. Sarilumab is a human monoclonal antibody against the IL-6 receptor-α. In Phase II and III clinical trials, sarilumab in the background of methotrexate showed superior clinical efficacy over placebo in RA patients with inadequate response to methotrexate or inadequate response or intolerance to TNF inhibitors. Sarilumab monotherapy also showed superior efficacy compared with adalimumab monotherapy in RA patients with inadequate response or intolerance to methotrexate...
October 18, 2017: Immunotherapy
https://www.readbyqxmd.com/read/29037956/a-simple-and-cost-effective-assay-for-measuring-anti-drug-antibody-in-human-patients-treated-with-adalimumab
#5
Maohua Li, Hongzhen Li, Kai Gao, Muyang Wang, Wenqi An, Yaran Zhu, Li Ding, Lan Wang, Jingliang Gu, Conglin Zuo, Le Sun
It has been reported that 90% of the anti-drug antibody (ADA) to Adalimumab in human patients bound to the TNF-binding area, resulted in the annual loss of responses to Adalimumab up to 24%. It is of urgency to develop a cost-effective and easy-to-use ADA diagnostic kit for diagnosis of potential drug-resistance in patients treated with Adalimumab in clinic hospitals to avoid the tremendous economic and human costs to patients and health-care providers. In this study, we reported the generations of mouse monoclonal and monkey polyclonal antibodies against Adalimumab as assay standards and positive quality controls respectively...
October 13, 2017: Journal of Immunological Methods
https://www.readbyqxmd.com/read/29020495/effect-of-adalimumab-on-peripheral-blood-mononuclear-cells-in-non-infectious-uveitis
#6
Karoline Walscheid, Toni Weinhage, Dirk Foell, Carsten Heinz, Maren Kasper, Arnd Heiligenhaus
PURPOSE: This study analyzed the effect of adalimumab on peripheral blood mononuclear cells (PBMCs) in uveitis. METHODS: PBMCs and serum S100A12 levels from 14 uveitis patients and 28 healthy controls were analyzed. Patient samples were taken before (w0), and 6 (w6) and 12 (w12) weeks after initiation of adalimumab therapy. RESULTS: Monocytes expressing CD124, CD86, CD39, CD115, and MHCII were decreased in patients. Adalimumab induced CD86+ and CD39+ monocytes, and further decreased the frequency of MHCII- and CD124-positive cells...
October 11, 2017: Ocular Immunology and Inflammation
https://www.readbyqxmd.com/read/28945638/tissue-drug-concentrations-of-anti-tumor-necrosis-factor-agents-are-associated-with-the-long-term-outcome-of-patients-with-crohn-s-disease
#7
Takeo Yoshihara, Shinichiro Shinzaki, Shoichiro Kawai, Hironobu Fujii, Shuko Iwatani, Toshio Yamaguchi, Manabu Araki, Satoshi Hiyama, Takahiro Inoue, Yoshito Hayashi, Kenji Watabe, Hideki Iijima, Tetsuo Takehara
BACKGROUND: Many reports indicate that a high-serum trough level of anti-tumor necrosis factor (TNF) agents is required for sustained remission in patients with Crohn's disease The pharmacokinetics of anti-TNF agents in inflamed intestinal tissue, however, is not well investigated. We investigated the association between the tissue concentration of anti-TNF agents and long-term disease outcome. METHODS: This was a prospective single-center study that enrolled 25 patients with Crohn's disease who were administered infliximab or adalimumab...
December 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28939629/successful-reduction-of-overexposure-in-patients-with-rheumatoid-arthritis-with-high-serum-adalimumab-concentrations-an-open-label-non-inferiority-randomised-clinical-trial
#8
Merel J l'Ami, Charlotte Lm Krieckaert, Michael T Nurmohamed, Ronald F van Vollenhoven, Theo Rispens, Maarten Boers, Gerrit Jan Wolbink
OBJECTIVE: High adalimumab serum concentrations do not result in better response in patients with rheumatoid arthritis (RA), suggesting overexposure. We investigated whether patients with adalimumab concentrations >8 µg/mL can prolong their dosing interval by 50% without a clinically relevant change in disease activity. METHODS: Consecutive patients with RA, treated with adalimumab 40 mg every other week for at least 28 weeks, were approached for this randomised, open-label, non-inferiority trial...
September 22, 2017: Annals of the Rheumatic Diseases
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
#9
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...
November 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
#10
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
#11
Dawn B Beaulieu, Ashwin N Ananthakrishnan, Christopher Martin, Russell D Cohen, Sunanda V Kane, Uma Mahadevan
BACKGROUND & AIMS: In women with inflammatory bowel diseases (IBDs), 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 through 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
#12
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
#13
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
#14
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
#15
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...
November 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
#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 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
#17
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
#18
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
#19
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
#20
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
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