Read by QxMD icon Read


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
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
Ling Zhou, Geng Wang, Xin Liu, Jing Song, Ling Chen, Huji Xu
BACKGROUND: This study aimed to investigate the reliability and validity of serum matrix metalloproteinase-3 (MMP-3) levels and articular ultrasound (US) scores in assessing disease activity and therapeutic response in rheumatoid arthritis (RA) patients. METHODS: A total of 151 RA patients were enrolled, of whom 22 were treated with certolizumab pegol (Cimzia, CZP). The RA patients were divided into the following four subgroups according to their disease activity score in 28 joints (DAS28): stable, mild activity, moderate activity, and high activity...
November 15, 2017: Arthritis Research & Therapy
Mark Corbett, Fadi Chehadah, Mousumi Biswas, Thirimon Moe-Byrne, Stephen Palmer, Marta Soares, Matthew Walton, Melissa Harden, Pauline Ho, Nerys Woolacott, Laura Bojke
BACKGROUND: Several biologic therapies are approved by the National Institute for Health and Care Excellence (NICE) for psoriatic arthritis (PsA) patients who have had an inadequate response to two or more synthetic disease-modifying antirheumatic drugs (DMARDs). NICE does not specifically recommend switching from one biologic to another, and only ustekinumab (UST; STELARA®, Janssen Pharmaceuticals, Inc., Horsham, PA, USA) is recommended after anti-tumour necrosis factor failure. Secukinumab (SEC; COSENTYX®, Novartis International AG, Basel, Switzerland) and certolizumab pegol (CZP; CIMZIA®, UCB Pharma, Brussels, Belgium) have not previously been appraised by NICE...
October 2017: Health Technology Assessment: HTA
Andrew Motlis, Moheb Boktor, Paul Jordan, Urska Cvek, Marjan Trutschl, J Steven Alexander
The effectiveness of ant-TNF 'biologic' therapy in is well supported in the management of moderate to severe Crohn's Disease (CD). Our first 'SAVANT' study was to our knowledge the first study report one- year outcomes in patients (n=60) who switched from previous anti-TNFa treatment to Cimzia/Certolizumab. This current study (SAVANT 2) follows up on longer term outcomes and provides additional clinical and biochemical data that may contribute to therapeutic responses. This IRB approved study was a retrospective analysis of the initial patients included in SAVANT 1...
December 2017: Pathophysiology: the Official Journal of the International Society for Pathophysiology
Iñigo Bermejo, Matt Stevenson, Rachel Archer, John W Stevens, Edward Goka, Mark Clowes, David L Scott, Adam Young
As part of its single technology appraisal (STA) process, the National Institute for Health and Care Excellence (NICE) invited the manufacturer (UCB Pharma) of certolizumab pegol (CZP; Cimzia®) to submit evidence of its clinical and cost effectiveness for the treatment of rheumatoid arthritis (RA) following inadequate response to a tumour necrosis factor-α inhibitor (TNFi). The School of Health and Related Research Technology Appraisal Group at the University of Sheffield was commissioned to act as the independent Evidence Review Group (ERG)...
November 2017: PharmacoEconomics
Iain Simpson
This Industry Update covers the period from 1 October through to 31 October 2016, and is based on information sourced from company press releases, scientific literature, patents and various news websites. The month saw several news items covering drug-delivery devices, including a new sensor to monitor and support the use of inhalers; launch in the UK of a new autoinjector for Cimzia(®), UCB's rheumatoid arthritis drug; and approval of Roche's Lucentis(®) in a prefilled syringe. Research was also published to show the value of continuous blood pressure monitoring in dementia management...
February 2017: Therapeutic Delivery
Emma D Deeks
Certolizumab pegol (Cimzia(®)) is a subcutaneously administered polyethylene glycolylated (PEGylated) antigen-binding fragment of a recombinant human monoclonal antibody that selectively neutralizes TNFα. The drug is indicated for a variety of inflammatory autoimmune diseases, including Crohn's disease (CD), rheumatoid arthritis (RA), psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA), based on its benefit in these settings in well-designed clinical trials. In these studies, certolizumab pegol (as first- or subsequent-line therapy) reduced the severity of CD when used as an induction or maintenance therapy, and improved the signs/symptoms and slowed the radiographic progression of RA (with or without concomitant methotrexate), PsA and axSpA...
December 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
Moheb Boktor, Andrew Motlis, Avinash Aravantagi, Ankur Sheth, Paul Jordan, James Morris, Kenneth Manas, Nazneen Hussain, Urska Cvek, Marjan Trutschl, Felix Becker, J Steven Alexander
BACKGROUND: Biological therapy targeting tumor necrosis factor-alfa has revolutionized the treatment of Crohn's disease (CD). Our study retrospectively reviewed clinical outcomes of 60 patients administratively substituted from Infliximab or Adalimumab to Certolizumab. Maintenance of disease and failure rates after substitution of anti-tumor necrosis factor-alfa agents in CD patients were monitored over 1 year, and this is the first outcomes study of patients maintained on Infliximab or Adalimumab substituted to Certolizumab...
June 2016: Inflammatory Bowel Diseases
Gloria S Z Tun, Alan J Lobo
INTRODUCTION: TNF-α antagonists have transformed the treatment of patients with Crohn's disease (CD). Certolizumab pegol (CZP) is the third TNF-α antagonist to be approved for use in the United States but is not currently approved in Europe. AREAS COVERED: This review evaluates the pharmacokinetics, pharmacodynamics and efficacy of CZP in CD. Safety, immunogenicity and its use in pregnancy have also been assessed. A literature search was conducted using Pub Med (2004 - 2014) for the terms 'Crohn's disease' and 'certolizumab pegol' or 'certolizumab' or 'cimzia'...
February 2015: Expert Opinion on Drug Metabolism & Toxicology
Shaun D Fontaine, Ralph Reid, Louise Robinson, Gary W Ashley, Daniel V Santi
Michael-addition of a thiol to a maleimide is commonly used for bioconjugation of drugs to macromolecules. Indeed, both current FDA-approved antibody-drug conjugates-Brentuximab vedotin and Trastuzumab emtansine-and one approved PEGylated conjugate-Cimzia-contain a thiol-maleimide adduct. However, the ultimate in vivo fate of such adducts is to undergo disruptive cleavage by thiol exchange or stabilizing ring opening. Therapeutic efficacy of a conjugate can be compromised by thiol exchange and the released drug may show toxicities...
January 21, 2015: Bioconjugate Chemistry
Sohita Dhillon
Certolizumab pegol (Cimzia(®)) is a polyethylene glycolylated antigen-binding fragment of a recombinant human monoclonal antibody that binds to and selectively neutralizes tumour necrosis factor (TNF) α. In the EU, subcutaneous certolizumab pegol is indicated for the treatment of adults with severe active axial spondyloarthritis (axSpA), comprising ankylosing spondylitis (AS) and non-radiographic axSpA (nr-axSpA), and for adults with active psoriatic arthritis (PsA). In the USA it is indicated for the treatment of adults with active AS or active PsA...
June 2014: Drugs
(no author information available yet)
No abstract text is available yet for this article.
February 3, 2014: Medical Letter on Drugs and Therapeutics
Emma D Deeks
Certolizumab pegol (Cimzia(®)) is a recombinant, polyethylene glycolylated, antigen-binding fragment of a humanized monoclonal antibody that selectively targets and neutralizes tumour necrosis factor (TNF)-α. The drug is indicated for subcutaneous use every 2 or 4 weeks (q2w or q4w) for the treatment of adults with moderate to severe active rheumatoid arthritis (RA). The efficacy of subcutaneous certolizumab pegol in adults with active RA has been investigated in several well designed, placebo-controlled trials...
January 2013: Drugs
J Rosa, M Sabelli, Enrique R Soriano
A new anti-tumor necrosis factor alpha (TNF-α) inhibitor with a novel mechanism of action has entered phase 3 trials in rheumatoid arthritis (RA). Certolizumab pegol (Cimzia(®)) is a humanized Fab' antibody fragment against TNF-α with a polyethylene glycol tail that prevents complement-dependent and antibody-dependent cell-mediated cytotoxicity or apoptosis. Four randomized clinical trials have been published so far. Reported results are similar to those published in previous studies with other TNF-α inhibitors, with ACR20, ACR50, and ACR70 responses of around 60%, 40%, and 20%, respectively, when combined with methotrexate and slightly lower when used as monotherapy...
2010: Medical Devices: Evidence and Research
Ruth Duncan
A growing number of polymer therapeutics have entered routine clinical use as nano-sized medicines. Early products were developed as anticancer agents, but treatments for a range of diseases and different routes of administration have followed--recently the PEGylated-anti-TNF Fab Cimzia® for rheumatoid arthritis and the PEG-aptamer Macugen® for age related macular degeneration. New polymer therapeutic concepts continue to emerge with a growing number of conjugates entering clinical development, for example PEGylated-aptamers and a polymer-based siRNA delivery system...
August 2011: Current Opinion in Biotechnology
Stephan R Vavricka, Alain M Schoepfer, Georg Bansky, Janek Binek, Christian Felley, Martin Geyer, Michael Manz, Gerhard Rogler, Philippe de Saussure, Bernhard Sauter, Michael Scharl, Frank Seibold, Alex Straumann, Pierre Michetti
BACKGROUND: Certolizumab pegol (Cimzia, CZP) was approved for the treatment of Crohn's disease (CD) patients in 2007 in Switzerland as the first country worldwide. This prospective phase IV study aimed to evaluate the efficacy and safety of CZP over 26 weeks in a multicenter cohort of practice-based patients. METHODS: Evaluation questionnaires at baseline, week 6, and week 26 were completed by gastroenterologists in hospitals and private practices. Adverse events were evaluated according to World Health Organization (WHO) guidelines...
July 2011: Inflammatory Bowel Diseases
M Connock, S Tubeuf, K Malottki, A Uthman, J Round, S Bayliss, C Meads, D Moore
This paper presents a summary of the evidence review group (ERG) report into the clinical effectiveness and cost-effectiveness of certolizumab pegol (CZP) for adults with active rheumatoid arthritis (RA) that have not responded adequately to treatment with conventional disease modifying anti-rheumatic drugs (DMARDs) including methotrexate (MTX), in accordance with the licensed indication, based upon the evidence submission from the manufacturer to the National Institute for Health and Clinical Excellence (NICE) as part of the single technology appraisal (STA) process...
October 2010: Health Technology Assessment: HTA
Aarat M Patel, Larry W Moreland
The past decade has been an exciting period for clinical research and patient care in rheumatoid arthritis. This is mostly due to targeted biologic agents that have changed the outcome of this disease. Certolizumab pegol (Cimzia(®), UCB Inc., GA, USA), which targets TNF-α with a different mechanism of action than widely used biologics, was initially investigated for Crohn's disease but has now been shown to be effective for rheumatoid arthritis. There have been three significant clinical trials demonstrating the efficacy of certolizumab pegol in active rheumatoid arthritis; two with combination methotrexate and one with monotherapy...
November 2010: Expert Review of Clinical Immunology
Trevor A Winter, William J Sandborn, Willem Js de Villiers, Stefan Schreiber
Biologic therapies have revolutionized the treatment of Crohn's disease (CD). Targeting TNF-alpha with monoclonal antibodies has changed the therapeutic landscape for tackling refractory and complicated CD. Intravenous use of infliximab, a chimeric monoclonal antibody to TNF-alpha is, however, limited by the occurrence of adverse events, infusion reactions, infectious complications, aggravation of heart failure, the occurrence of neurological demyelinating conditions and induction of rare malignancies. The incremental development of next-generation TNF-alpha antibodies and binding proteins through antibody-engineering techniques has followed, with the aim of producing efficacious drugs that are less expensive to produce, have a convenient route of administration and have fewer side effects...
September 2007: Expert Review of Clinical Immunology
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"