Subcutaneous Immunotherapy and Sublingual Immunotherapy: Comparative Efficacy, Current and Potential Indications, and Warnings-United States Versus Europe

Immunology and Allergy Clinics of North America

Volumn 36, Issue 1, 2016, Pages 13-24

  Nelson, Harold S ^a   Makatsori, Melina ^b   Calderon, Moises A ^b,c  

^a UNIVERSITY OF COLORADO SCHOOL OF MEDICINE   (United States)

^b ROYAL BROMPTON AND HAREFIELD NHS FOUNDATION TRUST   (United Kingdom)

^c Rodrigo Facio University City   (Costa Rica)

Author keywords

AIT; Allergic asthma; Allergic rhinitis; Immunotherapy; SCIT; SLIT

Indexed keywords

GRASS POLLEN EXTRACT; IMMUNOMODULATING AGENT; PLACEBO; ALLERGEN;

ALLERGIC ASTHMA; ALLERGIC RHINITIS; ANTIBODY RESPONSE; APPLICATION SITE REACTION; CYTOKINE RESPONSE; DRUG EFFICACY; DRUG MEGADOSE; DRUG MIXTURE; DRUG RESPONSE; DRUG SAFETY; DRUG SOLUBILITY; EAR PRURITUS; FOOD AND DRUG ADMINISTRATION; HELPER CELL; HOUSE DUST ALLERGY; HUMAN; IMMUNE RESPONSE; LICENSING; LOW DRUG DOSE; MOUTH EDEMA; ORAL PRURITUS; PRESCRIPTION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL (TOPIC); REVIEW; RHINOCONJUNCTIVITIS; SUBCUTANEOUS IMMUNOTHERAPY; SUBLINGUAL IMMUNOTHERAPY; THROAT IRRITATION; TREATMENT DURATION; TREATMENT OUTCOME; ANIMAL; COMPARATIVE STUDY; DESENSITIZATION; EUROPE; HYPERSENSITIVITY; IMMUNOLOGY; SUBCUTANEOUS DRUG ADMINISTRATION; SUBLINGUAL DRUG ADMINISTRATION; UNITED STATES;

ADMINISTRATION, SUBLINGUAL; ALLERGENS; ANIMALS; DESENSITIZATION, IMMUNOLOGIC; EUROPE; HUMANS; HYPERSENSITIVITY; INJECTIONS, SUBCUTANEOUS; UNITED STATES;

EID: 84947968199     PISSN: 08898561     EISSN: 15578607     Source Type: Journal    
DOI: 10.1016/j.iac.2015.08.005     Document Type: Review

References (65)

1. Noon L. Prophylactic inoculation against hay fever. Lancet 1911, i:1572.
2. Calderon M.A., Alves B., Jacobson M., et al. Allergy injection immunotherapy for sessional allergic rhinitis. Cochrane Database Syst Rev 2007, (1). CD001936.
3. Abramson M.J., Puy R.M., Winer J.M. Injection allergen immunotherapy for asthma. Cochrane Database Syst Rev 2010, (8). CD001186.
4. Boyle R.J., Elremelli M., Hockenhull J., et al. Venom immunotherapy for preventing allergic reactions to insect stings. Cochrane Database Syst Rev 2012, (10). CD0008838.
5. Nelson H.S. New forms of allergy immunotherapy for rhinitis and asthma. Allergy Asthma Proc 2014, 35:271-277.
6. Bae J.M., Choi Y.Y., Park C.O., et al. Efficacy of allergen-specific immunotherapy for atopic dermatitis: a systematic review and meta-analysis of randomized controlled trials. J Allergy Clin Immunol 2013, 132:110-117.
7. Patriarca G., Nucera E., Roncallo C., et al. Sublingual desensitization in patients with wasp venom allergy: preliminary results. Int J Immunopathol Pharmacol 2008, 21:669-677.
8. Severino M.G., Cortellinii G., Bonadonna P., et al. Sublingual immunotherapy for large local reactions caused by honeybee sting: a double-blind, placebo-controlled trail. J Allergy Clin Immunol 2008, 122:4-8.
9. Nelson H.S., Lahr J., Rule R., et al. Treatment of anaphylactic sensitivity to peanuts by immunotherapy with injections of aqueous peanut extract. J Allergy Clin Immunol 1997, 99:744-751.
10. Burks A.W., Wood R.A., Jones S.M., et al. Sublingual immunotherapy for peanut allergy: long-term follow-up of a randomized multicenter trial. J Allergy Clin Immunol 2015, 135(5):1240-1248.e1-3.
11. Cox L., Larenas Linnemann D., Nolte H., et al. Sublingual immunotherapy: a comprehensive review. J Allergy Clin Immunol 2006, 117:1021-1035.
12. Amar S.M., Harbeck R.J., Sills M., et al. Response to sublingual immunotherapy with grass pollen extract: monotherapy versus combination in a multiallergen extract. J Allergy Clin Immunol 2009, 124:150-156.
13. Nelson H.S. Subcutaneous immunotherapy versus sublingual immunotherapy: which is more effective?. J Allergy Clin Immunol Pract 2014, 1:144-149.
14. Aasbjerg K., Backer V., Lund G., et al. Immunological comparison of allergen immunotherapy tablet treatment and subcutaneous immunotherapy against grass allergy. Clin Exp Allergy 2014, 44:417-428.
15. Radulovic S., Wilson D., Calderon M., et al. Systematic reviews of sublingual immunotherapy (SLIT). Allergy 2011, 66:740-752.
16. Calamita Z., Saconato H., Pela A.B., et al. Efficacy of sublingual immunotherapy in asthma: systematic review of randomize-clinical trials using the Cochrane collaboration method. Allergy 2006, 61:1162-1172.
17. Erekosima N., Suarez-Cuervo C., Ramanathan M., et al. Effectiveness of subcutaneous immunotherapy for allergic rhinoconjunctivitis and asthma: a systematic review. Laryngoscope 2014, 124:616-627.
18. Lin S.Y., Erekosima N., Kim J.M., et al. Sublingual immunotherapy for the treatment of allergic rhinoconjunctivitis and asthma: a systematic review. JAMA 2013, 309:1278-1288.
19. Tankersley M.S. The stinging impact of the imported fire ant. Curr Opin Allergy Clin Immunol 2008, 8:354-359.
20. Enrique E., Pineda F., Malek T., et al. Sublingual immunotherapy for hazelnut food allergy: a randomized, double-blind, placebo-controlled study with a standardized hazelnut extract. J Allergy Clin Immunol 2005, 116:1073-1079.
21. Jutel M., Akdis M.N., Budak F., et al. IL-10 and TGF-beta cooperate in the regulatory T cell response to mucosa allergen in normal immunity and specific immunotherapy. Eur J Immunol 2003, 33:1205-1214.
22. Bohle B., Kinaciyan T., Gerstmayr M., et al. Sublingual immunotherapy induces IL-10-producing T regulator cells, allergen-specific T-cell tolerance, and immune deviation. J Allergy Clin Immunol 2007, 120:707-713.
23. Mobs C., Ipsen H., Mayer L., et al. Birch pollen immunotherapy results in long-term loss of Bet v 1-specific Th2 responses, transient TR1 activation, and synthesis of IgE-blocking antibodies. J Allergy Clin Immunol 2012, 130:1108-1116.
24. Hamid Q.A., Schotman E., Jacobson M.R., et al. Increases in IL-121 messenger RNA+ cells accompany inhibition of allergen-induced late skin responses after successful grass pollen immunotherapy. J Allergy Clin Immunol 1997, 99:454-460.
25. Li C.W., Lu H.G., Chen D.H., et al. In vivo and in vitro studies of Th17 response to specific immunotherapy in house dust mite-induced allergic rhinitis patients. PLoS One 2014, 9:e91950.
26. Tian M., Wang Y., Lu Y., et al. Effects of sublingual immunotherapy for Dermatophagoides farina on Th17 cells and CD4+CD25+ regularity T cells in peripheral blood of children with allergic asthma. Int Forum Allergy Rhinol 2014, 4(5):371-375.
27. Pajno G., Barberio G., De Luca F., et al. Prevention of sensitization in asthma children monosensitized to house dust mite by specific immunotherapy. A six-year follow-up study. Clin Exp Allergy 2001, 31:1392-1397.
28. Marogna M., Spadolini I., Massolo A., et al. Long-lasting effects of sublingual immunotherapy according to its duration: a 15-year prospective study. J Allergy Clin Immunol 2010, 126:969-975.
29. Jacobsen L., Niggemann B., Dreborg S., et al. Specific immunotherapy has long-term preventive effect of seasonal and perennial asthma: 10-year follow-8 on the PAT study. Allergy 2007, 62:943-948.
30. Marogna M., Tomassetti D., Bernasconi A., et al. Preventive effects of sublingual immunotherapy in childhood: an open randomized controlled study. Ann Allergy Asthma Immunol 2008, 101:206-211.
31. Ebner C., Kraft D., Ebner H. Booster Immunotheapy (BIT). Allergy 1994, 49:38-42.
32. Nelson H.S. Subcutaneous immunotherapy for optimal effectiveness. Immunol Allergy Clin North Am 2011, 31:211-226.
33. Kuna P., Kaczmarek J., Kupczyk M. Efficacy and safety of immunotherapy for allergies to Alternaria alternata in children. J Allergy Clin Immunol 2011, 127:502-508.
34. Didier A., Malling H.J., 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, 120:1338-1345.
35. Durham S.R., Yang W.H., Pedersen M.R., et al. Sublingual immunotherapy with once-daily grass allergen tablets: a randomized controlled trial in seasonal allergic rhinoconjunctivitis. J Allergy Clin Immunol 2006, 117:802-809.
36. Nolte H., Amar N., Bernstein D.I., et al. Safety and tolerability of a short ragweed sublingual immunotherapy tablet. Ann Allergy Asthma Immunol 2014, 113:93-100.
37. Nolte H., Malone J., Nelson H.S., et al. Onset and dose-related efficacy of house dust mite sublingual immunotherapy tablets in an environmental exposure chamber. J Allergy Clin Immunol 2015, 135(6):1494-1501.
38. Skoner D., Gentile D., Bush R., et al. Sublingual immunotherapy in patients with allergic rhinoconjunctivitis caused by ragweed pollen. J Allergy Clin Immunol 2010, 125:660-666.
39. Valovirta E., Jacobsen L., Ljorring C., et al. Clinical efficacy and safety of sublingual immunotherapy with tree pollen extract in children. Allergy 2006, 61:117-183.
40. Bush R.K., Swenson C., Fahlberg B., et al. House dust mite sublingual immunotherapy results of a US trial. J Allergy Clin Immunol 2011, 127:974-981.
41. Lowell F.C., Franklin W. A double-blind study of the effectiveness and specificity of injection therapy in ragweed hay fever. N Engl J Med 1965, 271:675-679.
42. Franklin W., Lowell F.C. Comparison of two dosages of ragweed extract in the treatment of pollenosis. JAMA 1967, 201:915-917.
43. Johnstone D.E., Dutton A. The value of hyposensitization therapy for bronchial asthma in children: a 14-year study. Pediatrics 1968, 42:793-802.
44. Reid M.J., Moss R.B., Hsu Y.P., et al. Seasonal asthma in northern California: allergic causes and efficacy of immunotherapy. J Allergy Clin Immunol 1986, 78:590-600.
45. Bousquet J., Becker W.M., Heijjaoui A., et al. Differences in clinical and immunologic reactivity of patients allergic to grass pollen and to multiple pollen species. II. Efficacy of double-blind placebo-controlled specific immunotherapy with standardized extracts. J Allergy Clin Immunol 1991, 88:43-53.
46. Adkinson N.R., Eggleston P.A., Eney D., et al. A controlled trial of immunotherapy for asthma in allergic children. N Engl J Med 1997, 336:324-331.
47. Marogna M., Spadolini I., Massolo A., et al. Effects of sublingual immunotherapy for multiple or single allergens in polysensitized patients. Ann Allergy Asthma Immunol 2007, 98:274-280.
48. Swamy R.S., Reshamwala N., Hunter T., et al. Epigenetic modifications and improved regulatory T-cell function in subjects undergoing dual sublingual immunotherapy. J Allergy Clin Immunol 2012, 130:215-224.
49. Lieberman P., Tankersley M. Significance of large local reactions that occur during allergen immunotherapy. J Allergy Clin Immunol Pract 2015, 3:310-311.
50. Nelson H.S. Oral/sublingual phlegm pretense grass tablet (grazax/grastek) to treat allergic rhinitis in the USA. Expert Rev Clin Immunol 2014, 10:1437-1451.
51. Creticos P.S., Maloney J., Bernstein D.I., et al. Randomized controlled trial of a ragweed allergy immunotherapy tablet in North American and European adults. J Allergy Clin Immunol 2013, 131:1342-1349.
52. Epstein T.G., Liss G.M., Murphy-Berendts K., et al. AAAAI/ACAAI surveillance study of subcutaneous immunotherapy, years 2008-2012: an update on fatal and nonfatal systemic allergic reactions. J Allergy Clin Immunol Pract 2014, 2:161-167.
53. Canonica G.W., Cox L., Pawankar R., et al. Sublingual immunotherapy: World Allergy Organization position paper 2013 update. World Allergy Organ J 2014, 7(1):6. Available at:. http://www.waojournal.org/content/7/1/6.
54. Maloney J., Durham S., Skoner D., et al. Safety of sublingual immunotherapy timothy grass tablet in subjects with allergic rhinitis with or without conjunctivitis and history of asthma. Allergy 2015, 70:302-309.
55. Maloney J, Casale TB, Lockey RF, et al. Epinephrine use in clinical trials of sublingual immunotherapy tablets for treatment of allergic rhinitis with/without conjunctivitis. Abstract presentation, Annual Meeting, American Academy of Allergy, Asthma and Immunology. Houston, Texas, 20-24 February 2015.
56. Nelson H., Carter S., Allen-Ramey F., et al. Network meta-analysis shows commercialized subcutaneous and sublingual grass products have comparable efficacy. J Allergy Clin Immunol Pract 2015, 3(2):256-266.e3.
57. Bordignon V., Parmiani S. Variation of the skin endpoint in patients treated with sublingual specific immunotherapy. J Investig Allergol Clin Immunol 2003, 13:170-176.
58. Senna G., Caminati M., Canonica G.W. Safety and tolerability of sublingual immunotherapy in clinical trials and real life. Curr Opin Allergy Clin Immunol 2013, 13(6):656-662.
59. Kiel M.A., Roder E., van Wijk R.G., et al. Real-life compliance and persistence among users of subcutaneous and sublingual allergen immunotherapy. J Allergy Clin Immunol 2013, 132:353-360.e2.
60. Bonini S. Regulatory aspects of allergen-specific immunotherapy: Europe sets the scene for a global approach. World Allergy Organ J 2012, 5(10):120-123.
61. Kaul S., May S., Lüttkopf D., et al. Regulatory environment for allergen-specific immunotherapy. Allergy 2011, 66(6):753-764.
62. Available at: . Accessed June 15, 2015. http://www.fda.gov/Advisory.
63. Prescribing information GRASTEK 2014, Merck Sharp & Dohme Corporation, Whitehouse Station (NJ).
64. Prescribing information RAGWITEK 2014, Merck Sharp & Dohme Corporation, Whitehouse station (NJ).
65. Prescribing information ORALAIR 2014, Greer Laboratories, Lenoir (NC).