An EAACI “European Survey on Adverse Systemic Reactions in Allergen Immunotherapy (EASSI)”: the methodology

Clinical and Translational Allergy

Pascal Demoly⁶  Allan Linneberg¹  Oliver Pfaar²  Jocelyne Just⁵  Carmen Vidal³  Pablo Rodríguez del Río⁴  Moises A Calderón⁷ 

[1] Department of Clinical Medicine, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark;Center for Rhinology and Allergology, Department of Otorhinolaryngology, Head and Neck Surgery, University Hospital Mannheim, Wiesbaden, Germany;Allergy Department, Complejo Hospitalario Universitario de Santiago, Santiago de Compostela, Spain;Allergy Section, Hospital Infantil Universitario Niño Jesús, Madrid, Spain;Allergology Department, Centre de l’Asthme et des Allergies. Hôpital d’Enfants Armand-Trousseau (APHP)-Sorbonne Universités, UPMC Univ Paris 06, UMR_S 1136, Institut Pierre Louis d’Epidémiologie et de Santé Publique, Equipe EPAR, Paris, F-75013 75571 Cedex 12, France;Département de Pneumologie et Addictologie, Hôpital Arnaud de Villeneuve, University Hospital of Montpellier, Sorbonne Universités, UPMC Paris 06, UMR-S 1136, IPLESP, Equipe EPAR, 75013 Paris, France;Section of Allergy and Clinical Immunology, Imperial College London, National Heart and Lung Institute, Royal Brompton Hospital, London, UK

关键词: Sublingual;    Subcutaneous;    Allergen immunotherapy;    Adverse systemic reactions;    Allergen;   

Others  :  1092784
DOI  :  10.1186/2045-7022-4-22

 received in 2014-04-03, accepted in 2014-07-15,  发布年份 2014

【 摘 要 】

At present, there is no European report on clinically relevant systemic reactions due to the regular use of allergen immunotherapy (AIT), administered either subcutaneously or sublingually (SCIT and SLIT, respectively) outside clinical trials. Using an electronic survey and a “harmonised terminology” according to MedDRA, we aimed to prospectively collect systemic adverse reactions due to AIT from real life clinical settings.

Under the framework of the EAACI, a team of European specialists in AIT, pharmacovigilance, epidemiology and drugs regulation set up a web-based prospective pilot survey to be conducted in three European countries (France, Germany and Spain). A designated “national coordinator” was responsible for following ethics requirements relative to each country and to select at least 30 doctors per country.

Patients were recruited the same day they received their first dose of either SCIT or SLIT. Patient inclusion criteria were: adults and children, with IgE mediated pollen, house dust mite, Alternaria, and/or animal dander respiratory allergies who will initiate AIT.

A list of 31 symptoms terms were extracted from the MedDRA (Medical Dictionary for Regulatory Activities) dictionary to harmonize the reporting of all adverse systemic reactions in this survey.

The SurveyMonkey® online instrument was used by participant doctors to submit information directly to a blinded central database.

Three questionnaires were generated: i) the Doctor Questionnaire, ii) the Patient Questionnaire and iii) the Adverse Reaction Questionnaire. A handbook and a mistake report form were given to each doctor.

In this paper, we describe the methodology followed.

【 授权许可】

   
2014 Calderón et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

【 参考文献 】

• [1]Bousquet J, Lockey R, Malling HJ: Allergen immunotherapy: therapeutic vaccines for allergic diseases. A WHO position paper. J Allergy Clin Immunol 1998, 102(4 Pt 1):558-562. Review
• [2]Durham SR, Walker SM, Varga EM, Jacobson MR, O’Brien F, Noble W, Till SJ, Hamid QA, Nouri-Aria KT: Long-term clinical efficacy of grass-pollen immunotherapy. N Engl J Med 1999, 341(7):468-475.
• [3]Calderón MA, Casale TB, Togias A, Bousquet J, Durham SR, Demoly P: Allergen-specific immunotherapy for respiratory allergies: from meta-analysis to registration and beyond. J Allergy Clin Immunol 2011, 127(1):30-38.
• [4]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 report. J Allergy Clin Immunol 2013, 131(5):1288-1296.
• [5]Roy SR, Sigmon JR, Olivier J, Moffitt JE, Brown DA, Marshall GD: Increased frequency of large local reactions among systemic reactors during subcutaneous allergen immunotherapy. Ann Allergy Asthma Immunol 2007, 99(1):82-86.
• [6]Greenberg MA, Kaufman CR, Gonzalez GE, Rosenblatt CD, Smith LJ, Summers RJ: Late and immediate systemic-allergic reactions to inhalant allergen immunotherapy. J Allergy Clin Immunol 1986, 77(6):865-870.
• [7]Epstein TG, Liss GM, Murphy-Berendts K, Bernstein DI: AAAAI and ACAAI surveillance study of subcutaneous immunotherapy, year 3: what practices modify the risk of systemic reactions? Ann Allergy Asthma Immunol 2013, 110(4):274-278.
• [8]CSM Update: Desensitising vaccines. Br Med J (Clin Res Ed) 1986, 293:948.
• [9]Lockey RF, Benedict LM, Turkeltaub PC, Bukantz SC: Fatalities from immuno- therapy (IT) and skin testing (ST). J Allergy Clin Immunol 1987, 79:660-677.
• [10]Reid MJ, Lockey RF, Turkeltaub PC, Platts-Mills TA: Survey of fatalities from skin testing and immunotherapy 1985–1989. J Allergy Clin Immunol 1993, 92(1 Pt 1):6-15.
• [11]Bernstein DI, Wanner M, Borish L, Liss GM, Immunotherapy Committee: Twelve-year survey of fatal reactions to allergen injections and skin testing: 1990–2001. J Allergy Clin Immunol 2004, 113(6):1129-1136.
• [12]Rezvani M, Bernstein DI: Anaphylactic reactions during immunotherapy. Immunol Allergy Clin North Am 2007, 27(2):295-307. viii
• [13]Schiappoli M, Ridolo E, Senna G, Alesina R, Antonicelli L, Asero R, Costantino MT, Longo R, Musarra A, Nettis E, Crivellaro M, Savi E, Massolo A, Passalacqua G: A prospective Italian survey on the safety of subcutaneous immunotherapy for respiratory allergy. Clin Exp Allergy 2009, 39(10):1569-1574.
• [14]Calderón MA, Simons FE, Malling HJ, Lockey RF, Moingeon P, Demoly P: Sublingual allergen immunotherapy: mode of action and its relationship with the safety profile. Allergy 2012, 67(3):302-311.
• [15]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):569-574.
• [16]Calderon MA, Alves B, Jacobson M, Hurwitz B, Sheikh A, Durham SR: Allergen injection immunotherapy for seasonal allergic rhinitis. Cochrane Database Syst Rev 2007., 1CD001936
• [17]Abramson MJ, Puy RM, Weiner JM: Injection allergen immunotherapy for asthma. Cochrane Database Syst Rev 2010., 8CD001186
• [18]Radulovic S, Wilson D, Calderon M, Durham S: Systematic reviews of sublingual immunotherapy (SLIT). Allergy 2011, 66(6):740-752.
• [19]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 trials. Ann Allergy Asthma Immunol 2006, 97(2):141-148.
• [20]Calamita Z, Saconato H, Pelá AB, Atallah AN: Efficacy of sublingual immunotherapy in asthma: systematic review of randomized-clinical trials using the Cochrane Collaboration method. Allergy 2006, 61(10):1162-1172.
• [21]Penagos M, Passalacqua G, Compalati E, Baena-Cagnani CE, Orozco S, Pedroza A, Canonica GW: Meta-analysis of the efficacy of sublingual immunotherapy in the treatment of allergic asthma in pediatric patients, 3 to 18 years of age. Chest 2008, 133(3):599-609.
• [22]Bousquet J, Lockey R, Malling HJ, Alvarez-Cuesta E, Canonica GW, Chapman MD, Creticos PJ, Dayer JM, Durham SR, Demoly P, Goldstein RJ, Ishikawa T, Ito K, Kraft D, Lambert PH, Løwenstein H, Müller U, Norman PS, Reisman RE, Valenta R, Valovirta E, Yssel H: Allergen immunotherapy: therapeutic vaccines for allergic diseases. World Health Organization. American Academy of Allergy, Asthma and Immunology. Ann Allergy Asthma Immunol 1998, 81(5 Pt 1):401-405. Review
• [23]van Cauwenberge P, Bachert C, Passalacqua G, Bousquet J, Canonica GW, Durham SR, Fokkens WJ, Howarth PH, Lund V, Malling HJ, Mygind N, Passali D, Scadding GK, Wang DY: Consensus statement on the treatment of allergic rhinitis. European Academy of Allergology and Clinical Immunology. Allergy 2000, 55(2):116-134.
• [24]Alvarez-Cuesta E, Bousquet J, Canonica GW, Durham SR, Malling HJ, Valovirta E, EAACI: Standards for practical allergen-specific immunotherapy. Allergy 2006, 61(Suppl 82):1-20.
• [25]Passalacqua G, Baena-Cagnani CE, Bousquet J, Canonica GW, Casale TB, Cox L, Durham SR, Larenas-Linnemann D, Ledford D, Pawankar R, Potter P, Rosario N, Wallace D, Lockey RF: Grading local side effects of sublingual immunotherapy for respiratory allergy: speaking the same language. J Allergy Clin Immunol 2013, 132(1):93-98.
• [26]Medical Dictionary for Regulatory Activities Website [http://www.meddra.org webcite]
• [27]SurveyMonkey Website [http://www.surveymonkey.com webcite]
• [28]Eysenbach G: Improving the quality of web surveys: the checklist for reporting results of internet e-surveys (CHERRIES). J Med Internet Res 2004, 6(3):e34.