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32. 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.

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

34. 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.

35. 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.

36. 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.

37. 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.

38. 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.

39. 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.

40. 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.

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

42. 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.

43. 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.

44. 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.

45. 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.

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

47. 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.

48. 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.

49. 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.

50. 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.

51. 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.

52. 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.

53. 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.

54. 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.

55. 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.

56. 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.

57. 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.

58. 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.

59. 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.

60. 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.

61. 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.

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

63. 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.

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

65. 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.

66. 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.

67. 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.

68. 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.

69. 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.

70. 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.

71. 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.

72. 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.

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

74. 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.

75. 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. 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.

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

3. 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.

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

5. 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.

6. 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.

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

8. 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.

9. 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.

10. 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.

11. 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.

12. 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.

13. 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.

14. 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. 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.

2. 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.

3. 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.

4. 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)

5. 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)

6. 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.

7. 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.

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

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

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

8. 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.

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

10. 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.

11. 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. 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.

2. 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.

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

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

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

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

7. 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.

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

9. 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.