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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/29130797/dose-finding-study-of-carbamylated-monomeric-allergoid-tablets-in-grass-allergic-rhinoconjunctivitis-patients
#2
Ralph Mösges, Christina Rohdenburg, Andrea Eichel, Gregor Zadoyan, Elena-Manja Kasche, Kija Shah-Hosseini, Walter Lehmacher, Petra Schmalz, Enrico Compalati
AIM: To determine the optimal effective and safe dose of sublingual immunotherapy tablets containing carbamylated monomeric allergoids in patients with grass pollen-induced allergic rhinoconjunctivitis. METHODS: In this prospective, randomized, double-blind, active-controlled, multicenter, Phase II study, four different daily doses were applied preseasonally for 12 weeks. RESULTS: Of 158 randomized adults, 155 subjects (safety population) received 300 units of allergy (UA)/day (n = 36), 600 UA/day (n = 43), 1000 UA/day (n = 39), or 2000 UA/day (n = 37)...
November 2017: Immunotherapy
https://www.readbyqxmd.com/read/29128092/quality-requirements-for-allergen-extracts-and-allergoids-for-allergen-immunotherapy
#3
REVIEW
J Zimmer, A Bonertz, S Vieths
All allergen products for allergen immunotherapy currently marketed in the European Union are pharmaceutical preparations derived from allergen-containing source materials like pollens, mites and moulds. Especially this natural origin results in particular demands for the regulatory requirements governing allergen products. Furthermore, the development of regulatory requirements is complicated by the so far missing universal link between certain quality parameters, in particular biological potency, on the one hand and clinical efficacy on the other hand...
November 8, 2017: Allergologia et Immunopathologia
https://www.readbyqxmd.com/read/28941667/advances-and-highlights-in-allergen-immunotherapy-on-the-way-to-sustained-clinical-and-immunologic-tolerance
#4
Margot Berings, Cagatay Karaaslan, Can Altunbulakli, Philippe Gevaert, Mübeccel Akdis, Claus Bachert, Cezmi A Akdis
Allergen immunotherapy (AIT) is an effective treatment strategy for allergic diseases and has been used for more than 100 years. In recent years, however, the expectations on concepts, conduct, statistical evaluation, and reporting have developed significantly. Products have undergone dose-response and confirmative studies in adults and children to provide evidence for the optimal dosage, safety, and efficacy of AIT vaccines using subcutaneous and sublingual delivery pathways in large patient cohorts, ensuring solid conclusions to be drawn from them for the advantage of patients and societies alike...
November 2017: Journal of Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/28696503/dose-response-relationship-of-a-new-timothy-grass-pollen-allergoid-in-comparison-with-a-6-grass-pollen-allergoid
#5
O Pfaar, J M Hohlfeld, B Al-Kadah, B Hauswald, B Homey, N Hunzelmann, S Schliemann, P Velling, M Worm, L Klimek
BACKGROUND: Subcutaneous allergen immunotherapy with grass pollen allergoids has been proven to be effective and safe in the treatment of patients with allergic rhinoconjunctivitis. Based on the extensive cross-reactivity among Pooideae species, it has been suggested that grass pollen extracts could be prepared from a single species, rather than from a multiple species mixture. OBJECTIVE: To find the optimal dose of a Phleum pratense (P. pratense) allergoid preparation and compare its efficacy and safety to a 6-grass pollen allergoid preparation...
November 2017: Clinical and Experimental Allergy: Journal of the British Society for Allergy and Clinical Immunology
https://www.readbyqxmd.com/read/28675499/ultra-short-course-booster-is-effective-in-recurrent-grass-pollen-induced-allergic-rhinitis
#6
O Pfaar, S Lang, U Pieper-Fürst, A Astvatsatourov, F Gerich, L Klimek, M F Kramer, Y Reydelet, K Shah-Hosseini, R Mösges
BACKGROUND: A relevant proportion of allergic rhinitis (AR) patients experience recurrent symptoms after successfully completing allergen immunotherapy (AIT). This prospective, controlled, non-interventional study used internationally standardised instruments to determine the clinical effects of a preseasonal, ultra-short-course booster AIT on clinical outcome parameters. METHODS: This two-arm study included patients aged ≥12 years with recurrent grass pollen-induced seasonal AR who had completed a successful course of any grass pollen AIT at least five years before enrolment...
July 4, 2017: Allergy
https://www.readbyqxmd.com/read/28532268/allergen-immunotherapy-in-allergic-rhinitis-current-use-and-future-trends
#7
Ludger Klimek, Oliver Pfaar, Jean Bousquet, Gabriela Senti, Thomas Kündig
Type-1 allergies are among the most chronic common diseases of humans. Allergen immunotherapy (AIT) is the only causative and disease-modifying treatment option besides allergen avoidance. Severe systemic adverse allergic reactions may be induced by every AIT treatment. Different approaches have been used to provide safer AIT preparations to lower or even totally overcome this risk. Areas covered: A structured literature recherche in Medline and Pubmed under inclusion of national and international guidelines and Cochrane meta-analyses has been performed aiming at reviewing clinical use of such approaches in AIT...
September 2017: Expert Review of Clinical Immunology
https://www.readbyqxmd.com/read/28451054/molecular-fingerprinting-of-complex-grass-allergoids-size-assessments-reveal-new-insights-in-epitope-repertoires-and-functional-capacities
#8
S Starchenka, A J Bell, J Mwange, M A Skinner, M D Heath
BACKGROUND: Subcutaneous allergen immunotherapy (SCIT) is a well-documented treatment for allergic disease which involves injections of native allergen or modified (allergoid) extracts. The use of allergoid vaccines is a growing sector of the allergy immunotherapy market, associated with shorter-course therapy. The aim of this study was the structural and immunological characterisation of group 1 (Lol p 1) IgG-binding epitopes within a complex mix grass allergoid formulation containing rye grass...
2017: World Allergy Organization Journal
https://www.readbyqxmd.com/read/28380494/accelerated-up-dosing-of-subcutaneous-immunotherapy-with-a-registered-allergoid-birch-pollen-preparation
#9
RANDOMIZED CONTROLLED TRIAL
Krzysztof Buczyłko, Jan F van der Werf, Diderik Boot, Ronald van Ree
BACKGROUND: Early pollen flight and new allergens prolonging the pollen season means that the time for up-dosing of allergen-specific subcutaneous immunotherapy (SCIT) outside the pollen season becomes shorter. Hence, for patients who wish or need to be up-dosed faster, an accelerated induction regimen would provide a useful treatment option. METHODS: An accelerated up-dosing regimen (0.1-0.3-0.5 mL at weekly intervals) was compared to conventional up-dosing (0...
2017: International Archives of Allergy and Immunology
https://www.readbyqxmd.com/read/28235411/in-vitro-evidence-of-efficacy-and-safety-of-a-polymerized-cat-dander-extract-for-allergen-immunotherapy
#10
María Morales, Mayte Gallego, Victor Iraola, Marta Taulés, Eliandre de Oliveira, Raquel Moya, Jerónimo Carnés
BACKGROUND: Allergy to cat epithelia is highly prevalent, being the major recommendation for allergy sufferers its avoidance. However, this is not always feasible. Allergen specific immunotherapy is therefore recommended for these patients. The use of polymerized allergen extracts, allergoids, would allow to achieve the high allergen doses suggested to be effective while maintaining safety. RESULTS: Cat native extract and its depigmented allergoid were manufactured and biochemically and immunochemically characterized...
February 24, 2017: BMC Immunology
https://www.readbyqxmd.com/read/28219062/the-impact-on-allergy-related-cells-of-a-birch-pollen-allergoid-with-and-without-monophosphoryl-lipid-a-in-comparison-with-the-native-equivalent
#11
Margitta Worm, Dennis Ernst, Markus Kraller, Magda Babina
BACKGROUND: The clinical efficacy and safety of allergoid immunotherapy have been demonstrated in clinical trials. However, simultaneous monitoring of the immunological changes by allergoids versus allergens in the cells of the same individual has not been extensively performed, and the impact of concurrent Toll-like receptor 4 (TLR4) ligation has not been specified. METHODS: Three types of birch allergen were utilized: glutaraldehyde-treated allergoid (extract A), the same allergoid plus monophosphoryl lipid A (MPL), i...
2017: International Archives of Allergy and Immunology
https://www.readbyqxmd.com/read/28141955/investigational-new-drugs-for-allergic-rhinitis
#12
REVIEW
Peter A Ricketti, Sultan Alandijani, Chen Hsing Lin, Thomas B Casale
Allergic rhinitis (AR) is a multifactorial disease characterized by paroxysmal symptoms of sneezing, rhinorrhea, postnasal drip and nasal congestion. For over a century, subcutaneous allergen immunotherapy (SCIT) has been recognized as the most effective therapy to date that may modify the underlying disease course and provide long-term benefits for individuals refractory to pharmacotherapy. However, over the past 25 years, there has been substantial growth in developing alternative therapies to traditional SCIT...
March 2017: Expert Opinion on Investigational Drugs
https://www.readbyqxmd.com/read/28133873/the-future-of-immunotherapy-for-canine-atopic-dermatitis-a-review
#13
REVIEW
Douglas J DeBoer
Allergen specific immunotherapy (ASIT) is a foundation treatment for canine atopic dermatitis (CAD), though few critical studies have documented its effectiveness as a disease-modifying treatment in dogs. The mechanisms by which ASIT works in dogs have not been elucidated, although they are likely to parallel those known for humans. Current ASIT approaches in CAD focus on either subcutaneous or sublingual administration. Greater knowledge of major allergens in dogs, ideal dosage regimes and details of allergen admixture are likely to lead to better efficacy in CAD...
February 2017: Veterinary Dermatology
https://www.readbyqxmd.com/read/28124639/new-routes-of-allergen-immunotherapy
#14
REVIEW
Mitat Aricigil, Nuray Bayar Muluk, Engin Umut Sakarya, Emine Güven Sakalar, Mehmet Senturk, William R Reisacher, Cemal Cingi
OBJECTIVES: Allergen immunotherapy is the only cure for immunoglobulin E mediated type I respiratory allergies. Subcutaneous immunotherapy (SCIT) and sublingual immunotherapy (SLIT) are the most common treatments. In this article, we reviewed new routes of allergen immunotherapy. METHODS: Data on alternative routes to allow intralymphatic immunotherapy (ILIT), epicutaneous immunotherapy (EPIT), local nasal immunotherapy (LNIT), oral immunotherapy (OIT), and oral mucosal immunotherapy (OMIT) were gathered from the literature and were discussed...
November 1, 2016: American Journal of Rhinology & Allergy
https://www.readbyqxmd.com/read/27637414/the-european-survey-on-adverse-systemic-reactions-in-allergen-immunotherapy-eassi-a-paediatric-assessment
#15
Pablo Rodríguez Del Río, Carmen Vidal, Jocelyne Just, Ana I Tabar, Inmaculada Sanchez-Machin, Peter Eberle, Jesus Borja, Petra Bubel, Oliver Pfaar, Pascal Demoly, Moises A Calderón
BACKGROUND: Safety data on 'real-life' allergen immunotherapy (AIT) in children and adolescents is usually extrapolated from studies in adults. METHODS: Patients aged 18 or under initiating aeroallergen AIT were evaluated in a prospective European survey. Patient profiles and systemic reactions (SRs) were recorded. Descriptive, univariate and multivariate analyses were used to identify risk factors for SRs. RESULTS: A total of 1563 patients (mean ± SD age: 11...
February 2017: Pediatric Allergy and Immunology
https://www.readbyqxmd.com/read/27605897/specific-immunotherapy-with-mugwort-pollen-allergoid-reduce-bradykinin-release-into-the-nasal-fluid
#16
Radoslaw Gawlik, Alicja Grzanka, Barbara Jawor, Eugeniusz Czecior
INTRODUCTION: A pathomechanism of allergic rhinitis is complex. A neurogenic mechanism seems to play a significant role in this phenomenon. AIM: The evaluation of influence of specific immunotherapy of mugwort pollen allergic patients on the bradykinin concentration in the nasal lavage fluid. MATERIAL AND METHODS: The study included 22 seasonal allergic rhinitis patients. Thirty persons with monovalent allergy to mugwort pollen, confirmed with skin prick tests and allergen-specific immunoglobulin E, underwent a 3-year-long allergen immunotherapy with the mugwort extract (Allergovit, Allergopharma, Germany)...
August 2016: Postȩpy Dermatologii i Alergologii
https://www.readbyqxmd.com/read/27499704/vitamin-d3-improves-the-effects-of-low-dose-der-p-2-allergoid-treatment-in-der-p-2-sensitized-balb-c-mice
#17
Claudia Petrarca, Emanuela Clemente, Valentina Amato, Alessia Gatta, Sara Cortese, Alessia Lamolinara, Cosmo Rossi, Stefania Zanotta, Gianni Mistrello, Roberto Paganelli, Mario Di Gioacchino
BACKGROUND: Airborne allergens can induce an immunological chronic disease characterized by airway hyper responsiveness and inflammation, mediated by exaggerated Th2 immune response. Allergen-specific immunotherapy (AIT) is effective for treating this condition because it is able to modify its natural course by opposing the underlying pathogenic mechanisms and determining immune suppression, immune deviation and tolerance. The rational for the present study was to investigate the possibility of improving allergoid-based IT in terms of efficacy and safety...
2016: Clinical and Molecular Allergy: CMA
https://www.readbyqxmd.com/read/27388990/a-novel-microcrystalline-tyrosine-adsorbed-mite-allergoid-subcutaneous-immunotherapy-1-year-follow-up-report
#18
Albert Roger, Nathalie Depreux, Yanina Jurgens, Aina T Serra, Matthew D Heath, Gloria Garcia, Murray A Skinner
AIM: A 1-year follow-up study comparing the safety and tolerability of the dosing schedules, satisfaction and effectiveness of a novel microcrystalline tyrosine-adsorbed mite (Dermatophagoides pteronyssinus)-allergoid subcutaneous immunotherapy (Acarovac Plus™) in 30 adult patients (18-65 years) with allergic rhinitis and/or asthma. MATERIALS & METHODS: The effectiveness of the product was assessed by nasal provocation test measuring peak nasal inspiratory flow/symptoms, in vitro immunologic changes (IgE, IgG4 and IL-10) and Treatment Satisfaction Questionnaire for Medication...
October 2016: Immunotherapy
https://www.readbyqxmd.com/read/27188493/specific-immunotherapy-for-rhinitis-and-asthma-with-a-subcutaneous-hypoallergenic-high-dose-house-dust-mite-extract-results-of-a-9-month-therapy
#19
David El-Qutob, Francisco Moreno, Alicia Subtil-Rodríguez
AIM: Effectiveness of a 9-month specific immunotherapy with a subcutaneous hypoallergenic high-dose house dust mite extract to reduce allergic symptoms as perceived by patients and physicians was assessed. PATIENTS & METHODS: An observational, retrospective, multicenter study was carried out in patients diagnosed with asthma and/or rhinitis caused by house dust mites having started specific immunotherapy with Acaroid(®). Primary end point was perceived effectiveness...
July 2016: Immunotherapy
https://www.readbyqxmd.com/read/27177779/novel-vaccines-targeting-dendritic-cells-by-coupling-allergoids-to-nonoxidized-mannan-enhance-allergen-uptake-and-induce-functional-regulatory-t%C3%A2-cells-through-programmed-death-ligand-1
#20
Sofía Sirvent, Irene Soria, Cristina Cirauqui, Bárbara Cases, Ana I Manzano, Carmen M Diez-Rivero, Pedro A Reche, Juan López-Relaño, Eduardo Martínez-Naves, F Javier Cañada, Jesús Jiménez-Barbero, Javier Subiza, Miguel Casanovas, Enrique Fernández-Caldas, José Luis Subiza, Oscar Palomares
BACKGROUND: Allergen immunotherapy (AIT) is the only curative treatment for allergy. AIT faces pitfalls related to efficacy, security, duration, and patient compliance. Novel vaccines overcoming such inconveniences are in demand. OBJECTIVES: We sought to study the immunologic mechanisms of action for novel vaccines targeting dendritic cells (DCs) generated by coupling glutaraldehyde-polymerized grass pollen allergoids to nonoxidized mannan (PM) compared with glutaraldehyde-polymerized allergoids (P) or native grass pollen extracts (N)...
August 2016: Journal of Allergy and Clinical Immunology
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