Choosing the optimal dose in sublingual immunotherapy: Rationale for the 300 index of reactivity dose

Clinical and Translational Allergy

Volumn 5, Issue 1, 2015, Pages

  Demoly, Pascal ^a   Passalacqua, Gianni ^b   Calderon, Moises A ^c   Yalaoui, Tarik ^d  

^a HÔPITAL ARNAUD DE VILLENEUVE   (France)

^b UNIVERSITY OF GENOA   (Italy)

^c ROYAL BROMPTON HOSPITAL   (United Kingdom)

^d Stallergenes SA   (France)

Author keywords

300 index of reactivity; Adherence; Allergen specific immunotherapy; Dose ranging; Grass pollen allergy; House dust mite allergy; Sublingual immunotherapy

Indexed keywords

ALLERGEN; GRASS POLLEN EXTRACT; GRASS POLLEN VACCINE; HOUSE DUST ALLERGEN; POLLEN EXTRACT;

ALLERGIC ASTHMA; ANAPHYLAXIS; ANTIGENICITY; APPLICATION SITE REACTION; ASTHMA; BIOEQUIVALENCE; BIRCH; BURNING SENSATION; DISEASE SEVERITY; DOSE RESPONSE; DRUG EFFICACY; DRUG MEGADOSE; DRUG POTENCY; DRUG QUALITY; DRUG SAFETY; DRUG TOLERABILITY; DYSPHAGIA; DYSPNEA; GASTROINTESTINAL SYMPTOM; GRASS POLLEN; HOUSE DUST ALLERGY; HUMAN; INDEX OF REACTIVITY; LONG TERM CARE; LOW DRUG DOSE; OPTIMAL DRUG DOSE; ORAL DROPS; ORAL PRURITUS; PATIENT COMPLIANCE; PATIENT SATISFACTION; PHARMACOLOGICAL PARAMETERS; POLLEN ALLERGY; PRIORITY JOURNAL; QUALITY OF LIFE; REVIEW; RHINOCONJUNCTIVITIS; SHORT COURSE THERAPY; SUBLINGUAL IMMUNOTHERAPY; SYMPTOM; TABLET; TONGUE SWELLING;

EID: 85006282620     PISSN: None     EISSN: 20457022     Source Type: Journal    
DOI: 10.1186/s13601-015-0088-1     Document Type: Review

References (53)

1. Ozdoganoglu T, Songu M. The burden of allergic rhinitis and asthma. Ther Adv Respir Dis. 2012;6:11-23.
2. 2LEN and AllerGen). Allergy. 2008;63(Suppl 86):8-160.
3. Sur DK, Scandale S. Treatment of allergic rhinitis. Am Fam Physician. 2010;81:1440-6.
4. 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.
5. Devillier P, Dreyfus JF, Demoly P, Calderon MA. A meta-analysis of sublingual allergen immunotherapy and pharmacotherapy in pollen-induced seasonal allergic rhinoconjunctivitis. BMC Med. 2014;12:71.
6. Focke M, Swoboda I, Marth K, Valenta R. Developments in allergen-specific immunotherapy: from allergen extracts to allergy vaccines bypassing allergen-specific immunoglobulin E and T cell reactivity. Clin Exp Allergy. 2010;40:385-97.
7. Incorvaia C. Preventive capacity of allergen immunotherapy on the natural history of allergy. J Prev Med Hyg. 2013;54:71-4.
8. 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: Rockville (MD); 2013.
9. Calderon MA, Simons FE, Malling HJ, et al. Sublingual allergen immunotherapy: mode of action and its relationship with the safety profile. Allergy. 2012;67:302-11.
10. Canonica GW, Cox L, Pawankar R, et al. Sublingual immunotherapy: World Allergy Organization position paper 2013 update. World Allergy Organ J. 2014;7:6.
11. Demoly P, Calderon MA. Dosing and efficacy in specific immunotherapy. Allergy. 2011;66(Suppl 95):38-40.
12. Meadows A, Kaambwa B, Novielli N et al. A systematic review and economic evaluation of subcutaneous and sublingual allergen immunotherapy in adults and children with seasonal allergic rhinitis. Health Technol Assess 2013;17:vi, xi-xiv, 1-322.
13. Demoly P, Calderon MA, Casale TB, et al. The value of pre- and co-seasonal sublingual immunotherapy in pollen-induced allergic rhinoconjunctivitis. Clin Transl Allergy. 2015;5:18.
14. 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;66:1345-59.
15. Bergmann KC, Demoly P, Worm M, et al. Efficacy and safety of sublingual tablets of house dust mite allergen extracts in adults with allergic rhinitis. J Allergy Clin Immunol. 2014;133(1608-1614):e1606.
16. 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.
17. Ott H, Sieber J, Brehler R, et al. Efficacy of grass pollen sublingual immunotherapy for three consecutive seasons and after cessation of treatment: the ECRIT study. Allergy. 2009;64:1394-401.
18. Wang L, Yin J, Fadel R, et al. House dust mite sublingual immunotherapy is safe and appears to be effective in moderate, persistent asthma. Allergy. 2014;69:1181-8.
19. Worm M, Rak S, de Blay F, et al. Sustained efficacy and safety of a 300IR daily dose of a sublingual solution of birch pollen allergen extract in adults with allergic rhinoconjunctivitis: results of a double-blind, placebo-controlled study. Clin Transl Allergy. 2014;4:7.
20. Larenas-Linnemann D, Cox LS, et al. European allergen extract units and potency: review of available information. Ann Allergy Asthma Immunol. 2008;100:137-45.
21. Frati F, Scurati S, Puccinelli P, et al. Development of an allergen extract for sublingual immunotherapy-evaluation of Staloral. Expert Opin Biol Ther. 2009;9:1207-15.
22. Pajno GB, Caminiti L, Crisafulli G, et al. Direct comparison between continuous and coseasonal regimen for sublingual immunotherapy in children with grass allergy: a randomized controlled study. Pediatr Allergy Immunol. 2011;22:803-7.
23. Stelmach I, Kaluzinska-Parzyszek I, Jerzynska J, et al. Comparative effect of pre-coseasonal and continuous grass sublingual immunotherapy in children. Allergy. 2012;67:312-20.
24. 2LEN/EAACI pocket guide for allergen-specific immunotherapy for allergic rhinitis and asthma. Allergy. 2010;65:1525-30.
25. 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. http://www.ema.europa.eu/docs/en-GB/document-library/Scientific-guideline/2009/09/WC500003605.pdf. Accessed 15 Sep 2015.
26. ® 100 IR & 300 IR sublingual tablets. Stallergènes S.A., 2013. http://www.stallergenes.com/fileadmin/images/corporate/Emmanuelle/Oralair-SmPC.pdf. Accessed 15 Sept 2015.
27. Archila LD, DeLong JH, Wambre E, et al. Grass-specific CD4(+) T-cells exhibit varying degrees of cross-reactivity, implications for allergen-specific immunotherapy. Clin Exp Allergy. 2014;44:986-98.
28. Zuberbier T, Canonica GW, da Silva B. Specific immunotherapy with allergens: an important tool in the treatment of the allergic diseases. J Dtsch Dermatol Ges. 2012;10:879-85.
29. Bonini S. Regulatory aspects of allergen-specific immunotherapy: europe sets the scene for a global approach. World Allergy Organ J. 2012;5:120-3.
30. Kaul S, May S, Luttkopf D, Vieths S. Regulatory environment for allergen-specific immunotherapy. Allergy. 2011;66:753-64.
31. Larsen TH, Poulsen LK, Melac M, et al. Safety and tolerability of grass pollen tablets in sublingual immunotherapy - a phase-1 study. Allergy. 2006;61:1173-6.
32. Malling HJ, Montagut A, Melac M, et al. Efficacy and safety of 5-grass pollen sublingual immunotherapy tablets in patients with different clinical profiles of allergic rhinoconjunctivitis. Clin Exp Allergy. 2009;39:387-93.
33. Didier A, Melac M, Montagut A, et al. Agreement of efficacy assessments for five-grass pollen sublingual tablet immunotherapy. Allergy. 2009;64:166-71.
34. Cox LS, Casale TB, Nayak AS, et al. Clinical efficacy of 300IR 5-grass pollen sublingual tablet in a US study: the importance of allergen-specific serum IgE. J Allergy Clin Immunol. 2012;130(1327-1334):e1321.
35. 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(160-166):e163.
36. Didier A, Malling HJ, 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.
37. Horak F, Zieglmayer P, Zieglmayer R et al. Early onset of action of a 5-grass-pollen 300-IR sublingual immunotherapy tablet evaluated in an allergen challenge chamber. J Allergy Clin Immunol 2009;124:471-7, 477 e471.
38. Stallergenes Symposium. EAACI 2015. "Thinking differently about house dust mite respiratory allergy". Crossing new frontiers in HDM allergy immunotherapy. http://eaaci2015-symposia.cyim.com/EAACI2015/#session-stallergenes. Accessed 12 Oct 2015.
39. Ferrés J, Justicia JL, García MP, et al. Efficacy of high-dose sublingual immunotherapy in children allergic to house dust mites in real-life clinical practice. Allergol Immunopathol (Madr). 2011;39:122-7.
40. Sieber J, Neis M, Brehler R, et al. Increasing long-term safety of seasonal grass pollen sublingual immunotherapy: the ECRIT study. Expert Opin Drug Saf. 2012;11:7-13.
41. Didier A, Bons B. Safety and tolerability of 5-grass pollen tablet sublingual immunotherapy: pooled analysis and clinical review. Expert Opin Drug Saf. 2015;14:777-88.
42. ®): a guide to its use as allergen-specific immunotherapy. Drugs Ther Perspect. 2014;. doi: 10.1007/s40267-40014-40165-x.
43. Demoly P, Le Gall M, Roux M, Zeldin RK. Safety and tolerability of high doses of sublingual tablet of house dust mite allergen extracts in subjects with house dust mite-associated respiratory allergy. Presented at: European Academy of Allergy and Clinical Immunology (EAACI) Congress 2015, Barcelona, Spain.
44. Seidenberg J, Pajno GB, Bauer CP, et al. Safety and tolerability of seasonal ultra-rush, high-dose sublingual-swallow immunotherapy in allergic rhinitis to grass and tree pollens: an observational study in 193 children and adolescents. J Investig Allergol Clin Immunol. 2009;19:125-31.
45. ® en niños. Presented at: XXXVI Congreso de la Sociedad Española de Inmunología Clínica y Alergología Pediátrica (SEICAP) 2012, Cádiz, Spain.
46. Trebuchon F, David M, Demoly P. Medical management and sublingual immunotherapy practices in patients with house dust mite-induced respiratory allergy: a retrospective, observational study. Int J Immunopathol Pharmacol. 2012;25:193-206.
47. Trebuchon F, Lheritier-Barrand M, David M, Demoly P. Characteristics and management of sublingual allergen immunotherapy in children with allergic rhinitis and asthma induced by house dust mite allergens. Clin Transl Allergy. 2014;4:15.
48. Antolin D, Valbuena T, Valls A et al. One season of treatment with 5 grass pollen tablets in adults demonstrated a reduction in disease symptoms and impacts. Findings of the SMILE study. Presented at: European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting 2013, Milan, Italy.
49. Fernandez-Nieto M, Alvarez JA, Alvarado MI et al. What is the opinion of the patients under 5 grass pollen tablets immunotherapy? First season assessment in adults. Findings of the SMILE study. Presented at: European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting 2013, Milan, Italy.
50. ®): a guide to their use as allergen immunotherapy for grass pollen-induced allergic rhinoconjunctivitis. Drugs Ther Perspect. 2014;. doi: 10.1007/s40267-40014-40131-40267.
51. 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.
52. Frati F, Sensi L, Di Rienzo V, et al. A model for management of sublingual immunotherapy. Eur Ann Allergy Clin Immunol. 2003;35:56-60.
53. WHO report. Adherence to long-term therapies, evidence for action. World Health Organization, 2003. http://apps.who.int/medicinedocs/en/d/Js4883e/. Accessed 15 Sept 2015.