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Certolizumab pegol

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https://www.readbyqxmd.com/read/28747607/safety-and-effectiveness-of-certolizumab-pegol-in-patients-with-rheumatoid-arthritis-interim-analysis-of-post-marketing-surveillance
#1
Hideto Kameda, Keiichiro Nishida, Toshihiro Nannki, Akira Watanabe, Yukiya Oshima, Shigaki Momohara
  Objective: To evaluate the safety and effectiveness of certolizumab pegol (CZP) in a real-world setting among Japanese patients with rheumatoid arthritis. METHODS: Post-marketing surveillance data from 2,579 patients treated with CZP were analyzed. Adverse events (AEs) observed during the 24-week CZP treatment period were recorded. Disease activity was evaluated using DAS28-ESR and DAS28-CRP at baseline, Week 12, Week 24, or at withdrawal. RESULTS: The total period of exposure to CZP was 1313...
2017: Nihon Rinshō Men'eki Gakkai Kaishi, Japanese Journal of Clinical Immunology
https://www.readbyqxmd.com/read/28729087/real-world-effectiveness-of-biologic-disease-modifying-antirheumatic-drugs-for-the-treatment-of-rheumatoid-arthritis-after-etanercept-discontinuation-in-the-united-kingdom-france-and-germany
#2
Nanxin Li, Keith A Betts, Andrew J Messali, Martha Skup, Vishvas Garg
PURPOSE: The purpose of this study was to assess the real-world effectiveness of patients with rheumatoid arthritis (RA) who discontinued etanercept treatment and subsequently received another tumor necrosis factor α (TNF-α) inhibitor or a non-TNF-α biologic in the United Kingdom, France, and Germany. METHODS: Medical record data of patients with RA were collected from a panel of rheumatologists in the United Kingdom, France, and Germany. Patients were required to have a diagnosis of RA, be ≥18 years old, and have initiated use of another TNF-α inhibitor (adalimumab, certolizumab pegol, golimumab, or infliximab) or a non-TNF-α biologic (abatacept or tocilizumab) between January 2014 and May 2015 after discontinuing use of etanercept...
July 17, 2017: Clinical Therapeutics
https://www.readbyqxmd.com/read/28725981/certolizumab-pegol-was-effective-for-treating-residual-synovitis-after-total-knee-arthroplasty-in-a-patient-with-rheumatoid-arthritis-therapeutic-monitoring-by-ultrasound
#3
Shin-Ya Kawashiri, Tohru Michitsuji, Atsushi Kawakami
We present the case of a 59-year-old female who developed rheumatoid arthritis in 2007. Right total knee arthroplasty (TKA) was performed in 2008. Although she was treated with methotrexate (MTX) after the operation, this treatment was insufficient. Infliximab (IFX) was introduced in 2001, and she achieved clinical remission. Left TKA was performed in October 2014. Because active synovitis was not detected by ultrasound after the operation, IFX was discontinued. She had been treated with MTX 8 mg weekly. However, arthralgia of the bilateral knees developed in March 2015...
July 19, 2017: Journal of Medical Ultrasonics
https://www.readbyqxmd.com/read/28717941/the-comparative-safety-of-tnf-inhibitors-in-ankylosing-spondylitis-a-meta-analysis-update-of-14-randomized-controlled-trials
#4
Li-Qiong Hou, Ga-Xue Jiang, Yan-Fei Chen, Xi-Mei Yang, Lei Meng, Miao Xue, Xiao-Guang Liu, Xi-Chao Chen, Xiao Li
TNF inhibitors have been used in ankylosing spondylitis (AS). The efficacy of TNF inhibitors was already evaluated by meta-analysis of randomized controlled trials (RCTs). However, the safety of TNF inhibitors is still unclear. Therefore, we aimed to evaluate and update the safety data from RCTs of TNF inhibitors in patients treated for AS. A systematic literature search was conducted from 1990 through May 31, 2016. All studies included were randomized, double-blind, controlled trials of patients with ankylosing spondylitis that evaluated adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab treatment...
July 17, 2017: Clinical Reviews in Allergy & Immunology
https://www.readbyqxmd.com/read/28712320/certolizumab-pegol-treatment-in-behcet-s-disease-with-different-organ-involvement-a-multicenter-retrospective-observational-study
#5
Giuseppe Lopalco, Giacomo Emmi, Stefano Gentileschi, Silvana Guerriero, Antonio Vitale, Elena Silvestri, Matteo Becatti, Iacopo Cavallo, Claudia Fabiani, Bruno Frediani, Florenzo Iannone, Luca Cantarini
OBJECTIVES: The purpose of the present study was to describe our experience with the recombinant Fab' antibody fragment against TNF-α Certolizumab Pegol (CZP) in patients with Behçet's disease (BD) refractory to standardized therapies and previous biologic agents. METHODS: Retrieved data including demographic characteristics, clinical manifestations, and previous treatments were collected in three different specialized Rheumatologic Units in Italy. In order to evaluate disease activity, the BD current activity form (BDCAF) has been used before starting CZP therapy and at each visit during treatment...
February 21, 2017: Modern Rheumatology
https://www.readbyqxmd.com/read/28705025/improving-the-sensitivity-and-specificity-of-a-bioanalytical-assay-for-the-measurement-of-certolizumab-pegol
#6
John Smeraglia, John-Paul Silva, Kieran Jones
AIM: In order to evaluate placental transfer of certolizumab pegol (CZP), a more sensitive and selective bioanalytical assay was required to accurately measure low CZP concentrations in infant and umbilical cord blood. Results & methodology: A new electrochemiluminescence immunoassay was developed to measure CZP levels in human plasma. Validation experiments demonstrated improved selectivity (no matrix interference observed) and a detection range of 0.032-5.0 μg/ml. Accuracy and precision met acceptance criteria (mean total error ≤20...
July 14, 2017: Bioanalysis
https://www.readbyqxmd.com/read/28674959/treatment-persistence-and-clinical-outcomes-of-tumor-necrosis-factor-inhibitor-cycling-or-switching-to-a-new-mechanism-of-action-therapy-real-world-observational-study-of-rheumatoid-arthritis-patients-in-the-united-states-with-prior-tumor-necrosis-factor-inhibitor
#7
Wenhui Wei, Keith Knapp, Li Wang, Chieh-I Chen, Gary L Craig, Karen Ferguson, Sergio Schwartzman
INTRODUCTION: To examine treatment persistence and clinical outcomes associated with switching from a tumor necrosis factor inhibitor (TNFi) to a medication with a new mechanism of action (MOA) (abatacept, anakinra, rituximab, tocilizumab, or tofacitinib) versus cycling to another TNFi (adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab) among patients with rheumatoid arthritis. METHODS: This retrospective, longitudinal study included patients with rheumatoid arthritis in the JointMan(®) US clinical database who received a TNFi in April 2010 or later and either cycled to a TNFi or switched to a new MOA therapy by March 2015...
July 3, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28666080/a-phase-3-study-evaluating-continuation-tapering-and-withdrawal-of-certolizumab-pegol-after-1-year-of-therapy-in-early-rheumatoid-arthritis-patients
#8
Michael E Weinblatt, Clifton O Bingham, Gerd-Rüdiger Burmester, Vivian P Bykerk, Daniel E Furst, Xavier Mariette, Désirée van der Heijde, Ronald van Vollenhoven, Brenda Van Lunen, Cécile Ecoffet, Christopher Cioffi, Paul Emery
OBJECTIVE: For DMARD-naïve, early rheumatoid arthritis patients who achieved sustained low disease activity (sLDA; DAS28[ESR]≤3.2 at both Weeks 40 and 52) after 1 year of treatment with certolizumab pegol (CZP 200mg Q2W+optimized MTX), we evaluated whether continuation of CZP as a standard (200mg Q2W+MTX) or reduced-frequency (200mg Q4W+MTX) dose was superior to stopping CZP (placebo+MTX) in maintaining LDA for 1 additional year. METHODS: 293 patients from C-EARLY Period 1 were re-randomized 2:3:2 in Period 2 to CZP standard (n=84), reduced-frequency (n=127), CZP stopped (n=82)...
June 30, 2017: Arthritis & Rheumatology
https://www.readbyqxmd.com/read/28595194/long-term-effiicacy-and-safety-of-certolizumab-pegol-in-an-unselected-crohn-s-disease-population-the-facts-iii-survey
#9
Stephan R Vavricka, Milos Spasojevic, Gerhard Rogler, Alain M Schoepfer, Frank Seibold, Jan Borovicka, Pascal Frei, Jonas Zeitz, Thomas Greuter, Christine Manser, Michael Scharl, Benjamin Misselwitz, Alex Straumann, Pierre Michetti, Luc Biedermann
BACKGROUND: Long-term data of certolizumab pegol (CZP) in Crohn's disease (CD) from pivotal registry trials are limited. We therefore aimed to evaluate the long-term efficacy of CZP in clinical practice in Switzerland. METHODS: In the First Approved Certolizumab Therapeutic Experience in Switzerland-III phase IV multicenter cohort, patients receiving CZP were prospectively included all over Switzerland in (non-) academic hospitals and private practice. RESULTS: We included 104 CD patients (52 male; only 22...
June 9, 2017: Digestive Diseases
https://www.readbyqxmd.com/read/28550592/certolizumab-pegol-for-treating-rheumatoid-arthritis-following-inadequate-response-to-a-tnf-%C3%AE-inhibitor-an-evidence-review-group-perspective-of-a-nice-single-technology-appraisal
#10
REVIEW
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)...
May 26, 2017: PharmacoEconomics
https://www.readbyqxmd.com/read/28523420/cost-utility-analysis-of-certolizumab-pegol-in-combination-with-methotrexate-in-patients-with-moderate-to-severe-active-rheumatoid-arthritis-in-greece
#11
C Tzanetakos, A Tzioufas, A Goules, G Kourlaba, T Theodoratou, P Christou, N Maniadakis
We aimed to evaluate the cost-effectiveness of certolizumab pegol (CZP), a pegylated fc-free anti-TNF, as add-on therapy to methotrexate (MTX) versus etanercept, adalimumab, or golimumab in patients with moderate-to-severe active rheumatoid arthritis (RA) not responding to the conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs). A Markov model (6-month cycle length) assessed health and cost outcomes of CZP versus other anti-TNFs recommended for RA in Greece over a patient's lifetime. Following discontinuation of first-line anti-TNF, patients switched to second anti-TNF and then to a biologic with another mode of action...
May 18, 2017: Rheumatology International
https://www.readbyqxmd.com/read/28498975/sustained-efficacy-safety-and-patient-reported-outcomes-of-certolizumab-pegol-in-axial-spondyloarthritis-4-year-outcomes-from-rapid-axspa
#12
Désirée van der Heijde, Maxime Dougados, Robert Landewé, Joachim Sieper, Walter P Maksymowych, Martin Rudwaleit, Filip Van den Bosch, Jürgen Braun, Philip J Mease, Alan J Kivitz, Jessica Walsh, Owen Davies, Lars Bauer, Bengt Hoepken, Luke Peterson, Atul Deodhar
Objective.: The aim was to assess the long-term safety and efficacy of certolizumab pegol over 4 years of continuous treatment in patients with axial spondyloarthritis (axSpA), including both AS and non-radiographic (nr-) axSpA. Methods.: RAPID-axSpA was a phase 3 randomized trial, double blind and placebo controlled to week 24, dose blind to week 48 and open label to week 204. Patients had a clinical diagnosis of axSpA, meeting Assessment of SpondyloArthritis international Society (ASAS) criteria, and had active disease...
May 12, 2017: Rheumatology
https://www.readbyqxmd.com/read/28483767/incidence-and-prevalence-of-psoriatic-arthritis-in-denmark-a-nationwide-register-linkage-study
#13
Alexander Egeberg, Lars Erik Kristensen, Jacob P Thyssen, Gunnar Hilmar Gislason, Alice B Gottlieb, Laura C Coates, Denis Jullien, Paolo Gisondi, Dafna D Gladman, Lone Skov, Lotus Mallbris
OBJECTIVES: To examine the incidence and temporal trends of psoriatic arthritis (PsA) in the general population in Denmark. METHODS: Using nationwide registry data, we estimated the number of patients with incident PsA within each 1-year period between 1997 and 2011 and calculated the rate of PsA cases within gender and age subgroups. Incidence rates were presented per 100 000 person-years. RESULTS: There was a female predominance ranging from 50...
May 8, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28481462/biologics-or-tofacitinib-for-people-with-rheumatoid-arthritis-naive-to-methotrexate-a-systematic-review-and-network-meta-analysis
#14
REVIEW
Jasvinder A Singh, Alomgir Hossain, Amy S Mudano, Elizabeth Tanjong Ghogomu, Maria E Suarez-Almazor, Rachelle Buchbinder, Lara J Maxwell, Peter Tugwell, George A Wells
BACKGROUND: Biologic disease-modifying anti-rheumatic drugs (biologics) are highly effective in treating rheumatoid arthritis (RA), however there are few head-to-head biologic comparison studies. We performed a systematic review, a standard meta-analysis and a network meta-analysis (NMA) to update the 2009 Cochrane Overview. This review is focused on the adults with RA who are naive to methotrexate (MTX) that is, receiving their first disease-modifying agent. OBJECTIVES: To compare the benefits and harms of biologics (abatacept, adalimumab, anakinra, certolizumab pegol, etanercept, golimumab, infliximab, rituximab, tocilizumab) and small molecule tofacitinib versus comparator (methotrexate (MTX)/other DMARDs) in people with RA who are naive to methotrexate...
May 8, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28452862/anti-tnf-treatment-for-extraintestinal-manifestations-of-inflammatory-bowel-disease-in-the-swiss-ibd-cohort-study
#15
Stephan R Vavricka, Martin Gubler, Claudine Gantenbein, Muriel Spoerri, Florian Froehlich, Frank Seibold, Marijana Protic, Pierre Michetti, Alex Straumann, Nicolas Fournier, Pascal Juillerat, Luc Biedermann, Jonas Zeitz, Benjamin Misselwitz, Michael Scharl, Henriette Heinrich, Christine N Manser, Ekaterina Safroneeva, Raja Affendi Raja Ali, Gerhard Rogler, Alain M Schoepfer, Thomas Greuter
BACKGROUND: Extraintestinal manifestations (EIMs) in patients with inflammatory bowel disease (IBD) are frequently observed. Little is known about the efficacy of anti-tumor necrosis factor (TNF) in EIM management. We assessed the effect of 3 anti-TNF agents (infliximab, adalimumab, and certolizumab pegol) on EIM evolution. METHODS: Data on 1249 patients from the Swiss IBD Cohort Study (SIBDCS) were analyzed. All EIMs were diagnosed by relevant specialists. Response was classified into improvement, stable disease, and clinical worsening based on the physician's interpretation...
July 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28410817/medication-adherence-and-persistence-over-time-with-self-administered-tnf-alpha-inhibitors-among-young-adult-middle-aged-and-older-patients-with-rheumatologic-conditions
#16
Gregory S Calip, Sruthi Adimadhyam, Shan Xing, Julian C Rincon, Wan-Ju Lee, Rebekah H Anguiano
OBJECTIVE: Self-injectable TNF inhibitors are increasingly used early in the chronic treatment of moderate to severe rheumatologic conditions. We estimated medication adherence/persistence over time following initiation in young adult and older adult patients with rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis. METHODS: We conducted a retrospective cohort study of patients aged 18+ years newly initiating etanercept, adalimumab, certolizumab pegol, or golimumab using the Truven Health MarketScan Database between 2009 and 2013...
March 21, 2017: Seminars in Arthritis and Rheumatism
https://www.readbyqxmd.com/read/28410341/effects-of-transient-and-persistent-anti-drug-antibodies-to-certolizumab-pegol-longitudinal-data-from-a-7-year-study-in-crohn-s-disease
#17
William J Sandborn, Douglas C Wolf, Gordana Kosutic, Gerry Parker, Stefan Schreiber, Scott D Lee, Bincy Abraham, Anita Afzali, Razvan I Arsenescu, Alexandra Gutierrez, Marshall Spearman, Jason Coarse, Brian G Feagan
BACKGROUND: Anti-drug antibodies (ADAbs) may decrease the efficacy of biologics and increase the risk of adverse events. A single positive test may not preclude further treatment because of variations in assays used, test timing, and patient variables. We evaluated the longitudinal patterns of immunogenicity during 7 years of antitumor necrosis factor-alpha drug certolizumab pegol (CZP) treatment for moderate-to-severe Crohn's disease. METHODS: PRECiSE 3 patients (n = 595) received open-label CZP 400 mg every 4 weeks up to 7 years...
July 2017: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/28405087/leukocytoclastic-vasculitis-drug-reaction-to-certolizumab-pegol
#18
Meghan Woody, Donald Warren, Laura Speck, Julie Jackson
Tumor necrosis factor (TNF)-alpha antagonists are a common treatment modality for autoimmune disorders, but their use can be associated with many side effects, including various dermatologic conditions. Certolizumab pegol, a newer TNF antagonist that lacks the Fc portion of the IgG antibody, has recently been approved to treat psoriatic arthritis, rheumatoid arthritis, and Crohn's disease. Though other TNF antagonists have been associated with leukocytoclastic vasculitis, this finding has not yet been reported with certolizumab pegol...
April 2017: Proceedings of the Baylor University Medical Center
https://www.readbyqxmd.com/read/28376912/head-to-head-comparison-of-aggressive-conventional-therapy-and-three-biological-treatments-and-comparison-of-two-de-escalation-strategies-in-patients-who-respond-to-treatment-study-protocol-for-a-multicenter-randomized-open-label-blinded-assessor-phase-4-study
#19
Daniel Glinatsi, Marte S Heiberg, Anna Rudin, Dan Nordström, Espen A Haavardsholm, Bjorn Gudbjornsson, Mikkel Østergaard, Till Uhlig, Gerdur Grondal, Kim Hørslev-Petersen, Ronald van Vollenhoven, Merete L Hetland
BACKGROUND: New targeted therapies and improved treatment strategies have dramatically improved the outcomes of patients with rheumatoid arthritis (RA). However, it is unknown whether different early aggressive interventions can induce stable remission or a low-active disease state that can be maintained with conventional synthetic disease-modifying antirheumatic drug (csDMARD) therapy, and whether they differ in efficacy and safety. The Nordic Rheumatic Diseases Strategy Trials And Registries (NORD-STAR) study will assess and compare (1) the proportion of patients who achieve remission in a head-to-head comparison between csDMARD plus glucocorticoid therapy and three different biological DMARD (bDMARD) therapies with different modes of action and (2) two de-escalation strategies in patients who respond to first-line therapy...
April 4, 2017: Trials
https://www.readbyqxmd.com/read/28353191/long-term-maintenance-of-certolizumab-pegol-safety-and-efficacy-in-combination-with-methotrexate-and-as-monotherapy-in-rheumatoid-arthritis-patients
#20
Roy Fleischmann, Ronald F van Vollenhoven, Jiri Vencovský, Rieke Alten, Owen Davies, Irina Mountian, Marc de Longueville, David Carter, Ernest Choy
INTRODUCTION: The safety and efficacy of certolizumab pegol (CZP) 400 mg every 4 weeks (Q4W) monotherapy (FAST4WARD/NCT00548834) and in combination with methotrexate (MTX) (014/NCT00544154) in active rheumatoid arthritis (RA) has been published previously. This report outlines final long-term outcomes from the open-label extension (OLE) study (015/NCT00160693), which enrolled patients from these randomized controlled trials (RCTs). METHODS: Patients who withdrew from or completed the 24-week 014/FAST4WARD RCTs were enrolled and received CZP 400 mg Q4W with/without MTX...
June 2017: Rheumatology and Therapy
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