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Certolizumab pegol

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https://www.readbyqxmd.com/read/29765257/spotlight-on-certolizumab-pegol-in-the-treatment-of-axial-spondyloarthritis-efficacy-safety-and-place-in-therapy
#1
REVIEW
Josefina Marin, María Laura Acosta Felquer, Enrique R Soriano
Certolizumab pegol (CZP) is a pegylated humanized tumor necrosis factor-α inhibitor (TNFi) approved for the treatment of ankylosing spondylitis (AS) in the USA and for AS and non-radiographic axial spondyloarthritis (nr-axSpA) in Europe and in some Latin American countries. CZP lacks Fc region, preventing complement fixation and cytotoxicity mediated by antibody; CZP does not actively cross the placenta, unlike other TNFi. RAPID-axSpA study is a Phase III trial conducted in patients with AS and nr-axSpA as double blind and placebo controlled to week 24, dose blind to week 48 and open label to week 204...
2018: Open Access Rheumatology: Research and Reviews
https://www.readbyqxmd.com/read/29731461/-diagnosis-and-treatment-of-rheumatoid-arthritis-toward-the-best-practice-the-best-practice-for-tnf-inhibitors
#2
Hideto Kameda
As of February 2018, 5 originator TNF inhibitors(infliximab, etanercept, adalimumab, golimumab and certolizumab pegol)and biosimilar agents of infliximab and etanercept are available for rheumatoid arthritis(RA)in Japan. The effectiveness of TNF inhibitors considerably improves with concomitant methotrexate regardless of their immunogenicity. The Japan College of Rheumatology guideline for TNF inhibitor use in RA has been updated in March 2017 according to recent evidences. During the remission induction phase, maintenance of drug trough level above effective blood concentration is paramount, while the tapering and withdrawal of TNF inhibitors may be considered after achieving sustained remission...
2018: Clinical Calcium
https://www.readbyqxmd.com/read/29718223/outcomes-of-treatment-for-latent-tuberculosis-infection-in-patients-with-inflammatory-bowel-disease-receiving-biologic-therapy
#3
Guilherme P Ramos, Gregory Stroh, Badr Al-Bawardy, William A Faubion, Konstantinos A Papadakis, Patricio Escalante
Background: Treatment for latent tuberculosis infection (LTBI) is of particular concern in patients with inflammatory bowel disease (IBD) initiating biologic therapies to prevent tuberculosis (TB) reactivation. This study aimed to evaluate the effectiveness of LTBI treatment in IBD patients receiving biologic therapy. Methods: There was a retrospective review of all IBD patients diagnosed with LTBI following a tuberculin skin test (TST) and/or interferon gamma release assay (IGRA) and who received biologic therapy between 2002 and 2016...
April 26, 2018: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/29718027/emerging-therapies-in-psoriasis-a-systematic-review
#4
Erica B Lee, Mina Amin, Tina Bhutani, Jashin J Wu
Many new biologics are being studied for use in psoriasis. In this review, we evaluate and summarize findings about emerging biologic therapies for psoriasis. We reviewed published data from phase 2 and 3 clinical trials of 2 IL-17 inhibitors (ixekizumab and brodalumab); 3 IL-23 inhibitors (guselkumab, tildrakizumab, and risankizumab); and 1 tumor necrosis factor (TNF) inhibitor (certolizumab pegol). Janus kinase inhibitors were not included in our review, as they currently are not approved by the US Food and Drug Administration (FDA) and there are no plans to further develop this class for treatment of psoriasis...
March 2018: Cutis; Cutaneous Medicine for the Practitioner
https://www.readbyqxmd.com/read/29717037/the-effect-of-biologic-and-targeted-synthetic-drugs-on-work-and-productivity-related-outcomes-for-patients-with-psoriatic-arthritis-a-systematic-review
#5
Nicolas Iragorri, Mark Hofmeister, Eldon Spackman, Glen S Hazlewood
OBJECTIVE: To systematically review the effects of biologic therapies for psoriatic arthritis [secukinumab, ustekinumab, adalimumab, etanercept, certolizumab pegol (CZP), apremilast, golimumab (GOL), or infliximab (IFX)] on work productivity. METHODS: A systematic review of Medline, EMBASE, CENTRAL, and ClinicalTrials.gov was conducted to identify randomized controlled trials reporting on work productivity outcomes at the end of the placebo-controlled double-blind period...
May 1, 2018: Journal of Rheumatology
https://www.readbyqxmd.com/read/29717036/pga%C3%A3-bsa-a-measure-of-psoriasis-severity-tested-in-patients-with-active-psoriatic-arthritis-and-treated-with-certolizumab-pegol
#6
Jessica A Walsh, Terri Arledge, Tommi Nurminen, Luke Peterson, Jeffrey Stark
OBJECTIVE: The product of physician's global assessment and body surface area (PGA×BSA) to assess psoriasis severity has previously been investigated in patients with psoriasis, with the aim of assessing PGA×BSA as an alternative to the time-consuming Psoriasis Area and Severity Index (PASI). Here, we investigate PGA×BSA as an alternative to PASI in patients with psoriatic arthritis (PsA). METHODS: Analyses used data from the double-blind, placebo-controlled, RAPID-PsA trial (NCT01087788) that investigated the efficacy of certolizumab pegol (CZP) in patients with PsA...
May 1, 2018: Journal of Rheumatology
https://www.readbyqxmd.com/read/29687787/drug-induced-thrombotic-microangiopathy-with-certolizumab-pegol
#7
Mehmet Baysal, Elif Gülsüm Ümit, Fatih Sarıtaş, Nil Su Kodal, Ahmet Muzaffer Demir
BACKGROUND: Certolizumab pegol is used to treat ankylosing spondylitis (AS), chron disease, psoriatic arthritis and rheumatoid arthritis. In contrast to other monoclonal antibodies such as infliximab and adalimumab, certolizumab does not contain an Fc fraction and hence, does not induce complement activation. In this case, we are presenting a case with thrombotic microangiopathy (TMA) due to certolizumab pegol, with a touch of pathophysiological approach to TMA. CASE REPORT: A-39-year-old man with AS of ten years presented with fatigue...
April 24, 2018: Balkan Medical Journal
https://www.readbyqxmd.com/read/29682324/certolizumab-pegol-in-a-heterogeneous-population-of-patients-with-moderate-to-severe-rheumatoid-arthritis
#8
Enrique R Soriano, Analia Dellepiane, Gabriela Salvatierra, Cristian Alejandro Benítez, Rodrigo Garcia Salinas, Carlos Baruzzo
Aim: To determine the efficacy and safety of certolizumab pegol for the treatment of rheumatoid arthritis in a real-world setting. Materials & methods: Patients with moderate-to-severe rheumatoid arthritis who initiated therapy with certolizumab were followed for 12 weeks. Response was assessed with Disease Activity Score of 28 joints, European Ligue Against Rheumatism criteria and Simplified Disease Activity Index. Predictors of response were analyzed with binary logistic regression models...
April 2018: Future Science OA
https://www.readbyqxmd.com/read/29670761/improvements-in-workplace-and-household-productivity-with-certolizumab-pegol-treatment-in-axial-spondyloarthritis-results-to-week-96-of-a-phase-iii-study
#9
Désirée van der Heijde, Jürgen Braun, Martin Rudwaleit, Oana Purcaru, Arthur F Kavanaugh
Objectives: To evaluate the effect of certolizumab pegol (CZP) on work and household productivity, and on participation in family, social and leisure activities in patients with axial spondyloarthritis (axSpA), including ankylosing spondylitis (AS) and non-radiographic (nr-) axSpA. Methods: RAPID-axSpA (NCT01087762) was a phase III, double-blind, placebo-controlled trial to week (Wk) 24, dose-blind to Wk48 and open-label to Wk204. A total of 325 patients were randomised 1:1:1 to placebo, CZP 200 mg Q2W or CZP 400 mg Q4W...
2018: RMD Open
https://www.readbyqxmd.com/read/29670468/analysis-of-drug-effects-on-primary-human-coronary-artery-endothelial-cells-activated-by-serum-amyloid-a
#10
K Lakota, D Hrušovar, M Ogrič, K Mrak-Poljšak, S Čučnik, M Tomšič, B Božič, P Žigon, S Sodin-Semrl
Background: RA patients have a higher incidence of cardiovascular diseases compared to the general population. Serum amyloid A (SAA) is an acute-phase protein, upregulated in sera of RA patients. Aim: To determine the effects of medications on SAA-stimulated human coronary artery endothelial cells (HCAEC). Methods: HCAEC were preincubated for 2 h with medications from sterile ampules (dexamethasone, methotrexate, certolizumab pegol, and etanercept), dissolved in medium (captopril) or DMSO (etoricoxib, rosiglitazone, meloxicam, fluvastatin, and diclofenac)...
2018: Mediators of Inflammation
https://www.readbyqxmd.com/read/29668917/nonadherence-to-biologic-therapies-in-inflammatory-bowel-disease
#11
Brian J Wentworth, Ross C D Buerlein, Anne G Tuskey, M Ashley Overby, Mark E Smolkin, Brian W Behm
Background: Nonadherence to medications is common with patients with inflammatory bowel disease (IBD). The aim of this study was to assess adherence to biologic medications prescribed for IBD and to identify risk factors for biologic nonadherence. Methods: This was a single center retrospective cohort study investigating IBD patient adherence to biologic therapies over a 2-year period from September 2014 to September 2016. Specialty pharmacy and infusion center records were obtained and a modified medication possession ratio was calculated...
April 13, 2018: Inflammatory Bowel Diseases
https://www.readbyqxmd.com/read/29665045/high-body-mass-index-is-associated-with-increased-risk-of-treatment-failure-and-surgery-in-biologic-treated-patients-with-ulcerative-colitis
#12
S Kurnool, N H Nguyen, J Proudfoot, P S Dulai, B S Boland, N Vande Casteele, E Evans, E L Grunvald, A Zarrinpar, W J Sandborn, S Singh
BACKGROUND: Though pharmacokinetic studies suggest accelerated biologic drug clearance with increasing body weight, evidence of obesity's impact on clinical outcomes in biologic-treated patients with ulcerative colitis (UC) is inconsistent. AIMS: To evaluate the impact of obesity on real world response to biological therapy in patients with UC. METHODS: In a single-centre retrospective cohort study between 2011-2016 of biologic-treated patients with UC, we evaluated treatment response by baseline body mass index (BMI)...
April 17, 2018: Alimentary Pharmacology & Therapeutics
https://www.readbyqxmd.com/read/29660425/certolizumab-pegol-for-the-treatment-of-chronic-plaque-psoriasis-results-through-48-weeks-of-a-phase-3-multicenter-randomized-double-blinded-etanercept-and-placebo-controlled-study-cimpact
#13
Mark Lebwohl, Andrew Blauvelt, Carle Paul, Howard Sofen, Jolanta Węgłowska, Vincent Piguet, Daniel Burge, Robert Rolleri, Janice Drew, Luke Peterson, Matthias Augustin
BACKGROUND: Phase 2 psoriasis studies with the Fc-free, PEGylated, anti-tumor necrosis factor biologic certolizumab pegol demonstrated meaningful clinical activity. OBJECTIVE: Assess safety and efficacy of certolizumab in adults with moderate-to-severe chronic plaque psoriasis. METHODS: Patients were randomized 3:3:1:3 to certolizumab 400 mg, 200 mg, or placebo every 2 weeks for 16 weeks or etanercept 50 mg twice-weekly for 12 weeks. Certolizumab-treated patients achieving ≥75% reduction in psoriasis area and severity index at Week 16 were re-randomized to certolizumab or placebo for 32 weeks...
April 13, 2018: Journal of the American Academy of Dermatology
https://www.readbyqxmd.com/read/29660421/certolizumab-pegol-for-the-treatment-of-chronic-plaque-psoriasis-results-through-48-weeks-from-two-phase-3-multicenter-randomized-double-blinded-placebo-controlled-studies-cimpasi-1-and-cimpasi-2
#14
Alice B Gottlieb, Andrew Blauvelt, Diamant Thaçi, Craig L Leonardi, Yves Poulin, Janice Drew, Luke Peterson, Catherine Arendt, Daniel Burge, Kristian Reich
BACKGROUND: Certolizumab pegol, the only Fc-Free, PEGylated anti-tumor necrosis factor biologic, demonstrated clinically meaningful improvements and suggested a positive risk-benefit balance in phase 2 studies in adults with moderate-to-severe chronic plaque psoriasis. OBJECTIVE: Assess certolizumab efficacy and safety versus placebo in phase 3 studies. METHODS: Patients with moderate-to-severe chronic plaque psoriasis were randomized 2:2:1 to certolizumab 400 mg, 200 mg, or placebo every 2 weeks...
April 13, 2018: Journal of the American Academy of Dermatology
https://www.readbyqxmd.com/read/29660056/pyomyositis-an-unusual-cause-of-hip-pain-in-a-patient-on-certolizumab-pegol-and-leflunomide
#15
Surabhi Wig, Paul S McCabe, Smrita Swamy, Jawad Sultan, Sreekanth Vasireddy
No abstract text is available yet for this article.
April 6, 2018: Rheumatology
https://www.readbyqxmd.com/read/29623679/pregnancy-outcomes-after-exposure-to-certolizumab-pegol-updated-results-from-a-pharmacovigilance-safety-database
#16
Megan E B Clowse, Angela E Scheuerle, Christina Chambers, Anita Afzali, Alexa B Kimball, John J Cush, Maureen Cooney, Laura Shaughnessy, Mark Vanderkelen, Frauke Förger
BACKGROUND: Anti-tumor necrosis factor medications (anti-TNFs) are effective in controlling chronic inflammatory diseases, but information about their use and safety in pregnancy is limited. Consequently, anti-TNFs are often discontinued early in gestation. Certolizumab pegol (CZP), a PEGylated, Fc-free anti-TNF approved for treatment of rheumatic diseases and/or Crohn's disease, has minimal to no active placental transfer. This project provides information on pregnancy outcomes in women receiving CZP, especially those with early pregnancy exposure...
April 5, 2018: Arthritis & Rheumatology
https://www.readbyqxmd.com/read/29618720/anti-tnf-and-thiopurine-therapy-in-pregnant-ibd-patients-does-not-significantly-alter-a-panel-of-b-cell-and-t-cell-subsets-in-1-year-old-infants
#17
Michael G Kattah, Jeffrey M Milush, Trevor Burt, Robert P McCabe, Michael I Whang, Averil Ma, Uma Mahadevan
OBJECTIVES: Infants exposed to combination therapy with anti-tumor necrosis factor (anti-TNF) agents and thiopurines may exhibit increased infections at 1 year of age compared to unexposed infants. We hypothesized that this increased risk of infection is due to abnormal development of the newborn immune system. METHODS: We immunophenotyped B-cell and T-cell subsets using multiparameter flow cytometry in 1-year-old infants whose mothers were exposed to therapeutic agents for IBD...
April 3, 2018: Clinical and Translational Gastroenterology
https://www.readbyqxmd.com/read/29603214/tumor-necrosis-factor-alpha-inhibitors-and-risk-of-non-hodgkin-lymphoma-in-a-cohort-of-adults-with-rheumatologic-conditions
#18
Gregory S Calip, Pritesh R Patel, Sruthi Adimadhyam, Shan Xing, Zhaoju Wu, Karen Sweiss, Glen T Schumock, Todd A Lee, Brian C-H Chiu
Based on limited evidence, the U.S. Food and Drug Administration (FDA) issued a black box warning for the use of tumor necrosis factor-alpha inhibitors (TNFIs) and risk of non-Hodgkin lymphoma (NHL). Our objective was to determine the risk of NHL associated with TNFI use by duration and type of anti-TNF agent. We performed a nested case-control study within a retrospective cohort of adults with rheumatologic conditions from a U.S. commercial health insurance database between 2009 and 2015. Use of TNFIs (infliximab, adalimumab, etanercept, golimumab and certolizumab pegol) and conventional-synthetic disease-modifying antirheumatic drugs (csDMARDs) was identified, and conditional logistic regression models were used to estimate adjusted odds ratios (OR) and 95% confidence intervals (CI) for risk of NHL...
March 30, 2018: International Journal of Cancer. Journal International du Cancer
https://www.readbyqxmd.com/read/29600931/effects-of-biologic-disease-modifying-anti-rheumatic-drugs-on-the-radiographic-progression-of-rheumatoid-arthritis-a-systematic-literature-review
#19
REVIEW
Bernard Combe, Sadiq Lula, Caroline Boone, Patrick Durez
OBJECTIVES: To evaluate the effect of biologic disease-modifying anti-rheumatic drugs (bDMARDs) on radiographic progression in patients with rheumatoid arthritis (RA). METHODS: A systematic review of electronic databases and conference proceedings was conducted through January 2015, to identify randomised controlled trials (RCTs) and observational studies that assessed the impact of bDMARDs [± conventional synthetic DMARDs (csDMARDs), mainly methotrexate (MTX)], versus csDMARDs alone, on radiographic progression in patients with RA...
March 20, 2018: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/29595841/correction-4-year-results-from-the-rapid-psa-phase-3-randomised-placebo-controlled-trial-of-certolizumab-pegol-in-psoriatic-arthritis
#20
(no author information available yet)
[This corrects the article DOI: 10.1136/rmdopen-2017-000582.][This corrects the article DOI: 10.1136/rmdopen-2017-000582.].
2018: RMD Open
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