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https://www.readbyqxmd.com/read/29782009/construction-of-synthetic-phage-displayed-fab-library-with-tailored-diversity
#1
Ganggang Huang, Zhenwei Zhong, Shane Miersch, Sachdev S Sidhu, Shin-Chen Hou, Donghui Wu
Demand for monoclonal antibodies (mAbs) in basic research and medicine is increasing yearly. Hybridoma technology has been the dominant method for mAb development since its first report in 1975. As an alternative technology, phage display methods for mAb development are increasingly attractive since Humira, the first phage-derived antibody and one of the best-selling mAbs, was approved for clinical treatment of rheumatoid arthritis in 2002. As a non-animal based mAb development technology, phage display bypasses antigen immunogenicity, humanization, and animal maintenance that are required from traditional hybridoma technology based antibody development...
May 1, 2018: Journal of Visualized Experiments: JoVE
https://www.readbyqxmd.com/read/29761222/english-language-videos-on-youtube-as-a-source-of-information-on-self-administer-subcutaneous-anti-tumour-necrosis-factor-agent-injections
#2
Sena Tolu, Ozan Volkan Yurdakul, Betul Basaran, Aylin Rezvani
The aim of this study was to evaluate the reliability, content, and quality of videos for patients available on YouTube for learning how to self-administer subcutaneous anti-tumour necrosis factor (TNF) injections. We searched for the terms Humira injection, Enbrel injection, Simponi injection, and Cimzia injection. Videos were categorised as useful information, misleading information, useful patient opinion, and misleading patient opinion by two physicians. Videos were rated for quality on a 5-point global quality scale (GQS; 1 = poor quality, 5 = excellent quality) and reliability and content using the 5-point DISCERN scale (higher scores represent greater reliability and more comprehensive videos)...
May 14, 2018: Rheumatology International
https://www.readbyqxmd.com/read/29616400/stable-expression-of-adalimumab-in-nicotiana-tabacum
#3
Tzvi Zvirin, Lena Magrisso, Amit Yaari, Oded Shoseyov
Production of monoclonal antibodies and pharmaceutical proteins in transgenic plants has been the focus of many research efforts for close to 30 years. Use of plants as bioreactors reduces large-scale production costs and minimizes risk for human pathogens contamination. Stable nuclear transformation of the plant genome offers a clear advantage in agricultural protein production platforms, limited only by the number of hectares that can be cultivated. We report here, for the first time, successful and stable expression of adalimumab in transgenic Nicotiana tabacum plants...
April 3, 2018: Molecular Biotechnology
https://www.readbyqxmd.com/read/29611342/the-economic-impacts-of-using-adalimumab-humira-%C3%A2-for-reducing-pain-in-people-with-ankylosing-spondylitis-a-microsimulation-study-for-australia
#4
Deborah Schofield, Rupendra Shrestha, Michelle Cunich
AIM: The onset and progression of ankylosing spondylitis (AS) usually occurs during the life stage when individuals are more likely to be working and receiving an income, but little is known about the effects of interventions that reduce pain and improve the economic circumstances of patients out of the labour force due to AS. This study evaluates the economic benefits of pain reduction among people aged 19-64 with AS using adalimumab (Humira® ) from the patient and governmental perspectives...
April 3, 2018: International Journal of Rheumatic Diseases
https://www.readbyqxmd.com/read/29600574/quantitative-assessment-of-mab-fc-glycosylation-of-cqa-importance-by-capillary-electrophoresis
#5
Marton Szigeti, Jeff Chapman, Beata Borza, Andras Guttman
The attached carbohydrates at the highly conserved asparagine-linked glycosylation site in the CH 2 domain of the fragment crystallizable (Fc) region of monoclonal antibody therapeutics can play an essential role in their mechanism of action, including ADCC, CDC, anti-inflammatory functions, and serum half-life. Thus, this particular glycosylation represents one of the important critical quality attributes (CQA) of therapeutic monoclonal antibodies, which should be closely monitored and controlled during all stages of biopharmaceutical manufacturing...
March 30, 2018: Electrophoresis
https://www.readbyqxmd.com/read/29574229/simple-and-robust-n-glycan-analysis-based-on-improved-2-aminobenzoic-acid-labeling-for-recombinant-therapeutic-glycoproteins
#6
Yeong Ran Jeong, Sun Young Kim, Young Sam Park, Gyun Min Lee
N-glycans of therapeutic glycoproteins are critical quality attributes that should be monitored throughout all stages of biopharmaceutical development. To reduce both the time for sample preparation and the variations in analytical results, we have developed an N-glycan analysis method that includes improved 2-aminobenzoic acid (2-AA) labeling to easily remove deglycosylated proteins. Using this analytical method, 15 major 2-AA labeled N-glycans of Enbrel® were separated into single peaks in hydrophilic interaction chromatography mode and therefore could be quantitated...
March 21, 2018: Journal of Pharmaceutical Sciences
https://www.readbyqxmd.com/read/29518978/structural-biology-of-the-tnf%C3%AE-antagonists-used-in-the-treatment-of-rheumatoid-arthritis
#7
REVIEW
Heejin Lim, Sang Hyung Lee, Hyun Tae Lee, Jee Un Lee, Ji Young Son, Woori Shin, Yong-Seok Heo
The binding of the tumor necrosis factor α (TNFα) to its cognate receptor initiates many immune and inflammatory processes. The drugs, etanercept (Enbrel® ), infliximab (Remicade® ), adalimumab (Humira® ), certolizumab-pegol (Cimzia® ), and golimumab (Simponi® ), are anti-TNFα agents. These drugs block TNFα from interacting with its receptors and have enabled the development of breakthrough therapies for the treatment of several autoimmune inflammatory diseases, including rheumatoid arthritis, Crohn's disease, and psoriatic arthritis...
March 7, 2018: International Journal of Molecular Sciences
https://www.readbyqxmd.com/read/29514803/similar-efficacy-safety-and-immunogenicity-of-adalimumab-biosimilar-bi-695501-and-humira-reference-product-in-patients-with-moderately-to-severely-active-rheumatoid-arthritis-results-from-the-phase-iii-randomised-voltaire-ra-equivalence-study
#8
Stanley B Cohen, Alberto Alonso-Ruiz, Piotr A Klimiuk, Eric C Lee, Nuala Peter, Ivo Sonderegger, Deepak Assudani
OBJECTIVE: To demonstrate clinical equivalence of adalimumab biosimilar candidate BI 695501 with Humira. METHODS: Patients with active rheumatoid arthritis on stable methotrexate were randomised to BI 695501 or Humira in a double-blind, parallel-group, equivalence study. At week 24, patients were rerandomised to continue BI 695501 or Humira, or switch from Humira to BI 695501. The coprimary endpoints were the percentage of patients achieving the American College of Rheumatology 20% response criteria (ACR20) at weeks 12 and 24...
June 2018: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/29499287/a-randomised-double-blind-placebo-controlled-crossover-trial-of-humira-adalimumab-for-erosive-hand-osteoarthritis-the-humor-trial
#9
D Aitken, L L Laslett, F Pan, I K Haugen, P Otahal, N Bellamy, P Bird, G Jones
OBJECTIVE: To assess the efficacy of adalimumab in patients with erosive hand osteoarthritis (OA). METHOD: Patients >50 years old, meeting the American College of Rheumatology (ACR) criteria for hand OA, with pain >50 on 100 mm visual analogue scale (VAS), morning stiffness >30 min and ≥1 erosive joint on X-ray with synovitis present on magnetic resonance imaging (MRI) were included in a randomised double-blind placebo-controlled crossover trial. Patients were randomised to adalimumab (40 mg subcutaneous injections every other week) or identical placebo injections for 12 weeks followed by an 8-week washout and then crossed over treatment groups for another 12 weeks...
March 2, 2018: Osteoarthritis and Cartilage
https://www.readbyqxmd.com/read/29439320/of-patents-and-patent-disputes-the-tnf%C3%AE-patent-files-part-2-enbrel-remicade-cimzia-and-simponi
#10
Ulrich Storz
This article is the second part of a trilogy that discusses IP issues related to anti-Tumor Necrosis factor α (TNFα) biologics. TNFα is the world's most valuable target, with accumulated sales of TNFα biologics of 34 bn USD in 2014. While in the first part of this trilogy, Humira was discussed, this second parts discusses the patent strategies of Enbrel, Remicade, Cimzia and Simponi.
February 5, 2018: Human Antibodies
https://www.readbyqxmd.com/read/29425077/the-nistmab-tryptic-peptide-spectral-library-for-monoclonal-antibody-characterization
#11
Qian Dong, Yuxue Liang, Xinjian Yan, Sanford P Markey, Yuri A Mirokhin, Dmitrii V Tchekhovskoi, Tallat H Bukhari, Stephen E Stein
We describe the creation of a mass spectral library composed of all identifiable spectra derived from the tryptic digest of the NISTmAb IgG1κ. The library is a unique reference spectral collection developed from over six million peptide-spectrum matches acquired by liquid chromatography-mass spectrometry (LC-MS) over a wide range of collision energy. Conventional one-dimensional (1D) LC-MS was used for various digestion conditions and 20- and 24-fraction two-dimensional (2D) LC-MS studies permitted in-depth analyses of single digests...
April 2018: MAbs
https://www.readbyqxmd.com/read/29417761/pharmacokinetic-equivalence-comparable-safety-and-immunogenicity-of-an-adalimumab-biosimilar-product-m923-to-humira-in-healthy-subjects
#12
Jan Hillson, Tim Mant, Molly Rosano, Carolyn Huntenburg, Mehrshid Alai-Safar, Siddhesh Darne, Donna Palmer, Borislava G Pavlova, Jennifer Doralt, Russell Reeve, Niti Goel, Doris Weilert, Paul W Rhyne, Kamali Chance, John Caminis, James Roach, Tanmoy Ganguly
The aims of this randomized, double-blind, three-arm, single-dose study were to demonstrate pharmacokinetic (PK) equivalence of the adalimumab biosimilar M923 (hereafter referred to as "M923") to each of 2 reference products, and to assess M923's safety and immunogenicity. Primary PK endpoints were maximum observed concentration (Cmax ), area under the curve (AUC) from time 0 extrapolated to infinity (AUC0-inf ), and AUC from time 0 to 336 hours (AUC0-336 ). Secondary endpoints included safety and immunogenicity assessments...
February 2018: Pharmacology Research & Perspectives
https://www.readbyqxmd.com/read/29282389/listeria-monocytogenes-brain-abscess-in-crohn-s-disease-treated-with-adalimumab
#13
Amporn Atsawarungruangkit, Fernando Dominguez, Gustavo Borda, Nikolaos Mavrogiorgos
Listeria monocytogenes is a gram-positive bacterium that causes listeriosis. Brain abscess is a very uncommon manifestation of listeriosis and has not been reported to be associated with adalimumab (humira), one of the approved medications for treating Crohn's disease. A 45-year-old female with Crohn's disease presented with sudden onset of fever, headache, nausea, vomiting, and altered mental status for 1 day. She was on prednisone and 6-mercaptopurine. She had started taking adalimumab 17 days prior to admission...
September 2017: Case Reports in Gastroenterology
https://www.readbyqxmd.com/read/29183563/a-systematic-review-and-economic-evaluation-of-adalimumab-and-dexamethasone-for-treating-non-infectious-intermediate-uveitis-posterior-uveitis-or-panuveitis-in-adults
#14
Hazel Squires, Edith Poku, Inigo Bermejo, Katy Cooper, John Stevens, Jean Hamilton, Ruth Wong, Alastair Denniston, Ian Pearce, Fahd Quhill
BACKGROUND: Non-infectious intermediate uveitis, posterior uveitis and panuveitis are a heterogeneous group of inflammatory eye disorders. Management includes local and systemic corticosteroids, immunosuppressants and biological drugs. OBJECTIVES: To evaluate the clinical effectiveness and cost-effectiveness of subcutaneous adalimumab (Humira® ; AbbVie Ltd, Maidenhead, UK) and a dexamethasone intravitreal implant (Ozurdex® ; Allergan Ltd, Marlow, UK) in adults with non-infectious intermediate uveitis, posterior uveitis or panuveitis...
November 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/29152118/sensitization-of-neuroblastoma-for-vincristine-induced-apoptosis-by-smac-mimetic-lcl161-is-attended-by-g2-cell-cycle-arrest-but-is-independent-of-nf%C3%AE%C2%BAb-rip1-and-tnf-%C3%AE
#15
Doerte Langemann, Magdalena Trochimiuk, Birgit Appl, Patrick Hundsdoerfer, Konrad Reinshagen, Georg Eschenburg
We demonstrated sensitization for chemotherapy by Smac mimetic (SM) LCL161, a potent antagonist of inhibitor of apoptosis proteins (IAP), in neuroblastoma (NB). Vinca alkaloids, particularly vincristine (VCR), displayed the strongest impact on inhibition of proliferation and apoptosis induction in combination with LCL161. The underlying signaling pathways remain elusive, though. LCL161 induces a quick degradation of cellular IAP 1 (cIAP-1). Combination of LCL161 with VCR had only marginal effects on X-linked IAP (XIAP) protein expression...
October 20, 2017: Oncotarget
https://www.readbyqxmd.com/read/29105621/adalimumab-etanercept-and-ustekinumab-for-treating-plaque-psoriasis-in-children-and-young-people-systematic-review-and-economic-evaluation
#16
Ana Duarte, Teumzghi Mebrahtu, Pedro Saramago Goncalves, Melissa Harden, Ruth Murphy, Stephen Palmer, Nerys Woolacott, Mark Rodgers, Claire Rothery
BACKGROUND: Psoriasis is a chronic inflammatory disease that predominantly affects the skin. Adalimumab (HUMIRA® , AbbVie, Maidenhead, UK), etanercept (Enbrel® , Pfizer, New York, NY, USA) and ustekinumab (STELARA® , Janssen Biotech, Inc., Titusville, NJ, USA) are the three biological treatments currently licensed for psoriasis in children. OBJECTIVE: To determine the clinical effectiveness and cost-effectiveness of adalimumab, etanercept and ustekinumab within their respective licensed indications for the treatment of plaque psoriasis in children and young people...
November 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/29063827/subcutaneous-injection-of-adalimumab-trial-compared-with-control-sciatic-a-randomised-controlled-trial-of-adalimumab-injection-compared-with-placebo-for-patients-receiving-physiotherapy-treatment-for-sciatica
#17
Nefyn H Williams, Alison Jenkins, Nia Goulden, Zoe Hoare, Dyfrig A Hughes, Eifiona Wood, Nadine E Foster, David A Walsh, Dawn Carnes, Valerie Sparkes, Elaine M Hay, John Isaacs, Kika Konstantinou, Dylan Morrissey, Jaro Karppinen, Stephane Genevay, Clare Wilkinson
BACKGROUND: Biological treatments such as adalimumab (Humira® ; AbbVie Ltd, Maidenhead, UK) are antibodies targeting tumour necrosis factor alpha, released from ruptured intervertebral discs, which might be useful in sciatica. Recent systematic reviews concluded that they might be effective, but that a definitive randomised controlled trial was needed. Usual care in the NHS typically includes a physiotherapy intervention. OBJECTIVES: To test whether or not injections of adalimumab plus physiotherapy are more clinically effective and cost-effective than injections of saline plus physiotherapy for patients with sciatica...
October 2017: Health Technology Assessment: HTA
https://www.readbyqxmd.com/read/28836749/real-life-safety-profile-of-zrc3197-adalimumab-biosimilar-in-indian-patients-with-common-rheumatic-diseases
#18
Ashish J Mathew, Arvind Ganapati, Sathish Kumar T, Ruchika Goel, Sandhya P, Debashish Danda
The advent of biologic therapies has brought in significant improvement in the outcome of patients suffering from chronic inflammatory arthritis. High costs and unavailability have however, limited their utility in some parts of the world. These limitations have been overcome to a good extent by the introduction of biosimilar versions of original products, which are gaining momentum, of late. Adalimumab (Humira®), a TNF-α inhibitor has been successfully used in patients with inflammatory arthritis for more than a decade now...
May 2017: Journal of the Association of Physicians of India
https://www.readbyqxmd.com/read/28836746/review-of-biosimilars-of-adalimumab
#19
V V Kaushik
A first fully humanized monoclonal antibody approved by US Food and Drug Administration (FDA) in 2002 was Adalimumab. Clinical efficacy and safety of adalimumab has been assessed in various trials in rheumatoid arthritis, ankylosing spondylitis, psoriasis, psoriatic arthritis, Crohn's Disease, and ulcerative colitis. It is one of the major sales success among biological and still one of the greatest blockbuster amongst monoclonal antibodies. With the advent of patent expiry of the parent drug HUMIRA, several potential biosimilars have debuted in various markets worldwide...
May 2017: Journal of the Association of Physicians of India
https://www.readbyqxmd.com/read/28790437/meniscal-ossicles-as-micro-ct-imaging-biomarker-in-a-rodent-model-of-antigen-induced-arthritis-a-synchrotron-based-x-ray-pilot-study
#20
Sandro Donato, Serena Pacilè, Federico Colombo, Chiara Garrovo, Simeone Dal Monego, Paolo Macor, Giuliana Tromba, Stefania Biffi
It is increasingly recognized that early detection of bone erosion plays an important role in the overall evaluation of rheumatoid arthritis and in the choice of the correct treatment approach. Since an appropriate use of imaging biomarkers in preclinical settings offers the prospect of smaller and optimized sample size, in the present study we define an anatomical imaging biomarker that could be objectively measured from micro-CT imaging data as an indicator of bone erosion in arthritis process. The well-characterized antigen-induced arthritis (AIA) model in rats was used...
August 8, 2017: Scientific Reports
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