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https://www.readbyqxmd.com/read/28643478/critical-role-of-tnf-inhibition-in-combination-therapy-for-elderly-mice-with-atherosclerosis
#1
Kyung-Yeon Park, Tae-Hwe Heo
We have previously shown that the combination of pravastatin and sarpogrelate is synergistically beneficial for atherosclerosis. In this study, we investigated whether the pravastatin-sarpogrelate combination was sufficient for treatment in an old mouse model of atherosclerosis or if additional intervention would be needed to address the newly included aging factor and its complex pathophysiological impact on the atherosclerogenic state. We added an anti-TNF biologic to the combination treatment cocktail because of the known pathologic roles of TNF in the aging process...
June 23, 2017: Cardiovascular Therapeutics
https://www.readbyqxmd.com/read/28640088/safety-of-tumor-necrosis-factor-alpha-inhibitors-for-treatment-of-ankylosing-spondylitis-a-meta-analysis
#2
Zeren Ma, Xiaoping Liu, Xiaosheng Xu, Jie Jiang, Jian Zhou, Jia Wang, Dewang Chen, Song Luo
BACKGROUND: Ankylosing spondylitis (AS) is a chronic immune-mediated disease affecting the sacroiliac joints and the spine, manifesting with new bone formation and osteopenia. Five tumor necrosis factor-alpha (TNF-α) inhibitors (infliximab, etanercept, adalimumab, certolizumab, and golimumab) are available for the treatment of AS, however, the results for the safety of TNF-α inhibitors in the treatment of AS are not consistent. METHODS: In this study, we conducted a meta-analysis to determine the safety of TNF-α inhibitors compared with placebo in reducing pain, swelling, and inflammation of AS patients...
June 2017: Medicine (Baltimore)
https://www.readbyqxmd.com/read/28639118/pharmacokinetics-and-immunogenicity-of-t0001-a-newly-developed-anti-tnf%C3%AE-fusion-protein-in-healthy-volunteers
#3
Yitong Wang, Chang Liu, Shi Chen, Wei Wang, Lihou Dong, Qian Wang, Yan Wang, Libo Zhao, Yannan Zang, Zhenwei Xie, Yang Liu, Yanjun Liu, Haifeng Song, Zhanguo Li, Yi Fang
PURPOSE: T0001 was the first mutant of recombinant fusion protein of human tumor necrosis factor receptor and Fc fragment (rhTNFR:Fc) based on etanercept on a global scale. This study was carried out to investigate the pharmacokinetics (PK) and immunogenicity of T0001 in healthy Chinese volunteers. METHODS: This study was randomized, with a single ascending dose, and the first-in-human clinical trial of T0001. Healthy Chinese volunteers (n = 56; male: female = 1:1) were randomly assigned to receive a single subcutaneous (sc) injection of 10, 20, 35, 50, 65 or 75 mg of T0001...
June 21, 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/28638688/spontaneous-regression-of-epstein-barr-virus-associated-lymphoproliferative-disorder-in-a-juvenile-idiopathic-arthritis-patient-after-the-discontinuation-of-methotrexate-and-etanercept
#4
Ariane Klein, Harald Reinhard, Annette M Mueller, Gerd Horneff
A case of a 16-year-old female with polyarticular juvenile idiopathic arthritis (JIA) since the age of 4 years is reported here. This patient also suffered from multiple congenital anomalies. On long-term treatment with oral methotrexate (MTX) and etanercept, multiple subcutaneous nodules were detected, which were accompanied by increased lactate dehydrogenase and uric acid levels. A biopsy of the largest nodule revealed Epstein-Barr (EB) virus-positive diffuse large B-cell lymphoma (DLBCL). The patient was classified as clinical stage IIIA due to a mediastinal lesion...
June 2017: European Journal of Rheumatology
https://www.readbyqxmd.com/read/28638112/the-structure-function-relationship-of-disulfide-bonds-in-etanercept
#5
William C Lamanna, Robert Ernst Mayer, Alfred Rupprechter, Michael Fuchs, Fabian Higel, Cornelius Fritsch, Cornelia Vogelsang, Andreas Seidl, Hansjoerg Toll, Martin Schiestl, Johann Holzmann
Etanercept is a TNFα receptor Fc fusion protein used for the treatment of rheumatic disease and psoriasis. Physicochemical and functional investigation of process fractions during development of the etanercept biosimilar GP2015 (Erelzi(®)) revealed a correlation between reduced potency and incorrect disulfide bridging between specific cysteines in the receptor domain. This novel structure-function relationship was found to be the molecular basis for reduced potency in recent Enbrel(®) batches, which exhibit higher levels of incorrect disulfide bridging...
June 21, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28630629/the-cedar-study-a-longitudinal-study-of-the-clinical-effects-of-conventional-dmards-and-biologic-dmards-in-australian-rheumatology-practice
#6
Lynden Roberts, Kathleen Tymms, Julien de Jager, Geoffrey Littlejohn, Hedley Griffiths, Dave Nicholls, Paul Bird, Jennifer Young, Julie Hill, Jane Zochling
OBJECTIVES: To observe the choices of conventional disease modifying antirheumatic drugs (cDMARDs) and biologic DMARDs (bDMARDs) in the management of rheumatoid arthritis (RA) in Australian routine clinical practice, to assess treatment survival and determine the effect of cDMARDs/bDMARDs on disease activity. METHODS: Routinely collected, deidentified clinical data was sourced from 20 Australian rheumatology practices. RA patients aged ≥18 years, who had received cDMARDs/bDMARDs and a recorded subsequent visit, were included...
2017: International Journal of Rheumatology
https://www.readbyqxmd.com/read/28623625/switching-between-reference-biologics-and-biosimilars-for-the-treatment-of-rheumatology-gastroenterology-and-dermatology-inflammatory-conditions-considerations-for-the-clinician
#7
REVIEW
Robert Moots, Valderilio Azevedo, Javier L Coindreau, Thomas Dörner, Ehab Mahgoub, Eduardo Mysler, Morton Scheinberg, Lisa Marshall
PURPOSE OF REVIEW: Biosimilars of the reference biologic therapeutics infliximab, etanercept, adalimumab, and rituximab are entering the market. Clinical and real-world data on the effects of reference → biosimilar switching are limited. This review was carried out to assess the current body of switching data. RECENT FINDINGS: Fifty-three switching studies were identified. Infliximab publications covered CT-P13 (25 studies), SB2 (1), infliximab NK (1), and unspecified infliximab biosimilars (2)...
June 2017: Current Rheumatology Reports
https://www.readbyqxmd.com/read/28620302/adoption-of-biosimilar-infliximab-for-rheumatoid-arthritis-ankylosing-spondylitis-and-inflammatory-bowel-diseases-in-the-eu5-a-budget-impact-analysis-using-a-delphi-panel
#8
Tim A Kanters, Jelena Stevanovic, Isabelle Huys, Arnold G Vulto, Steven Simoens
Introduction: Introducing biosimilar infliximab for the treatment in rheumatology (rheumatoid arthritis and ankylosing spondylitis) and inflammatory bowel disease (Crohn's disease and ulcerative colitis) may reduce treatment costs associated with biologics. This study aimed to investigate the budget impact of adopting biosimilar infliximab in five European countries, considering that the budget impact includes the adoption of biosimilar infliximab and the availability of biologic alternatives such as vedolizumab, biosimilar etanercept, biosimilar rituximab, and other relevant factors...
2017: Frontiers in Pharmacology
https://www.readbyqxmd.com/read/28615036/predictors-of-the-response-to-etanercept-in-patients-with-juvenile-idiopathic-arthritis-without-systemic-manifestations-within-12-months-results-of-an-open-label-prospective-study-conducted-at-the-national-scientific-and-practical-center-of-children-s-health
#9
Ekaterina I Alexeeva, Leyla S Namazova-Baranova, Tatyana M Bzarova, Saniya I Valieva, Rina V Denisova, Tatyana V Sleptsova, Kseniya B Isaeva, Alexandra M Chomahidze, Nikolay I Taibulatov, Anna N Fetisova, Anna V Karaseva, Alexandr A Baranov
BACKGROUND: The aim of this study was to investigate the efficacy of etanercept treatment and to identify predictors of response to therapy within 12 months in patients with juvenile idiopathic arthritis (JIA) without systemic manifestations. METHODS: A total of 197 juvenile patients were enrolled in this study. Response to therapy was assessed using the ACRPedi 30/50/70/90 criteria, the Wallace criteria, and the Juvenile Arthritis Disease Activity Score 71 (JADAS-71)...
June 14, 2017: Pediatric Rheumatology Online Journal
https://www.readbyqxmd.com/read/28614922/-recombinant-human-tumor-necrosis-factor-receptor-type-%C3%A2-igg-fc-fusion-protein-for-treatment-of-occupational-medicamentosa-like-dermatitis-induced-by-trichloroethylene
#10
L L Lv, Z H Yan, X Shi, R Q Liu, X Ling, S P Ji, J Zhang, P Li, Y L Cai, L L Chen, X J Chen, L X Xie, D D Lu, L Ding, Q Q Xu, Y Zhang, X W Yang, J Jing, L Ying, C P Yu, J J Chen, X D Sun
Objective: To investigate the efficacy and safety of the recombinant human tumor necrosis factor receptor Ⅱ-IgG Fc fusion protein (rhTNFR: Fc, etanercept) for the treatment of occupational medicamentosa-like dermatitis induced by trichloroethylene (OMLDT) . Methods: In September 2011 to February 2016, 12 patients with OMLDT were treated with etanercept 25 mg, subcutaneous injection, twice per week, doubling of first dose. The course of treatment was 6 weeks. The drug eruption area and severity index (DASI) score, the proportion of patients achieving a 50%, 75% and 90% reduction in DASI (DASI50, DASI75, DASI90) and the serum level of TNF-α were used to assess the efficacy at different times...
April 20, 2017: Chinese Journal of Industrial Hygiene and Occupational Diseases
https://www.readbyqxmd.com/read/28612180/immunogenicity-of-biologics-in-chronic-inflammatory-diseases-a-systematic-review
#11
REVIEW
Vibeke Strand, Alejandro Balsa, Jamal Al-Saleh, Leonor Barile-Fabris, Takahiko Horiuchi, Tsutomu Takeuchi, Sadiq Lula, Charles Hawes, Blerina Kola, Lisa Marshall
OBJECTIVES: A systematic review was conducted to explore the immunogenicity of biologic agents across inflammatory diseases and its potential impact on efficacy/safety. METHODS: Literature searches were conducted through November 2016 to identify controlled and observational studies of biologics/biosimilars administered for treatment of rheumatoid arthritis (RA), psoriatic arthritis (PsA), juvenile idiopathic arthritis (JIA), ankylosing spondylitis (AS), non-radiographic axial spondyloarthritis (nr-axSpA), psoriasis (Ps), Crohn's disease, and ulcerative colitis...
June 13, 2017: BioDrugs: Clinical Immunotherapeutics, Biopharmaceuticals and Gene Therapy
https://www.readbyqxmd.com/read/28610606/biologic-therapies-for-refractory-juvenile-dermatomyositis-five-years-of-experience-of-the-childhood-arthritis-and-rheumatology-research-alliance-in-north-america
#12
C H Spencer, K Rouster-Stevens, H Gewanter, G Syverson, R Modica, K Schmidt, H Emery, C Wallace, S Grevich, K Nanda, Y D Zhao, S Shenoi, S Tarvin, S Hong, C Lindsley, J E Weiss, M Passo, K Ede, A Brown, K Ardalan, W Bernal, M L Stoll, B Lang, R Carrasco, C Agaiar, L Feller, H Bukulmez, R Vehe, H Kim, H Schmeling, D Gerstbacher, M Hoeltzel, B Eberhard, R Sundel, S Kim, A M Huber, A Patwardhan
BACKGROUND: The prognosis of children with juvenile dermatomyositis (JDM) has improved remarkably since the 1960's with the use of corticosteroid and immunosuppressive therapy. Yet there remain a minority of children who have refractory disease. Since 2003 the sporadic use of biologics (genetically-engineered proteins that usually are derived from human genes) for inflammatory myositis has been reported. In 2011-2016 we investigated our collective experience of biologics in JDM through the Childhood Arthritis and Rheumatology Research Alliance (CARRA)...
June 13, 2017: Pediatric Rheumatology Online Journal
https://www.readbyqxmd.com/read/28609574/factors-associated-with-the-choice-of-the-first-biologic-in-psoriasis-real-life-analysis-from-the-psobioteq-cohort
#13
Emilie Sbidian, Caroline Giboin, Hervé Bachelez, Carle Paul, Marie Beylot-Barry, Alain Dupuy, Manuelle Viguier, Jean-Philippe Lacour, Jean-Luc Schmutz, Pierre Bravard, Emmanuel Mahé, Nathalie Beneton, Laurent Misery, Emmanuel Delaporte, Philippe Modiano, Sébastien Barbarot, Elodie Regnier, Denis Jullien, Marie-Aleth Richard, Pascal Joly, Florence Tubach, Olivier Chosidow
BACKGROUND: Decision making is a complex process. The aim of our study was to assess factors associated with the choice of the first biological treatment in patients with moderate-to-severe psoriasis. METHODS: Data on all patients included in the French prospective, observational, cohort, Psobioteq and initiating a first biologic prescription between July 2012 and July 2016 were analysed. Demographic information and clinical features were collected during routine clinical assessments by the dermatology team at the recruiting centres using a standardized case report form...
June 13, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/28604144/anti-tnf-%C3%AE-effects-on-anemia-in-rheumatoid-and-psoriatic-arthritis
#14
Addolorata Corrado, Valeria Di Bello, Francesca d'Onofrio, Nicola Maruotti, Francesco Paolo Cantatore
A key role in the pathogenesis of rheumatoid arthritis (RA) and psoriatic arthritis (PsA) is played by inflammatory cytokines, including tumor necrosis factor-α (TNF-α), which are also involved in inducing inflammatory anemia. We have followed 67 RA patients and 64 PsA patients for 1 year to evaluate the effects of TNF-α inhibitors on disease activity and on inflammatory anemia. Patients were divided into three different treatment groups, according to a randomized assignment to receive therapy with etanercept, adalimumab, or infliximab...
June 1, 2017: International Journal of Immunopathology and Pharmacology
https://www.readbyqxmd.com/read/28600810/infections-from-7-clinical-trials-of-ixekizumab-an-anti-interleukin-17a-monoclonal-antibody-in-patients-with-moderate-to-severe-psoriasis
#15
K A Papp, H Bachelez, A Blauvelt, K L Winthrop, R Romiti, M Ohtsuki, N Acharya, D K Braun, L Mallbris, F Zhao, W Xu, C D Walls, B Strober
BACKGROUND: Infections are associated with biologic therapies in psoriasis. OBJECTIVES: To summarise the incidence of infections in moderate-to-severe psoriasis patients treated with ixekizumab, an anti-interleukin (IL)-17A monoclonal antibody. METHODS: Infections are summarised from an integrated database of 7 controlled and uncontrolled ixekizumab psoriasis trials. Data are presented from placebo-controlled induction (Weeks 0-12; UNCOVER-1, -2, and -3) and maintenance periods (Weeks 12-60; UNCOVER-1 and -2) as well as all ixekizumab-exposed patients pooled from all 7 trials...
June 10, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28598787/severe-adverse-drug-reactions-to-biological-disease-modifying-anti-rheumatic-drugs-in-elderly-patients-with-rheumatoid-arthritis-in-clinical-practice
#16
Leticia Leon, Alejandro Gomez, Cristina Vadillo, Esperanza Pato, Luis Rodriguez-Rodriguez, Juan Angel Jover, Lydia Abasolo
OBJECTIVES: Biological DMARDs are widely used in the treatment of rheumatoid arthritis (RA) but their relationship with adverse drug reaction (ADR) is important. RA is now known to increase in incidence and prevalence with age. Our objective was to assess the incidence of severe ADR in the long term, compare safety between the different bDMARDs and identify other possible risk factors for severe ADR in elderly RA patients. METHODS: A 14-year retrospective longitudinal study was performed...
June 6, 2017: Clinical and Experimental Rheumatology
https://www.readbyqxmd.com/read/28597306/maintenance-of-remission-with-combination-etanercept-dmard-therapy-versus-dmards-alone-in-active-rheumatoid-arthritis-results-of-an-international-treat-to-target-study-conducted-in-regions-with-limited-biologic-access
#17
Karel Pavelka, Nurullah Akkoç, Mustafa Al-Maini, Cristiano A F Zerbini, Dmitry E Karateev, Evgeny L Nasonov, Mahboob U Rahman, Ronald Pedersen, Andrew Dinh, Qi Shen, Radu Vasilescu, Sameer Kotak, Ehab Mahgoub, Bonnie Vlahos
In this transglobal, randomized, double-blind, placebo-controlled, treat-to-target study, the maintenance of efficacy was compared between biologic-and biologic-free-disease-modifying antirheumatic drug (DMARD) combination regimens after low disease activity (LDA) was achieved with biologic DMARD induction therapy. Patients with moderate-to-severe rheumatoid arthritis despite methotrexate therapy received open-label etanercept 50 mg subcutaneously once weekly plus methotrexate with or without other conventional synthetic (cs) DMARDs for 24 weeks...
June 9, 2017: Rheumatology International
https://www.readbyqxmd.com/read/28597251/occurrence-of-multiple-sclerosis-after-drug-exposure-insights-from-evidence-mapping
#18
Ippazio Cosimo Antonazzo, Emanuel Raschi, Luca Vignatelli, Elisa Baldin, Trond Riise, Roberto D'Alessandro, Fabrizio De Ponti, Elisabetta Poluzzi
INTRODUCTION: The role of drugs in the occurrence of multiple sclerosis (MS) is perceived to be insufficiently investigated. OBJECTIVE: The aim of this study was to map and assess the evidence on MS occurrence after drug exposure, in order to identify possible signals of causal association. METHODS: A search strategy was performed in MEDLINE and Embase as of July 2016; references consistent with the aim of the study were analysed to extract relevant measures of causal association between drugs and MS...
June 9, 2017: Drug Safety: An International Journal of Medical Toxicology and Drug Experience
https://www.readbyqxmd.com/read/28597181/clinical-signs-pathophysiology-and-management-of-cutaneous-side-effects-of-anti-tumor-necrosis-factor-agents
#19
REVIEW
Siegfried Segaert, Caroline Hermans
Approximately one in four patients treated with anti-TNF agents (infliximab, etanercept, adalimumab, certolizumab, and golimumab) develops cutaneous adverse events, typically months to years after the initiation of treatment, with xerosis cutis, eczema (often psoriasiform), psoriasis, palmoplantar pustulosis, cutaneous infections, alopecia, and skin cancer being the most frequently encountered. The typical skin lesion of anti-tumor necrosis factor (TNF)-treated patients is orange-red psoriasiform eczema affecting the flexures, genitalia, scalp, or face, with high susceptibility to bacterial superinfection with Staphylococcus aureus...
June 8, 2017: American Journal of Clinical Dermatology
https://www.readbyqxmd.com/read/28597133/real-life-10-year-retention-rate-of-first-line-anti-tnf-drugs-for-inflammatory-arthritides-in-adult-and-juvenile-onset-populations-similarities-and-differences
#20
Ennio Giulio Favalli, Irene Pontikaki, Andrea Becciolini, Martina Biggioggero, Nicola Ughi, Micol Romano, Chiara Crotti, Maurizio Gattinara, Valeria Gerloni, Antonio Marchesoni, Pier Luigi Meroni
The aim of this study is to retrospectively analyze 10-year drug survival of first-line TNF inhibitor (TNFi) in rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), and juvenile idiopathic arthritis (JIA) patients, comparing withdrawal rates and discontinuation pattern between adult- and juvenile-onset populations. RA, AS, PsA, and JIA patients treated with infliximab, etanercept, or adalimumab as first TNFi between 1999 and 2015 were extracted from a local registry. Drug survival up to 10-year follow-up was evaluated by the Kaplan-Meier method and compared according to age (adult vs juvenile onset), TNFi agent, and discontinuation reason by a stratified log-rank test...
June 8, 2017: Clinical Rheumatology
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