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https://www.readbyqxmd.com/read/28884785/certolizumab-pegol-cdp870-for-rheumatoid-arthritis-in-adults
#1
REVIEW
Vicente Ruiz Garcia, Amanda Burls, Juan B Cabello, Paloma Vela Casasempere, Sylvia Bort-Marti, José A Bernal
BACKGROUND: Tumour necrosis factor (TNF)-alpha inhibitors are beneficial for the treatment of rheumatoid arthritis (RA) for reducing the risk of joint damage, improving physical function and improving the quality of life. This review is an update of the 2014 Cochrane Review of the treatment of RA with certolizumab pegol. OBJECTIVES: To assess the clinical benefits and harms of certolizumab pegol (CZP) in people with RA who have not responded well to conventional disease-modifying anti-rheumatic drugs (DMARDs)...
September 8, 2017: Cochrane Database of Systematic Reviews
https://www.readbyqxmd.com/read/28877634/certolizumab-an-anti-tnf-safe-during-pregancy-the-crib-study-results-an-interview-with-professor-xavier-mariette
#2
Xavier Mariette
Professor Xavier Mariette, MD, PhD, has served as the Head of the Rheumatology Department of Bicêtre Hospital, Paris-Sud University since 1999, a role he took following 10 years of practice of clinical immunology. Professor Mariette has initiated a number of clinical research studies on biotherapies in autoimmune diseases. He is the head of the French RATIO (Research Axed on Tolerance of Biotherapy) observatory, collecting specific rare serious adverse events in patients treated with anti-TNF. He initiated the French AIR (Autoimmunity and Rituximab) and ORA (Orencia and Rheumatoid arthritis) registries of patients with autoimmune diseases treated with rituximab and abatacept...
September 2017: Immunotherapy
https://www.readbyqxmd.com/read/28870657/use-of-biologic-therapy-by-pregnant-women-with-inflammatory-bowel-disease-does-not-affect-infant-response-to-vaccines
#3
Dawn B Beaulieu, Ashwin N Ananthakrishnan, Christopher Martin, Russell D Cohen, Sunanda V Kane, Uma Mahadevan
BACKGROUND & AIMS: In women with inflammatory bowel diseases (IBD), exposure to immunomodulator or biologic therapy has not been associated with adverse events during pregnancy or outcomes of newborns. We investigated whether exposure of patients to these agents during pregnancy affects serologic responses to vaccines in newborns. METHODS: We collected data from the Pregnancy in IBD and Neonatal Outcomes registry, which records outcomes of pregnant women with diagnosis of IBD receiving care at multiple centers in the United States, from 2007 - 2016...
September 1, 2017: Clinical Gastroenterology and Hepatology
https://www.readbyqxmd.com/read/28852832/down-titration-of-biologics-for-the-treatment-of-rheumatoid-arthritis-a-systematic-literature-review
#4
Chak Sing Lau, Allan Gibofsky, Nemanja Damjanov, Sadiq Lula, Lisa Marshall, Heather Jones, Paul Emery
Biologic therapies have improved the management of rheumatoid arthritis (RA) and the treat-to-target approach has resulted in many patients achieving remission. In the current treatment landscape, clinicians have begun considering dose reduction/tapering for their patients. Rheumatology guidelines in Asia, Europe, and the United States include down-titration of biologics but admit that the level of evidence is moderate. We conducted a systematic literature review to assess the published studies that evaluate down-titration of biologics in RA...
August 29, 2017: Rheumatology International
https://www.readbyqxmd.com/read/28839870/use-of-anti-tnf-drug-levels-to-optimise-patient-management
#5
REVIEW
Konstantinos Papamichael, Adam S Cheifetz
Anti-tumour necrosis factor (TNF) therapies, such as infliximab, adalimumab, certolizumab pegol and golimumab, have been proven to be effective for the treatment of patients with Crohn's disease and ulcerative colitis. However, 10%-30% of patients with inflammatory bowel disease (IBD) show no initial clinical benefit to anti-TNF therapy (primary non-response), and over 50% after an initial favourable outcome will lose response over time (secondary loss of response (SLR)). Numerous recent studies in IBD have revealed an exposure-response relationship suggesting a positive correlation between high serum anti-TNF concentrations and favourable therapeutic outcomes including clinical, biomarker and endoscopic remission, whereas antidrug antibodies have been associated with SLR and infusion reactions...
October 2016: Frontline Gastroenterology
https://www.readbyqxmd.com/read/28838285/a-review-on-golimumab-in-the-treatment-of-psoriatic-arthritis
#6
Maria Urdaneta, Hannah Jethwa, Reshma Sultan, Sonya Abraham
Psoriatic arthritis (PsA) causes inflammation in and around the joints and usually affects people who already have psoriasis. However, some patients develop the joint problems before the psoriasis. Currently, there are five anti-TNF-α agents licensed for use in patients with PsA: adalimumab, certolizumab pegol, etanercept, golimumab and infliximab. Golimumab, a human monoclonal antibody, has been approved by the US FDA for the treatment of PsA and is targeted against the pro-inflammatory molecule TNF-α. The Phase III GO-REVEAL study confirmed this drug was well tolerated and showed significant improvement in disease activity compared with placebo...
August 25, 2017: Immunotherapy
https://www.readbyqxmd.com/read/28837372/update-upon-efficacy-and-safety-of-etanercept-for-the-treatment-of-spondyloarthritis-and-juvenile-idiopathic-arthritis
#7
Giuseppe Murdaca, Simone Negrini, Ottavia Magnani, Elena Penza, Marco Pellecchio, Rossella Gulli, Paola Mandich, Francesco Puppo
TNF-α inhibitors have demonstrated efficacy both as monotherapy and in combination with disease-modifying anti-rheumatic drugs (DMARDs) in the treatment of chronic inflammatory immune-mediated diseases such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis (AS), psoriasis (Ps) and/or psoriatic arthritis (PsA) and may be administered off-label to treat disseminated granuloma annulare, systemic lupus erythematosus and systemic sclerosis. There are several TNF-α inhibitors available for clinical use including infliximab, adalimumab, golimumab, certolizumab pegol and etanercept...
August 24, 2017: Modern Rheumatology
https://www.readbyqxmd.com/read/28826742/a-comprehensive-review-and-update-on-crohn-s-disease
#8
Mahesh Gajendran, Priyadarshini Loganathan, Anthony P Catinella, Jana G Hashash
The term inflammatory bowel disease (IBD) refers principally to two major categories of chronic relapsing inflammatory intestinal disorders: Crohn's disease (CD) and ulcerative colitis (UC). In the United States, it is currently estimated that about 1.5 million people suffer from IBD, causing considerable suffering, mortality and economic loss every year. Yet the cause of IBD is unknown, and until we understand more, prevention or cure will not be possible. There is a lot of variation in the incidence and prevalence of CD based on geographic region, environment, immigrant population, and ethnic groups...
August 18, 2017: Disease-a-month: DM
https://www.readbyqxmd.com/read/28818362/two-year-follow-up-of-crohn-s-patients-substituted-to-certolizumab-anti-tnfa-therapy-savant-2
#9
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...
August 9, 2017: Pathophysiology: the Official Journal of the International Society for Pathophysiology
https://www.readbyqxmd.com/read/28814432/minimal-to-no-transfer-of-certolizumab-pegol-into-breast-milk-results-from-cradle-a-prospective-postmarketing-multicentre-pharmacokinetic-study
#10
Megan Eb Clowse, Frauke Förger, Caroline Hwang, John Thorp, Radboud Jem Dolhain, Astrid van Tubergen, Laura Shaughnessy, Jeff Simpson, Marie Teil, Nathalie Toublanc, Maggie Wang, Thomas W Hale
BACKGROUND: Women with chronic inflammatory diseases face uncertainty regarding the safety of biologics during breast feeding. CRADLE was the first industry-sponsored study to evaluate certolizumab pegol (CZP) concentrations in human breast milk and estimate average daily infant dose (ADID) of maternal CZP. METHODS: CRADLE (NCT02154425) was a pharmacokinetic study of lactating mothers receiving CZP. After ≥3 CZP doses, breast milk samples were collected across one dosing period (14 days for 200 mg every 2 weeks [Q2W]; 28 days for 400 mg every 4 weeks [Q4W])...
August 16, 2017: Annals of the Rheumatic Diseases
https://www.readbyqxmd.com/read/28805137/differential-influences-of-fc-gamma-receptor-blocking-on-the-effects-of-certolizumab-pegol-and-infliximab-on-human-monocytes
#11
Takayuki Hoshiyama, Yu Matsueda, Toshihiro Tono, Yoshiyuki Arinuma, Tatsuo Nagai, Shunsei Hirohata
OBJECTIVES: To compare the effects of certolizumab pegol (CZP) and infliximab (IFX) on human monocytes. METHODS: Highly purified monocytes from healthy donors were cultured with CZP, IFX, control IgG1, or polyethylene glycol (PEG) at pharmacological attainable concentrations in culture medium with 10% autologous normal human serum (NHS) or with fetal bovine serum (FBS) for 24 h, after which the supernatants were replaced by fresh culture medium containing LPS...
August 14, 2017: Modern Rheumatology
https://www.readbyqxmd.com/read/28747607/safety-and-effectiveness-of-certolizumab-pegol-in-patients-with-rheumatoid-arthritis-interim-analysis-of-post-marketing-surveillance
#12
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/28737992/temporal-trends-in-use-of-biologic-dmards-for-rheumatoid-arthritis-in-the-united-states-a-cohort-study-of-publicly-and-privately-insured-patients
#13
Rishi J Desai, Daniel H Solomon, Yinzhu Jin, Jun Liu, Seoyoung C Kim
BACKGROUND: Ten biologic disease-modifying antirheumatic drugs (bDMARDs) are available as treatment for rheumatoid arthritis (RA), but relatively little is known about population-level time trends in the use of these agents. OBJECTIVE: To describe time trends in the use of bDMARDs in RA patients with private or public insurance in the United States. METHODS: Claims data from private (Optum Clinformatics, 2004-2015) and public (Medicaid Analytic eXtract [MAX], 2000-2010) insurance programs were used...
August 2017: Journal of Managed Care & Specialty Pharmacy
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
#14
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...
August 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
#15
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
#16
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
#17
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
#18
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...
August 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
#19
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-iii-study-evaluating-continuation-tapering-and-withdrawal-of-certolizumab-pegol-after-one-year-of-therapy-in-patients-with-early-rheumatoid-arthritis
#20
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 VanLunen, Cécile Ecoffet, Christopher Cioffi, Paul Emery
OBJECTIVE: In disease-modifying antirheumatic drug-naive patients with early rheumatoid arthritis (RA) who had achieved sustained low disease activity (a Disease Activity Score in 28 joints using the erythrocyte sedimentation rate of ≤3.2 at both week 40 and week 52) after 1 year of treatment with certolizumab pegol (CZP) at a standard dose (200 mg every 2 weeks plus optimized methotrexate [MTX]), we evaluated whether continuation of CZP treatment at a standard dose or at a reduced frequency (200 mg every 4 weeks plus MTX) was superior to stopping CZP (placebo plus MTX) in maintaining low disease activity for 1 additional year...
June 30, 2017: Arthritis & Rheumatology
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