An observational, real-life safety study of a 5-grass pollen sublingual tablet in children and adolescents

Pediatric Allergy and Immunology

Volumn 25, Issue 8, 2014, Pages 760-766

  Eberle, Peter ^a   Brueck, Helmut ^b   Gall, Ralph ^c   Hadler, Meike ^d   Sieber, Jochen ^d   Karagiannis, Efstrathios ^d  

^a Private Office   (Germany)

^b Private Office   (Germany)

^c Private Office   (Germany)

^d Stallergenes GmbH   (Germany)

Author keywords

Adolescents; Allergen immunotherapy; Allergic rhinitis; Children; Grass pollen sublingual tablet; Safety; Sublingual immunotherapy; Tolerability

Indexed keywords

GRASS POLLEN EXTRACT; ALLERGEN; TABLET;

ABDOMINAL PAIN; ADOLESCENT; ALLERGIC RHINITIS; ANGIONEUROTIC EDEMA; APPLICATION SITE IRRITATION; ARTICLE; ASTHMA; ATOPIC DERMATITIS; CHEILITIS; CHILD; CHILD SAFETY; CLINICAL PRACTICE; CLINICAL PROTOCOL; CONJUNCTIVITIS; CONTROLLED STUDY; COUGHING; DISEASE EXACERBATION; DIZZINESS; DRUG DOSE TITRATION; DRUG EFFICACY; DRUG ERUPTION; DRUG HYPERSENSITIVITY; DRUG INDUCED HEADACHE; DRUG SAFETY; DRUG SURVEILLANCE PROGRAM; DRUG TOLERABILITY; DRUG WITHDRAWAL; DYSPNEA; EAR DISEASE; EAR PRURITUS; FEMALE; FOREIGN BODY REACTION; GASTROINTESTINAL DISEASE; HAND DISEASE; HOT FLUSH; HUMAN; INNER EAR DISEASE; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; MEDICATION COMPLIANCE; MOUTH DISCOMFORT; MOUTH DISEASE; MOUTH EDEMA; MULTICENTER STUDY; NAUSEA; OBSERVATIONAL STUDY; OCULAR PRURITUS; ODYNOPHAGIA; OPEN STUDY; ORAL PARESTHESIA; ORAL PRURITUS; PATIENT COMPLIANCE; PATIENT REFERRAL; PHARYNGITIS; PHYSICIAN; POLLEN ALLERGY; PRIORITY JOURNAL; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; RESPIRATORY TRACT DISEASE; RHINOPHARYNGITIS; SCHOOL CHILD; SINGLE DRUG DOSE; STOMATITIS; SUBLINGUAL IMMUNOTHERAPY; TABLET; THORAX DISEASE; THROAT IRRITATION; THROAT TIGHTNESS; TONGUE EDEMA; ADMINISTRATION AND DOSAGE; ADVERSE EFFECTS; CLINICAL TRIAL; DESENSITIZATION; EDEMA; IMMUNOLOGY; PARESTHESIA; POACEAE; POLLEN; PRESCHOOL CHILD; PROCEDURES; PRURITUS; RHINITIS, ALLERGIC; SUBLINGUAL DRUG ADMINISTRATION; TREATMENT WITHDRAWAL;

ADMINISTRATION, SUBLINGUAL; ADOLESCENT; ALLERGENS; CHILD; CHILD, PRESCHOOL; DESENSITIZATION, IMMUNOLOGIC; EDEMA; FEMALE; HUMANS; MALE; PARESTHESIA; POACEAE; POLLEN; PROSPECTIVE STUDIES; PRURITUS; RHINITIS, ALLERGIC; TABLETS; WITHHOLDING TREATMENT;

EID: 84922612858     PISSN: 09056157     EISSN: 13993038     Source Type: Journal    
DOI: 10.1111/pai.12298     Document Type: Article

References (22)

1. Wallace DV, Dykewicz MS, Bernstein DI, et al. The diagnosis and management of rhinitis: an updated practice parameter. J Allergy Clin Immunol 2008: 122: S1-84.
2. Cox L. Overview of serological-specific IgE antibody testing in children. Curr Allergy Asthma Rep 2011: 11: 447-53.
3. Bousquet J, van Cauwenberge P, Khaltaev N, the ARIA Workshop Group. Allergic rhinitis and its impact on asthma. J Allergy Clin Immunol 2001: 108 (Suppl. 5): S147-334.
4. Bousquet J, Khaltaev N, Cruz AA, et al. Allergic rhinitis and its impact on asthma (ARIA) 2008 update (in collaboration with the World Health Organization, GA(2)LEN and AllerGen). Allergy 2008: 63(Suppl. 86): 8-160.
5. Wilson DR, Torres Lima M, Durham SR. Sublingual immunotherapy for allergic rhinitis: systematic review and meta-analysis. Allergy 2005: 60: 4-12.
6. Cox L, Nelson H, Lockey R, et al. Allergen immunotherapy: a practice parameter third update. J Allergy Clin Immunol 2011: 127: S1-55.
7. Olaguibel JM, Alvarez Puebla MJ. Efficacy of sublingual allergen vaccination for respiratory allergy in children. Conclusions from one meta-analysis. J Investig Allergol Clin Immunol 2005: 15: 9-16.
8. Penagos M, Compalati E, Tarantini F, et al. 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: 141-8.
9. Wahn U, Tabar A, Kuna P, et al. Efficacy and safety of 5-grass-pollen sublingual immunotherapy tablets in pediatric allergic rhinoconjunctivitis. J Allergy Clin Immunol 2009: 123: 160-6.e3.
10. Halken S, Agertoft L, Seidenberg J, et al. Five-grass pollen 300IR SLIT tablets: efficacy and safety in children and adolescents. Pediatr Allergy Immunol 2010: 21: 970-6.
11. Costa DJ, Amouyal M, Lambert P, et al. How representative are clinical study patients with allergic rhinitis in primary care? J Allergy Clin Immunol 2011: 127: 920-6.e1.
12. Calderon 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: 30-8.
13. Garcia MA, Antolin D, Valbuena T, Valls A, Garrido S, Blanco C. First season with five grass pollen tablets in allergic children/teenagers. A real-life disease impact in terms of symptoms and medication. SMILE study. Allergy 2014: 69(Suppl. 99): 411-2.
14. Summary of product characteristics. "Oralair Sublingual Tablets". 2009.
15. Didier A, Malling HJ, 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: 1338-45.
16. Bufe A, Eberle P, Franke-Beckmann E, 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.e7.
17. Didier A, Worm M, Horak F, et al. Sustained 3-year efficacy of pre- and coseasonal 5-grass-pollen sublingual immunotherapy tablets in patients with grass pollen-induced rhinoconjunctivitis. J Allergy Clin Immunol 2011: 128: 559-66.
18. 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.
19. Dávila I, Navarro A, Domínguez-Ortega J, et al. SLIT: indications, follow-up, and management. J Investig Allergol Clin Immunol 2014: 24(Suppl. 1): 1-35.
20. Passalacqua G, Baena-Cagnani CE, Bousquet J, et al. Grading local side effects of sublingual immunotherapy for respiratory allergy: speaking the same language. J Allergy Clin Immunol 2013: 132: 93-8.
21. Rienzo VD, Minelli M, Musarra A, et al. Post-marketing survey on the safety of sublingual immunotherapy in children below the age of 5 years. Clin Exp Allergy 2005: 35: 560-4.
22. Canonica GW, Cox L, Pawankar R, et al. Sublingual immunotherapy: World Allergy Organization position paper 2013 update. World Allergy Organ J 2014: 7: 6.