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adalimumab pharmacokinetics

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https://www.readbyqxmd.com/read/29104132/clinical-and-pharmacokinetic-factors-associated-with-adalimumab-induced-mucosal-healing-in-patients-with-crohn-s-disease
#1
Kenji Watanabe, Takayuki Matsumoto, Tadakazu Hisamatsu, Hiroshi Nakase, Satoshi Motoya, Naoki Yoshimura, Tetsuya Ishida, Shingo Kato, Tomoo Nakagawa, Motohiro Esaki, Masakazu Nagahori, Toshiyuki Matsui, Yuji Naito, Takanori Kanai, Yasuo Suzuki, Masanori Nojima, Mamoru Watanabe, Toshifumi Hibi
BACKGROUND & AIMS: We previously reported results from a prospective randomized controlled trial comparing the efficacy of adalimumab monotherapy vs combination with azathioprine for patients with Crohn's disease (CD) who were naïve to biologics and thiopurines. We performed a sub-analysis of data from this study to evaluate factors associated with endoscopic response and mucosal healing in study participants. METHODS: We compared simple endoscopic scores for CD (SES-CD) in between patients with moderate to severe active CD randomly assigned groups that received adalimumab monotherapy (n=85) or adalimumab in combination with azathioprine (n=91), from June 2011 to June 2014 in Japan...
November 2, 2017: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28950421/phase-3-randomized-study-of-sb5-an-adalimumab-biosimilar-versus-reference-adalimumab-in-patients-with-moderate-to-severe-rheumatoid-arthritis
#2
Michael E Weinblatt, Asta Baranauskaite, Jaroslaw Niebrzydowski, Eva Dokoupilova, Agnieszka Zielinska, Janusz Jaworski, Artur Racewicz, Margarita Pileckyte, Krystyna Jedrychowicz-Rosiak, Soo Yeon Cheong, Jeehoon Ghil
OBJECTIVES: SB5 is a proposed adalimumab biosimilar. This study compared the efficacy, pharmacokinetics (PK), safety, and immunogenicity of SB5 versus reference adalimumab (ADL) in patients with rheumatoid arthritis (RA). METHODS: In this phase 3, randomized, double-blind, parallel-group study, patients with moderate to severe RA despite methotrexate treatment were randomized 1:1 to receive SB5 or ADL 40 mg subcutaneously every other week. The primary efficacy endpoint was the American College of Rheumatology 20% (ACR20) response at week 24 in the per-protocol set (PPS; completer analysis)...
September 26, 2017: Arthritis & Rheumatology
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
#3
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/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
#4
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/28791718/dried-blood-spots-from-finger-prick-facilitate-therapeutic-drug-monitoring-of-adalimumab-and-anti-adalimumab-in-patients-with-inflammatory-diseases
#5
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/28755394/clinical-similarity-of-the-biosimilar-abp%C3%A2-501-compared-with-adalimumab-after-single-transition-long-term-results-from-a-randomised-double-blind-52-week-phase-3-study-in-moderate-to-severe-plaque-psoriasis-patients
#6
K Papp, H Bachelez, A Costanzo, P Foley, M Gooderham, P Kaur, S Philipp, L Spelman, N Zhang, B Strober
BACKGROUND: ABP 501, an FDA- and EMA-approved biosimilar, is highly similar to adalimumab in structure, function, and pharmacokinetics. OBJECTIVE: Demonstrate similarity in efficacy, safety, and immunogenicity of ABP 501 versus adalimumab for moderate-to-severe plaque psoriasis. METHODS: Patients were randomised (1:1) to receive ABP 501 or adalimumab 40 mg every 2 weeks for 16 weeks. At Week 16, patients with ≥50% improvement from baseline in psoriasis area-and-severity index score (PASI) were eligible to continue to Week 52...
July 28, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28737053/efficacy-of-baricitinib-in-the-treatment-of-rheumatoid-arthritis
#7
Christophe Richez, Marie-Elise Truchetet, Marie Kostine, Thierry Schaeverbeke, Bernard Bannwarth
although the outcome for patients with rheumatoid arthritis (ra) has improved in the past decades, adequate disease control cannot be achieved in a substantial proportion of patients. new drugs with a novel mechanism of action, may represent a valuable addition to the current armamentarium. Areas covered: This review focuses on the pharmacodynamics and pharmacokinetics of baricitinib. Furthermore, the article summarizes and comments the drug's efficacy and safety profile in RA patients. Expert opinion: Baricitinib is an oral targeted synthetic (ts) disease-modifying antirheumatic drug (DMARD) that mainly inhibits JAK1 and JAK2...
July 27, 2017: Expert Opinion on Pharmacotherapy
https://www.readbyqxmd.com/read/28708805/serum-adalimumab-levels-predict-successful-remission-and-safe-deintensification-in-inflammatory-bowel-disease-patients-in-clinical-practice
#8
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
#9
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/28632883/importance-of-immunogenicity-testing-for-cost-effective-management-of-psoriasis-patients-treated-with-adalimumab
#10
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
#11
RANDOMIZED CONTROLLED TRIAL
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...
October 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
#12
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
#13
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
#14
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...
August 2017: Pharmaceutical Research
https://www.readbyqxmd.com/read/28363434/switching-biologics-in-the-treatment-of-psoriatic-arthritis
#15
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...
August 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
#16
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
#17
REVIEW
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...
May 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
#18
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
#19
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
#20
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
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