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Research bibliography

The following pages are a comprehensive bibliography of studies divided into six categories, with citations presented in chronological order;

1. Scientific research and related publications
The following pages are a comprehensive bibliography of studies divided into six categories, with citations presented in chronological order;
1. Recent Major Guidelines, Reviews and Papers; includes over 70 significant position papers
2. Studies/Abstracts; includes over 75 studies
3. Comparison Studies of Sublingual and Subcutaneous Antigen Administration
4. Mechanisms of Sublingual Immunotherapy; current understanding of mucosal immunity.
5. Safety and Quality-of-Life Related Studies; growing body of evidence
6. Other Indications for Treatment; other sensitizations where SLIT has worked

The scrutiny of SLIT has been intense, particularly in the past five to 10 years. The volume of research and its consistency in showing safety and efficacy is evidence of the value of SLIT to patients. We thank you for your interest in this topic and invite you to provide us feedback and let us know if you would like to receive updates a new research and publications are added.

1) Recent Major Texts, Guidelines, Reviews, Papers and Editorials

1. Marogna M et al “Long-Lasting Effects of Sublingual Immunotherapy for House Dust Mites in Allergic Rhinitis with Bronchial Hyperreactivity: A Long-Term (13-Year) Retrospective Study in Real Life,” Int Arch Allergy Immunol, Vol. 142, (1) pages 70-78, October 2006.

2. Passalacqua G and G. Walter Canonica “Sublingual immunotherapy: Update 2006,” Current Opinion Allergy Clin Immunol, Vol. 6, pgs. 449-454, 2006.

3. Werner-Klein, Melanie “Sublingual immunotherapy of allergic diseases,” Expert Opin.Drug Deliv Vol 3 (5) pgs. 599-612, 2006.

4. Berto, Patrizia et al “Economic evaluation of sublingual immunotherapy vs. symptomatic treatment in adults with pollen-induced respiratory allergy: the Sublingual Immunotherapy Pollen Allergy Italy (SPAI) study,” Annals of Allergy, Asthma and Immunology, Vol. 97, pgs. 615-621, November 2006.

5. Passalacqua, Giovanni, et al “New Insights in Sublingual Immunotherapy,” Current Allergy and Asthma Reports, Vol. 6, pgs. 407-412, 2006.

6. McEldowney, Steven J. et al “Pollen Immunotherapy: Selection, Prevention, and Future Directions,” Current Allergy and Asthma Reports, Vol. 4, pgs. 420-426, 2006.

7. Bousquet, Jean, Editorial “Sublingual Immunotherapy: Validated!”, Allergy, Vol. 61, Issue S81, page 5, July 2006.

8. Burastero, Samuele E. “Sublingual immunotherapy for allergic rhinitis: an update,” Current Opinion in Otolaryngology & Head and Neck Surgery, Vol. 14, pgs. 197-201, 2006.

9. Didier, Alain, “Future developments in sublingual immunotherapy,” Allergy, Vol. 61, (Suppl. 81), pages 29-31, 2006.

10. Malling, H-J, “Sublingual immunotherapy: Efficacy – methodology and outcome of clinical trials,” Allergy, Vol. 61, (Suppl. 81), pages 24-28, 2006.

11. Moingeon, P. “Sublingual immunotherapy: from biological extracts to recombinant allergens,” Allergy, Vol. 61, (Suppl. 81), pages 15-19, 2006.

12. Passalacqua, G, et al “Randomized double-blind controlled study with sublingual carbamylated allergoid immunotherapy in mild rhinitis due to mites,” Allergy, Vol. 61, pages 849-854, 2006.

13. Canonica, GW, Passalacqua G., “Sublingual Immunotherapy in the Treatment of Adult Allergic Rhinitis Patients,” Allergy, Vol. 61, page 20, July 2006.

14. Pham-Thi, N. et al “Sublingual immunotherapy in the treatment of children,” Allergy, Vol. 61, (Suppl. 81): pages 7-10, 2006.

15. Guerra, Laura, et al “Randomized open comparison of the safety of SLIT in a no-updosing and traditional updosing schedule in patients with Parietaria allergy,” Allergologia et immunopatologia, Vol. 34, No. 02, pgs. 82-83, March 2006.

16. Mascarell, L, et al “Novel Ways for Immune Intervention in Immunotherapy: Mucosal Allergy Vaccines,” Immunol Allergy Clin N Am, Vol. 26, pgs. 283-306, 2006.

17. Cox, Linda, et al “Sublingual immunotherapy: A comprehensive review,” J Allergy Clin Immunology, Vol. 117, No. 5, pgs. 1021-1035, May 2006.

18. Nelson, Harold “Advances in upper airway diseases and allergen immunotherapy,” J Allergy and Clin Immunology, Vol. 117, No. 5, pgs. 1047-1053, May 2006.

19. Durham, Stephen et al “Sublingual immunotherapy with once-daily grass allergen tablets: A randomized controlled trial in seasonal allergic rhinoconjunctivitis,” Vol. 117, No. 4, pgs. 802-809, April 2006.

20. Passalacqua, Giovanni et al “Non-Injection Routes for Allergen Immunotherapy: Focus on Sublingual Immunotherapy,” Inflammation & Allergy – Drug Targets, Vol. 5, pgs. 43-51, 2006.

21. Passalacqua, Giovanni et al “Quantitative assessment of the compliance with once-daily sublingual immunotherapy regimen in real life (EASY Project: Evaluation of A novel SLIT formulation during a Year, ” (Letter to the Editor) J Allergy Clin Immunology, Vol. 117, Number 4, April 2006.

22. Bieber, T. Editorial “Allergen-specific sublingual immunotherapy: less mystic, more scientific,” Allergy, Vol. 61, pgs. 149-150, 2006.

23. Dahl R. et al, “Specific immunotherapy with SQ standardized grass allergen tablets in asthmatics with rhinoconjunctivitis,” Allergy, Vol. 61, pgs. 185-190, 2006.

24. Marogna, Maurizio, et al, “Clinical, functional, and immunologic effects of sublingual immunotherapy in birch pollinosis: A 3-year randomized controlled study,” J Allergy Clin Immunol, Vol. 115, Number 6, pgs. 1184-1188, June 2005.

25. Cingi, C. et al “Efficacy of long-term sublingual-oral immunotherapy in allergic rhinitis,” ACTA Otorhinolaryngol Ital 25, pgs. 214-219, 2005.

26. Gidaro, G.B., et al, “The safety of sublingual-swallow immunotherapy: an analysis of published studies,” Clin Exp Allergy, Vol. 35, pgs. 565-571, 2005.

27. Pajno, Giovanni “Allergen immunotherapy in early childhood: between Scylla and Charybdis!,” Clin Exp Allergy, Vol. 35, pgs. 551-553, 2005.

28. Courtney, A.U, et al, “ Childhood Asthma: Treatment Update,” American Family Physician, Vol. 71, No. 10, pgs. 1959-1968, May 2005.

29. Parks, Kevin “Advances in Immunotherapy: Current Considerations and Beyond,” The Allergy and Immunology Report, Vol. 1 No. 2, Spring 2005.

30. Bousquet, J “Sublingual immunotherapy: from proven prevention to putative rapid relief of allergic symptoms,” Editorial, Allergy, Vol. 60, Issue pgs. 1-3, January 2005.

31. Lambrecht, BN “Dendritic cells in the pathogenesis of asthma” Clinical and Exp. Allergy Rev 2004, 4:123-128.

32. Nelson, Harold “Advances in upper airway diseases and allergen immunotherapy,” Journal of Allergy and Clinical Immunology, Vol. 113, No. 4, Pages 635-42, April 2004.

33. Passalacqua, Giovanni, et al, “Efficacy and safety of sublingual immunotherapy,” Annals of Allergy, Asthma, and Immunology, Vol. 93; 1, pgs. 3-12, 2004.

34. Portnoy J. “Allergen Immunotherapy in the Prevention of Asthma” Current Opinion Allergy Clinical Immunology 4(2): 131-136, 2004.

35. Passalacqua, G, Canonica, GW, “Sublingual or injection immunotherapy: the final answer?” Allergy 2004: 59: 37-38.

36. Malling, Hans-Jorgen “Comparison of the clinical efficacy and safety of subcutaneous and sublingual immunotherapy: methodological approaches and experimental results,” Current Opinion in Allergy and Clinical Immunology, Vol. 4, pgs. 539-542, 2004.

37. Mosages, R “The role of hyposensitization: do we need to start rethinking?” Clinical Opinion in Allergy and Clinical Immunology, 2004, Vol. 4, pgs. 155-157.

38. Norman, Philip S. “Immunotherapy: 1999-2004,” Journal of Allergy and Clinical Immunology, June 2004 Vol. 113, No. 6, pgs. 1013-1023.

39. Passalacqua G, Lombardi C, Canonica GW “Sublingual Immunotherapy: An Update,” Current Opinion in Allergy and Clinical Immunology, Vol. 4 (1), February 2004.

40. Markert, UR and Elsner P. Local Immunotherapy in Allergy, Chemical Immunology and Allergy (lead chapter by D. Morris, et al,) Vol. 82, Karger, Basel, Switzerland 2003.

41. Wilson, DR Torres, LM, and Durham SR “Sublingual immunotherapy for allergic rhinitis” (Cochrane Review), The Cochrane Library, Oxford, England, Issue 2. 2003.

42. Canonica, G. Walter and Passalacqua, G. “Non-injection routes for immunotherapy,” Journal of Allergy and Clinical Immunology, Vol. 111, No. 3 pgs. 437-448, March 2003.

43. Nelson, Harold S. “Advances in upper airway diseases and allergen immunotherapy,” Journal of Allergy and Clinical Immunology, Vol. 111, No. 3, pgs. S793-798, March 2003.

44. Di Rienzo, V., Canonica, GW, and Passalacqua G. “Long-lasting effect of sublingual immunotherapy in children with asthma due to house dust mite: a 10 year prospective study,” Clinical and Experimental Allergy, Vol. 33, pgs. 206-210, 2003.

45. Bielory L. and Heimall “Review of complementary and alternative medicine in treatment of ocular allergies,” Current Opinion in Allergy and Clinical Immunology, Vol. 3, pgs. 395-399, 2003.

46. Passalacqua, G, Baena-Cagnani, Carlos, Berardi, M, Canonica, G Walter “Oral and sublingual immunotherapy in pediatric patients,” Current Opinion in Allergy and Clinical Immunology, Vol. 3(2), pgs. 139-145, April 2003.

47. Li, J et al, “Allergen immunotherapy: a practice parameter,” Journal of Allergy and Clinical Immunology, Vol. 90, January 2003 (see Summary Statement 57, Page 27).

48. Kagi M.K. and B. Wuthrich, Review Article, “Different methods of local allergen-specific immunotherapy,” Allergy, Vol. 57, pgs. 379-388, 2002.

49. Reiber, Mark E. “Sublingual Administration of Allergen Desensitization” Tennessee Medicine, pgs. 465-467, November 2002.

50. Douglass, J. and O'Hehir, R. (Editorial) "Specific allergen immunotherapy: time for alternatives?,” Clinical and Experimental Allergy, Vol. 32, pgs. 1-3, 2002.

51. Bousquet, J. The new ARIA guidelines: putting science into practice, Clin Exp All Rev 2002; 2:38-43.

52. Volpe, A. Della, et al, “Sublingual Allergen-Specific Immunotherapy in Allergic Rhinitis and Related Pathologies: Efficacy in a Paediatric Population” International Journal of Immunopathology and Pharmacology, Vol 15, No. 1, pgs. 35-40, 2002.

53. Malling, H. “Is Sublingual Immunotherapy Clinically Effective?” Current Opinion Allergy and Clinical Immunology, Vol 2, No. 6 pgs. 523-532, 2002.

54. Allergic Rhinitis and its impact on Asthma (ARIA) Workshop Report. ARIA Workshop Group, Journal of Allergy and Clinical Immunology, Supplement, 11/2001:Vol. 108, No. 5.

55. Bousquet, J., ARIA Workshop Group Guidelines J All Clin Immunol pgs S242-S245, 2001.

56. Passalacqua G. & Canonica, G.W. "Allergen-Specific Sublingual Immunotherapy for Respiratory Allergy,” BioDrugs, Vol. 15 (8) pgs. 509-519, 2001.

57. Morris, D.L. "Current use of sublingual-swallow immunotherapy,” Current Opinion in Otolaryngology & Head and Neck Surgery, Vol. 9, No. 3, pgs. 179-180, June 2001.

58. Marogna, M. et al, “Clinical Practice Improvement Program for Immunotherapy of Respiratory Allergic Diseases,” International Journal of Immunopathology and Pharmacology, Vol. 14, No. 2, pgs 93-101, 2001.

59. Allergen Immunotherapy: Guidelines, Update and Recommendations of the World Health Organization, Theodoropoulos & Lockey, Allergy & Asthma Proc. Pg. 159-66, May-June 2000, Vol. 21, No.3.

60. Frew, Anthony, et al, "Sublingual Immunotherapy,” Journal of Allergy Clinical Immunology, pgs. 441-444, March 2001.

61. Brown, J.L. & Frew, A.J. (Editorial) "The efficacy of oromucosal immunotherapy in respiratory allergy,” Clinical & Experimental Allergy, Vol. 31, Is. 1, pg 8-10, January 2001.

62. Editorial, "The efficacy of oromucosal immunotherapy in respiratory allergy,” Clinical and Experimental Allergy, Vol. 31, pgs. 8-10, 2001.

63. Rakoski, Jurgen and Wessner, Dirk "A Short Assessment of Sublingual Immunotherapy,” International Archives of Allergy and Immunology, Vol. 126, pgs. 185-187, 2001.

64. Pineda-Algorta, J. et al, “Study of the efficacy of sublingual immunotherapy in patients with grass pollen sensitization,” (abstract) “Mini Symposium 3 Sublingual Immunotherapy” Allergy 55 Suppl. Vol. 63: pg. 24, 2000.

65. Ano-Garcia, M. et al, “Efficacy and safety of sublingual immunotherapy in patients with sensitization to Dermtophagoides pteronyssinus” (abstract) “Mini Symposium 3 Sublingual Immunotherapy” Allergy 55 Suppl. Vol 63: pg. 24, 2000.

66. Khinchi, M.S. et al, “Clinical efficacy of sublingual-swallow and subcutaneous immunotherapy in patients with allergic rhinoconjunctivitis due to birch pollen. A double-blind, double dummy placebo-controlled study (abstract), “Mini Symposium 3 Sublingual Immunotherapy” Allergy 55 Suppl. Vol 63: pg 24, 2000.

67. Donato, R.M. Patients with allergic rhinitis from Argentine treated with SLIT (sublingual immunotherapy) a non-injective route - Abstract presented October 2000 IACAI Conf.

68. Malling, Hans-Jergen "Allergen-specific immunotherapy. Present state and directions for the future,” Allergy, Vol 54, pgs. 30-33, 1999.

69. Passalacqua, G. et al, "Oral and Sublingual Immunotherapy: General Aspects and Critical Considerations,” WMW Themenheft: Hyposensibilsierung, pgs 433-437, 1999.

70. Donahue, JG et al, “Utilization and cost of immunotherapy for allergic asthma and rhinitis,” Annals of Allergy, Asthma and Immunology, Vol. 82, pgs. 339-347, April 1999.

71. Bousquet J, Lockey R. Malling HJ, Allergen immunotherapy: therapeutic vaccines for allergic diseases. World Health Organization Position Paper Allergy Vol 53 Suppl 44 pgs 1-29, 1998.

72. Malling, H.J. Editorial "Sublingual Immunotherapy,” Clinical Experimental Allergy, Vol. 26, pgs. 1228-1231, 1996.

73. Passalacqua G. et and G.W. Canonica “Alternative routes for allergen-specific immunotherapy” J Invest Allergol Clin Immunol, Vol. 6(2) pgs. 81-87, March-April 1996.

74. Creticos, P.S. A review of oral specific immunotherapy, Expressions on allergen specific immunotherapy, Stallergenes S.A., Vol. 1, June 1995. (US Based DBPC Study).

2) Studies/Abstracts

1. Dahl, Ronald, et al “Efficacy and safety of sublingual immunotherapy with grass allergen tablets for seasonal allergic rhinoconjunctivitis,” J Allergy Clin Immunol, Vol. 118, No. 2, pgs. 434-440, August 2006.

2. Valovirta, E. et al, “Clinical efficacy and safety of sublingual immunotherapy with tree pollen extract in children,” Allergy, Vol. 61, pgs. 1177-1183, 2006.

3. Calamita, Z. et al “Efficacy of sublingual immunotherapy in asthma: systematic review of randomized-clinical trials using the Cochrane Collaboration method,” Allergy, Vol. 61, pgs. 1162-1172, 2006.

4. Bernardini, Roberto, et al “Sublingual immunotherapy with a latex extract in paediatric patients: a double blind, placebo-controlled study,” Current Medical Research and Opinions, Vol. 22, No. 8, pgs. 1515-1522, 2006.

5. Niu, Chen-Kuang, et al, “Efficacy of sublingual immunotherapy with high-dose mite extracts in asthma; A multi-center, double-blind, randomized and placebo -controlled study in Taiwan,” Respiratory Medicine, pgs 1-10.

6. Di Rienzo, V. et al, “Post-marketing survey on the safety of sublingual immunotherapy in children below the age of 5 years,” Clinical and Experimental Allergy, Vol. 35, Issue 5, pg. 560, May 2005.

7. Fiocchi, A. et al, “A Prospective Study on Safety of Sublingual Immunotherapy in Children Aged 3 to 6 Years,” Journal of Allergy and Clinical Immunology, Vol. 115, No. 2, pg S265, February 2005.

8. Tesse, R. et al, “Effects of Oral Bacterial Immunotherapy in Children With Atopic Eczema/Dermatitis Syndrome,” Journal of Allergy and Clinical Immunology, Vol. 115, No. 2, pg S266, February 2005.

9. Bahceciler N.N. et al, “Impact of Sublingual Immunotherapy on Specific Antibody Levels in Children Allergic to House Dust Mites, Int Arch Allergy Immunol, Vol. 136, No. 3, pgs. 287-294, February 2005.

10. Wilson, D.R. et al, “Sublingual immunotherapy for allergic rhinitis: systematic review and meta-analysis*,” Allergy, Vol. 60, Issue 1, page 4, January 2005.

11. Marogna, M et al, “Randomized controlled open study of sublingual immunotherapy for respiratory allergy in real-life: clinical efficacy and more,” Allergy, Vol. 59, No. 11, pgs 1205-1210, November 2004.

12. Novembre, E. et al, “Coseasonal sublingual immunotherapy reduces the development of asthma in children with allergic rhinoconjunctivitis,” Journal Allergy and Clinical Immunology, Vol. 114, No, 4, pgs 851-857, October 2004.

13. Smith, Helen et al, “Randomized controlled trial of high-dose sublingual immunotherapy to treat allergic rhinitis,” Journal Allergy and Clinical Immunology, Vol. 114, No. 4, pgs. 831- 837, October 2004.

14. Savi, E, et al, “A latex-containing hepatitis-B vaccine administered in a severely latex allergic paediatric patient after specific sublingual immunotherapy: a case report. Allergy, Vol. 59, No. 9, pgs. 1014-1015, September 2004.

15. Drachenberg, K.J. et al, “Sublingual specific immunotherapy for adults and children: a post marketing surveillance study” Allergol Immunopathol, Vol. 32, No. 2, pgs 76-81, March-April 2004.

16. Mastrandrea F. “The potential role of allergen-specific sublingual immunotherapy in atopic dermatitis,” Am J Clin Dermatol, Vol. 5, No. 5, pgs 281-294, 2004.

17. Cistero, B.A. et al, “Tolerance and effects on skin reactivity to latex of sublingual rush immunotherapy with a latex extract,” J Investig Alllergol Clin Immunol, Vol. 14, No. 1, pgs 17-25, 2004.

18. Khinchi…Malling, “ Clinical efficacy of sublingual and subcutaneous birch pollen allergen-specific immunotherapy: a randomized, placebo-controlled, double-blind, double-dummy study,” Allergy, 2004: 59: 45-53.

19. Tonnel, A.B. et al, “Allergic rhinitis due to house dust mites: evaluation of the efficacy of specific sublingual immunotherapy,” Allergy, Vol. 59, pgs. 491-197, 2004.

20. Bufe, A. et al, “Efficacy of sublingual swallow immunotherapy in children with severe grass pollen allergic symptoms: a double-blind placebo-controlled study, Allergy, Vol. 59(5), pgs 498-504, May 2004.

21. Pajno, GB, et al, “Sublingual immunotherapy abrogates seasonal bronchial hyperresponsiveness in children with Parietaria-induced respiratory allergy: a randomized controlled trial dagger,” Allergy, Vol. 59(8), pgs. 883-887, August 2004.

22. Pajno, G.B. et al, “Comparisons between injection and sublingual immunotherapy for rhinitis and asthma in allergic children to house dust mite or parietaria pollen. A case controlled study,” Journal of Allergy and Clinical Immunology, February 2004 Supplement, Vol. 113, Number 2. (abs.)

23. Niu, C. et al, “Efficacy and safety of sublingual immunotherapy with high dose house dust mite extract in asthmatic children – a multicenter randomized double-blind, and placebo-controlled study, February 2004 Supplement, Vol. 113, Number 2. (abs.)

24. Mauro, M. et al, “Efficacy and safety of subcutaneous and sublingual immunotherapy in birch pollinosis,” Journal of Allergy and Clinical Immunology, February 2004 Supplement, Vol. 113, Number 2.

25. Melranci, C. Matteoli M. “Efficacy of allergoid sublingual immunotherapy in children with asthma and/or allergic rhinoconjunctivitis: Comparison study with drugs” Journal of Allergy and Clinical Immunology, February 2004 Supplement, Vol. 113, Number 2. (abs.).

26. Bassi M. et al, “High dose sublingual immunotherapy: Economic evaluation from an Italian observational data base study” Journal of Allergy and Clinical Immunology, February 2004 Supplement, Vol. 113, Number 2. (abs.)

27. Pajno, GB “Efficacy of sublingual immunotherapy in asthma and eczema,” Chem Immunol Allergy, Vol. 82, pgs 77-88, 2003.

28. Wuthrich, B et al, “Double-Blind, Placebo-Controlled Study with Sublingual Immunotherapy in Children with Seasonal Allergic Rhinitis to Grass Pollen,” Journal Invest Allergol Clin Immunol, Vol. 13(3), pgs. 145-148, 2003.

29. Andre, et al, “A Double-Blind Placebo-Controlled Evaluation of Sublingual Immunotherapy with a Standardized Ragweed Extract in Patients with Seasonal Rhinitis,” Int Arch Allergy Immunol, 131: pgs. 111-118, 2003.

30. Ippoliti, F, et al, “Immunomodulation during sublingual therapy in allergic children,” Pediatric Allergy and Immunology, Vol. 14, pgs. 216-221, 2003.

31. Pajno, G.B. et al, Abstract “Parietaria Pollen Sublingual Immunotherapy for Asthmatic Children: Seasonal Behavior in Methacholine PC20, Journal of Allergy and Clinical Immunology, February 2003.

32. Mortemousque, B, et al, “House-dust mite sublingual –swallow immunotherapy in perennial conjunctivitis: a double-blind, placebo-controlled study,” Clinical and Experimental Allergy, Vol. 33, pgs. 464-469, 2003.

33. Gonzalez, E. et al, Abstract “Efficacy and Safety of a Standardized Sublingual Therapeutic Vaccine of Cat Epithelia Extract, Journal of Allergy and Clinical Immunology, page S200, February 2003.

34. Cirla, A.M. et al, “A pre-seasonal birch/hazel sublingual immunotherapy can improve the outcome of grass pollen injective treatment in bisensitized individuals. A case-referent, two year controlled study,” Allergol et Immunopath Vol. 31(1) 31-43, 2003.

35. Madonini, F, et al, “Long-term and preventive effects of Sublingual Allergen Specific Immunotherapy: A retrospective, multicentric study, Int’l Journal of Immunopathology and Pharmacology, Vol.16 no. 1, 73-79 (2003).

36. Bordignon V. and S. Parmiani, “Variation of the skin end-point in patients treated with sublingual specific immunotherapy,” Journal of Investig Allergol Clin Immunol, Vol. 13 (3): pgs. 170-176, 2003.

37. Torres Lima, M. et al, Grass pollen sublingual immunotherapy for seasonal rhinoconjunctivitis: a randomized controlled trial, Clin Exp Allergy 2002; 32-507-14.

38. Silvestri, M et al,. “Changes in Inflammatory and Clinical Parameters and in Bronchial Hyperreactivity in Asthmatic Children Sensitized to House Dust Mites Following Sublingual Immunotherapy,” J Invest Allergol Clin Immunol (abstract) Vol 12: No. 1 pgs 6-7, 2002.

39. Velarde-Domiquez, T. et al, Abstract “Clinical effectiveness and security of sublingual immunotherapy as a treatment for allergy asthma secondary to Dermaphgoides in pediatric population,” Rev Sanid, Milit Mex Vol. 56, No. 1, pgs 10-14, 2002.

40. Molina, A. Criado et al, “Inmunoterapia con un extracto oral de Alternaria en el asma infanil. Eficacia clinica, seguridad, repercusiones sobre parametros in vivo e in vitro Allergol et Immunpathol, Vol. 30(6) 319-30, 2002.

41. Olaguibel, J.M., et al, “Adherence to and Safety of a High Dose Sublingual Immunotherapy Regimen With a Standardized Grass Pollen Extract,” Journal Allergy Clinical Immunology, Vol. 109, No. 1, pg. S201, January 2002.

42. Pajno, G.B. et al, “Impact of Sublingual Immunotherapy on Seasonal Asthma of Allergic Children to Parietaria Pollen Treated with Inhaled Fluticasone Propionate, Journal Allergy Clinical Immunology, Vol. 109, No. 1, pg. S200, January 2002.

43. Ariano, R. et al, “Efficacy of sublingual specific immunotherapy in Cupressaceae allergy using an extract of Cupressus arizonica. A double blind study, Allergol Immunopathol, Vol. 29, No. 6, pgs. 238-244, 2001.

44. Bahceciler, et al,. "Efficacy of sublingual immunotherapy in children with asthma and rhinitis: a double-blind, placebo-controlled study." Pediatric Pulmonology, 32:49-55 2001.

45. Caffarelli, C, et al,. "Preseasonal local allergoid immunotherapy to grass pollen in children,” Allergy, 2000, 55, 1142-1147.

46. Course of Birch, Bat V1 and Bat V2, IgE levels following Sublingual-Swallow and Parenteral Birch Immunotherapy. Khinchi, Poulsen, Malling-Denmark. Dieierlaurent, Berjout, Andre-France July 2000.

47. Valle, C. et al, "Effects of sublingual immunotherapy in patients sensitized to Ambrosia. An open controlled study" Allergol et Immunopathol, Vol. 28 (6) pgs 311-317, 2000.

48. Mastrandrea, F. et al, "Specific sublingual immunotherapy in atopic dermatitis. Results of a 6-year follow-up of 35 consecutive patients,” Allergol et Immunopathol, Vol. 28 (2) pgs. 54-62, 2000.

49. Pajno, GB, et al, "Clinical and Immunological Effects of Long-term Sublingual Immunotherapy in Asthmatic Children Sensitized to Mites: A Double-blind Placebo Controlled Study, Allergy, Vol. 55, pgs 842-849, 2000.

50. Guez, S. et al, "House dust mite SLIT in perennial rhinitis: A double blind placebo controlled study, Allergy, Vol. 55, pgs. 369-75, 2000.

51. Pradalier, A. et al, "Sublingual-swallow immunotherapy (SLIT) with a standardized five-grass-pollen extract (drops and sublingual tablets) versus placebo in seasonal rhinitis,” Allergy, Vol. 54, pgs. 819-828, February 1999.

52. Bousquet, J. et al, "Sublingual-swallow immunotherapy (SLIT) in patients with asthma due to house-dust mites: a double blind, placebo-controlled study,” Allergy, Vol. 54 (3) pgs. 249-260, March 1999.

53. Purello, D'Ambrosio, et al, "Sublingual immunotherapy: a double blind placebo controlled trial with Parietaria judaica extract standardized in mass units in patients with rhinoconjunctivitis, asthma or both,” Allergy, Vol. 54: 968-973, 1999.

54. La Rosa, Mario, et al, "Double-blind placebo-controlled evaluation of sublingual-swallow immunotherapy with standardized Parietaria judaica extract in children with allergic rhinoconjunctivitis,” Journal AllergyClinical Immunology, pgs. 425-432, August 1999.

55. Passalacqua, Giovanni, et al, "Clinical and immunologic effects of a rush sublingual immunotherapy to Parietaria species: A double-blind, placebo-controlled trial,” J Allergy Clin Immunol, pgs 964-968, November 1999.

56. Di Rienzo, V, et al, "Grass pollen specific sublingual/swallow immunotherapy in children: open-controlled comparison among different treatment protocols,” Allergol et Immunopathol, Vol. 27 (3) pgs 145-151, 1999.

57. Vourdas, D. et al, "Double-blind, placebo-controlled evaluation of sublingual immunotherapy with standardized olive pollen extract in pediatric patients with allergic rhinoconjunctivitis and mild asthma due to olive pollen sensitization,” Allergy, Vol 53, pgs 662-672, 1998.

58. Clavel, R., Bousquet, J., et al, "Clinical efficacy of sublingual-swallow immunotherapy: a double-blind, placebo-controlled trial of standardized five-grass-pollen extract in rhinitis,” Allergy, Vol. 53, pgs 493-498, May 1998.

59. Horak, F. et al, "Immunotherapy with sublingual birch pollen extract. A short-term double blind placebo study,” Invest Allergol Clin Immunol, V 8, No. 3, pgs. 165-71, May-Jun 98.

60. Hordijk, G.J., et al, "Sublingual immunotherapy with a standardised grass pollen extract; a double-blind placebo-controlled study,” Allergol, et Immunopathol., Vol. 26, No. 5, pages 234-240.

61. Passalacqua, Giovanni, et al, "Randomised controlled trial of local allergoid immunotherapy on allergic inflammation in mite-induced rhinoconjunctivitis,” The Lancet, Vol. 351, pgs 629-632, February 28, 1998.

62. Luwema, R.A., et al, "Sublingual Immunotherapy with a Standardized Grass Pollen Extract (Oralgen); a placebo controlled study,” The Journal of Allergy and Clinical Immunology, Vol. 99, No. 1, Part 2, Abstract #282, January 1997.

63. Passalacqua, G., et al, "Clinical and Immunological Effects of a Long-term Sublingual-oral Immunotherapy to Mite: A Double Blind Study,” The Journal of Allergy and Clinical Immunology, Vol. 99, No. 1, Part 2, Abstract # 1630, January 1997.

64. Van Deusen, Matthew, et al, “Efficacy and safety of oral immunotherapy with short ragweed” Annals of Allergy, Asthma & Immunology, Vol. 78, pgs 573-580, June 1997.

65. Gozalo, F. et al, "Clinical efficacy and tolerance of two year Lolium perenne sublingual immunotherapy,” Allergol. Et Immunopathol., Vol 25 (5), pgs. 219-227, 1997.

66. Passalacqua, G. "Sublingual immunotherapy: Accumulated experience,” J Invest Allergol Clin Immunol, Vol. 7(5), pgs. 364-366, September/October 1997.

67. Hirsh, T. et al,. Double blind placebo controlled study of sublingual immunotherapy with house dust mites extracts in children. Pediatric Allergy & Immunology, 1997: 8: 21-27.

68. D'Ambrosio, F. Purello, et al, "Rush sublingual immunotherapy in parietaria allergic patients,” Allergol. Et Immunopathol, Vol: 21: No 4, pgs 146-151, 1996.

69. Troise, C. et al,. "Sublingual immunotherapy in Parietaria pollen-induced rhinitis: A double-blind study,” Journal of Investigational Allergology and Clinical Immunology, Vol. 5(1), pgs. 25-30, 1995.

70. Clavel, R. et al,. "Reduction of Corticosteroid Therapy by Sublingual Immunotherapy. Double Blind Study Against Placebo of Standardised 5 Grass Pollen Extract in Rhinitis,” Allergy, Vol. 50(26), pg. 279, 1995.

71. Giovane, A.L., et al,. "A three-year double-blind placebo-controlled study with specific oral immunotherapy to Dermatophagoides: evidence of safety and efficacy in paediatric patients,” Clinical and Experimental Allergy, Vol. 24, pgs. 53-59, 1994.

72. Sabbah, A. et al,. "A double-blind, placebo-controlled trial by the sublingual route of immunotherapy with a standardized grass pollen,” Allergy, Vol. 49, pgs. 309-13, 1994.

73. Casanovas, M. et. al. "Double-blind, placebo-controlled clinical trial of preseasonal treatment with allergenic extracts of Olea europaea pollen administered sublingually,” Journal of Investigational Allergology and Clinical Immunology Vol. 4(6), pgs. 305-314, November-December 1994.

74. Tari, M.G., et al,. "Immunologic evaluation of 24 month course of sublingual immunotherapy." Allergol.Et Immunopathol., Vol. 22, No. 5, pgs. 209-216, 1994.

75. Tari, M.G., et al,. "Efficacy of sublingual immunotherapy in patients with rhinitis and asthma due to house dust mite-A double blind study.,” Allergol. Et Immunopathol., Vol. 18, No. 5, pgs. 277-284, 1990.

76. Leng, Xiao, et al,. "A double-blind trial of oral immunotherapy for Artemisia pollen asthma with evaluation of bronchial response to the pollen allergen and serum-specific IgE antibody,” Annals of Allergy, Vol. 64, pgs. 27-31, Jan. 1990.

77. Taudorf, Ebbe, et. al. "Oral immunotherapy in birch pollen hay fever,” J Allergy Clinical Immunology, Vol. 80, No. 2, pgs. 153-161, Aug. 1987.

78. Van Nierkerk, C.H. and J.I De Wet. "Efficacy of grass-maize pollen oral immunotherapy in patients with seasonal hay-fever; a double blind study,” Clinical Allergy, Vol. 17, pgs. 507-513, 1987.

79. Scadding, Glenis K. and J. Brostoff. "Low dose sublingual therapy in patients with allergic rhinitis due to house dust mite,” Clinical Allergy, Vol. 16, pgs. 483-491, 1986.

3) Comparison Studies of Sublingual and Subcutaneous Antigen Administration

1. Khinchi…Malling, “ Clinical efficacy of sublingual and subcutaneous birch pollen allergen-specific immunotherapy: a randomized, placebo-controlled, double-blind, double-dummy study,” Allergy, 2004: 59: 45-53.

2. Mungan, Dilsad, et al, "Comparison of the efficacy of subcutaneous and sublingual immunotherapy in mite-sensitive patients with rhinitis and asthma - a placebo controlled study,” Annals of Allergy, Asthma, and Immunology, Vol. 82, pgs. 485-490, May 1999.

3. Quirino, T. et al, "Sublingual versus injective immunotherapy in grass pollen allergic patients: a double blind (double dummy) study, Clinical and Experimental Allergy, Vol. 26, pgs. 1253-1261, 1996.

4. Bernardis, P., et al,. "Injective versus sublingual immunotherapy in Alternaria tenuis allergic patients,” Journal of Investigational Allergology and Clinical Immunology, Vol 6(1), pgs. 55-62, January-February 1996.

4) Mechanisms of Sublingual Immunotherapy

1. Rossi RE et al “Evaluation of serum IgG4 antibodies specific to grass pollen allergen components in the follow up of allergic patients undergoing subcutaneous and sublingual immunotherapy,” Vaccine (2006), doi:10.1016/j.vaccine.2006.08.040.

2. Savolainen, J, et al “Sublingual immunotherapy in children modulates allergen-induced in vitro expression of cytokine mRNA in PBMC,” Allergy Vol. 61, pgs. 1184-1190, 2006.

3. Sun, J-B, et al “Sublingual Tolerance Induction with Antigen Conjugated to Cholera Toxin B Subunit Induces Foxp3+CD25+CD4+ Regulatory T Cells and Suppresses Delayed-Type Hypersensitivity Reactions,” Scandinavian Journal of Immunology, Vol. 64, pgs. 251-259, 2006.

4. Akdis, CA, et al “Immunological Mechanisms of Sublingual Immunotherapy,” Allergy, Vol. 61, page 11, July 2006.

5. Ciprandi, Giorgio et al “Sublingual immunotherapy induces spirometric improvement associated with IL-10 production: Preliminary reports,” International Immunopharmacology, Vol. 6, pgs. 1370-1373, 2006.

6. Jutel, M. et al “Mechanisms of allergen specific immunotherapy – T-cell tolerance and more,” Allergy, Vol. 61, pgs. 796-807, 2006.

7. Malling, H-J, et al “Safety and Immunological Changes during Sublingual Immunotherapy with Standarized Quality Grass Allergen Tablets,” J Investig Allergol Clin Immunol, Vol. 16 (3), pages 162-168, 2006.

8. Cosmi, L. et al “Sublingual immunotherapy with Dermatophagoides monomeric allergoid down-regulates allergen-specific immunoglobulin E and increases both interferon-y-and interleukin-10-production,” Clinical and Experimental Allergy, Vol. 36, pgs. 261-272, 2006.

9. Ciprandi, G. et al “Allergen-specific immunotherapy: an update on immunological mechanisms of action,” Monaldi Arch Chest Dis, Vol 65, No. 1, pgs 34-37 2006.

10. Ciprani, G. et Al “Sublingual immunotherapy and regulatory T-cells,” Allergy Vol. 61, pgs. 511-513, 2006.

11. Dehlink, E et al, “Absence of systemic immunologic changes during dose build-up phase and early maintenance period in effective specific sublingual immunotherapy in children,” Clinical and Experimental Allergy, Vol. 36, pgs. 32-39, 2006.

12. Moingeon, et al, “Immune mechanisms of allergen-specific sublingual immunotherapy,” Allergy, Vol. 61, pgs. 151-165, 2006.

13. Ciprandi, G et al, “Induction of interleukin 10 by sublingual immunotherapy for house dust mites: a preliminary report,” Annals of Allergy, Asthma & Immunology, Vol. 95, July 2005.

14. Lambrecht, BN “Dendritic cells in the pathogenesis of asthma” Clinical and Exp. Allergy Rev 2004, 4:123-128.

15. Jan de Heer, Hendrick, et al, “Essential Role of Lung Plasmacytoid Dendritic Cells in Preventing Asthmatic Reactions to Harmless Inhaled Antigen,” J Exp. Med, Vol. 200, Number 1, pgs, 89-98, July 5, 2004.

16. Arikan, C et al,. “BCG-induced IL-12 did not improve parameters in asthmatic children treated w/sublingual immunotherapy,” Clinical and Exp. Allergy, 34-398-405, 2004.

17. Reich, M et al,. “Nonspecific Plasma Proteins during Sublingual Immunotherapy,” Local Immunotherapy in Allergy, Chem Immunol. Basel, Karger, Vol. 82, pgs. 99-108, 2003.

18. Bagnasco, et al, "Pharmacokinetics of an allergen and a monomeric allergoid for oromucosal immunotherapy in allergic volunteers,” Clinical and Experimental Allergy, Vol 31, pgs. 54-60, 2001.

19. Marcucci, F. et al, "Sublingual tryptase and ECP in children treated with grass pollen sublingual immunotherapy (SLIT): safety and immunologic implications,” Allergy, Vol. 56, pgs. 1091-1095, 2001.

20. Preliminary analysis of clinical parameters, plasma proteins and T cell functions of allergic patients after up to 3 years sublingual immunotherapy- Abstract presented October 2000 0 IACAI conference, U.R. Markert, MD.

21. Fanta, C. et al, "Systemic Immunological Changes Induced by Administration of Grass Pollen Allergens via the Oral Mucosa during Sublingual Immunotherapy,” Int Arch Allergy Immunol, 120: pgs. 218-224, February 5, 1999.

22. Yuksel, H. et al, "Sublingual immunotherapy and influence on urinary leukotrienes in seasonal pediatric allergy,” Invest Allergol Clin Immunol, Vol. 9(5), pgs 305-313, September/October 1999.

23. Bagnasco, M et al, "Absorption and distribution kinetics of the major Parietaria allergen administered by noninjectable routes to healthy human beings, Journal Allergy Clinical Immunology, Vol. 100: pgs. 13-18, 1997.

24. Giannarini, L. "Decrease of allergen-specific T cell response induced by local nasal immunotherapy,” Clin Exp Allergy, Vol. 28, pgs, 547-551, 1998.

5) Safety and Quality-of-Life Related Studies

1. Dunsky, E.H. et al “Anaphylaxis to sublingual immunotherapy,” Allergy, Vol. 61, pgs 1235-1244, 2006.

2. Antico, A. et al “Anaphylaxis by latex sublingual immunotherapy,” Allergy, Vol. 61, pgs 1236-1237, 2006.

3. Larsen, T.H., et al “Safety and tolerability of grass pollen tablets in sublingual immunotherapy – a phase-1 study,” Allergy, Vol. 61, pgs. 1173-1176, 2006.

4. Frati, F, et al “Dose dependence of efficacy but not of safety in sublingual immunotherapy”, Monaldi Arch Chest Dis, Vol. 65, No. 1, pgs. 38-40, 2006.

5. Tripodi, S, et al, “Safety and Tolerability of Ultra-Rush Induction, Less than One Hour, of Sublingual Immunotherapy in Children,” Int Arch Allergy Immunol, Vol. 139, pgs 149-152, 2006.

6. Kleine-Tebbe, J et al, “Safety of a SQ-standarized grass allergen tablet for sublingual immunotherapy: a randomized, placebo-controlled trial,” Allergy, Vol. 61, pgs. 181-184, 2006.

7. Di Rienzo, V. et al, “ Post-marketing survey on the safety of sublingual immunotherapy in children below the age of 5 years,” Clin Exp Allergy, Vol. 35, pgs. 560-564, 2005.

8. Scolozzi, RM “Tolerability of the allergoid sublingual immunotherapy with a monomeric allergoid in patients with allergic rhinitis and/or asthma” Journal of Allergy and Clinical Immunology, February 2004 Supplement, Vol. 113, No. 2. (abstract)

9. Silvestris, A. “Tolerability of sublingual immunotherapy with monomeric allergoid in allergic sensitizations to house dust mite, Parietaria and grass, Journal of Allergy and Clinical Immunology, February 2004 Supplement, Vol. 113, No. 2. (abstract)

10. Grosclaude, M, et al, “Safety of Various Dosage Regimens during Induction of Sublingual Immunotherapy,” International Archives Allergy and Applied Immunology, Vol. 129 (3), pgs 248-253, March 2003.

11. Hasan, H., et al, “Short Report – Evaluation of Immunotherapy for Seasonal and Perennial Allergic Rhinitis Using Quality of Life Questionnaires,” Current Allergy & Clinical Immunology, Vol. 16, No. 1, March 2003.

12. Lombardi, C. et al, "Safety of sublingual immunotherapy with monomeric allergoid in adults: multicenter post-marketing surveillance study,” Allergy: 56: 989-992, 2001.

13. Lombardi C, et al, "Sublingual immunotherapy is clinically safe in patients with oral allergy syndrome,” Allergy 2000 in press.

14. Andre, C. et al, “Safety of sublingual immunotherapy in children and adults, “Int Arch Allergy Immunol Vol. 121, pgs. 229-234, 2000.

15. Madonini, E. et al, “Safety and Efficacy Evaluation of Sublingual Allergen-Specific Immunotherapy – A Retrospective, Multicenter Study, International Journal of Immunopathology and Pharmacology, Vol. 13, No. 2, pgs. 77-81, 2000.

16. Di Rienzo, V. et al, "Post-marketing surveillance study on the safety of sublingual immunotherapy in children," Allergy, Vol. 54, pgs. 1110-1113, 1999.

17. Ariano, R., et al, "Efficacy and safety of oral immunotherapy in respiratory allergy to Parietaria judaica pollen. A double-blind study." Invest Allergol Clin Immunol, Vol. 8, No. 3, pgs. 155-160, May-June 1998.

18. Feliziani, V. et. al. "Safety and efficacy of sublingual rush immunotherapy with grass allergen extracts. A double blind study." Allergol. Et. Immunopathol., Vol. 23, No. 5, pgs. 224-230, 1995.

6) Other Indications for Treatment (Foods and Chemicals)

1. D. de Boissieu and C. Dupont “Sublingual immunotherapy for cow’s milk protein allergy: a preliminary report,” Allergy, Vol. 61, pgs 1238-1239, 2006.

2. Kerzl, Regina et al “Life-threatening anaphylaxis to kiwi fruit: Protective sublingual allergen immunotherapy effect persists even after discontinuation,” Letter to the Editor, J Allergy Clinic Immunol, 2006.

3. Enrique, E. et al, “Sublingual immunotherapy for hazelnut food allergy: A randomized, double-blind, placebo-controlled study with a standardized hazelnut extract,” J Allergy Clin Immunol, Vol. 116 (5) page 1073-1079, November 2005.

4. Bahima, A. Cistero “Tolerance and effects on skin reactivity to latex of sublingual rush immunotherapy with a latex extract,” J Invest Allergol Clin Immunol, Vol. 14 (1) pages 17-25, 2004.

5. Severe anaphylaxis to kiwi fruit: Immunologic changes related to successful sublingual allergen immunotherapy, Letter to the editor, JACI, page 1406-09, June 2003.

6. Patriarca, G. et al,. “Oral desensitizing treatment in food allergy: clinical and immunologic results,” Ailment Pharmacol Ther, Vol 17, pgs. 459-465, 2003.

7. Patriarca, G. “Sublingual Desensitization: A New Approach to Latex Allergy Problem” Anesth Analg, Vol. 95, pgs. 956-960, 2002.

8. Nucera, E. “Immunological Aspects of Oral Desensitization in Food Allergy,” Digestive Diseases and Sciences, Vol. 45, No. 3, pgs. 637-641, March 2000.

9. Patriarca, G., et al, "Food allergy in children: results of a standardized protocol for oral desensitization,” Hepatogastroenterology, Vol. 45 (19): pgs. 52-58, January-February 1998.

10. Morris, D.L. "Intradermal Testing and Sublingual Desensitization for Nickel,” Cutis, Vol. 61, No. 3, pgs. 129-132. March 1998.

11. Panzani, R.C., et al,. "Oral hyposensitization to nickel allergy: preliminary clinical results,” Int Arch Allergy Immunol, Vol. 107 (1-3): pgs. 251-254, May-June 1995.

 

 

 


 

 

 
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