Comparison of allergenic extracts from different origins: the value of the FDA’s bioequivalent allergy unit (BAU)

References

• Rossi O, Massaro I, Caminati M, et al. Escaping the trap of allergic rhinitis. Clin Mol Allergy. 2015;13:17.
   PubMedGoogle Scholar
• Fajt ML, Wenzel SE. Asthma phenotypes and the use of biologic medications in asthma and allergic disease: the next steps toward personalized care. J Allergy Clin Immunol. 2015;135:299–310.
   PubMed Web of Science ®Google Scholar
• Jutel M, Kosowska A, Smolinska S. Allergen immunotherapy: past, present, and future. Allergy Asthma Immunol Res. 2016;8:191–197.
   PubMed Web of Science ®Google Scholar
• Focke M, Swoboda I, Marth K, et al. Developments in allergen-specific immunotherapy: from allergen extracts to allergy vaccines bypassing allergen-specific immunoglobulin E and T cell reactivity. Clin Exp Allergy. 2010;40:385–397.
   PubMed Web of Science ®Google Scholar
• Incorvaia C. Preventive capacity of allergen immunotherapy on the natural history of allergy. J Prev Med Hyg. 2013;54:71–74.
   PubMedGoogle Scholar
• Calderon MA, Simons FE, Malling HJ, et al. Sublingual allergen immunotherapy: mode of action and its relationship with the safety profile. Allergy. 2012;67:302–311.
   PubMed Web of Science ®Google Scholar
• Canonica GW, Cox L, Pawankar R, et al. Sublingual immunotherapy: World Allergy Organization position paper 2013 update. World Allergy Organ J. 2014;7:6.
   PubMedGoogle Scholar
• Akdis CA, Akdis M. Mechanisms of allergen-specific immunotherapy and immune tolerance to allergens. World Allergy Organ J. 2015;8:17.
   PubMed Web of Science ®Google Scholar
• Moingeon P. Update on immune mechanisms associated with sublingual immunotherapy: practical implications for the clinician. J Allergy Clin Immunol Pract. 2013;1:228–241.
   PubMed Web of Science ®Google Scholar
• Moingeon P, Mascarell L. Novel routes for allergen immunotherapy: safety, efficacy and mode of action. Immunotherapy. 2012;4:201–212.
   PubMed Web of Science ®Google Scholar
• Bachert C, Larche M, Bonini S, et al. Allergen immunotherapy on the way to product-based evaluation-a WAO statement. World Allergy Organ J. 2015;8:29.
   PubMed Web of Science ®Google Scholar
• Nelson MR, Petersen MM, Wolverton WO, et al. Allergen immunotherapy extract treatment set preparation: making a safer and higher quality product for patients. Curr Allergy Asthma Rep. 2013;13:399–405.
   PubMed Web of Science ®Google Scholar
• Calderon MA, Larenas D, Kleine-Tebbe J, et al. European Academy of Allergy and Clinical Immunology task force report on ‘dose-response relationship in allergen-specific immunotherapy’. Allergy. 2011;66:1345–1359.
   PubMed Web of Science ®Google Scholar
• Larenas-Linnemann D, Cox LS. Immunotherapy and Allergy Diagnostics Committee of the American Academy of Allergy Asthma and Immunology. European allergen extract units and potency: review of available information. Ann Allergy Asthma Immunol. 2008;100:137–145.
   PubMed Web of Science ®Google Scholar
• Sander I, Fleischer C, Meurer U, et al. Allergen content of grass pollen preparations for skin prick testing and sublingual immunotherapy. Allergy. 2009;64:1486–1492.
   PubMed Web of Science ®Google Scholar
• US Prescribing Information: Oralair® (Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract) Tablet for Sublingual Use. Stallergenes-Greer; 2014 [cited 2014 May 11]. Available from: http://oralair.com/docs/ORALAIR%20Prescribing%20Information-Med%20Guide.pdf
   Google Scholar
• Lin SY, Erekosima N, Suarez-Cuervo C, et al. Allergen-specific immunotherapy for the treatment of allergic rhinoconjunctivitis and/or asthma: comparative effectiveness review. Rockville (MD): Agency for Healthcare Research and Quality (US); 2013.
   Google Scholar
• Larenas-Linnemann DE, Mosges R. Dosing of European sublingual immunotherapy maintenance solutions relative to monthly recommended dosing of subcutaneous immunotherapy. Allergy Asthma Proc. 2016;37:50–56.
   PubMed Web of Science ®Google Scholar
• US Prescribing Information: Grastek® (Timothy Grass Pollen Allergen Extract) Tablet for Sublingual Use. ALK-Abelló/Merck; 2014 [cited 2014 May 11]. Available from: http://www.merck.com/product/usa/pi_circulars/g/grastek/grastek_pi.pdf
   Google Scholar
• Frati F, Scurati S, Puccinelli P, et al. Development of an allergen extract for sublingual immunotherapy – evaluation of Staloral. Expert Opin Biol Ther. 2009;9:1207–1215.
   PubMed Web of Science ®Google Scholar
• Durham SR, Yang WH, Pedersen MR, et al. Sublingual immunotherapy with once-daily grass allergen tablets: a randomized controlled trial in seasonal allergic rhinoconjunctivitis. J Allergy Clin Immunol. 2006;117:802–809.
   PubMed Web of Science ®Google Scholar
• Committee for Medicinal Products for Human Use (CHMP). Guideline on the Clinical Development of Products for Specific Immunotherapy for the Treatment of Allergic Diseases (CHMP/EWP/18504/2006). European Medicines Agency; 2008 [cited 2015 Sept 18]. Available from: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2009/09/WC500003605.pdf
   Google Scholar
• Guidance, compliance & regulatory information (Biologics). US Food and Drug Administration; 2015 [cited 2015 Sept 18]. Available from: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm
   Google Scholar
• Biologics part 680 – additional standards for miscellaneous products section 680.3 – tests. US Government Publishing Office; 2010 [cited 2015 Sept 18]. Available from: http://www.gpo.gov/fdsys/granule/CFR-2010-title21-vol7/CFR-2010-title21-vol7-sec680-3
   Google Scholar
• van Ree R, Chapman MD, Ferreira F, et al. The CREATE project: development of certified reference materials for allergenic products and validation of methods for their quantification. Allergy. 2008;63:310–326.
   PubMed Web of Science ®Google Scholar
• Jeong KY, Hong C-S, Lee J-S, et al. Optimization of allergen standardization. Yonsei Med J. 2011;52:393–400.
   PubMed Web of Science ®Google Scholar
• Batard T, Nony E, Hrabina M, et al. Advances in the quantification of relevant allergens in allergenic extracts. Eur Ann Allergy Clin Immunol. 2013;45(Suppl 2):33–37.
   PubMedGoogle Scholar
• Testing limits in stability protocols for standardized grass pollen extracts – guidance for industry. Center for Biologics Evaluation and Research (CBER); 2000 [cited 2015 Sept 18]. Available from: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Allergenics/ucm072426.htm
   Google Scholar
• Morrow KS, Slater JE. Regulatory aspects of allergen vaccines in the US. Clin Rev Allergy Immunol. 2001;21:141–152.
   PubMed Web of Science ®Google Scholar
• Turkeltaub PC. Biological standardization based on quantitative skin testing – the ID50EAL method (intradermal dilution for 50 mm sum of erythema diameters determines the allergy unit). Arb Paul Ehrlich Inst Georg Speyer Haus Ferdinand Blum Inst Frankf A M. 1987;80:169–173.
   PubMedGoogle Scholar
• Demoly P, Calderon MA. Dosing and efficacy in specific immunotherapy. Allergy. 2011;66(Suppl 95):38–40.
   PubMed Web of Science ®Google Scholar
• Didier A, Malling H-J, Worm M, et al. Optimal dose, efficacy, and safety of once-daily sublingual immunotherapy with a 5-grass pollen tablet for seasonal allergic rhinitis. J Allergy Clin Immunol. 2007;120:1338–1345.
   PubMed Web of Science ®Google Scholar
• Vieths S, Barber D, Chapman M, et al. Establishment of recombinant major allergens Bet v 1 and Phl p 5a as Ph. Eur. reference standards and validation of ELISA methods for their measurement. Results from feasibility studies. Pharmeur Bio Sci Notes. 2012;2012:118–134.
   PubMedGoogle Scholar
• Nelson HS, Makatsori M, Calderon MA. Subcutaneous immunotherapy and sublingual immunotherapy: comparative efficacy, current and potential indications, and warnings – United States versus Europe. Immunol Allergy Clin North Am. 2016;36:13–24.
   PubMed Web of Science ®Google Scholar
• Didier A, Malling H-J, Worm M, et al. Prolonged efficacy of the 300IR 5-grass pollen tablet up to 2 years after treatment cessation, as measured by a recommended daily combined score. Clin Transl Allergy. 2015;5:12.
   PubMed Web of Science ®Google Scholar
• Didier A, Bons B. Safety and tolerability of 5-grass pollen tablet sublingual immunotherapy: pooled analysis and clinical review. Expert Opin Drug Saf. 2015;14:777–788.
   PubMed Web of Science ®Google Scholar
• Durham SR, Emminger W, Kapp A, et al. SQ-standardized sublingual grass immunotherapy: confirmation of disease modification 2 years after 3 years of treatment in a randomized trial. J Allergy Clin Immunol. 2012;129:717–725.
   PubMed Web of Science ®Google Scholar
• Bonini S. Regulatory aspects of allergen-specific immunotherapy: Europe sets the scene for a global approach. World Allergy Organ J. 2012;5:120–123.
   PubMedGoogle Scholar
• Larenas-Linnemann D, Esch R, Plunkett G, et al. Maintenance dosing for sublingual immunotherapy by prominent European allergen manufacturers expressed in bioequivalent allergy units. Ann Allergy Asthma Immunol. 2011;107:448–458.e3.
   Web of Science ®Google Scholar
• Zimmer J, Vieths S, Kaul S. Standardization and regulation of allergen products in the European Union. Curr Allergy Asthma Rep. 2016;16:21.
   PubMed Web of Science ®Google Scholar
• Moingeon P. Biomarkers for allergen immunotherapy: a “panoromic” view. Immunol Allergy Clin North Am. 2016;36:161–179.
   PubMed Web of Science ®Google Scholar