High-dose sublingual immunotherapy with single-dose aqueous grass pollen extract in children is effective and safe: A double-blind, placebo-controlled study

Journal of Allergy and Clinical Immunology

Volumn 130, Issue 4, 2012, Pages

  Wahn, Ulrich ^a   Klimek, Ludger ^b   Ploszczuk, Anna ^c   Adelt, Thomas ^d,e   Sandner, Bernhard ^d,e   Trebas Pietras, Ewa ^f   Eberle, Peter ^g   Bufe, Albrecht ^e,h  

^a CHARITÉ UNIVERSITÄTSMEDIZIN BERLIN   (Germany)

^b Center for Rhinology and Allergology   (Germany)

^c MEDICAL UNIVERSITY OF BIALYSTOK   (Poland)

^d Pediatric Centre   (Germany)

^e Network of Pediatricians for Clinical Studies   (Germany)

^f Health Care Center for Allergology Pulmonology   (Poland)

^g Pediatric Centre Allergology Pediatric Pneumology and General Medicine   (Germany)

^h RUHR UNIVERSITY BOCHUM   (Germany)

Author keywords

Allergic rhinitis rhinoconjunctivitis; Children; Double blind placebo controlled trial; Efficacy; Grass pollen; High dose; Pre co seasonal treatment; Safety; Single dose; Sublingual immunotherapy

Indexed keywords

GRASS POLLEN EXTRACT; IMMUNOGLOBULIN E; IMMUNOGLOBULIN G; IMMUNOMODULATING AGENT; PLACEBO;

ALLERGIC RHINITIS; APPLICATION SITE REACTION; ARTICLE; ASTHMA; CHILD; CONTROLLED STUDY; COUGHING; DOUBLE BLIND PROCEDURE; DRUG EFFICACY; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; DYSPNEA; EAR PRURITUS; FEMALE; HUMAN; INNER EAR DISEASE; MAJOR CLINICAL STUDY; MALE; MULTICENTER STUDY; NAUSEA AND VOMITING; OUTCOME ASSESSMENT; PRESCHOOL CHILD; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; RHINOCONJUNCTIVITIS; SCHOOL CHILD; SIDE EFFECT; SINGLE DRUG DOSE; SKIN DISEASE; SNEEZING; SUBLINGUAL IMMUNOTHERAPY; THROAT IRRITATION; TREATMENT RESPONSE;

EID: 84869120896     PISSN: 00916749     EISSN: 10976825     Source Type: Journal    
DOI: 10.1016/j.jaci.2012.06.047     Document Type: Article

References (33)

1. Canonica GW, Bousquet J, Casale T, Lockey RF, Baena-Cagnani CE, Pawankar R, et al. Sub-lingual immunotherapy: World Allergy Organization Position Paper 2009. Allergy 2009;64(S91):1-59.
2. Passalacqua G, Canonica GW. Sublingual immunotherapy for allergic respiratory diseases: Efficacy and safety. Immunol Allergy Clin North Am 2011;31:265-77.
3. Larenas-Linnemann DE, Cox LS. Sublingual immunotherapy for asthma: Need for high quality meta-analyses to prove the concept. Allergy 2007;62:704-5.
4. Nieto A, Mazon A, Pamies R, Bruno L, Navarro M, Montanes A. Sublingual immunotherapy for allergic respiratory diseases: An evaluation of meta-analyses. J Allergy Clin Immunol 2009;124:157-61.
5. Di Bona D, Plaia A, Scafidi V, Leto-Barone MS, Di Lorenzo G. Efficacy of sublingual immunotherapy with grass allergens for seasonal allergic rhinitis: A systematic review and meta-analysis. J Allergy Clin Immunol 2010;126:558-66.
6. Wilson DR, Torres Lima M, Durham SR. Sublingual immunotherapy for allergic rhinitis: Systematic review and meta-analysis. Allergy 2005;60:4-12.
7. Radulovic S, Wilson D, Calderon M, Durham S. Systematic reviews of sublingual immunotherapy (SLIT). Allergy 2011;66:740-52.
8. Cox L. Sublingual immunotherapy in pediatric allergic rhinitis and asthma: Efficacy, safety, and practical considerations. Curr Allergy Asthma Rep 2007;7:410-20.
9. Larenas-Linnemann D. Sublingual immunotherapy in children: Complete and updated review supporting evidence of effect. Curr Opin Allergy Clin Immunol 2009;9:168-76.
10. Larenas-Linnemann D. Sublingual immunotherapy in children: More optimism today. Pediatr Allergy Immunol 2009;20:399-400.
11. Akdis CA, Akdis M. Mechanisms of allergen-specific immunotherapy. J Allergy Clin Immunol 2011;127:18-27.
12. Didier A, Malling HJ, Worm M, Horak F, Jager S, Montagut A, 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;120:1338-45.
13. Durham SR, Yang WH, Pedersen MR, Johansen N, Rak S. Sublingual immunotherapy with once-daily grass allergen tablets: A randomized controlled trial in seasonal allergic rhinoconjunctivitis. J Allergy Clin Immunol 2006;117:802-9.
14. Calderon MA, Larenas D, Kleine-Tebbe J, Jacobsen L, Passalacqua G, Eng PA, et al. European Academy of Allergy and Clinical Immunology task force report on 'dose-response relationship in allergen-specific immunotherapy'. Allergy 2011;66:1345-59.
15. Worm M. Efficacy and tolerability of high dose sublingual immunotherapy in patients with rhinoconjunctivitis. Eur Ann Allergy Clin Immunol 2006;38:355-60.
16. European Medicines Agency. Guideline on the Clinical Development of Products for Specific Immunotherapy for the Treatment of Allergic Diseases. London, 20 November 2008. Doc. Ref. CHMP/EWP/18504/2006.
17. Hafner D, Reich K, Matricardi PM, Meyer H, Kettner J, Narkus A. Prospective validation of 'Allergy-Control-SCORETM': A novel symptom-medication score for clinical trials. Allergy 2011;66:629-36.
18. Canonica GW, Baena-Cagnani CE, Bousquet J, Bousquet PJ, Lockey RF, Malling HJ, et al. Recommendations for standardization of clinical trials with Allergen Specific Immunotherapy for respiratory allergy. A statement of a World Allergy Organization (WAO) taskforce. Allergy 2007;62:317-24.
19. Casale TB, Canonica GW, Bousquet J, Cox L, Lockey R, Nelson HS, et al. Recommendations for appropriate sublingual immunotherapy clinical trials. J Allergy Clin Immunol 2009;124:665-70.
20. Bousquet J, Schunemann HJ, Bousquet PJ, Bachert C, Canonica GW, Casale TB, et al. How to design and evaluate randomized controlled trials in immunotherapy for allergic rhinitis: An ARIA-GA(2) LEN statement. Allergy 2011;66:765-74.
21. Bousquet PJ, Brozek J, Bachert C, Bieber T, Bonini S, Burney P, et al. The CONSORT statement checklist in allergen-specific immunotherapy: A GA2LEN paper. Allergy 2009;64:1737-45.
22. EMA/PDCO Standard Paediatric Investigation Plan for Allergen Products for Specific Immunotherapy. 3 March 2010. EMA/PDCO/737605/2009.
23. Blaiss M, Maloney J, Nolte H, Gawchik S, Yao R, Skoner DP. Efficacy and safety of timothy grass allergy immunotherapy tablets in North American children and adolescents. J Allergy Clin Immunol 2011;127:64-71.
24. Bufe A, Eberle P, Franke-Beckmann E, Funck J, Kimmig M, Klimek L, et al. Safety and efficacy in children of an SQ-standardized grass allergen tablet for sublingual immunotherapy. J Allergy Clin Immunol 2009;123:167-73.
25. Wahn U, Tabar A, Kuna P, Halken S, Montagut A, de Beaumont O, et al. Efficacy and safety of 5-grass-pollen sublingual immunotherapy tablets in pediatric allergic rhinoconjunctivitis. J Allergy Clin Immunol 2009;123:160-6.
26. Sander I, Fleischer C, Meurer U, Bruning T, Raulf-Heimsoth M. Allergen content of grass pollen preparations for skin prick testing and sublingual immunotherapy. Allergy 2009;64:1486-92.
27. Lombardi C, Incorvaia C, Braga M, Senna G, Canonica GW, Passalacqua G. Administration regimens for sublingual immunotherapy to pollen allergens: What do we know? Allergy 2009;64:849-54.
28. Dahl R, Kapp A, Colombo G, de Monchy JG, Rak S, Emminger W, et al. Sublingual grass allergen tablet immunotherapy provides sustained clinical benefit with progressive immunologic changes over 2 years. J Allergy Clin Immunol 2008; 121:512-8.
29. Durham SR, Emminger W, Kapp A, Colombo G, de Monchy JG, Rak S, et al. Long-term clinical efficacy in grass pollen-induced rhinoconjunctivitis after treatment with SQ-standardized grass allergy immunotherapy tablet. J Allergy Clin Immunol 2010;125:131-8.
30. Senna G, Lombardi C, Canonica GW, Passalacqua G. How adherent to sublingual immunotherapy prescriptions are patients? The manufacturers' viewpoint. J Allergy Clin Immunol 2010;126:668-9.
31. Pfaar O, Kleine-Tebbe J, Hormann K, Klimek L. Allergen-specific immunotherapy: Which outcome measures are useful in monitoring clinical trials? Immunol Allergy Clin North Am 2011;31:289-309.
32. Novak N, Bieber T, Allam JP. Immunological mechanisms of sublingual allergenspecific immunotherapy. Allergy 2011;66:733-9.
33. Calderon MA, Gerth van Wijk R, Eichler I, Matricardi PM, Varga EM, Kopp MV, et al. Perspectives on allergen-specific immunotherapy in childhood: An EAACI position statement. Pediatr Allergy Immunol 2012;23:300-6.