Volume 27, Issue 1 - Vaccines and Immunotherapies

Allergen immunotherapy in the European regulatory environment

Author: Ulrike Lehnigk

Abstract

Download the full article

References

1. Pfaar O, Bonini S, Cardona V, Demoly P, Jakob T, Jutel M et al. Perspectives in allergen immunotherapy: 2017 and beyond. Allergy. 2018 Jan;73 Suppl 104:5–23.
2. Roberts G, Pfaar O, Akdis CA, Ansotegui IJ, Durham SR, van Gerth Wijk R et al. EAACI Guidelines on Allergen Immuno - therapy: Allergic rhino conjunctivitis. Allergy. 2017 Sep 23. doi:10.1111/ all.13317. [Epub ahead of print]
3. Pfaar O, Bachert C, Bufe A, Buhl R, Ebner C, Eng P et al. Guideline on allergenspecific immunotherapy in IgE-mediated allergic diseases: S2k Guideline of the German Society for Allergology and Clinical Immunology (DGAKI), the Society for Pediatric Allergy and Environmental Medicine (GPA), the Medical Association of German Allergologists (AeDA), the Austrian Society for Allergy and Immunology (ÖGAI), the Swiss Society for Allergy and Immunology (SGAI), the German Society of Dermatology (DDG), the German Society of Oto- Rhino-Laryngology, Head and Neck Surgery (DGHNO-KHC), the German Society of Pediatrics and Adolescent Medicine (DGKJ), the Society for Pediatric Pneumology (GPP), the German Respiratory Society (DGP), the German Association of ENT Surgeons (BV-HNO), the Professional Federation of Paediatricians and Youth Doctors (BVKJ), the Federal Association of Pulmonologists (BDP) and the German Dermatologists Association (BVDD). Allergo J Int. 2014;23(8):282–319.
4. Bonertz A, Roberts G, Hoefnagel M, Timon M, Slater J, Rabin R et al. Challenges in the implementation of EAACI Guidelines on Allergen Immunotherapy: A global perspective on the regulation of allergen products. Allergy. 2017 [cited 2017 Aug 11]. Allergy. 2018 Jan;73(1):64–76.
5. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the community code relating to medicinal products for human use Official Journal L - 311, 28/11/2004, p. 67-128; 2004.
6. 2001/20/EC D. Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. In: Official Journal of the European Communities. 2001. Available from: https://www.eortc.be/services/doc/clinical-eu-directive-04-april-01.pdf
7. Guideline on the clinical development of products for specific immunotherapy for the treatment of allergic diseases: European Medicines Agency (EMEA). Committee for Medicinal Products of Human Use (CHMP); 2008.
8. Passalacqua G, Baena-Cagnani CE, Bousquet J, Canonica GW, Casale TB, Cox L et al. Grading local side effects of sublingual immunotherapy for respiratory allergy: Speaking the same language. J Allergy Clin Immunol. 2013;132(1):93–8.
9. Cox L, Larenas-Linnemann D, Lockey RF, Passalacqua G. Speaking the same language: The World Allergy Organization Subcutaneous Immunotherapy Systemic Reaction Grading System. J Allergy Clin Immunol. 2010;125(3):569–74, 574.e 1-574.e7.
10. Pfaar O, Demoly P, van Gerth Wijk R, Bonini S, Bousquet J, Canonica GW et al. Recommendations for the standardization of clinical outcomes used in allergen: immunotherapy trials for allergic rhinoconjunctivitis: An EAACI Position Paper. Allergy. 2014;69(7):854–67.
11. Rösner-Friese K, Kaul S, Vieths S, Pfaar O. Environmental exposure chambers in allergen immunotherapy trials: Current status and clinical validation needs. J Allergy Clin Immunol 2015;135(3): 636–43.
12. Durham SR, Nelson HS, Nolte H, Bernstein DI, Creticos PS, Li Z et al. Magnitude of efficacy measurements in grass allergy immunotherapy trials is highly dependent on pollen exposure. Allergy. 2014;69(5):617–23.
13. Pfaar O, Hohlfeld JM, Al-Kadah B, Hauswald B, Homey B, Hunzelmann N et al. Dose-response relationship of a new Timothy grass pollen allergoid in comparison to a 6-grass pollen allergoid. Clin Exp Allergy. 2017;47(11):1445–55.
14. Corrigan CJ, Kettner J, Doemer C, Cromwell O, Narkus A. Efficacy and safety of preseasonal-specific immunotherapy with an aluminium-adsorbed six-grass pollen allergoid. Allergy. 2005;60(6): 801–7.