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https://www.readbyqxmd.com/read/29150848/allergen-manufacturing-and-quality-aspects-for-allergen-immunotherapy-in-europe-and-the-united-states-an-analysis-from-the-eaaci-ait-guidelines-project
#1
REVIEW
A Bonertz, G Roberts, J E Slater, J Bridgewater, R L Rabin, M Hoefnagel, M Timon, C Pini, O Pfaar, A Sheikh, D Ryan, C Akdis, J Goldstein, L K Poulsen, R van Ree, C Rhyner, D Barber, O Palomares, R Pawankar, D Hamerlijnk, L Klimek, I Agache, E Angier, T Casale, M Fernandez-Rivas, S Halken, M Jutel, S Lau, G Pajno, G Sturm, E M Varga, R Gerth van Wijk, S Bonini, A Muraro, S Vieths
Adequate quality is essential for any medicinal product to be eligible for marketing. Quality includes verification of the identity, content and purity of a medicinal product in combination with a specified production process and its control. Allergen products derived from natural sources require particular considerations to ensure adequate quality. Here, we describe key aspects of the documentation on manufacturing and quality aspects for allergen immunotherapy products in the European Union and the United States...
November 17, 2017: Allergy
https://www.readbyqxmd.com/read/29143737/validation-of-elisa-methods-for%C3%A2-quantification-of-the-major-birch-allergen-bet-v-1-bsp090
#2
S Kaul, J Zimmer, O Dehus, A Constanzo, A DaasConstanzo, K-H Buchheit, J Asturias, M C Arilla, D Barber, A Bertocchi, B Brunetto, J A Carnes, M Chapman, G Chaudemanche, J Dayan-Kenigsberg, S Döring, F Führer, M T Gallego, P Iacovacci, K M Hanschmann, T Holzhauser, M Hrabina, A Ledesma, P Moingeon, E Nony, C Pini, G Plunkett, M Raulf, G Reese, E Sandberg, I Sander, B Smith, D Strecker, C Valerio, R van Ree, B Weber, S Vieths
To date, the potency of allergen products in Europe is expressed in manufacturer-specific units relative to a product-specific in-house reference. Consequently, cross-product comparability of allergen products from different manufacturers with respect to strength and efficacy is impossible. The Biological Standardisation Programme (BSP) project BSP090 addresses this issue via the establishment of reference standards in conjunction with ELISA methods for the quantification of major allergens in allergen products...
2017: Pharmeuropa Bio & Scientific Notes
https://www.readbyqxmd.com/read/29108772/debates-in-allergy-regarding-the-symposium-on-position-statements-and-therapeutic-guidelines
#3
P Rodríguez Del Río, A Cisteró-Bahima, R van Ree
No abstract text is available yet for this article.
November 3, 2017: Allergologia et Immunopathologia
https://www.readbyqxmd.com/read/29055680/oxytocin-increases-attention-to-the-eyes-and-selectively-enhances-self-reported-affective-empathy-for-fear
#4
Kelly Hubble, Katie Daughters, Antony S R Manstead, Aled Rees, Anita Thapar, Stephanie H M van Goozen
Oxytocin (OXT) has previously been implicated in a range of prosocial behaviors such as trust and emotion recognition. Nevertheless, recent studies have questioned the evidence for this link. In addition, there has been relatively little conclusive research on the effect of OXT on empathic ability and such studies as there are have not examined the mechanisms through which OXT might affect empathy, or whether OXT selectively facilitates empathy for specific emotions. In the current study, we used eye-tracking to assess attention to socially relevant information while participants viewed dynamic, empathy-inducing video clips, in which protagonists expressed sadness, happiness, pain or fear...
October 18, 2017: Neuropsychologia
https://www.readbyqxmd.com/read/28986984/crd-and-beyond-multivariable-regression-models-to-predict-severity-of-hazelnut-allergy
#5
Mareen R Datema, Ronald van Ree, Riccardo Asero, Laura Barreales, Simona Belohlavkova, Frédéric de Blay, Michael Clausen, Ruta Dubakiene, Cristina Fernández-Perez, Philipp Fritsche, David Gislason, Karin Hoffmann-Sommergruber, Monika Jedrzejczak-Czechowicz, Laurian Jongejan, André C Knulst, Marek Kowalski, Tanya Z Kralimarkova, Thuy-My Le, Jonas Lidholm, Nikolaos G Papadopoulos, Todor A Popov, Nayade Del Prado, Ashok Purohit, Isabel Reig, Suranjith L Seneviratne, Athanassios Sinaniotis, Serge A Versteeg, Stefan Vieths, A H Zwinderman, E N Clare Mills, Montserrat Fernández-Rivas, Barbara Ballmer-Weber
BACKGROUND: Component-resolved diagnosis (CRD) has revealed significant associations between IgE against individual allergens and severity of hazelnut allergy. Less attention has been given to combining them with clinical factors in predicting severity. AIM: To analyze associations between severity and sensitization patterns, patient characteristics and clinical history, and to develop models to improve predictive accuracy. METHODS: Patients reporting hazelnut allergy (n=423) from 12 European cities were tested for IgE against individual hazelnut allergens...
October 7, 2017: Allergy
https://www.readbyqxmd.com/read/28940458/eaaci-guidelines-on-allergen-immunotherapy-allergic-rhinoconjunctivitis
#6
G Roberts, O Pfaar, C A Akdis, I J Ansotegui, S R Durham, R Gerth van Wijk, S Halken, D Larenas-Linnemann, R Pawankar, C Pitsios, A Sheikh, M Worm, S Arasi, M A Calderon, C Cingi, S Dhami, J L Fauquert, E Hamelmann, P Hellings, L Jacobsen, E F Knol, S Y Lin, P Maggina, R Mösges, J N G Oude Elberink, G B Pajno, E A Pastorello, M Penagos, G Rotiroti, C B Schmidt-Weber, F Timmermans, O Tsilochristou, E-M Varga, J N Wilkinson, A Williams, L Zhang, I Agache, E Angier, M Fernandez-Rivas, M Jutel, S Lau, R van Ree, D Ryan, G J Sturm, A Muraro
Allergic rhinoconjunctivitis (AR) is an allergic disorder of the nose and eyes affecting about a fifth of the general population. Symptoms of AR can be controlled with allergen avoidance measures and pharmacotherapy. However, many patients continue to have ongoing symptoms and an impaired quality of life; pharmacotherapy may also induce some side-effects. Allergen immunotherapy (AIT) represents the only currently available treatment that targets the underlying pathophysiology, and it may have a disease-modifying effect...
September 23, 2017: Allergy
https://www.readbyqxmd.com/read/28912804/assessment-of-nutritional-status-digestion-and-absorption-and-quality-of-life-in-patients-with-locally-advanced-pancreatic-cancer
#7
J E Witvliet-van Nierop, C M Lochtenberg-Potjes, N J Wierdsma, H J Scheffer, G Kazemier, K Ottens-Oussoren, M R Meijerink, M A E de van der Schueren
BACKGROUND AND AIM: To provide a comprehensive quantitative assessment of nutritional status, digestion and absorption, and quality of life (QoL) in patients with locally advanced pancreatic cancer (LAPC). METHODS: Sixteen patients with LAPC were prospectively assessed for weight loss (WL), body mass index (BMI), fat-free mass index (FFMI), handgrip strength (HGS), dietary macronutrient intake, serum vitamin levels, resting and total energy expenditure (REE and TEE, indirect calorimetry), intestinal absorption capacity and fecal losses (bomb calorimetry), exocrine pancreatic function (fecal elastase-1 (FE1)), and gastrointestinal quality of life (GIQLI)...
2017: Gastroenterology Research and Practice
https://www.readbyqxmd.com/read/28902467/eaaci-guidelines-on-allergen-immunotherapy-prevention-of-allergy
#8
REVIEW
Susanne Halken, Desiree Larenas-Linnemann, Graham Roberts, Moises A Calderón, Elisabeth Angier, Oliver Pfaar, Dermot Ryan, Ioana Agache, Ignacio J Ansotegui, Stefania Arasi, George Du Toit, Montserrat Fernandez-Rivas, Roy Geerth van Wijk, Marek Jutel, Jörg Kleine-Tebbe, Susanne Lau, Paolo M Matricardi, Giovanni B Pajno, Nikolaos G Papadopoulos, Martin Penagos, Alexandra F Santos, Gunter J Sturm, Frans Timmermans, R van Ree, Eva-Maria Varga, Ulrich Wahn, Maria Kristiansen, Sangeeta Dhami, Aziz Sheikh, Antonella Muraro
Allergic diseases are common and frequently coexist. Allergen immunotherapy (AIT) is a disease-modifying treatment for IgE-mediated allergic disease with effects beyond cessation of AIT that may include important preventive effects. The European Academy of Allergy and Clinical Immunology (EAACI) has developed a clinical practice guideline to provide evidence-based recommendations for AIT for the prevention of (i) development of allergic comorbidities in those with established allergic diseases, (ii) development of first allergic condition, and (iii) allergic sensitization...
September 13, 2017: Pediatric Allergy and Immunology
https://www.readbyqxmd.com/read/28867147/lmo1-synergizes-with-mycn-to-promote-neuroblastoma-initiation-and-metastasis
#9
Shizhen Zhu, Xiaoling Zhang, Nina Weichert-Leahey, Zhiwei Dong, Cheng Zhang, Gonzalo Lopez, Ting Tao, Shuning He, Andrew C Wood, Derek Oldridge, Choong Yong Ung, Janine H van Ree, Amish Khan, Brittany M Salazar, Edroaldo Lummertz da Rocha, Mark W Zimmerman, Feng Guo, Hong Cao, Xiaonan Hou, S John Weroha, Antonio R Perez-Atayde, Donna S Neuberg, Alexander Meves, Mark A McNiven, Jan M van Deursen, Hu Li, John M Maris, A Thomas Look
A genome-wide association study identified LMO1, which encodes an LIM-domain-only transcriptional cofactor, as a neuroblastoma susceptibility gene that functions as an oncogene in high-risk neuroblastoma. Here we show that dβh promoter-mediated expression of LMO1 in zebrafish synergizes with MYCN to increase the proliferation of hyperplastic sympathoadrenal precursor cells, leading to a reduced latency and increased penetrance of neuroblastomagenesis. The transgenic expression of LMO1 also promoted hematogenous dissemination and distant metastasis, which was linked to neuroblastoma cell invasion and migration, and elevated expression levels of genes affecting tumor cell-extracellular matrix interaction, including loxl3, itga2b, itga3, and itga5...
September 11, 2017: Cancer Cell
https://www.readbyqxmd.com/read/28790443/endocannabinoid-tone-is-higher-in-healthy-lean-south-asian-than-white-caucasian-men
#10
Vasudev Kantae, Kimberly J Nahon, Maaike E Straat, Leontine E H Bakker, Amy C Harms, Mario van der Stelt, Thomas Hankemeier, Ingrid M Jazet, Mariëtte R Boon, Patrick C N Rensen
South Asians have a higher risk to develop obesity and related disorders compared to white Caucasians. This is likely in part due to their lower resting energy expenditure (REE) as related with less energy-combusting brown adipose tissue (BAT). Since overactivation of the endocannabinoid system is associated with obesity and low BAT activity, we hypothesized that South Asians have a higher endocannabinoid tone. Healthy lean white Caucasian (n = 10) and South Asian (n = 10) men were cold-exposed to activate BAT...
August 8, 2017: Scientific Reports
https://www.readbyqxmd.com/read/28771830/challenges-in-the-implementation-of-eaaci-guidelines-on-allergen-immunotherapy-a-global-perspective-on-the-regulation-of-allergen-products
#11
REVIEW
A Bonertz, G C Roberts, M Hoefnagel, M Timon, J E Slater, R L Rabin, J Bridgewater, C Pini, O Pfaar, C Akdis, J Goldstein, L K Poulsen, R van Ree, C Rhyner, D Barber, O Palomares, A Sheikh, R Pawankar, D Hamerlijnk, L Klimek, I Agache, E Angier, T Casale, M Fernandez-Rivas, S Halken, M Jutel, S Lau, G Pajno, G Sturm, E M Varga, R Gerth van Wijk, S Bonini, A Muraro, S Vieths
Regulatory approaches for allergen immunotherapy (AIT) products and the availability of high-quality AIT products are inherently linked to each other. While allergen products are available in many countries across the globe, their regulation is very heterogeneous. First, we describe the regulatory systems applicable for AIT products in the European Union (EU) and in the United States (US). For Europe, a depiction of the different types of relevant procedures, as well as the committees involved, is provided and the fundamental role of national agencies of the EU member states in this complex and unique network is highlighted...
August 3, 2017: Allergy
https://www.readbyqxmd.com/read/28632898/hbsag-loss-after-peginterferon-and-nucleotide-combination-treatment-in-chronic-hepatitis-b-patients-5-years-of-follow-up
#12
Femke Stelma, Meike H van der Ree, Louis Jansen, Martine W Peters, Harry L A Janssen, Hans L Zaaijer, R Bart Takkenberg, Hendrik W Reesink
BACKGROUND AND AIMS: Combining peginterferon alfa-2a (pegIFN) with a nucleotide analogue can result in higher rates of HBsAg loss than either therapy given alone. Here we investigated the durability of the response to combination therapy in chronic hepatitis B (CHB) patients after 5 years of follow-up. METHODS: In the initial study, 92 CHB patients (44 HBeAg positive, 48 HBeAg negative) with HBV DNA > 100,000 c/mL (~20,000 IU/mL) and active hepatitis were treated for 48 weeks with pegIFN 180 μg/week and 10 mg adefovir dipivoxil daily...
June 20, 2017: Journal of Viral Hepatitis
https://www.readbyqxmd.com/read/28390867/efficacy-and-safety-of-medi2070-an-antibody-against-interleukin-23-in-patients-with-moderate-to-severe-crohn-s-disease-a-phase-2a-study
#13
RANDOMIZED CONTROLLED TRIAL
Bruce E Sands, Jingjing Chen, Brian G Feagan, Mark Penney, William A Rees, Silvio Danese, Peter D R Higgins, Paul Newbold, Raffaella Faggioni, Kaushik Patra, Jing Li, Paul Klekotka, Chris Morehouse, Erik Pulkstenis, Jörn Drappa, René van der Merwe, Robert A Gasser
BACKGROUND & AIMS: MEDI2070 is a human monoclonal antibody that selectively inhibits interleukin 23 (IL23), a cytokine implicated in the pathogenesis of Crohn's disease (CD). We analyzed its safety and efficacy in treatment of CD in a phase 2a study. METHODS: We conducted a double-blind, placebo-controlled study of 119 adults with moderate to severe CD failed by treatment with tumor necrosis factor antagonists. Patients were randomly assigned (1:1) to groups given MEDI2070 (700 mg) or placebo intravenously at weeks 0 and 4...
July 2017: Gastroenterology
https://www.readbyqxmd.com/read/28368488/plasma-microrna-levels-are-associated-with-hepatitis-b-e-antigen-status-and-treatment-response-in-chronic-hepatitis-b-patients
#14
Meike H van der Ree, Louis Jansen, Zita Kruize, Ad C van Nuenen, Karel A van Dort, R Bart Takkenberg, Hendrik W Reesink, Neeltje A Kootstra
Background.: Hepatitis B virus (HBV) modulates microRNA (miRNA) expression to support viral replication. The aim of this study was to identify miRNAs associated with hepatitis B e antigen (HBeAg) status and response to antiviral therapy in patients with chronic hepatitis B (CHB) , and to assess if these miRNAs are actively secreted by hepatoma cells. Methods.: Plasma miRNA levels were measured by reverse-transcription quantitative polymerase chain reaction in healthy controls (n = 10) and pretreatment samples of an identification cohort (n = 24) and a confirmation cohort (n = 64) of CHB patients treated with peginterferon/nucleotide analogue combination therapy...
May 1, 2017: Journal of Infectious Diseases
https://www.readbyqxmd.com/read/28341788/discovery-and-pharmacological-characterization-of-jnj-42756493-erdafitinib-a-functionally-selective-small-molecule-fgfr-family-inhibitor
#15
Timothy P S Perera, Eleonora Jovcheva, Laurence Mevellec, Jorge Vialard, Desiree De Lange, Tinne Verhulst, Caroline Paulussen, Kelly Van De Ven, Peter King, Eddy Freyne, David C Rees, Matthew Squires, Gordon Saxty, Martin Page, Christopher W Murray, Ron Gilissen, George Ward, Neil T Thompson, David R Newell, Na Cheng, Liang Xie, Jennifer Yang, Suso J Platero, Jayaprakash D Karkera, Christopher Moy, Patrick Angibaud, Sylvie Laquerre, Matthew V Lorenzi
Fibroblast growth factor (FGF) signaling plays critical roles in key biological processes ranging from embryogenesis to wound healing and has strong links to several hallmarks of cancer. Genetic alterations in FGF receptor (FGFR) family members are associated with increased tumor growth, metastasis, angiogenesis, and decreased survival. JNJ-42756493, erdafitinib, is an orally active small molecule with potent tyrosine kinase inhibitory activity against all four FGFR family members and selectivity versus other highly related kinases...
June 2017: Molecular Cancer Therapeutics
https://www.readbyqxmd.com/read/28258356/the-role-of-initial-clinical-presentation-comorbidity-and-treatment-in-multiple-myeloma-patients-on-survival-a-detailed-population-based-cohort-study
#16
B E Oortgiesen, E N van Roon, P Joosten, R E Kibbelaar, H Storm, S Hovenga, B van Rees, G Woolthuis, N Veeger, E G de Waal, M Hoogendoorn
PURPOSE: This prospective, observational population-based cohort study was performed to determine overall survival (OS) in multiple myeloma (MM) patients in Friesland, the Netherlands, in the era of novel agents and to analyse the influence of first-line treatment, MM-related end-organ damage and comorbidities at initial presentation on OS. METHODS: Detailed clinical information was obtained from the population-based registry 'HemoBase' during the period January 2005 to January 2013, with a follow-up to January 2014...
June 2017: European Journal of Clinical Pharmacology
https://www.readbyqxmd.com/read/27923730/are-neurocognitive-factors-associated-with-repetition-of-self-harm-a-systematic-review
#17
REVIEW
Angharad N de Cates, Karen Rees, Fabrice Jollant, Benjamin Perry, Karina Bennett, Katie Joyce, Eimear Leyden, Catherine Harmer, Keith Hawton, Kees van Heeringen, Matthew R Broome
BACKGROUND: Prediction of self-harm is limited clinically. Early identification of individuals likely to repeat self-harm could improve outcomes and reduce suicide risk. Various neurocognitive deficits have been found in people who self-harm, but the ability of these to predict repetition has yet to be established AIMS: Identify neurocognitive factors that may predict repetition of self-harm. METHODS: Systematic narrative review of English language publications assessing neurocognitive functioning and self-harm repetition, searching multiple databases from inception to March 2015...
January 2017: Neuroscience and Biobehavioral Reviews
https://www.readbyqxmd.com/read/27895895/allergy-immunotherapy-across-the-life-cycle-to-promote-active-and-healthy-ageing-from-research-to-policies-an-airways-integrated-care-pathways-icps-programme-item-action-plan-b3-of-the-european-innovation-partnership-on-active-and-healthy-ageing-and-the-global
#18
REVIEW
M A Calderon, P Demoly, T Casale, C A Akdis, C Bachert, M Bewick, B M Bilò, B Bohle, S Bonini, A Bush, D P Caimmi, G W Canonica, V Cardona, A M Chiriac, L Cox, A Custovic, F De Blay, P Devillier, A Didier, G Di Lorenzo, G Du Toit, S R Durham, P Eng, A Fiocchi, A T Fox, R Gerth van Wijk, R M Gomez, T Haathela, S Halken, P W Hellings, L Jacobsen, J Just, L K Tanno, J Kleine-Tebbe, L Klimek, E F Knol, P Kuna, D E Larenas-Linnemann, A Linneberg, M Matricardi, H J Malling, R Moesges, J Mullol, A Muraro, N Papadopoulos, G Passalacqua, E Pastorello, O Pfaar, D Price, P Rodriguez Del Rio, R Ruëff, B Samolinski, G K Scadding, G Senti, M H Shamji, A Sheikh, J C Sisul, D Sole, G J Sturm, A Tabar, R Van Ree, M T Ventura, C Vidal, E M Varga, M Worm, T Zuberbier, J Bousquet
Allergic diseases often occur early in life and persist throughout life. This life-course perspective should be considered in allergen immunotherapy. In particular it is essential to understand whether this al treatment may be used in old age adults. The current paper was developed by a working group of AIRWAYS integrated care pathways for airways diseases, the model of chronic respiratory diseases of the European Innovation Partnership on active and healthy ageing (DG CONNECT and DG Santé). It considered (1) the political background, (2) the rationale for allergen immunotherapy across the life cycle, (3) the unmet needs for the treatment, in particular in preschool children and old age adults, (4) the strategic framework and the practical approach to synergize current initiatives in allergen immunotherapy, its mechanisms and the concept of active and healthy ageing...
2016: Clinical and Translational Allergy
https://www.readbyqxmd.com/read/27884935/diagnostic-value-of-exome-and-whole-genome-sequencing-in-craniosynostosis
#19
Kerry A Miller, Stephen R F Twigg, Simon J McGowan, Julie M Phipps, Aimée L Fenwick, David Johnson, Steven A Wall, Peter Noons, Katie E M Rees, Elizabeth A Tidey, Judith Craft, John Taylor, Jenny C Taylor, Jacqueline A C Goos, Sigrid M A Swagemakers, Irene M J Mathijssen, Peter J van der Spek, Helen Lord, Tracy Lester, Noina Abid, Deirdre Cilliers, Jane A Hurst, Jenny E V Morton, Elizabeth Sweeney, Astrid Weber, Louise C Wilson, Andrew O M Wilkie
BACKGROUND: Craniosynostosis, the premature fusion of one or more cranial sutures, occurs in ∼1 in 2250 births, either in isolation or as part of a syndrome. Mutations in at least 57 genes have been associated with craniosynostosis, but only a minority of these are included in routine laboratory genetic testing. METHODS: We used exome or whole genome sequencing to seek a genetic cause in a cohort of 40 subjects with craniosynostosis, selected by clinical or molecular geneticists as being high-priority cases, and in whom prior clinically driven genetic testing had been negative...
April 2017: Journal of Medical Genetics
https://www.readbyqxmd.com/read/27866504/oxytocin-reduces-face-processing-time-but-leaves-recognition-accuracy-and-eye-gaze-unaffected
#20
Kelly Hubble, Katie Daughters, Antony S R Manstead, Aled Rees, Anita Thapar, Stephanie H M van Goozen
OBJECTIVES: Previous studies have found that oxytocin (OXT) can improve the recognition of emotional facial expressions; it has been proposed that this effect is mediated by an increase in attention to the eye-region of faces. Nevertheless, evidence in support of this claim is inconsistent, and few studies have directly tested the effect of oxytocin on emotion recognition via altered eye-gaze Methods: In a double-blind, within-subjects, randomized control experiment, 40 healthy male participants received 24 IU intranasal OXT and placebo in two identical experimental sessions separated by a 2-week interval...
January 2017: Journal of the International Neuropsychological Society: JINS
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