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Certolizumab pegol

Kosuke Ebina, Motomu Hashimoto, Wataru Yamamoto, Akira Ohnishi, Daijiro Kabata, Toru Hirano, Ryota Hara, Masaki Katayama, Shuzo Yoshida, Koji Nagai, Yonsu Son, Hideki Amuro, Kengo Akashi, Takanori Fujimura, Makoto Hirao, Keiichi Yamamoto, Ayumi Shintani, Atsushi Kumanogoh, Hideki Yoshikawa
The purpose of this study was to evaluate the retention and discontinuation reasons of seven biological disease-modifying antirheumatic drugs (bDMARDs) in a real-world setting of patients with rheumatoid arthritis (RA). 1,037 treatment courses with bDMARDs from 2009 to 2016 [female, 81.8%; baseline age, 59.6 y; disease duration 7.8 y; rheumatoid factor positivity 81.5%; Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR), 4.4; concomitant prednisolone 43.5% and methotrexate 68...
2018: PloS One
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
Shijie Ren, Iñigo Bermejo, Emma Simpson, Ruth Wong, David L Scott, Adam Young, Matt Stevenson
As part of its single technology appraisal process, the National Institute for Health and Care Excellence invited the manufacturer (Eli Lilly) of baricitinib (BARI; Olumiant® ; a Janus kinase inhibitor that is taken orally) to submit evidence of its clinical and cost effectiveness for the treatment of moderate to severe rheumatoid arthritis (RA) after the failure of disease-modifying antirheumatic drugs (DMARDs). 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)...
March 3, 2018: PharmacoEconomics
J W Baddley, F Cantini, D Goletti, J J Gómez-Reino, E Mylonakis, R San-Juan, M Fernández-Ruiz, J Torre-Cisneros
BACKGROUND: The present review is part of the ESCMID Study Group for Infections in Compromised Hosts (ESGICH) Consensus Document on the safety of targeted and biological therapies. AIMS: To review, from an Infectious Diseases perspective, the safety profile of agents targeting tumour necrosis factor-α (TNF-α) and to suggest preventive recommendations. SOURCES: Computer-based MEDLINE searches with MeSH terms pertaining to each agent or therapeutic family...
February 6, 2018: Clinical Microbiology and Infection
Thomas Reygaerts, Stéphane Mitrovic, Bruno Fautrel, Laure Gossec
OBJECTIVES: Fatigue is a significant issue in psoriatic arthritis. The objective was to assess the effect of biological disease modifying antirheumatic drugs and apremilast on fatigue in psoriatic arthritis randomised controlled trials and to compare this effect with the effect in the same trials, on pain, through a systematic literature review and meta-analysis. METHODS: A systematic literature review was performed up to January 2017 in PubMed, Embase and Cochrane databases...
February 13, 2018: Joint, Bone, Spine: Revue du Rhumatisme
A Campanati, E Molinelli, G Ganzetti, V Brisigotti, A Offidani
BACKGROUND: Psoriasis is a chronic immune-mediated inflammatory disorder, with an estimated global prevalence of 2-3%. Psoriasis is associated with an impaired health-related quality of life and a substantial economic burden. Biologics, which target the pathways involved in the pathogenesis of psoriasis, represent an established therapeutic approach for moderate-to-severe plaque psoriasis, with remarkable efficacy and safety profile extensively examined and monitored. METHODS: Biological therapies currently available can be divided into three main categories: the TNFα antagonists (infliximab, adalimumab, etanercept, golimumab, certolizumab pegol), the interleukin (IL)-12/23 monoclonal antibody (ustekinumab), and IL-17 inhibitor (secukinumab, ixekizumab)...
February 9, 2018: Current Pharmaceutical Biotechnology
Sarah Onuora
No abstract text is available yet for this article.
March 2018: Nature Reviews. Rheumatology
N D Vlieland, M R Nejadnik, H Gardarsdottir, S Romeijn, A S Sediq, M L Bouvy, A C G Egberts, B J F van den Bemt, W Jiskoot
PURPOSE: To measure aggregate and particle formation in tumor necrosis factor-alpha (TNF-α) inhibitors etanercept, adalimumab and certolizumab pegol product samples after exposure to freezing temperature conditions similar to storage conditions previously observed in patients' homes. METHODS: TNF-α inhibitors in their original primary and secondary packaging were exposed to 32 freeze-thaw cycles (-10°C for 120min/5°C for 60 min) or continuous low storage temperature (-20°C for 96 h) before thawing at 2-8°C...
February 5, 2018: Pharmaceutical Research
Byung Hoon Ban, Jayne Littlejohn Crowe
No abstract text is available yet for this article.
January 30, 2018: Journal of Clinical Rheumatology: Practical Reports on Rheumatic & Musculoskeletal Diseases
Séverine Vermeire, Ann Gils, Paola Accossato, Sadiq Lula, Amy Marren
Crohn's disease and ulcerative colitis are chronic inflammatory disorders of the gastrointestinal tract. Treatment options include biologic therapies; however, a proportion of patients lose response to biologics, partly due to the formation of anti-drug antibodies (ADAbs). Concomitant immunosuppressive agents reduce the development of ADAbs. This review article aims to assess the immunogenicity of biologic therapies and their clinical implications. A comprehensive literature search was conducted for articles published January 2009 to August 2015 reporting immunogenicity to adalimumab (ADM), certolizumab pegol (CZP), golimumab, infliximab (IFX), ustekinumab, and vedolizumab in inflammatory bowel disease (IBD)...
2018: Therapeutic Advances in Gastroenterology
Désirée van der Heijde, Xenofon Baraliakos, Kay-Geert A Hermann, Robert B M Landewé, Pedro M Machado, Walter P Maksymowych, Owen R Davies, Natasha de Peyrecave, Bengt Hoepken, Lars Bauer, Tommi Nurminen, Juergen Braun
OBJECTIVES: To report 4-year imaging outcomes in the RAPID-axSpA (NCT01087762) study of patients with ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA), treated with certolizumab pegol (CZP). METHODS: This phase III, randomised trial was placebo-controlled and double-blind to week 24, dose-blind to week 48 and open-label to week 204. Patients fulfilling the Assessment of Spondyloarthritis International Society (ASAS) axSpA criteria with active disease were stratified (AS/nr-axSpA) according to the modified New York (mNY) criteria at randomisation...
January 17, 2018: Annals of the Rheumatic Diseases
Runsheng Wang, Abhijit Dasgupta, Michael M Ward
OBJECTIVE: To compare the efficacy of 6 tumor necrosis factor-α inhibitors (TNFi) in treatment of ankylosing spondylitis (AS) at 12 weeks and 24 weeks. METHODS: We performed a systematic literature review of randomized controlled trials of TNFi in patients with active AS. We included trials that reported efficacy at 10 to 14 weeks (12-week analysis) and at 24 to 30 weeks (24-week analysis). We used Bayesian network metaanalysis (NMA) to compare their relative efficacy to improve the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI), Bath Ankylosing Spondylitis Functional Index (BASFI), and C-reactive protein (CRP) level...
January 15, 2018: Journal of Rheumatology
Leslie R Harrold, Heather J Litman, Katherine C Saunders, Kimberly J Dandreo, Bernice Gershenson, Jeffrey D Greenberg, Robert Low, Jeffrey Stark, Robert Suruki, Srihari Jaganathan, Joel M Kremer, Mohamed Yassine
BACKGROUND: Registry studies provide a valuable source of comparative safety data for tumor necrosis factor inhibitors (TNFi) used in rheumatoid arthritis (RA), but they are subject to channeling bias. Comparing safety outcomes without accounting for channeling bias can lead to inaccurate comparisons between TNFi prescribed at different stages of the disease. In the present study, we examined the incidence of serious infection and other adverse events during certolizumab pegol (CZP) use vs other TNFi in a U...
January 2, 2018: Arthritis Research & Therapy
Margaret Coutts, Rowena Soriano, Rajendran Naidoo, Habib Torfi
Clinical and laboratory results document psoriatic arthritis in a 56-year old patient. The symptoms did not resolve with standard treatments (nonsteroidal anti-inflammatory drugs, steroids and methotrexate). TNF-alpha inhibitors (certolizumab pegol and adalimumab) were added to the treatment regime, with some adverse effects. A trial of human umbilical cord stem cell therapy was then initiated. The stem cells were enriched and concentrated from whole cord blood, by removal of erythrocytes and centrifugation...
December 26, 2017: World Journal of Stem Cells
Young Mo Kang, Young-Eun Park, Won Park, Jung-Yoon Choe, Chul-Soo Cho, Seung-Cheol Shim, Sang Cheol Bae, Chang-Hee Suh, Hoon-Suk Cha, Eun Mi Koh, Yeong-Wook Song, Bin Yoo, Shin-Seok Lee, Min-Chan Park, Sang-Heon Lee, Catherine Arendt, Willem Koetse, Soo-Kon Lee
Background/Aims: The objective of this study was to determine the efficacy and safety of add-on therapy with certolizumab pegol (CZP) in active rheumatoid arthritis (RA) patients of a single ethnicity. Methods: In this 24-week, phase 3, randomized, double-blind, placebo-controlled trial, eligible patients (n = 127) were randomized 2:1 to subcutaneous CZP + methotrexate (MTX; 400 mg at week 0, 2, and 4 followed by 200 mg every 2 weeks) or placebo + MTX. Results: At week 24, the American College of Rheumatology criteria for 20% (ACR20) response rate was significantly greater with CZP + MTX than with placebo (66...
January 5, 2018: Korean Journal of Internal Medicine
Michele Maria Luchetti, Devis Benfaremo, Armando Gabrielli
BACKGROUND: Biologic drugs, introduced in clinical practice almost twenty years ago, represent nowadays a prominent treatment option in patients with chronic inflammatory arthritis, such as Rheumatoid Arthritis, Psoriatic Arthritis and Spondyloarthritis, that include ankylosing spondylitis and non-radiographic axial spondyloarthritis. METHODS: Several compounds targeting different pathways have been marketed and approved for the treatment of inflammatory arthritis, with a significant impact on the clinical outcomes and the natural history of the diseases...
December 26, 2017: Current Pharmaceutical Biotechnology
Jeffrey R Curtis, Kevin Winthrop, Cathy O'Brien, Matladi N Ndlovu, Marc de Longueville, Boulos Haraoui
BACKGROUND: The risk of serious infectious events (SIEs) is increased in patients with rheumatoid arthritis (RA). The aim of this study was to develop an age-adjusted comorbidity index (AACI) to predict, using baseline characteristics, the SIE risk in patients with RA treated with certolizumab pegol (CZP). METHODS: Data of CZP-treated patients with RA were pooled from the RAPID1/RAPID2 randomized controlled trials (RCT CZP) and their open-label extensions (All CZP)...
December 15, 2017: Arthritis Research & Therapy
Karina Lazarewicz, Steven Shaw, Sahena Haque
No abstract text is available yet for this article.
December 12, 2017: Journal of Clinical Rheumatology: Practical Reports on Rheumatic & Musculoskeletal Diseases
Barbara Domańska, Oliver Stumpp, Steven Poon, Serkan Oray, Irina Mountian, Clovis Pichon
INTRODUCTION: We incorporated patient feedback from human factors studies (HFS) in the patient-centric design and validation of ava® , an electromechanical device (e-Device) for self-injecting the anti-tumor necrosis factor certolizumab pegol (CZP). METHODS: Healthcare professionals, caregivers, healthy volunteers, and patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, or Crohn's disease participated in 11 formative HFS to optimize the e-Device design through intended user feedback; nine studies involved simulated injections...
January 2018: Advances in Therapy
Annunziata Dattola, Maria Vittoria Cannizzaro, Mauro Mazzeo, Luca Bianchi
In the original publication, part Fig. 3b and c were interchanged. The correct versions are given below.
March 2018: Dermatology and Therapy
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