Sublingual immunotherapy: World Allergy Organization position paper 2013 update

Abstract

We have prepared this document, "Sublingual Immunotherapy: World Allergy Organization Position Paper 2013 Update", according to the evidence-based criteria, revising and updating chapters of the originally published paper, "Sublingual Immunotherapy: World Allergy Organization Position Paper 2009", available at http://www.waojournal.org. Namely, these comprise: "Mechanisms of sublingual immunotherapy;" "Clinical efficacy of sublingual immunotherapy" - reporting all the data of all controlled trials published after 2009; "Safety of sublingual immunotherapy" - with the recently published Grading System for adverse reactions; "Impact of sublingual immunotherapy on the natural history of respiratory allergy" - with the relevant evidences published since 2009; "Efficacy of SLIT in children" - with detailed analysis of all the studies; "Definition of SLIT patient selection" - reporting the criteria for eligibility to sublingual immunotherapy; "The future of immunotherapy in the community care setting"; "Methodology of clinical trials according to the current scientific and regulatory standards"; and "Guideline development: from evidence-based medicine to patients' views" - including the evolution of the methods to make clinical recommendations.Additionally, we have added new chapters to cover a few emerging crucial topics: "Practical aspects of schedules and dosages and counseling for adherence" - which is crucial in clinical practice for all treatments; "Perspectives and new approaches" - including recombinant allergens, adjuvants, modified allergens, and the concept of validity of the single products. Furthermore, "Raising public awareness about sublingual immunotherapy", as a need for our patients, and strategies to increase awareness of allergen immunotherapy (AIT) among patients, the medical community, all healthcare stakeholders, and public opinion, are also reported in detail.

Shown for reading. Its publisher allows quoting it, not republishing it.

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     de Bot CM Moed H Berger MY Roder E de Groot H de Jongste JC van Wijk RG van der Wouden JC Randomized double-blind placebo-controlled trial of sublingual immunotherapy in children with house dust mite allergy in primary care: study design and recruitmentBMC Fam Pract2008 759

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     Berto P Frati F Incorvaia C Cadario G Contiguglia R Di Gioacchino M Puccinelli P Senna GE Valle C Comparison of costs of sublingual immunotherapy and drug treatment in grass-pollen induced allergy: results from the SIMAP database studyCurr Med Res Opin2008 7261266

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     Brüggenjürgen B Reinhold T Brehler R Laake E Wiese G Machate U Willich SN Cost-effectiveness of specific subcutaneous immunotherapy in patients with allergic rhinitis and allergic asthmaAnn Allergy Asthma Immunol2008 7316324

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196. 196.

     Canonica GW Poulsen PB Vestenbaek U Cost-effectiveness of GRAZAX for prevention of grass pollen induced rhinoconjunctivitis in Southern EuropeRespir Med2007 718851894

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198. 198.

     Mösges R Brüning H Hessler HJ Gotz G Knaussmann HG Sublingual immunotherapy in pollen-induced seasonal rhinitis and conjunctivitis: a randomized controlled trialActa Dermatovenerol Alp Panonica Adriat2007 7143148

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     Antúnez C Mayorga C Corzo JL Jurado A Torres MJ Two year follow-up of immunological response in mite-allergic children treated with sublingual immunotherapy. Comparison with subcutaneous administrationPediatr Allergy Immunol2008 7210218

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     Cadario G Galluccio AG Pezza M Appino A Milani M Pecora S Mastrandrea F Sublingual immunotherapy efficacy in patients with atopic dermatitis and house dust mites sensitivity: a prospective pilot studyCurr Med Res Opin2007 725032506

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     Marogna M Bruno M Massolo A Falagiani P Long-lasting effects of sublingual immunotherapy for house dust mites in allergic rhinitis with bronchial hyperreactivity: a long-term (13-year) retrospective study in real lifeInt Arch Allergy Immunol2007 77078

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     Pajno GB Caminiti L Vita D Barberio G Salzano G Lombardo F Canonica GW Passalacqua G Sublingual immunotherapy in mite-sensitized children with atopic dermatitis: a randomized, double-blind, placebo-controlled studyJ Allergy Clin Immunol2007 7164170

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     Marogna M Spadolini I Massolo A Zanon P Berra D Chiodini E Canonica WG Passalacqua G Effects of sublingual immunotherapy for multiple or single allergens in polysensitized patientsAnn Allergy Asthma Immunol2007 7274280

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     Bousquet PJ Calderon MA Demoly P Larenas D Passalacqua G Bachert C Brozek J Canonica GW Casale T Fonseca J Dahl R Durham SR Merk H Worm M Wahn U Zuberbier T Schunemann HJ Bousquet J The Consolidated Standards of Reporting Trials (CONSORT) Statement applied to allergen-specific immunotherapy with inhalant allergens: a Global Allergy and Asthma European Network (GA(2)LEN) articleJ Allergy Clin Immunol2011 7495656 e41-11

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     Bousquet PJ Brozek J Bachert C Bieber T Bonini S Burney P Calderon M Canonica GW Compalati E Daures JP Delgado L Demoly P Dahl R Durham SR Kowalski ML Malling HJ Merk H Papadopoulos N Passalacqua G Simon HU Worms M Wahn U Zuberbier T Schunemann HJ Bousquet J The CONSORT statement checklist in allergen-specific immunotherapy: a GA2LEN paperAllergy2009 717371745

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     Bousquet J Schunemann HJ Bousquet PJ Bachert C Canonica GW Casale TB Demoly P Durham S Carlsen KH Malling HJ Passalacqua G Simons FE Anto J Baena-Cagnani CE Bergmann KC Bieber T Briggs AH Brozek J Calderon MA Dahl R Devillier P Gerth van Wijk R Howarth P Larenas D Papadopoulos NG Schmid-Grendelmeier P Zuberbier T How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: an ARIA-GA(2)LEN statementAllergy2011 7765774

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     Howarth P Malling HJ Molimard M Devillier P Analysis of allergen immunotherapy studies shows increased clinical efficacy in highly symptomatic patientsAllergy2012 7321327

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     Kulis M Saba K Kim EH Bird JA Kamilaris N Vickery BP Staats H Burks AW Increased peanut-specific IgA levels in saliva correlate with food challenge outcomes after peanut sublingual immunotherapyJ Allergy Clin Immunol2012 711591162

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     Narisety SD Keet CA Sublingual vs oral immunotherapy for food allergy: identifying the right approachDrugs2012 719771989

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     Cortellini G Spadolini I Santucci A Cova V Conti C Corvetta A Passalacqua G Improvement of shrimp allergy after sublingual immunotherapy for house dust mites: a case reportEur Ann Allergy Clin Immunol2011 7162164

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     Mauro M Russello M Incorvaia C Gazzola G Frati F Moingeon P Passalacqua G Birch-apple syndrome treated with birch pollen immunotherapyInt Arch Allergy Immunol2011 7416422

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     Nucera E Aruanno A Rizzi A Buonomo A Pecora V Colagiovanni A Pascolini L Ricci AG Schiavino D Profilin desensitization in two patients with plant-derived food allergyInt J Immunopathol Pharmacol2012 7531535

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     Compalati E Rogkakou A Passalacqua G Canonica GW Evidences of efficacy of allergen immunotherapy in atopic dermatitis: an updated reviewCurr Opin Allergy Clin Immunol2012 7427433

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     Lasa Luaces EM Tabar Purroy AI Garcia Figueroa BE Anda Apinaniz M Sanz Laruga ML Raulf-Heimsoth M Barber Hernandez D Component-resolved immunologic modifications, efficacy, and tolerance of latex sublingual immunotherapy in childrenAnn Allergy Asthma Immunol2012 7367372

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     Gastaminza G Algorta J Uriel O Audicana MT Fernandez E Sanz ML Munoz D Randomized, double-blind, placebo-controlled clinical trial of sublingual immunotherapy in natural rubber latex allergic patientsTrials2011 7191

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     van Ree R Chapman MD Ferreira F Vieths S Bryan D Cromwell O Villalba M Durham SR Becker WM Aalbers M Andre C Barber D Cistero Bahima A Custovic A Didierlaurent A Dolman C Dorpema JW Di Felice G Eberhardt F Fernandez Caldas E Fernandez Rivas M Fiebig H Focke M Fotisch K Gadermaier G Das RG Gonzalez Mancebo E Himly M Kinaciyan T Knulst AC The CREATE project: development of certified reference materials for allergenic products and validation of methods for their quantificationAllergy2008 7310326

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     Chapman MD Ferreira F Villalba M Cromwell O Bryan D Becker WM Fernandez-Rivas M Durham S Vieths S van Ree R The European Union CREATE project: a model for international standardization of allergy diagnostics and vaccinesJ Allergy Clin Immunol2008 7882889e882

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     Bousquet J Anto JM Demoly P Schunemann HJ Togias A Akdis M Auffray C Bachert C Bieber T Bousquet PJ Carlsen KH Casale TB Cruz AA Keil T Lodrup Carlsen KC Maurer M Ohta K Papadopoulos NG Roman Rodriguez M Samolinski B Agache I Andrianarisoa A Ang CS Annesi-Maesano I Ballester F Baena-Cagnani CE Basagana X Bateman ED Bel EH Bedbrook A Severe chronic allergic (and related) diseases: a uniform approach–a MeDALL–GA2LEN–ARIA position paperInt Arch Allergy Immunol2012 7216231

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     Braido F Bousquet PJ Brzoza Z Canonica GW Compalati E Fiocchi A Fokkens W Gerth van Wijk R La Grutta S Lombardi C Maurer M Pinto AM Ridolo E Senna GE Terreehorst I Todo Bom A Bousquet J Zuberbier T Baiardini I Specific recommendations for PROs and HRQoL assessment in allergic rhinitis and/or asthma: a GA(2)LEN taskforce position paperAllergy2010 7959968

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     Senna G Ridolo E Calderon M Lombardi C Canonica GW Passalacqua G Evidence of adherence to allergen-specific immunotherapyCurr Opin Allergy Clin Immunol2009 7544548

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288. 288.

     Larenas-Linnemann D Ortega-Martell JA Del Rio-Navarro B Rodriguez-Perez N Arias-Cruz A Estrada A Becerril-Angeles M Pietropaolo-Cienfuegos DR Ambriz-Moreno Mde J Baez-Loyola C Cossio-Ochoa E Gonzalez-Diaz SN Hidalgo-Castro EM Huerta-Hernandez RE Macias-Weinmann A Oyoqui-Flores J Stone-Aguilar H Trevino-Salinas MB Zarate-Hernandez Mdel C [Mexican clinical practice guidelines of immunotherapy 2011]Rev Alerg Mex2011 7375

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     Subspecialty Group of RhinologyExpert consensus on allergen specific immunotherapy of allergic rhinitisZhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi [Chinese Journal of Otorhinolaryngology Head and Neck Surgery]2011 712976980[Article in Chinese]

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     Valovirta E Korhonen K Kuitunen M Kukkonen-Harjula K Lammintausta K Pallasaho P Ralli P Savolainen J Toskala E Virtanen T [Update on current care guidelines: allergen specific immunotherapy]Duodecim; laaketieteellinen aikakauskirja2012 7108109

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     Bousquet J Van Cauwenberge P Khaltaev N Allergic rhinitis and its impact on asthmaJ Allergy Clin Immunol2001 7S147S334

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     Brozek JL Bousquet J Baena-Cagnani CE Bonini S Canonica GW Casale TB van Wijk RG Ohta K Zuberbier T Schunemann HJ Global A, Asthma European N, Grading of Recommendations Assessment D, Evaluation Working G: Allergic Rhinitis and its Impact on Asthma (ARIA) guidelines: 2010 revisionJ Allergy Clin Immunol2010 7466476

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     Zuberbier T Bachert C Bousquet PJ Passalacqua G Walter Canonica G Merk H Worm M Wahn U Bousquet J GA(2) LEN/EAACI pocket guide for allergen-specific immunotherapy for allergic rhinitis and asthmaAllergy2010 715251530

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294. 294.

     Krishna MT Ewan PW Diwakar L Durham SR Frew AJ Leech SC Nasser SM British Society for A, Clinical I: Diagnosis and management of hymenoptera venom allergy: British Society for Allergy and Clinical Immunology (BSACI) guidelinesClin Exp Allergy2011 712011220

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295. 295.

     Ring J Alomar A Bieber T Deleuran M Fink-Wagner A Gelmetti C Gieler U Lipozencic J Luger T Oranje AP Schafer T Schwennesen T Seidenari S Simon D Stander S Stingl G Szalai S Szepietowski JC Taieb A Werfel T Wollenberg A Darsow U European Dermatology F, European Academy of D, Venereology, European Task Force on Atopic D, European Federation of A, European Society of Pediatric D, Global A, Asthma European N: guidelines for treatment of atopic eczema (atopic dermatitis) Part IIJournal of the European Academy of Dermatology and Venereology: JEADV2012 711761193

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296. 296.

     Coifman RE Cox LS American Academy of Allergy, Asthma & Immunology member immunotherapy practice patterns and concernsJ Allergy Clin Immunol2006 711910121013

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297. 297.

     Sikora JM Tankersley MS Immunotherapy A Diagnostics C Perception and practice of sublingual immunotherapy among practicing allergists in the United States: a follow-up surveyAnn Allergy Asthma Immunol2013 7194197e194

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298. 298.

     Tucker MH Tankersley MS Perception and practice of sublingual immunotherapy among practicing allergistsAnn Allergy Asthma Immunol2008 7419425

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299. 299.

     Bernstein DI Blaiss MS Cox LS Finegold I Lanier BQ Nelson HS Wallace DV Current standards and future directions in immunotherapy: perspectives on challenges and opportunities for the allergistAnn Allergy Asthma Immunol2011 7422425

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     Antonicelli L Braschi MC Bilo MB Angino A Pala AP Baldacci S Maio S Bonifazi F Congruence between international guidelines and mite specific immunotherapy prescribing practicesRespir Med2011 714411448

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301. 301.

     Bernstein DI Epstein T Murphy-Berendts K Liss GM Surveillance of systemic reactions to subcutaneous immunotherapy injections: year 1 outcomes of the ACAAI and AAAAI collaborative studyAnn Allergy Asthma Immunol2010 7530535

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302. 302.

     Scadding GK Brostoff J Low dose sublingual therapy in patients with allergic rhinitis due to house dust miteClin Allergy1986 7483491

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303. 303.

     Larenas-Linneman D Cox LS European allergen extract units and potency: review of available informationAnn Allergy Asthma Immunol2008 72137145

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304. 304.

     Sander I Fleischer C Meurer U Bruning T Raulf-Heimsoth M Allergen content of grass pollen preparations for skin prick testing and sublingual immunotherapyAllergy2009 714861492

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305. 305.

     Distler A Lumovic J [Majorallergenbestimmung: publizierte Daten aus sublingualen Allergenpräparaten (AP) bei Gräserpollen (Phelum pratense, Phl p 5) und Birkenpollen (Betula verrucosa, Bet v1) von verschiedenen Herstellern im Vergleich zu Messergebnissen aus externen Laboratorien]Allergo J2011 7S41S42

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     van den Hout R Peekel I Busch M Kervliet E Amount of major allergen Phl p 5 and allergen activity in different European products for sublingual immunotherapy (317)Allergy2010 7Suppl 92133

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     Kerkvliet E Peekel I van Tuyn J Sleijster H van den Hout R Amount of major allergen Bet v 1 and allergen activity in different European products for sublingual immunotherapyAllergy2011 7Suppl 94622623

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     Pfaar O Klimek L Subcutaneous and sublingual immunotherapy [in German]CME2010 7 doi:10.1007/s11298-11010-10657-11295

     Not in our library

309. 309.

     Pfaar O Klimek L [Specific immunotherapy for allergic rhinitis. Current methods and innovative developments]HNO2008 7764775

     Not in our library10.1007/s00106-008-1732-z

310. 310.

     Osterberg L Blaschke T Adherence to medicationN Engl J Med2005 7487497

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311. 311.

     Lombardi C Gani F Landi M Falagiani P Bruno M Canonica GW Passalacqua G Quantitative assessment of the adherence to sublingual immunotherapyJ Allergy Clin Immunol2004 712191220

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312. 312.

     Marogna M Spadolini I Massolo A Canonica GW Passalacqua G Randomized controlled open study of sublingual immunotherapy for respiratory allergy in real-life: clinical efficacy and moreAllergy2004 712051210

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313. 313.

     Passalacqua G Musarra A Pecora S Amoroso S Antonicelli L Cadario G Di Gioacchino M Lombardi C Ridolo E Sacerdoti G Schiavino D Senna G Quantitative assessment of the compliance with a once-daily sublingual immunotherapy regimen in real life (EASY Project: Evaluation of A novel SLIT formulation during a Year)J Allergy Clin Immunol2006 7946948

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314. 314.

     Passalacqua G Musarra A Pecora S Amoroso S Antonicelli L Cadario G Di Gioacchino M Lombardi C Ridolo E Sacerdoti G Schiavino D Senna G Quantitative assessment of the compliance with once-daily sublingual immunotherapy in children (EASY project: evaluation of a novel SLIT formulation during a year)Pediatr Allergy Immunol2007 75862

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315. 315.

     Röder E Berger MY de Groot H Gerth van Wijk R Sublingual immunotherapy in youngsters: adherence in a randomized clinical trialClin Exp Allergy2008 716591667

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316. 316.

     Egert-Schmidt A Martin E Mueller J Schulte M Thum-Oltmer S Patients’ compliance towards high-dose hypoallergenic and unmodified SCIT treatment schedules is superior to sublingual immunotherapy [abstract 1669]Allergy2011 7628629

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     Kiel MA Roder E Gerth van Wijk R Al MJ Hop WC Rutten-van Molken MP Real-life compliance and persistence among users of subcutaneous and sublingual allergen immunotherapyJ Allergy Clin Immunol2013 7353360e352

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318. 318.

     Incorvaia C Rapetti A Scurati S Puccinelli P Capecce M Frati F Importance of patient’s education in favouring compliance with sublingual immunotherapyAllergy2010 713411342

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319. 319.

     Jansen A Andersen KF Bruning H Evaluation of a compliance device in a subgroup of adult patients receiving specific immunotherapy with grass allergen tablets (GRAZAX) in a randomized, open-label, controlled study: an a priori subgroup analysisClin Ther2009 7321327

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320. 320.

     Senna G Caminati M Canonica GW Safety and tolerability of sublingual immunotherapy in clinical trials and real lifeCurr Opin Allergy Clin Immunol2013 7656662

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321. 321.

     Valenta R Campana R Marth K van Hage M Allergen-specific immunotherapy: from therapeutic vaccines to prophylactic approachesJ Intern Med2012 7144157

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322. 322.

     Cromwell O Hafner D Nandy A Recombinant allergens for specific immunotherapyJ Allergy Clin Immunol2011 7865872

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323. 323.

     Braido F Holgate S Canonica GW From “blockbusters” to “biosimilars”: an opportunity for patients, medical specialists and health care providersPulm Pharmacol Ther2012 7483486

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324. 324.

     Allam JP Peng WM Appel T Wenghoefer M Niederhagen B Bieber T Berge S Novak N Toll-like receptor 4 ligation enforces tolerogenic properties of oral mucosal Langerhans cellsJ Allergy Clin Immunol2008 7368374e361

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325. 325.

     Moingeon P Lombardi V Saint-Lu N Tourdot S Bodo V Mascarell L Adjuvants and vector systems for allergy vaccinesImmunol Allergy Clin North Am2011 7407419xii

     Not in our library10.1016/j.iac.2011.03.001

326. 326.

     Smits HH Engering A van der Kleij D de Jong EC Schipper K van Capel TM Zaat BA Yazdanbakhsh M Wierenga EA van Kooyk Y Kapsenberg ML Selective probiotic bacteria induce IL-10-producing regulatory T cells in vitro by modulating dendritic cell function through dendritic cell-specific intercellular adhesion molecule 3-grabbing nonintegrinJ Allergy Clin Immunol2005 712601267

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     Pizza M Giuliani MM Fontana MR Monaci E Douce G Dougan G Mills KH Rappuoli R Del Giudice G Mucosal vaccines: non toxic derivatives of LT and CT as mucosal adjuvantsVaccine2001 725342541

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328. 328.

     Saint-Lu N Tourdot S Razafindratsita A Mascarell L Berjont N Chabre H Louise A Van Overtvelt L Moingeon P Targeting the allergen to oral dendritic cells with mucoadhesive chitosan particles enhances tolerance inductionAllergy2009 710031013

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329. 329.

     Uddowla S Freytag LC Clements JD Effect of adjuvants and route of immunizations on the immune response to recombinant plague antigensVaccine2007 779847993

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330. 330.

     Mistrello G Brenna O Roncarolo D Zanoni D Gentili M Falagiani P Monomeric chemically modified allergens: immunologic and physicochemical characterizationAllergy1996 7815

     Not in our library10.1111/j.1398-9995.1996.tb04543.x

331. 331.

     Cosmi L Santarlasci V Angeli R Liotta F Maggi L Frosali F Rossi O Falagiani P Riva G Romagnani S Annunziato F Maggi E Sublingual immunotherapy with dermatophagoides monomeric allergoid down-regulates allergen-specific immunoglobulin E and increases both interferon-gamma- and interleukin-10-productionClin Exp Allergy2006 7261272

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332. 332.

     Passalacqua G Albano M Fregonese L Riccio A Pronzato C Mela GS Canonica GW Randomised controlled trial of local allergoid immunotherapy on allergic inflammation in mite-induced rhinoconjunctivitisLancet1998 7629632

     Not in our library10.1016/s0140-6736(97)07055-4

333. 333.

     Bagnasco M Mariani G Passalacqua G Motta C Bartolomei M Falagiani P Mistrello G Canonica GW Absorption and distribution kinetics of the major Parietaria judaica allergen (Par j 1) administered by noninjectable routes in healthy human beingsJ Allergy Clin Immunol1997 7122129

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334. 334.

     Burks AW Calderon MA Casale T Cox L Demoly P Jutel M Nelson H Akdis CA Update on allergy immunotherapy: American Academy of Allergy, Asthma & Immunology/European Academy of Allergy and Clinical Immunology/PRACTALL consensus reportJ Allergy Clin Immunol2013 712881296e1283

     Not in our library10.1016/j.jaci.2013.01.049

335. 335.

     Penagos M Compalati E Tarantini F Baena-Cagnani R Huerta J Passalacqua G Canonica GW Efficacy of sublingual immunotherapy in the treatment of allergic rhinitis in pediatric patients 3 to 18 years of age: a meta-analysis of randomized, placebo-controlled, double-blind trialsAnn Allergy Asthma Immunol2006 7141148

     Not in our library10.1016/s1081-1206(10)60004-x

336. 336.

     Penagos M Passalacqua G Compalati E Baena-Cagnani CE Orozco S Pedroza A Canonica GW Metaanalysis of the efficacy of sublingual immunotherapy in the treatment of allergic asthma in pediatric patients, 3 to 18 years of ageChest2008 7599609

     Not in our library10.1378/chest.06-1425

337. 337.

     Bachert C Canonica GW Bufe A SIT: efficacy depends on product, not on route of applicationPediatr Allergy Immunol2012 7401author reply 401-402

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338. 338.

     Sade K Berkun Y Dolev Z Shalit M Kivity S Knowledge and expectations of patients receiving aeroallergen immunotherapyAnn Allergy Asthma Immunol2003 7444448

     Not in our library10.1016/s1081-1206(10)61511-6

339. 339.

     Baiardini I Puggioni F Menoni S Boot JD Diamant Z Braido F Canonica GW Patient knowledge, perceptions, expectations and satisfaction on allergen-specific immunotherapy: a surveyRespir Med2013 7361367

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340. 340.

     Calderon MA Demoly P Gerth Van Wijk R Bousquet J Sheikh A Frew A Scadding G Bachert C Malling HJ Valenta R Bilo B Nieto A Akdis C Just J Vidal C Varga EM Alvarez-Cuesta E Bohle B Bufe A Canonica WG Cardona V Dahl R Didier A Durham SR Eng P Fernandez-Rivas M Jacobsen L Jutel M Kleine-Tebbe J Klimek L EAACI: A European Declaration on Immunotherapy. Designing the future of allergen specific immunotherapyClin Transl Allergy2012 720

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     Pawankar R, Canonica GW, Holgate ST, Lockey RFWorld Allergy Organization (WAO) White Book on Allergy2011 Milwaukee, WI: WAO

     Not in our library

Cited by papers we hold 5

• Modulating Th2 Cell Immunity for the Treatment of Asthma · 2021
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• Research Progress in Atopic March · 2020
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• Allergic rhinitis · 2018
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• Mechanisms of allergen-specific immunotherapy and immune tolerance to allergens · 2015
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• A WAO - ARIA - GA²LEN consensus document on molecular-based allergy diagnostics · 2013
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