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adalimumab pharmacokinetics

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https://www.readbyqxmd.com/read/28632883/importance-of-immunogenicity-testing-for-cost-effective-management-of-psoriasis-patients-treated-with-adalimumab
#1
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/28584187/efficacy-and-safety-of-the-biosimilar-abp-501-compared-with-adalimumab-in-patients-with-moderate-to-severe-rheumatoid-arthritis-a-randomised-double-blind-phase-iii-equivalence-study
#2
Stanley Cohen, Mark C Genovese, Ernest Choy, Fernando Perez-Ruiz, Alan Matsumoto, Karel Pavelka, Jose L Pablos, Warren Rizzo, Pawel Hrycaj, Nan Zhang, William Shergy, Primal Kaur
OBJECTIVES: ABP 501 is a Food and Drug Administration-approved biosimilar to adalimumab; structural, functional and pharmacokinetic evaluations have shown that the two are highly similar. We report results from a phase III study comparing efficacy, safety and immunogenicity between ABP 501 and adalimumab. METHODS: In this randomised, double-blind, active comparator-controlled, 26-week equivalence study, patients with moderate to severe active rheumatoid arthritis (RA) despite methotrexate were randomised (1:1) to ABP 501 or adalimumab (40 mg) every 2 weeks...
June 5, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28562666/quantitative-analysis-of-the-cd4-t-cell-response-to-therapeutic-antibodies-in-healthy-donors-using-a-novel-t-cell-pbmc-assay
#3
Heidi S Schultz, Stine Louise Reedtz-Runge, B Thomas Bäckström, Kasper Lamberth, Christian R Pedersen, Anne M Kvarnhammar
Many biopharmaceuticals (BPs) are known to be immunogenic in the clinic, which can result in modified pharmacokinetics, reduced efficacy, allergic reactions and anaphylaxis. During recent years, several technologies to predict immunogenicity have been introduced, but the predictive value is still considered low. Thus, there is an unmet medical need for optimization of such technologies. The generation of T cell dependent high affinity anti-drug antibodies plays a key role in clinical immunogenicity. This study aimed at developing and evaluating a novel in vitro T cell:PBMC assay for prediction of the immunogenicity potential of BPs...
2017: PloS One
https://www.readbyqxmd.com/read/28533919/combination-therapy-for-inflammatory-bowel-disease
#4
REVIEW
Keith S Sultan, Joshua C Berkowitz, Sundas Khan
Biologic therapies such as infliximab and adalimumab have become mainstays of treatment for inflammatory bowel disease. Early studies suggested that combination therapy (CT) with infliximab and an immunomodulator drug such as azathioprine may help optimize biologic pharmacokinetics, minimize immunogenicity, and improve outcomes. The landmark SONIC trial in Crohn's disease and the UC SUCCESS trial in ulcerative colitis demonstrated CT with infliximab and azathioprine to be superior to monotherapy with either agent alone at inducing clinical remission in treatment naïve patients with moderate to severe disease...
May 6, 2017: World Journal of Gastrointestinal Pharmacology and Therapeutics
https://www.readbyqxmd.com/read/28374338/therapeutic-drug-monitoring-of-golimumab-in-the-treatment-of-ulcerative-colitis
#5
REVIEW
Niels Vande Casteele, Reena Khanna
Ulcerative colitis (UC) is a relapsing-remitting chronic inflammatory disorder affecting the mucosal surface in a continuous manner from the rectum through part of, or the entire, colon. Patients with severe disease and those who become refractory or intolerant to corticosteroids and/or immunosuppressants, require treatment with biologic agents that target tumor necrosis factor-α (TNF). Golimumab, a fully human monoclonal antibody, is the latest TNF antagonist to get approved for the treatment of moderate-to-severe UC...
April 3, 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28363434/switching-biologics-in-the-treatment-of-psoriatic-arthritis
#6
REVIEW
Joseph F Merola, Benjamin Lockshin, Elinor A Mody
OBJECTIVE: Psoriatic arthritis (PsA) is a heterogeneous inflammatory disorder that requires targeted treatment based on clinical manifestations, symptom severity, comorbidities, and other factors. Moderate or severe peripheral arthritis symptoms are typically treated with disease-modifying antirheumatic drugs (DMARDs) or biologic DMARDs (bDMARDs), and early and aggressive treatment is recommended in order to prevent permanent damage. Although rheumatologists are now able to choose between several bDMARDs for PsA that have different chemical structures, pharmacokinetic properties, dosing regimens, immunogenicity, safety profiles, and mechanisms of action, there is a lack of typical patient profiles or detailed treatment algorithms that can be followed when patients require alterations in their therapeutic regimens...
February 8, 2017: Seminars in Arthritis and Rheumatism
https://www.readbyqxmd.com/read/28318043/the-effects-of-pregnancy-on-the-pharmacokinetics-of-infliximab-and-adalimumab-in-inflammatory-bowel-disease
#7
C H Seow, Y Leung, N Vande Casteele, E Ehteshami Afshar, D Tanyingoh, G Bindra, M J Stewart, P L Beck, G G Kaplan, S Ghosh, R Panaccione
BACKGROUND: Transplacental transfer of infliximab and adalimumab results in detectable drug levels in the cord blood and infant. AIM: To determine if pregnancy influenced the pharmacokinetics of anti-TNF agents in women with inflammatory bowel disease. METHODS: Twenty-five women from the University of Calgary inflammatory bowel disease(IBD) pregnancy clinic on maintenance infliximab or adalimumab were recruited prospectively with serum bio-banking performed each trimester...
May 2017: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/28316250/adalimumab-in-ulcerative-colitis-efficacy-safety-and-optimization-in-the-era-of-treat-to-target
#8
Miles P Sparrow
Active ulcerative colitis is associated with significant morbidity and impairment to quality of life. Adalimumab is a welcome addition to the therapeutic armamentarium for clinicians treating patients with moderate-severe ulcerative colitis refractory to conventional therapies, an indication with few prior treatment options. It offers the convenience of self-injection and is most appropriate for outpatients with moderate disease activity. Areas covered: This review briefly summarizes data from well-designed clinical trials and observational real-life studies that demonstrate the safety and efficacy of adalimumab in UC...
March 28, 2017: Expert Opinion on Biological Therapy
https://www.readbyqxmd.com/read/28290731/a-randomized-double-blind-single-dose-two-arm-parallel-study-comparing-pharmacokinetics-immunogenicity-and-tolerability-of-branded-adalimumab-and-its-biosimilar-lbal-in-healthy-male-volunteers
#9
RANDOMIZED CONTROLLED TRIAL
Kyoung Ryun Park, Hyewon Chung, Sung Mo Yang, SeungHwan Lee, Seo Hyun Yoon, Joo-Youn Cho, In-Jin Jang, Kyung-Sang Yu
OBJECTIVES: This study aimed to compare the pharmacokinetics (PK), immunogenicity, and tolerability of LBAL, a biosimilar of adalimumab, with the originator, Humira®, in healthy volunteers. METHODS: A randomized, double-blind, single-dose, two-arm, parallel-group study was conducted in 116 healthy subjects. They randomly received a single subcutaneous (SC) 40 mg injection of LBAL or Humira. Blood samples were collected for PK and immunogenicity assessment. PK parameters were determined using the noncompartmental method, and primary endpoint parameters were compared using the point estimates and 90% confidence intervals (CIs) of the geometric mean ratios (GMRs)...
May 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28286562/golimumab-pharmacokinetics-in-ulcerative-colitis-a-literature-review
#10
REVIEW
Ines Harzallah, Josselin Rigaill, Nicolas Williet, Stephane Paul, Xavier Roblin
Golimumab (GLM) is the latest anti-tumor necrosis factor (TNF) that gained its marketing license. Thanks to the PURSUIT induction and maintenance trials, it was approved for the treatment of ulcerative colitis (UC) in 2013. The other anti-TNF drugs available are infliximab and adalimumab. These two drugs have validated algorithms concerning prescription and therapeutic drug monitoring (TDM) but little is known about GLM. The available data on GLM's exposure-response relationship in UC are from the PURSUIT trials and are recently published...
January 2017: Therapeutic Advances in Gastroenterology
https://www.readbyqxmd.com/read/28209290/efficacy-safety-and-pharmacokinetics-of-biosimilars-of-anti-tumor-necrosis-factor-%C3%AE-agents-in-rheumatic-diseases-a-systematic-review-and-meta-analysis
#11
REVIEW
Yuga Komaki, Akihiro Yamada, Fukiko Komaki, Praneeth Kudaravalli, Dejan Micic, Akio Ido, Atsushi Sakuraba
OBJECTIVE: To evaluate the efficacy and safety of biosimilars of anti-tumor necrosis factor (TNF)-α agents compared to their reference agents in immune mediated diseases. METHODS: Electronic databases were searched for randomized controlled trials (RCTs) assessing the efficacy and safety of biosimilars of anti-TNF-α agents compared to their reference agents in patients with various immune mediated diseases. The outcomes were the rates of clinical response and adverse events among patients treated with biosimilars compared to their reference agents...
May 2017: Journal of Autoimmunity
https://www.readbyqxmd.com/read/28173018/p557-utility-of-trough-levels-adalimumab-determination-in-patients-with-inflammatory-bowel-disease-estimation-of-individual-pharmacokinetic-parameters-through-population-pharmacokinetic-model
#12
G Juan, A Alvariño, M Mora, L Oltra, N Maroto, I Ferrer, E Hinojosa, M D Hinojosa, J Hinojosa
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28172759/p523-association-between-pharmacokinetics-of-adalimumab-and-disease-outcome-in-japanese-patients-with-biologics-na%C3%A3-ve-crohn-s-disease-a%C3%A2-subanalysis-of-diamond-trial
#13
S Motoya, H Nakase, T Matsumoto, K Watanabe, T Hisamatsu, N Yoshimura, T Ishida, S Kato, T Nakagawa, M Nagahori, M Esaki, T Matsui, Y Naito, T Kanai, Y Suzuki, M Nojima, M Watanabe, T Hibi
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28172702/p377-evaluation-of-the-pharmacokinetic-profiles-of-sb5-and-reference-adalimumab
#14
D Shin, J W Kang, S Park, S Y Cheong, E Hong
No abstract text is available yet for this article.
February 1, 2017: Journal of Crohn's & Colitis
https://www.readbyqxmd.com/read/28148280/optimizing-adalimumab-treatment-in-psoriasis-with-concomitant-methotrexate-optimap-study-protocol-for-a-pragmatic-single-blinded-investigator-initiated-randomized-controlled-trial
#15
C I Busard, S P Menting, J S van Bezooijen, J M van den Reek, B A Hutten, E P Prens, E M de Jong, M B van Doorn, P I Spuls
BACKGROUND: The introduction of anti-tumor necrosis factor medications has revolutionized the treatment of psoriasis with achievement of treatment goals (Psoriasis Area and Severity Index score 75, remission) that are not usually met with conventional systemics. Nevertheless, some patients continue to experience persistent disease activity or treatment failure over time. Strategies to optimize treatment outcomes include the use of concomitant methotrexate, which has demonstrated beneficial effects on pharmacokinetics and treatment efficacy in psoriasis and other inflammatory diseases...
February 2, 2017: Trials
https://www.readbyqxmd.com/read/28133772/pharmacokinetics-safety-tolerability-and-immunogenicity-of-fkb327-a-new-biosimilar-medicine-of-adalimumab-humira-in-healthy-subjects
#16
Adeep Puri, Andrew Niewiarowski, Yasumasa Arai, Hideaki Nomura, Mark Baird, Isobel Dalrymple, Steve Warrington, Malcolm Boyce
AIMS: To compare the pharmacokinetics, safety, tolerability and immunogenicity of FKB327, a biosimilar of adalimumab, with European Union (EU)-approved Humira and US-licensed Humira after single subcutaneous doses in healthy subjects. METHODS: In a randomized, double-blind, parallel-group study, 180 healthy subjects received by subcutaneous injection 40 mg of EU-Humira, or US-Humira, or FKB327, in a 1:1:1 ratio, stratified by bodyweight. Pharmacokinetics, local tolerability, immunogenicity, adverse events, vital signs, electrocardiography and laboratory safety tests were assessed prior to and up to 1536 h after treatment...
July 2017: British Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28095262/biosimilars-in-inflammatory-bowel-disease-accumulating-clinical-evidence
#17
REVIEW
Sean McConachie, Sheila M Wilhelm, Pramodini B Kale-Pradhan
Biologic antagonists to tumor necrosis factor alpha (TNF- α) are effective medications and have become well established in the treatment of both Crohn's disease and ulcerative colitis. Biosimilar medications, which are medications deemed to be equivalent to reference biologic products in terms of clinical effectiveness, safety, pharmacokinetic analysis, and immunogenicity, have now been approved in inflammatory bowel diseases (IBD) based on indication exploration from clinical data in alternate disease states...
April 2017: Expert Review of Clinical Pharmacology
https://www.readbyqxmd.com/read/28078646/mucosal-healing-in-ulcerative-colitis-a-comprehensive-review
#18
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...
February 2017: Drugs
https://www.readbyqxmd.com/read/28066879/population-pharmacokinetics-and-immunogenicity-of-adalimumab-in-adult-patients-with-moderate-to-severe-hidradenitis-suppurativa
#19
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
#20
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
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