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Margitta Worm, Sabina Rak, Boleslaw Samoliński, Jukka Antila, Ann-Sofi Höiby, Brigitte Kruse, Agnieszka Lipiec, Michael Rudert, Erkka Valovirta
BACKGROUND: Previous clinical trials with birch pollen subcutaneous immunotherapy have been conducted over a 1-2 year treatment period and involved mostly a single geographic location. OBJECTIVE: This study (EudraCT-Number: 2005-000025-35) intended to evaluate the effect of subcutaneous immunotherapy with high-dose hypoallergenic birch pollen allergoid in patients with confirmed moderate to severe seasonal allergic rhinitis/rhinoconjunctivitis over a 3-year course in 19 European centers...
December 20, 2018: Clinical and Experimental Allergy: Journal of the British Society for Allergy and Clinical Immunology
Cristina Benito-Villalvilla, Irene Soria, José Luis Subiza, Oscar Palomares
Allergen-specific immunotherapy (AIT) is the single disease-modifying treatment for allergy. Clinical trials show AIT to be safe and effective for many patients; however, it still faces problems related to efficacy, safety, long treatment duration and low patient adherence. There has been intensive research to develop alternative strategies, including novel administration routes, adjuvants or hypoallergenic molecules. Promising results are reported for some of them, but clinical progress is still moderate...
2018: Allergo Journal International
Ludger Klimek, Gabriele-Cornelia Fox, Susanne Thum-Oltmer
Background: Efficacy of house dust mite (HDM) allergen immunotherapy (AIT) in allergic rhinitis and controlled allergic asthma has been documented in controlled trials with adults and children. However, tolerability comparing clinical development and post marketing data, particularly in different subgroups, is missing. Methods: We performed an analysis of pooled safety data for subcutaneous AIT (SCIT) with a high-dose house dust mite allergoid from 6 randomized, controlled trials (RCT) in HDM allergic respiratory disease (ARD) and of post marketing safety data from more than 10 years including different subgroups (age, gender, asthma status)...
2018: Allergo Journal International
José-Luis González, Vicente Zalve, Enrique Fernández-Caldas, Bárbara Cases, José-Luis Subiza, Miguel Casanovas
BACKGROUND: Polymerized allergoids coupled to nonoxidized mannan (PM-allergoids) are novel allergen preparations used for immunotherapy. OBJECTIVE: To evaluate PM-allergoids as an alternative immunotherapy for dogs with canine atopic dermatitis (cAD) associated with serological responses to Dermatophagoides farinae allergens. ANIMALS: Sixteen dogs with history and clinical signs of cAD; positive on serum allergen specific IgE testing to D...
October 2018: Veterinary Dermatology
Ulrich Wahn, Claus Bachert, Joachim Heinrich, Hartmut Richter, Stefan Zielen
BACKGROUND: Real-world evidence is sparse on the benefits of allergen immunotherapy [AIT; subcutaneous/sublingual immunotherapy (SCIT/SLIT)], the only disease-modifying intervention for allergic rhinitis (AR) with long-term efficacy. This real-life study evaluated the effect of 6 AITs (native pollen SLIT/SCIT, 4 allergoid SCITs) versus symptomatic medication use, on AR symptoms and asthma symptoms/onset, in patients with birch pollen-associated AR and/or asthma. METHODS: In this retrospective cohort analysis of a German longitudinal prescription database, AIT patients received ≥2 successive seasonal treatment cycles; non-AIT patients had ≥3 AR prescriptions in 3 seasons or previous month...
September 5, 2018: Allergy
Marek Jutel, Michael Rudert, Fabian Kreimendahl, Piotr Kuna
AIM: This multicenter randomized placebo-controlled double-blind clinical trial investigated which maintenance dose shows the optimal benefit-risk ratio for subcutaneous immunotherapy with a Dermatophagoides pteronyssinus allergoid preparation. OBJECTIVE: To evaluate four maintenance doses of the allergoid preparation versus placebo. METHODS: The late-phase reaction of the intracutaneous test was chosen as efficacy parameter and minimal dose of fluticasone required for asthma control...
August 9, 2018: Immunotherapy
C Caruso, L Borgonovo, B Bramé, A Cocconcelli, S Colantuono, M Piantanida, S Scarpa, G Zisa, A Romano
No abstract text is available yet for this article.
August 2018: Journal of Investigational Allergology & Clinical Immunology
Natasha C Gunawardana, Stephen R Durham
OBJECTIVE: New insights into mechanisms should enable strategic improvement of allergen immunotherapy, aiming to make it safer, faster, more effective, and able to induce long-term tolerance. We review novel approaches with potential to translate into clinical use. DATA SOURCES: Database searches were conducted in PubMed, Scopus, and Google Scholar. STUDY SELECTIONS: Search terms were based on current and novel approaches in immunotherapy...
September 2018: Annals of Allergy, Asthma & Immunology
Janina Köther, Alicia Mandl, Silke Allekotte, Anatoli Astvatsatourov, Janin Chwieralski, Jan-Patrick Liedtke, Ursula Pieper-Fürst, Esther Raskopf, Kija Shah-Hosseini, Ralph Mösges
Background: Clinical practice needs a common parameter that can provide an early, reliable estimation of the outcome of sublingual immunotherapy (SLIT) in an upcoming pollen season. We investigated whether the conjunctival provocation test (CPT) can predict the beneficial outcome of SLIT in patients with allergic rhinoconjunctivitis after 4 weeks of treatment. Methods: We conducted two separate prospective, randomized, double-blind, placebo-controlled, multicenter trials...
2018: Clinical and Translational Allergy
M Worm, T Higenbottam, O Pfaar, R Mösges, W Aberer, K Gunawardena, D Wessiepe, D Lee, M F Kramer, M Skinner, B Lees, S Zielen
BACKGROUND: The Birch Allergoid, Tyrosine Adsorbate, Monophosphoryl Lipid A (POLLINEX® Quattro Plus 1.0 ml Birch 100%) is an effective, well-tolerated short course subcutaneous immunotherapy. We performed 2 phase II studies to determine its optimal cumulative dose. METHODS: The studies were conducted in Germany, Austria and Poland (EudraCT numbers: 2012-004336-28 PQBirch203 and 2015-000984-15 PQBirch204) using a wide range of cumulative doses. In both studies, subjects were administered 6 therapy injections weekly outside the pollen season...
September 2018: Allergy
Mohana Rajakulendran, Elizabeth Huiwen Tham, Jian Yi Soh, H P Van Bever
Conventional immunotherapy (IT) for optimal control of respiratory and food allergies has been fraught with concerns of efficacy, safety, and tolerability. The development of adjuvants to conventional IT has potentially increased the effectiveness and safety of allergen IT, which may translate into improved clinical outcomes and sustained unresponsiveness even after cessation of therapy. Novel strategies incorporating the successful use of adjuvants such as allergoids, immunostimulatory DNA sequences, monoclonal antibodies, carriers, recombinant proteins, and probiotics have now been described in clinical and murine studies...
April 2018: Asia Pacific Allergy
R S Mueller, E Jensen-Jarolim, F Roth-Walter, E Marti, J Janda, A A Seida, D DeBoer
In human patients with seasonal allergic rhinoconjunctivitis sensitized to grass pollen, the first successful allergen immunotherapy (AIT) was reported in 1911. Today, immunotherapy is an accepted treatment for allergic asthma, allergic rhinitis and hypersensitivities to insect venom. AIT is also used for atopic dermatitis and recently for food allergy. Subcutaneous, epicutaneous, intralymphatic, oral and sublingual protocols of AIT exist. In animals, most data are available in dogs where subcutaneous AIT is an accepted treatment for atopic dermatitis...
October 2018: Allergy
Jeronimo Carnes, Maria T Gallego, Raquel Moya, Victor Iraola
Background Chemically modified allergen extracts, known as allergoids, are commonly used for treating allergic patients. In general terms, the concept of allergoids implies allergen extracts with a reduction of their allergenicity maintaining their immunogenicity. Different methods to obtain allergoids have been developed in the past years, opening attractive lines of research. Objective To review the different approaches to allergoid development as well as their characterization, mechanism of action and efficacy and safety issues...
February 21, 2018: Recent Patents on Inflammation & Allergy Drug Discovery
Pattraporn Satitsuksanoa, Anna Głobińska, Kirstin Jansen, Willem van de Veen, Mübeccel Akdis
PURPOSE OF REVIEW: During the past few decades, modified allergens have been developed for use in allergen-specific immunotherapy (AIT) with the aim to improve efficacy and reduce adverse effects. This review aims to provide an overview of the different types of modified allergens, their mechanism of action and their potential for improving AIT. RECENT FINDINGS: In-depth research in the field of allergen modifications as well as the advance of recombinant DNA technology have paved the way for improved diagnosis and research on human allergic diseases...
February 16, 2018: Current Allergy and Asthma Reports
Andrzej Bożek, Izabella Krupa-Borek, Jerzy Jarzab
Introduction: It is valuable to determine the long-term efficacy of allergen-specific immunotherapy (SIT) and whether it can cure allergy. Aim: For this study, patients were prospectively observed for 20 years after completion of SIT to determine its effectiveness. Material and methods: A total of 1006 patients who underwent SIT for pollen allergy were observed for 20 years to assess the efficacy of SIT. The rhinitis symptom score (RSS) and asthma symptom score (ASS) were measured after SIT completion...
December 2017: Postȩpy Dermatologii i Alergologii
Giovanni Passalacqua, Diego Bagnasco, Matteo Ferrando, Enrico Heffler, Francesca Puggioni, Giorgio Walter Canonica
OBJECTIVE: Allergen-specific immunotherapy (AIT) in its subcutaneous and sublingual forms is currently a well-established and experimentally supported treatment for respiratory allergy and hymenoptera venom allergy. There have been advances in its use linked strictly to the advancement in the knowledge of the molecular mechanisms of allergy, the production of well-characterized extracts, and diagnostic techniques. The use of AIT in asthma and the application of new approaches are expanding...
February 2018: Annals of Allergy, Asthma & Immunology
J P Sola, Y Pedreño, A Cerezo, M Peñalver-Mellado
BACKGROUND: Allergy to cats is a frequent cause of sensitization to indoor allergens and currently there are few alternatives to specific immunotherapy with cat native extracts. The objective is to develop and characterize a new allergoid to increase the tools available for use in clinical practice. METHODS: The allergoid cat dander extract (ACD) was developed from a native cat dander extract (NCD) by modification with glutaraldehyde, and the optimal process control was determined by SDS-PAGE, DOT BLOT and determination of free amine groups...
September 2018: Allergologia et Immunopathologia
I Soria, J López-Relaño, M Viñuela, J-I Tudela, A Angelina, C Benito-Villalvilla, C M Díez-Rivero, B Cases, A I Manzano, E Fernández-Caldas, M Casanovas, O Palomares, J L Subiza
BACKGROUND: Polymerized allergoids coupled to nonoxidized mannan (PM-allergoids) may represent novel vaccines targeting dendritic cells (DCs). PM-allergoids are better captured by DCs than native allergens and favor Th1/Treg cell responses upon subcutaneous injection. Herein we have studied in mice the in vivo immunogenicity of PM-allergoids administered sublingually in comparison with native allergens. METHODS: Three immunization protocols (4-8 weeks long) were used in Balb/c mice...
April 2018: Allergy
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...
April 2018: Allergy
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
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