keyword
MENU ▼
Read by QxMD icon Read
search

adalimumab pharmacokinetics

keyword
https://www.readbyqxmd.com/read/28078646/mucosal-healing-in-ulcerative-colitis-a-comprehensive-review
#1
REVIEW
Pedro Boal Carvalho, José Cotter
Ulcerative colitis (UC) is a chronic inflammatory bowel disease characterized by periods of remission and periods of relapse. Patients often present with symptoms such as rectal bleeding, diarrhea and weight loss, and may require hospitalization and even colectomy. Long-term complications of UC include decreased quality of life and productivity and an increased risk of colorectal cancer. Mucosal healing (MH) has gained progressive importance in the management of UC patients. In this article, we review the endoscopic findings that define both mucosal injury and MH, and the strengths and limitations of the scoring systems currently available in clinical practice...
January 11, 2017: Drugs
https://www.readbyqxmd.com/read/28066879/population-pharmacokinetics-and-immunogenicity-of-adalimumab-in-adult-patients-with-moderate-to-severe-hidradenitis-suppurativa
#2
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/28000101/remarkable-pharmacokinetics-of-monoclonal-antibodies-a-quest-for-an-explanation
#3
Joannes A A Reijers, Matthijs Moerland, Jacobus Burggraaf
Monoclonal antibodies (MAbs) usually display slow and limited distribution with combined linear and non-linear elimination mechanisms. While studying individual pharmacokinetic profiles, it was noticed that MAb plasma concentration can vary abruptly over time, with one or more increases after the time to maximum plasma concentration when theoretically the concentration should only decline. This article summarizes the frequency of these additional peaks and assesses whether normal intra-subject and assay variability can explain the observations...
December 20, 2016: Clinical Pharmacokinetics
https://www.readbyqxmd.com/read/27965661/clinical-evaluation-of-humira-%C3%A2-biosimilar-ons-3010-in-healthy-volunteers-focus-on-pharmacokinetics-and-pharmacodynamics
#4
Marlous R Dillingh, Joannes A A Reijers, Karen E Malone, Jacobus Burggraaf, Kenneth Bahrt, Liz Yamashita, Claudia Rehrig, Matthijs Moerland
ONS-3010 is being developed by Oncobiologics Inc. (Cranbury, NJ, USA) as a biosimilar of Humira(®). This randomized, double blind, single-center phase I study (EudraCT registration # 2013-003551-38) was performed to demonstrate pharmacokinetic (PK) biosimilarity between two reference products (Humira(®) EU and US) and ONS-3010 in healthy volunteers, and to compare the safety and immunogenicity profiles. In addition, the intended pharmacological activity was assessed and compared by application of a whole blood challenge...
2016: Frontiers in Immunology
https://www.readbyqxmd.com/read/27883215/effects-of-concomitant-immunomodulators-on-the-pharmacokinetics-efficacy-and-safety-of-adalimumab-in-patients-with-crohn-s-disease-or-ulcerative-colitis-who-had-failed-conventional-therapy
#5
J-F Colombel, B Jharap, W J Sandborn, B Feagan, L Peyrin-Biroulet, S F Eichner, A M Robinson, N M Mostafa, Q Zhou, R B Thakkar
BACKGROUND: Adalimumab is approved for use in patients with moderate to severe Crohn's disease (CD) or ulcerative colitis (UC) who have not achieved disease control with conventional therapies including corticosteroids and/or immunomodulators (IMM). AIM: To analyse six studies that examined efficacy, pharmacokinetics and safety of combination IMM/adalimumab therapy, compared with adalimumab monotherapy in patients with inadequate disease control on conventional therapy...
January 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/27813422/bioequivalence-safety-and-immunogenicity-of-bi-695501-an-adalimumab-biosimilar-candidate-compared-with-the-reference-biologic-in-a-randomized-double-blind-active-comparator-phase-i-clinical-study-voltaire%C3%A2-pk-in-healthy-subjects
#6
Christopher Wynne, Mario Altendorfer, Ivo Sonderegger, Lien Gheyle, Rod Ellis-Pegler, Susanne Buschke, Benjamin Lang, Deepak Assudani, Sandeep Athalye, Niklas Czeloth
BACKGROUND: This Phase I study (VOLTAIRE®-PK) aimed to evaluate three-way pharmacokinetic similarity (bioequivalence), safety, and immunogenicity of BI 695501 (a Humira® [adalimumab] biosimilar candidate) compared with US- and EU-approved Humira in healthy male subjects. METHODS: Subjects (N = 327) were randomized 1:1:1 to receive one 40-mg subcutaneous dose of BI 695501, US- or EU-approved Humira; safety was assessed for 70 days. Bioequivalence was evaluated using the average bioequivalence method to test if the 90% confidence intervals (CIs) of the geometric means (BI 695501 vs US- and EU-approved Humira) for the primary end points were within prespecified acceptance ranges (80-125%)...
December 2016: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/27737604/biology-of-anti-tnf-agents-in-immune-mediated-inflammatory-diseases-therapeutic-implications
#7
Roger A Levy, Renato Guzman, Gilberto Castañeda-Hernández, Manuel Martinez-Vazquez, Guilherme Damian, Carlos Cara
Biologics are increasingly being used to modify the course of immune-mediated inflammatory diseases. Some main agents are monoclonal antibodies and a fusion-protein that target TNF. This group includes adalimumab, infliximab, certolizumab pegol, golimumab and etanercept. Although the efficacy of anti-TNFs is supported by numerous randomized clinical trials, their pharmacokinetics depend on many factors, in particular immunogenicity, which can cause marked and rapid clearance and a consequent decrease in efficacy...
December 2016: Immunotherapy
https://www.readbyqxmd.com/read/27598372/utility-of-immunodeficient-mouse-models-for-characterizing-the-preclinical-pharmacokinetics-of-immunogenic-antibody-therapeutics
#8
Maria Myzithras, Tammy Bigwarfe, Hua Li, Erica Waltz, Jennifer Ahlberg, Craig Giragossian, Simon Roberts
Prior to clinical studies, the pharmacokinetics (PK) of antibody-based therapeutics are characterized in preclinical species; however, those species can elicit immunogenic responses that can lead to an inaccurate estimation of PK parameters. Immunodeficient (SCID) transgenic hFcRn and C57BL/6 mice were used to characterize the PK of three antibodies that were previously shown to be immunogenic in mice and cynomolgus monkeys. Four mouse strains, Tg32 hFcRn SCID, Tg32 hFcRn, SCID and C57BL/6, were administered adalimumab (Humira®), mAbX and mAbX-YTE at 1 mg/kg, and in SCID strains there was no incidence of immunogenicity...
November 2016: MAbs
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
#9
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/27531618/adalimumab-for-the-treatment-of-hidradenitis-suppurativa-acne-inversa
#10
Christos C Zouboulis
INTRODUCTION: Hidradenitis suppurativa/acne inversa (HS) is a chronic, inflammatory, recurrent, debilitating skin disease of the hair follicle that usually presents after puberty with painful, deep-seated, inflamed lesions in the apocrine gland-bearing areas of the body, most commonly the axillae, inguinal and anogenital regions. A mean disease incidence of 6.0 per 100,000 persons-years and a varying prevalence of 0.05-1% have been reported worldwide. AREAS COVERED: This manuscript summarizes the current evidence on chemistry, pharmacodynamics, pharmacokinetics, as well as clinical efficacy, safety and tolerability of the currently approved biologic drug adalimumab in the treatment of active moderate to severe HS in adults...
October 2016: Expert Review of Clinical Immunology
https://www.readbyqxmd.com/read/27479756/improving-the-efficacy-and-safety-of-biologic-drugs-with-tolerogenic-nanoparticles
#11
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/27466231/a-randomised-single-blind-single-dose-three-arm-parallel-group-study-in-healthy-subjects-to-demonstrate-pharmacokinetic-equivalence-of-abp-501-and-adalimumab
#12
Primal Kaur, Vincent Chow, Nan Zhang, Michael Moxness, Arunan Kaliyaperumal, Richard Markus
OBJECTIVE: To demonstrate pharmacokinetic (PK) similarity of biosimilar candidate ABP 501 relative to adalimumab reference product from the USA and European Union (EU) and evaluate safety, tolerability and immunogenicity of ABP 501. METHODS: Randomised, single-blind, single-dose, three-arm, parallel-group study; healthy subjects were randomised to receive ABP 501 (n=67), adalimumab (USA) (n=69) or adalimumab (EU) (n=67) 40 mg subcutaneously. Primary end points were area under the serum concentration-time curve from time 0 extrapolated to infinity (AUCinf) and the maximum observed concentration (Cmax)...
July 27, 2016: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/27438459/pharmacokinetics-interactions-of-monoclonal-antibodies
#13
REVIEW
Nicola Ferri, Stefano Bellosta, Ludovico Baldessin, Donatella Boccia, Giorgi Racagni, Alberto Corsini
The clearance of therapeutic monoclonal antibodies (mAbs) typically does not involve cytochrome P450 (CYP450)-mediated metabolism or interaction with cell membrane transporters, therefore the pharmacokinetics interactions of mAbs and small molecule drugs are limited. However, a drug may affect the clearance of mAbs through the modulation of immune response (e.g., methotrexate reduces the clearance of infliximab, adalimumab, and golimumab, possibly due to methotrexate's inhibitory effect on the formation of antibodies against the mAbs)...
September 2016: Pharmacological Research: the Official Journal of the Italian Pharmacological Society
https://www.readbyqxmd.com/read/27307526/methotrexate-dosage-reduction-upon-adalimumab-initiation-clinical-and-ultrasonographic-outcomes-from-the-randomized-noninferiority-musica-trial
#14
Gurjit S Kaeley, Amy M Evangelisto, Midori J Nishio, Sandra L Goss, Shufang Liu, Jasmina Kalabic, Hartmut Kupper
OBJECTIVE: To examine the clinical and ultrasonographic (US) outcomes of reducing methotrexate (MTX) dosage upon initiating adalimumab (ADA) in MTX-inadequate responders with moderately to severely active rheumatoid arthritis (RA). METHODS: MUSICA (NCT01185288) was a double-blind, randomized, parallel-arm study of 309 patients with RA receiving MTX ≥ 15 mg/week for ≥ 12 weeks before screening. Patients were randomized to high dosage (20 mg/week) or low dosage (7...
August 2016: Journal of Rheumatology
https://www.readbyqxmd.com/read/27285856/comparison-of-the-pharmacokinetics-safety-and-immunogenicity-of-msb11022-a-biosimilar-of-adalimumab-with-humira-%C3%A2-in-healthy-subjects
#15
Elizabeth Hyland, Tim Mant, Pantelis Vlachos, Neil Attkins, Martin Ullmann, Sanjeev Roy, Volker Wagner
AIMS: The aim of the study was to compare the pharmacokinetics (PK), safety and tolerability of the proposed adalimumab biosimilar MSB11022 (Merck) with Humira(®) (AbbVie), sourced from both the US (US reference product [US-RP]) and Europe (European reference medicinal product [EU-RMP]). METHODS: In this phase 1 double-blind, parallel group trial (EMR200588-001), 213 healthy volunteers were randomized 1 : 1 : 1 to receive a single dose (40 mg) of MSB11022, US-RP or EU-RMP in order to achieve 80% power assuming a 5% difference among groups and a 10% dropout rate...
October 2016: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27240112/maintenance-therapy-options-for-ulcerative-colitis
#16
María Chaparro, Javier P Gisbert
INTRODUCTION: Medical therapy is the cornerstone of the management of ulcerative colitis (UC) and the goal of the treatment is the induction and maintenance of remission. AREAS COVERED: Mesalamine is the first line treatment in patients with mild to moderate UC. Despite having different formulations available, clinically significant differences in pharmacokinetics and exposure to these drugs have not been observed. Evidence supporting the efficacy of azathioprine and mercaptopurine for maintaining remission is UC patients come from both observational cohorts and clinical trials...
July 2016: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/27175116/adalimumab-induction-and-maintenance-therapy-achieve-clinical-remission-and-response-in-chinese-patients-with-crohn-s-disease
#17
Kai-Chun Wu, Zhi Hua Ran, Xiang Gao, Minhu Chen, Jie Zhong, Jian-Qiu Sheng, Michael A Kamm, Simon Travis, Kori Wallace, Nael M Mostafa, Marisa Shapiro, Yao Li, Roopal B Thakkar, Anne M Robinson
BACKGROUND/AIMS: This was a Phase 2 study (NCT02015793) to evaluate the pharmacokinetics, safety, and efficacy of adalimumab in Chinese patients with Crohn's disease (CD). METHODS: Thirty, adult Chinese patients with CD (CD Activity Index [CDAI] 220-450; high-sensitivity [hs]-C-reactive protein [CRP] ≥3 mg/L) received double-blind adalimumab 160/80 mg or 80/40 mg at weeks 0/2, followed by 40 mg at weeks 4 and 6. An open-label extension period occurred from weeks 8-26; patients received 40 mg adalimumab every other week...
April 2016: Intestinal Research
https://www.readbyqxmd.com/read/27079249/role-of-quantitative-clinical-pharmacology-in-pediatric-approval-and-labeling
#18
Nitin Mehrotra, Atul Bhattaram, Justin C Earp, Jeffry Florian, Kevin Krudys, Jee Eun Lee, Joo Yeon Lee, Jiang Liu, Yeruk Mulugeta, Jingyu Yu, Ping Zhao, Vikram Sinha
Dose selection is one of the key decisions made during drug development in pediatrics. There are regulatory initiatives that promote the use of model-based drug development in pediatrics. Pharmacometrics or quantitative clinical pharmacology enables development of models that can describe factors affecting pharmacokinetics and/or pharmacodynamics in pediatric patients. This manuscript describes some examples in which pharmacometric analysis was used to support approval and labeling in pediatrics. In particular, the role of pharmacokinetic (PK) comparison of pediatric PK to adults and utilization of dose/exposure-response analysis for dose selection are highlighted...
July 2016: Drug Metabolism and Disposition: the Biological Fate of Chemicals
https://www.readbyqxmd.com/read/26978723/thiopurine-metabolism-in-the-era-of-combotherapy
#19
Xavier Roblin, Nicolas Williet, Laurent Peyrin-Biroulet
6-thioguanine nucleotides levels are associated with clinical remission in patients with inflammatory bowel disease (IBD) on thiopurine monotherapy. Recently, few studies investigated the interaction between thiopurine metabolism and anti-tumor necrosis factor therapy among patients with IBD on combotherapy. Two studies demonstrated that infliximab therapy increases 6-thioguanine nucleotides level, while such effect could not be observed with adalimumab. Three studies showed that a Delta mean corpuscular volume >7 and high 6-thioguanine nucleotides levels are associated with favorable outcomes, i...
June 2016: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/26685205/igg1-allotypes-influence-the-pharmacokinetics-of-therapeutic-monoclonal-antibodies-through-fcrn-binding
#20
David Ternant, Christophe Arnoult, Martine Pugnière, Christine Dhommée, Daniel Drocourt, Eric Perouzel, Christophe Passot, Nadine Baroukh, Denis Mulleman, Gérard Tiraby, Hervé Watier, Gilles Paintaud, Valérie Gouilleux-Gruart
Because IgG1 allotypes might have different half-lives, their influence on infliximab (G1m17,1 allotype) pharmacokinetics was investigated in a group of spondyloarthritis patients. Infliximab was found to have a shorter half-life in patients homozygous for the G1m17,1 allotypes than in those carrying the G1m3 with no G1m1 (G1m3,-1) allotype. Because the neonatal FcR (FcRn) is involved in the pharmacokinetics of mAbs, the interaction of different IgG1 allotypes with FcRn was examined using cellular assays and surface plasmon resonance...
January 15, 2016: Journal of Immunology: Official Journal of the American Association of Immunologists
keyword
keyword
53793
1
2
Fetch more papers »
Fetching more papers... Fetching...
Read by QxMD. Sign in or create an account to discover new knowledge that matter to you.
Remove bar
Read by QxMD icon Read
×

Search Tips

Use Boolean operators: AND/OR

diabetic AND foot
diabetes OR diabetic

Exclude a word using the 'minus' sign

Virchow -triad

Use Parentheses

water AND (cup OR glass)

Add an asterisk (*) at end of a word to include word stems

Neuro* will search for Neurology, Neuroscientist, Neurological, and so on

Use quotes to search for an exact phrase

"primary prevention of cancer"
(heart or cardiac or cardio*) AND arrest -"American Heart Association"