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Certolizumab pegol

Athanasios Tragiannidis, Ioannis Kyriakidis, Ilse Zündorf, Andreas H Groll
Macromolecular immunosuppressive monoclonal antibodies and fusion proteins directed against molecules or cells involved in inflammation and immunity represent a recent and important addition to our therapeutic armamentarium. Tumor necrosis alpha (TNFα) is a cytokine involved in systemic inflammation and clinical utilization of its antagonists has revolutionized treatment of juvenile rheumatoid and psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, and plaque psoriasis. Clinical utility has also been demonstrated for use against steroid-refractory graft-vs-host disease and other immune-mediated conditions...
October 21, 2016: Mycoses
Keith A Betts, Jenny Griffith, Yan Song, Manish Mittal, Avani Joshi, Eric Q Wu, Arijit Ganguli
INTRODUCTION: Biologic therapies have improved the clinical management of ankylosing spondylitis (AS). Few head-to-head studies have directly compared the efficacy of these agents. This study was conducted to indirectly compare the efficacy of biologic agents for treatment of active AS. METHODS: A targeted literature review was conducted to identify randomized clinical trials for adalimumab, infliximab, golimumab, certolizumab pegol, etanercept, and secukinumab for the treatment of active AS...
July 25, 2016: Rheumatol Ther
Tiffany Y Loh, Philip R Cohen
BACKGROUND: Tumor necrosis factor-α (TNF-α) inhibitors, such as infliximab, adalimumab, and certolizumab pegol are effective agents in the treatment of inflammatory bowel disease. Some individuals undergoing anti-TNF-α therapy for Crohn's disease or ulcerative colitis develop psoriasiform lesions. This is a paradoxical finding, as classical psoriasis is known to respond to these agents. PURPOSE: The clinical features of anti-TNF-α-induced psoriatic dermatitis are described...
September 9, 2016: Curēus
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...
October 14, 2016: Immunotherapy
Rafael Alfonso-Cristancho, Nigel Armstrong, Ramesh Arjunji, Rob Riemsma, Gill Worthy, Rita Ganguly, Jos Kleijnen
Our aim was to establish the comparative effectiveness of rheumatoid arthritis (RA) biologics, using a systematic review and network meta-analysis. The systematic review used randomized controlled trials (RCTs) in adults with RA who failed treatment with conventional disease-modifying agents for rheumatoid disease (cDMARDs). We compared the effectiveness of abatacept, adalimumab, etanercept, infliximab, certolizumab pegol, golimumab, and rituximab to tocilizumab, a recent biologic with a different mechanism of action (anti-IL-6 receptor)...
October 10, 2016: Clinical Rheumatology
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...
October 4, 2016: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
D van der Heijde, A Deodhar, R Fleischmann, P J Mease, M Rudwaleit, T Nurminen, O Davies BPharm
Objective Early identification of patients unlikely to achieve good long-term disease control with anti-TNF therapy in axial spondyloarthritis (axSpA) and psoriatic arthritis (PsA) is important for physicians following treat-to-target recommendations. Here we assess associations between disease activity or clinical response during the first 12 weeks (wks) of treatment and attainment of treatment targets at Wk48 in axSpA and PsA patients receiving certolizumab pegol (CZP). Methods The relationship between disease activity or clinical response during the first 12 wks of treatment, and achievement of Wk48 targets (axSpA: ASDAS-CRP inactive disease or BASDAI <2 with normal CRP; PsA: minDA), was assessed post-hoc using RAPID-axSpA (NCT01087762) and RAPID-PsA (NCT01087788) trial data...
October 1, 2016: Arthritis Care & Research
Paweł Moćko, Paweł Kawalec, Andrzej Pilc
BACKGROUND: Crohn disease (CD) is an inflammatory bowel disease which occurs especially in developed countries of Western Europe and North America. The aim of the study was to compare the safety profile of biologic drugs in patients with CD. METHODOLOGY: A systematic literature search was performed using PubMed, Embase, and CENTRAL databases, until April 27, 2016. We included randomized controlled trials (RCTs) that compared the safety of biologic drugs (infliximab, adalimumab, vedolizumab, certolizumab pegol, and ustekinumab) with one another or with placebo in patients with CD...
August 1, 2016: Pharmacological Reports: PR
Eric Ku, Valentina Pedoia, Matthew Tanaka, Ursula Heilmeier, John Imboden, Jonathan Graf, Thomas Link, Xiaojuan Li
PURPOSE: To evaluate the feasibility of MR T1ρ in assessing radiocarpal cartilage matrix changes following rheumatoid arthritis (RA) treatment. MATERIALS AND METHODS: Five healthy controls and nine RA patients were studied: three RA patients with low disease activity that were treated with methotrexate (MTX) alone and six with active disease despite MTX treatment who were additionally treated with certolizumab pegol, an anti-tumor necrosis factor biologic. Wrist 3 Tesla MRI were acquired at baseline and 3-month follow-up...
September 23, 2016: Journal of Magnetic Resonance Imaging: JMRI
Marta Olejárová
UNLABELLED: The biological treatment which is the most effective type of therapy for inflammatory rheumatic diseases, has become part of a standard clinical rheumatology practice in recent years. Thousands of patients in the Czech Republic with rheumatoid arthritis, different forms of spondyloarthritides and with psoriatic arthritis are now successfully treated in this way. The following medications are registered in the Czech Republic for the treatment of rheumatic diseases: infliximab, adalimumab, golimumab, certolizumab pegol, etanercept, abatacept, rituximab, tocilizumab and belimumab, newly also secukinumab...
2016: Vnitr̆ní Lékar̆ství
R Talotta, F Atzeni, A Batticciotto, D Ventura, P Sarzi-Puttini
It is still unknown whether there is an association between the use of certolizumab pegol (CZP) in rheumatic patients and the onset of cardiac arrhythmias. We describe the cases of two patients with rheumatoid arthritis (RA) treated with CZP as the first-line biological drug and methotrexate (MTX), who developed an arrhythmic event. The first was a 60-year-old, hypertensive male smoker, the second a 66-year-old dyslipidemic female non-smoker. Both were diagnosed as having RA in 2010, and started treatment with MTX plus CZP...
2016: Reumatismo
Paweł Moćko, Paweł Kawalec, Andrzej Pilc
BACKGROUND AND OBJECTIVES: Biologic drugs are used in innovative therapies for the management of inflammatory bowel diseases (IBDs). The aim of this study was to compare the safety profile of biologic drugs in patients with IBD. METHODS: A systematic literature search was performed using PubMed, Embase, and CENTRAL databases, up to 22 August 2016. We included randomized, placebo-controlled, or head-to-head clinical trials that compared the safety of different biologics in patients with IBDs...
September 7, 2016: Clinical Drug Investigation
Hiroki Mitoma, Takahiko Horiuchi, Hiroshi Tsukamoto, Naoyasu Ueda
Tumor necrosis factor (TNF)-α is a potent pro-inflammatory and pathological cytokines in inflammatory diseases such as rheumatoid arthritis and inflammatory bowel diseases. Anti-TNF-α therapy has been established as an efficacious therapeutic strategy in these diseases. In clinical settings, three monoclonal anti-TNF-α full IgG1 antibodies infliximab, adalimumab, and golimumab, PEGylated Fab' fragment of anti-TNF-α antibody certolizumab pegol, extracellular domain of TNF receptor 2/IgG1-Fc fusion protein etanercept, are almost equally effective for rheumatoid arthritis...
August 24, 2016: Cytokine
Marijana Protic, Alain Schoepfer, Nikhil Yawalkar, Stephan Vavricka, Frank Seibold
BACKGROUND: The cause of anti-TNF-induced psoriasis is still unknown. OBJECTIVE: We aimed to evaluate if the appearance of psoriasis under anti-TNF therapy is associated with anti-TNF antibody levels and TNF-antagonist trough levels. METHODS: In this case-control study we identified 23 patients (21 with Crohn's disease [CD], two with ulcerative colitis [UC]) who developed psoriasis under infliximab (IFX, n = 20), adalimumab (ADA, n = 2), and certolizumab pegol (CZP, n= 1) and compared them regarding the anti-TNF-antagonist antibody levels with 85 IBD patients (72 with CD, 13 with UC) on anti-TNF therapy without psoriasis...
December 2016: Scandinavian Journal of Gastroenterology
Walter Alexander
We present EULAR sessions on the latest treatments for rheumatic disease with an infliximab biosimilar, certolizumab pegol, secukinumab, and bimekizumab. We also report on significant developments in diabetes presented at ADA's Scientific Sessions.
August 2016: P & T: a Peer-reviewed Journal for Formulary Management
Gil Y Melmed, Dermot McGovern, Stefan Schreiber, Gordana Kosutic, Marshall Spearman, Jason Coarse, William J Sandborn
BACKGROUND: In Crohn's disease (CD), rapid response to anti-tumor necrosis factor therapy improves short- and medium-term outcomes, but the relationship between early remission (ER) and long-term remission is unclear. AIMS: This exploratory analysis of PRECiSE 3 (NCT00160524) assessed whether ER after initiation of certolizumab pegol predicted long-term remission. METHODS: Patients enrolled in PRECiSE 3 had completed PRECiSE 1 or 2, two randomized placebo-controlled studies for moderate to severe CD, and received open-label certolizumab pegol 400 mg every 4 weeks for a total treatment duration of ≤7...
August 5, 2016: Current Medical Research and Opinion
Julien Paccou, René-Marc Flipo
Golimumab (Simponi(®)) is a fully human tumor necrosis factor α inhibitor (TNFi) antibody administered subcutaneously. In the European Union, golimumab is indicated for the treatment of adults with severe, active axial spondyloarthritis (axSpA), which includes both ankylosing spondylitis (AS) and nonradiographic axSpA (nr-axSpA). In the US, it is indicated for the treatment of adults with active AS only. This article reviews the efficacy and tolerability of golimumab in nr-axSpA patients compared to other TNFi agents (adalimumab, infliximab, etanercept, and certolizumab pegol)...
2016: Drug Design, Development and Therapy
Edward V Loftus, Jean-Frederic Colombel, Stefan Schreiber, Charles W Randall, Miguel Regueiro, Tauseef Ali, Catherine Arendt, Jason Coarse, Marshall Spearman, Gordana Kosutic
BACKGROUND & AIMS: Treatments for Crohn's disease (CD) have been linked to serious infections, malignancies, and dermatologic complications. We pooled and analyzed clinical trials of certolizumab pegol, a pegylated humanized Fab' fragment against tumor necrosis factor, to quantify safety events in patients with CD. METHODS: We collected data from 5 placebo-controlled trials, 9 open-label studies, and 1 dose-regimen study, conducted globally through April 2014. A total of 2570 patients with moderate to severe CD were treated with certolizumab pegol, with 4378...
July 25, 2016: Clinical Gastroenterology and Hepatology
Philippe Carron, Bieke Lambert, Liesbet Van Praet, Filip De Vos, Gaëlle Varkas, Lennart Jans, Dirk Elewaut, Filip Van den Bosch
BACKGROUND: Biologicals are the cornerstone for many treatment algorithms in inflammatory arthritis. While tumour necrosis factor (TNF) inhibitors may achieve important responses in ∼50% of patients with rheumatoid arthritis (RA) and spondyloarthritis (SpA), a significant fraction of patients are partial or non-responders. We hypothesised that in vivo assessment of TNF by scintigraphy with 99mTc-radiolabelled certolizumab pegol (CZP) might lead to a more 'evidence-based biological therapy'...
2016: RMD Open
Scott D Lee, David T Rubin, William J Sandborn, Charles Randall, Ziad Younes, Stefan Schreiber, David A Schwartz, Robert Burakoff, David Binion, Themos Dassopoulos, Razvan Arsenescu, Alexandra Gutierrez, Ellen Scherl, Cem Kayhan, Iram Hasan, Gordana Kosutic, Marshall Spearman, David Sen, Jason Coarse, Stephen Hanauer
BACKGROUND: Patients with Crohn's disease in whom tumor necrosis factor antagonist therapy fails have limited treatment options, and the benefit of reintroducing the same therapy remains unclear. Here, we report results from PRECiSE 4 (NCT00160706), an open-label extension study of certolizumab pegol in patients who withdrew from the placebo-controlled studies PRECiSE 1 or 2. METHODS: Patients eligible for PRECiSE 4 had Crohn's disease exacerbation on placebo or primary or secondary failure to certolizumab pegol in PRECiSE 1 or 2, and received 400 mg certolizumab pegol subcutaneously at weeks 0, 2, and 4 and every 4 weeks thereafter up to 360 weeks...
August 2016: Inflammatory Bowel Diseases
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