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https://www.readbyqxmd.com/read/29054603/risk-of-serious-infection-in-patients-with-psoriasis-on-biologic-therapies-a-prospective-cohort-study-from-the-british-association-of-dermatologists-biologic-interventions-register-badbir
#1
Zenas Z N Yiu, Catherine H Smith, Darren M Ashcroft, Mark Lunt, Shernaz Walton, Ruth Murphy, Nick J Reynolds, Anthony D Ormerod, Christopher E M Griffiths, Richard B Warren
Serious infection is a concern for patients with psoriasis on biologic therapies. We assessed the risk of serious infections of biologics used to treat psoriasis by comparison with a cohort on non-biologic systemic therapies in a propensity-score weighted Cox proportional hazards model using data from the British Association of Dermatologists Biologic Interventions Register (BADBIR). 1352, 3271 and 994 participants were included in the etanercept, adalimumab, ustekinumab cohorts respectively and 3421 participants in the non-biologic cohort...
October 17, 2017: Journal of Investigative Dermatology
https://www.readbyqxmd.com/read/29042704/alternative-to-rituximab-therapy-for-a-patient-with-ankylosing-spondylitis-who-was-unable-to-continue-anti-tnf-therapy
#2
Eri Katsuyama, Hiroshi Wakabayashi, Ken-Ei Sada, Sumie Hiramatsu, Yoshia Miyawaki, Michiko Morishita, Keiji Ohashi, Haruki Watanabe, Takayuki Katsuyama, Sonia Zeggar, Mariko Narazaki, Noriko Tatebe, Katsue Sunahori-Watanabe, Tomoko Kawabata, Jun Wada
We herein present a case of a 38-year-old man who had bamboo spine and severe sacroiliitis and who was diagnosed with ankylosing spondylitis (AS). Infliximab (IFX) markedly improved the axial symptom but was discontinued due to the side effect of peripheral neuropathy. Switching from IFX to etanercept worsened the side effect. Rituximab (RTX) administration elicited a good response without side effects. RTX might be a suitable option for AS therapy when TNF inhibitors are difficult to use.
October 2017: Acta Medica Okayama
https://www.readbyqxmd.com/read/29039054/treatment-persistence-and-healthcare-costs-among-patients-with-rheumatoid-arthritis-changing-biologics-in-the-usa
#3
Benjamin Chastek, Chieh-I Chen, Clare Proudfoot, Shraddha Shinde, Andreas Kuznik, Wenhui Wei
INTRODUCTION: After a patient with rheumatoid arthritis (RA) fails tumor necrosis factor inhibitor (TNFi) treatment, clinical guidelines support either cycling to another TNFi or switching to a different mechanism of action (MOA), but payers often require TNFi cycling before they reimburse switching MOA. This study examined treatment persistence, cost, and cost per persistent patient among MOA switchers versus TNFi cyclers. METHODS: This study of Commercial and Medicare Advantage claims data from the Optum Research Database included patients with RA and at least one claim for a TNFi (adalimumab, certolizumab pegol, etanercept, golimumab, or infliximab) between January 2012 and September 2015 who changed to another TNFi or a different MOA therapy (abatacept, tocilizumab, or tofacitinib) within 1 year...
October 16, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/29037310/latent-tuberculosis-infection-screening-in-juvenile-idiopathic-arthritis-patients-preceding-anti-tnf-therapy-in-a-tuberculosis-high-risk-country
#4
Juliana Barbosa Brunelli, Karina Rossi Bonfiglioli, Clovis A Silva, Katia Tomie Kozu, Claudia Goldenstein-Schainberg, Eloisa Bonfa, Nadia Emi Aikawa
OBJECTIVES: To evaluate, in an endemic country, the long-term efficacy of latent tuberculosis infection (LTBI) screening and primary prophylaxis in patients with JIA receiving TNF blockers. METHODS: This was a retrospective cohort that included JIA patients eligible to anti-TNF therapy. Patients were screened for LTBI prior to anti-TNF using tuberculin skin test (TST), chest X-ray and history of exposure to TB. Subjects were regularly followed at 2-month intervals...
September 2017: Revista Brasileira de Reumatologia
https://www.readbyqxmd.com/read/29036254/evaluation-of-risk-of-major-adverse-cardiovascular-events-with-biologic-therapy-in-patients-with-psoriasis
#5
Robert Bissonnette, Francisco Kerdel, Luigi Naldi, Kim Papp, Claudia Galindo, Wayne Langholff, K L Tang, Philippe Szapary, Steven Fakharzadeh, Bhaskar Srivastava, Kavitha Goyal, Alice B Gottlieb
BACKGROUND: Psoriasis is associated with increased risk of major adverse cardiovascular events (MACE). OBJECTIVES: Compare MACE risk with biologics vs topical/phototherapy use. METHODS: Psoriasis Longitudinal Assessment Registry (PSOLAR) is an international psoriasis registry of patients eligible to receive biologic/systemic treatments prospectively. MACE is defined as myocardial infarction, stroke, or cardiovascular death. Biologic cohorts, including tumor necrosis factor-alpha (TNF-α) inhibitors (ie, adalimumab, etanercept, and infliximab) and ustekinumab, combined and by class, were compared with a topical/phototherapy cohort...
October 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/29036249/cost-effectiveness-analysis-of-ixekizumab-vs-etanercept-and-their-manufacturer-recommended-dosing-regimens-in-moderate-to-severe-plaque-psoriasis
#6
Jeremy Udkoff, Lawrence F Eichenfield
INTRODUCTION: Biologic therapies have revolutionized the treatment of psoriasis; however, their use is limited by costs. Ixekizumab was more effective than etanercept in the UNCOVER trials, and the Food and Drug Administration (FDA) approved ixekizumab for treating psoriasis. Evaluating the cost-effectiveness of these therapies is crucial for medical decision making and our objective was to determine the cost-effectiveness of various ixekizumab dosing frequencies compared with etanercept...
October 1, 2017: Journal of Drugs in Dermatology: JDD
https://www.readbyqxmd.com/read/29034547/refractory-pityriasis-rubra-pilaris-treated-with-etanercept-adalimumab-or-ustekinumab-a-retrospective-investigation
#7
Nolan J Maloney, Lisa D Hisaw, Scott Worswick
Pityriasis rubra pilaris (PRP) is a rare, difficult to treat papulosquamous disorder that responds variably to retinoids and immunosuppression. Successful use of biologics for treating PRP has been described in the literature by case reports and a limited number of case series. To provide additional data, we retrospectively analyzed cases of PRP treated with biologics at our institution. We identified seven patients with a clear diagnosis of PRP treated with adalimumab, etanercept, and/or ustekinumab at our institution from January 1, 2014 to April 1, 2017...
October 15, 2017: Dermatologic Therapy
https://www.readbyqxmd.com/read/29034454/successful-treatment-of-sapho-syndrome-with-apremilast
#8
S Adamo, J Nilsson, A Krebs, U Steiner, A Cozzio, L E French, A G A Kolios
Synovitis, acne, pustulosis, hyperostosis and osteitis (SAPHO) syndrome is a rare disease with inflammatory osteoarticular and skin involvement. The pathogenesis of SAPHO syndrome remains unclear, but evidence suggests it may be an autoinflammatory disease triggered upon exposure to infectious agents in genetically predisposed individuals. Induction of the IL-23/Th17 axis as well as neutrophil activation seem to play a key role, and therapies targeting these immunological pathways, including TNF-inhibitors, ustekinumab, secukinumab and the IL-1 inhibitor anakinra are potential treatment options that need further investigation...
October 16, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/29028148/follow-up-of-1887-patients-receiving-tumor-necrosis-alpha-antagonists-tuberculin-skin-test-conversion-and-tuberculosis-risk
#9
Tulin Cagatay, Zuleyha Bingol, Esen Kıyan, Zeynep Yegin, Gulfer Okumus, Orhan Arseven, Feyza Erkan, Ziya Gulbaran, Mustafa Erelel, Turhan Ece, Penbe Cagatay', Zeki Kılıçaslan
OBJECTIVES: To evaluate the characteristics of patients who developed tuberculosis while receiving tumor necrosis factor-alpha (TNF-α) antagonists and the related factors with tuberculosis. METHODS: Patient's demographics, tuberculin skin test (TST), isoniazid prophylaxis, type of TNF-α antagonist were recorded. TST conversion (>5mm increase) was evaluated for patients who had baseline and 1-year TST. RESULTS: Files of 1887 patients who were receiving TNF-α antagonists between August2005 and June 2015 were evaluated...
October 13, 2017: Clinical Respiratory Journal
https://www.readbyqxmd.com/read/29026983/quartz-crystal-microbalance-as-an-assay-to-detect-anti-drug-antibodies-for-the-immunogenicity-assessment-of-therapeutic-biologics
#10
Evan A Dubiel, Tamás Fülöp, Sylvain Vigier, Patrick Vermette
Because of their biological origins, therapeutic biologics can trigger an unwanted deleterious immune response with some patients. The immunogenicity of therapeutic biologics can affect drug efficacy and patient safety by the production of circulating anti-drug antibodies (ADA). In this study, quartz crystal microbalance (QCM) was developed as an assay to detect ADA. Etanercept (Enbrel®) was covalently grafted to dextran-modified QCM surfaces. Rabbits were immunized with etanercept to generate ADA. Results showed the QCM assay could detect purified ADA from rabbits at concentrations as low as 50 ng/mL, within the sensitivity range of ELISA...
October 12, 2017: Analytical and Bioanalytical Chemistry
https://www.readbyqxmd.com/read/29026072/dynamic-regulation-of-canonical-tgf%C3%AE-signalling-by-endothelial-transcription-factor-erg-protects-from-liver-fibrogenesis
#11
Neil P Dufton, Claire R Peghaire, Lourdes Osuna-Almagro, Claudio Raimondi, Viktoria Kalna, Abhishek Chuahan, Gwilym Webb, Youwen Yang, Graeme M Birdsey, Patricia Lalor, Justin C Mason, David H Adams, Anna M Randi
The role of the endothelium in protecting from chronic liver disease and TGFβ-mediated fibrosis remains unclear. Here we describe how the endothelial transcription factor ETS-related gene (ERG) promotes liver homoeostasis by controlling canonical TGFβ-SMAD signalling, driving the SMAD1 pathway while repressing SMAD3 activity. Molecular analysis shows that ERG binds to SMAD3, restricting its access to DNA. Ablation of ERG expression results in endothelial-to-mesenchymal transition (EndMT) and spontaneous liver fibrogenesis in EC-specific constitutive hemi-deficient (Erg (cEC-Het) ) and inducible homozygous deficient mice (Erg (iEC-KO) ), in a SMAD3-dependent manner...
October 12, 2017: Nature Communications
https://www.readbyqxmd.com/read/29024536/etanercept-induced-lymphocytic-infiltration-of-jessner-kanof
#12
Noémie Abbad, Tristan Lanal, Céline Brenuchon, Gauthier Morel, Xavier Deprez
The patient, a 52-year-old man presented a two-week history of asymptomatic multiple erythematous papules on the upper back (Panel A). The skin lesion had arisen 3 weeks after starting therapy with etanercept for axial spondyloarthritis. For several months, the patient had been taking NSAI and tramadol. A biopsy specimen from a lesion revealed a dense lymphocytic infiltrate of the superficial and mid-dermis (arrow) with perivascular and perifollicular distribution (Panel B). This article is protected by copyright...
October 12, 2017: Arthritis & Rheumatology
https://www.readbyqxmd.com/read/29024096/state-of-the-art-immunogenicity-evaluation-in-phase-3-confirmatory-study-egality-with-etanercept-biosimilar-gp2015
#13
J Poetzl, I Arlt, O von Richter, H Wöhling, M Afonso, G Schaffar
Immunogenicity is an important aspect of all biologics. Switching between biological products has triggered intensive discussion on the interchangeability of a biosimilar with its reference medicine, with the main focus being immunogenicity and different perspectives within Europe(1) and the United States.(2) Given that immunogenicity assay validation and performance characteristics differ from assay to assay, the immunogenicity assay parameters discussed here enable the interpretation of the immunogenicity results...
October 10, 2017: Journal of the European Academy of Dermatology and Venereology: JEADV
https://www.readbyqxmd.com/read/29024042/pro-inflammatory-m1-macrophage-enhances-metastatic-potential-of-ovarian-cancer-cells-through-nf-%C3%AE%C2%BAb-activation
#14
Untack Cho, Boyun Kim, Soochi Kim, Youngjin Han, Yong Sang Song
Obesity is a serious health problem and critically related to poor prognosis in cancer, presumably through induction of chronic inflammation. The major culprit for cancer progression in obesity is presumed to be macrophages. Accumulation of macrophages in adipose tissue due to obesity induced chronic inflammation has been observed. However, obesity-induced macrophage accumulation related to ovarian cancer progression remains unclear. So, the role of macrophage in cancer progression is needed to be further defined for therapeutic intervention...
October 12, 2017: Molecular Carcinogenesis
https://www.readbyqxmd.com/read/29023827/tnf%C3%AE-and-il-17a-are-differentially-expressed-in-psoriasis-like-vs-eczema-like-drug-reactions-to-tnf%C3%AE-antagonists
#15
C Deubelbeiss, A G A Kolios, L E French, N Yawalkar, W Kempf, K Kerl, B Meier, F Anzengruber, A A Navarini
BACKGROUND: Tumor necrosis factor α (TNFα) blocking drugs are in use for a wide range of autoimmune disorders. In up to 5% of patients, this class of drugs produces puzzling cutaneous side effects that are the subject of this investigation, namely psoriasiform and eczema-like skin inflammation. These side effects can occur after any time of treatment and regardless of the underlying disorders. The exact pathophysiology is as yet unknown. METHODS: 33 patients (19 female, average age 52 years) who had a cutaneous reaction to infliximab, adalimumab or etanercept were included...
October 10, 2017: Journal of Cutaneous Pathology
https://www.readbyqxmd.com/read/29020515/manufacturing-history-of-etanercept-enbrel-%C3%A0-consistency-of-product-quality-through-major-process-revisions
#16
Brian Hassett, Ena Singh, Ehab Mahgoub, Julie O'Brien, Steven M Vicik, Brian Fitzpatrick
Etanercept (ETN) (Enbrel®) is a soluble protein that binds to, and specifically inhibits, tumor necrosis factor (TNF), a proinflammatory cytokine. ETN is synthesized in Chinese hamster ovary cells by recombinant DNA technology as a fusion protein, with a fully human TNFRII ectodomain linked to the Fc portion of human IgG1. Successful manufacture of biologics, such as ETN, requires sophisticated process and product understanding, as well as meticulous control of operations to maintain product consistency. The objective of this evaluation was to show that the product profile of ETN drug substance (DS) has been consistent over the course of production...
October 11, 2017: MAbs
https://www.readbyqxmd.com/read/29020508/variability-of-intended-copies-for-etanercept-enbrel%C3%A2-data-on-multiple-batches-of-seven-products
#17
Brian Hassett, Morton Scheinberg, Gilberto Castañeda-Hernández, Mengtao Li, Uppuluri Rk Rao, Ena Singh, Ehab Mahgoub, Javier Coindreau, Julie O'Brien, Steven M Vicik, Brian Fitzpatrick
Fusion protein and monoclonal antibody-based tumor necrosis factor (TNF) inhibitors represent established treatment options for a range of inflammatory diseases. Regulatory authorities have outlined the structural characterization and clinical assessments necessary to establish biosimilarity of a new biotherapeutic product with the innovator biologic drug. Biologic products that would not meet the minimum World Health Organization's standard for evaluation of similar biotherapeutic products are available in some countries; in some cases relevant data to assess biosimilarity and appropriate regulatory approval pathways are lacking...
October 11, 2017: MAbs
https://www.readbyqxmd.com/read/28991370/ixekizumab-treatment-for-psoriasis-integrated-efficacy-analysis-of-three-double-blinded-controlled-studies-uncover-1-uncover-2-uncover-3
#18
K A Papp, C L Leonardi, A Blauvelt, K Reich, N J Korman, M Ohtsuki, C Paul, S Ball, G S Cameron, J Erickson, L Zhang, L Mallbris, C E M Griffiths
BACKGROUND: Ixekizumab, a high-affinity monoclonal antibody that selectively targets interleukin (IL)-17A, is approved for the treatment of moderate-to-severe psoriasis. OBJECTIVES: This analysis represents an overview of the efficacy outcomes from three Phase 3 psoriasis studies. METHODS: Data were integrated from the 12-week induction period of three studies in which patients received ixekizumab 80 mg every 2 (IXE Q2W; N=1169) or 4 weeks (IXE Q4W; N=1165) after an initial 160-mg dose for both, etanercept (ETN) (50 mg biweekly; N=740; two studies), or placebo (PBO) (N=792)...
October 9, 2017: British Journal of Dermatology
https://www.readbyqxmd.com/read/28979022/a-case-of-cutaneous-t-cell-lymphoma-masquerading-as-psoriasis-was-given-etanercept-and-secukinumab-emphasizing-the-need-for-biopsy-confirmation-before-starting-biologics
#19
Abhishek De, Tanumay Raychaudhury, Murlidhar Rajagopalan, Aarti Sarda, Nidhi Sharma
No abstract text is available yet for this article.
September 2017: Indian Journal of Dermatology
https://www.readbyqxmd.com/read/28976302/certolizumab-pegol-and-secukinumab-for-treating-active-psoriatic-arthritis-following-inadequate-response-to-disease-modifying-antirheumatic-drugs-a-systematic-review-and-economic-evaluation
#20
Mark Corbett, Fadi Chehadah, Mousumi Biswas, Thirimon Moe-Byrne, Stephen Palmer, Marta Soares, Matthew Walton, Melissa Harden, Pauline Ho, Nerys Woolacott, Laura Bojke
BACKGROUND: Several biologic therapies are approved by the National Institute for Health and Care Excellence (NICE) for psoriatic arthritis (PsA) patients who have had an inadequate response to two or more synthetic disease-modifying antirheumatic drugs (DMARDs). NICE does not specifically recommend switching from one biologic to another, and only ustekinumab (UST; STELARA(®), Janssen Pharmaceuticals, Inc., Horsham, PA, USA) is recommended after anti-tumour necrosis factor failure. Secukinumab (SEC; COSENTYX(®), Novartis International AG, Basel, Switzerland) and certolizumab pegol (CZP; CIMZIA(®), UCB Pharma, Brussels, Belgium) have not previously been appraised by NICE...
October 2017: Health Technology Assessment: HTA
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