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From the Townsend Letter
April 2016

Allergy and Immunotherapy
by Diego Saporta, MD, FAAOA
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Low-Dose Allergen Immunotherapy (LDA)
This treatment modality, while being effective, does not conform to "usual" immunotherapy. With LDA, allergens are diluted to the order of 10−6 to 10−17. A major controversy about this treatment is a lack of understanding about its mechanisms. An attempt to get approved by the FDA failed.51 LDA efficacy information is mostly anecdotal. It uses proprietary information in its formulation, and there is only one source for the treatment sets.52 LDA reportedly uses all allergens present in the environment as well as foods. Immediately before administration these allergens are mixed with the enzyme beta-glucuronidase.

Knowledge of LDA stems mainly from observations of Dr. Leonard McEwen, a British allergist who realized that beta-glucuronidase had antiallergenic properties. The treatment was popularized in the US by Dr. Welman Shrader.51 The most remarkable fact about LDA is that it works. LDA is administered initially once every 2 months. It takes usually 12 to 18 months to attain a 2-month improvement, at which time the interval between administrations is increased. Eventually the patient can be managed with treatments once a year or longer.51

LDA advantages:
Administration is based on a clinical diagnosis of the allergic condition. An allergy test is not necessary because:
a.   All allergens are covered; therefore there is no need to diagnose which are the responsible allergens.
b.  The administered dose is so diluted that it will never give a reaction as can happen with SCIT; therefore the concept of "safe dose to start immunotherapy" does not apply.
     
The cost of this treatment decreases over time, since the number of administrations diminishes as the patient improves.
     
LDA administration treats hypersensitivity to not only inhalant allergens but also foods. The prevalence of food reactivities is on the rise worldwide. The patient with allergies commonly reacts to one or more foods. There are no FDA-approved therapies for food allergy.53 The standard of care consists of allergen avoidance and, if needed, prompt treatment of allergic reactions after accidental ingestion. Oral and sublingual food immunotherapy are being evaluated, and reports are optimistic.53,54 LDA offers another option for the management of food allergies and reactivities.
     
Anecdotal information suggests that LDA is effective.51 In a study comparing results of patients treated with LDA or with standard immunotherapy, no statistical differences between the groups were found, but the LDA group included patients who failed standard immunotherapy.55 If these patients had continued with usual immunotherapy rather than switching to LDA, it could be assumed that the results in the LDA group would have been better than with the standard immunotherapy group.
     
Lastly, LDA offers the possibility of managing other conditions, including chemical sensitivity or autoimmune conditions.51

Summary
Highlights on diagnosis and management of allergies were presented. Immunotherapy is an excellent treatment modality able to induce a change in the dysfunctional immunological system, leading to a cure or at least long-lasting control of the allergic conditions. Different methods of administration have been succinctly described. The value of a safer approach such as SLIT has been underlined. SLIT can be considered for patients with asthma and sometimes in cases where SCIT is considered dangerous or its administration elicited problems. The potential role of LDA for the management of the allergic patient has also been stressed.
     
Practitioners interested in the management of allergic conditions should consider attending courses offered by mainstream academies (AAOA, AAAI) as well as smaller medical societies such as the Pan American Allergy Society and the American Academy of Environmental Medicine where management of inhalant and food-related allergic conditions, LDA, and other treatment modalities can be learned.

Notes
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5.     Paul WE, ed. Fundamental Immunology. 5th ed. Lippincott, Williams &. Wilkins. 2003:1439.
6.     Gell PGH, Coombs RRA, eds. Clinical Aspects of Immunology. 1st ed. Oxford: Blackwell; 1963.
7.     Van der Valk JP, de Jong NW, Gerth van Wijk R. Review on immunotherapy in airway allergen sensitised patients. Neth J Med. 2015 Jul;73(6):263–269.
8.     Genuis SJ. Sensitivity-related illness: the escalating pandemic of allergy, food intolerance and chemical sensitivity. Sci Total Environ. 2010;408(24):6047– 6061.
9.     O'Sullivan S. Charles Blackley and allergy research, 1873–1973. New Scientist. 1973;58(852):818.
10.   Fornadley JA. Skin testing in the diagnosis of inhalant allergy. In: Krouse JH, Chadwick SJ, Gordon BR, Derebery MJ, eds. Allergy and Immunology: An Otolaryngic Approach. Philadelphia: Lippincott Williams & Wilkins; 2002:114–123.
12.   Harvima IT, Nilsson G. Mast cells as regulators of skin inflammation and immunity. Acta Derm Venereol. 91(6):644–650. doi:10.2340/00015555-1197.
13.   Bernstein L, Li JT, Bernstein DI et al. Allergy diagnostic testing: an updated practice parameter. Ann Allergy Asthma Immunol. 2008;100(3):S22–S23.
14.   Cox L, Nelson H, Lockey R. Allergen immunotherapy: A practice parameter third update. J Allergy Clin Immunol. 2011:S34.
15.   Davis WE, Cook PR, McKinsey JP, Templer JW. Anaphylaxis in immunotherapy. Otolaryngol Head Neck Surg. 1992;107(1):78–83.
16.   Lockey RF, Benedict LM, Turkeltaub PC, Bukantz, SC. Fatalities from immunotherapy (IT) and skin testing (ST). J Allergy Clinical Immunol. 1987;79(4):660–677.
17.   Cook PR, Bryant JL, Davis WE, et al. Systemic reactions to immunotherapy: the American Academy of Otolaryngic Allergy morbidity and mortality survey. Otolaryngol Head Neck Surg. 1994;110(6):487–493.
18.   Gungor A, Houser SM, Aquino BF, et al. A comparison of skin endpoint titration and skin-prick testing in the diagnosis of allergic rhinitis. Ear Nose Throat J. 2004;83(1):54–60.
19.   Adkinson NF Jr. The radioallergosorbent test in 1981--limitations and refinements. J Allergy Clin Immunol. 1981 Feb;67(2):87–89.
20.   Passante E, Frankish N. The RBL-2H3 cell line: its provenance and suitability as a model for the mast cell. Inflamm Res. 58:737–745.
21.   Suurmond J et al. Toll-like receptor triggering augments activation of human mast cells by anti-citrullinated protein antibodies. Ann Rheum Dis. 2015;74(10):1915–1923.
22.   Weiss J, Saporta D. A group of patients that underwent skin testing donated blood. Specific antibodies were measured at Allermetrix (www.allermetrix.com). Combined results of sIgE and sIgG4 predicted patient's reactivity better than measuring only sIgE and approximated the results obtained by the IDT. Unpublished data.
23.   Akdis M, Akdis CA. Mechanisms of allergen-specific immunotherapy: multiple suppressor factors at work in immune tolerance to allergens. J Allergy Clin Immunol. 2014;133:621–31.
24.   Akdis M, Burgler S, Crameri R, et al. Interleukins, from 1 to 37, and interferon-gamma: receptors, functions, and roles in diseases. J Allergy Clin Immunol. 2011;127:701–721.
25.   Haydon RC, Gordon BR. Aeroallergen immunotherapy. In: Krouse JH, Chadwick SJ, Gordon BR, Derebery MJ, eds. Allergy and Immunology: An Otolaryngic Approach:151–182.
26.   As taught by the American Academy of Otolaryngic Allergy, the Pan American Allergy Society, and other small societies.
27.   Boyles JH. A comparison of techniques for evaluating IgE-mediated allergies. Ear Nose Throat J. 2011(90)4:164–169.
28.   Seshul M, Pillsbury H, Eby T. Use of intradermal dilutional testing and skin prick testing: clinical relevance and cost efficiency. Laryngoscope. 2006;116(9):1530–1538.
29.   Saporta D. Efficacy of sublingual immunotherapy versus subcutaneous injection immunotherapy in allergic patients. J Environ Public Health. 2012. Article ID 492405, 6 pages doi:10.1155/2012/492405
30.   Mauroa M, Russelloa M, Incorvaiab C, et al. Comparison of efficacy, safety and immunologic effects of subcutaneous and sublingual immunotherapy in birch pollinosis: a randomized study. Eur Ann Allergy Clin Immunol. 2007;39(4):119–122.
31.   Khinchi MS, Poulsen LK, Carat F, et al. Clinical efficacy of sublingual and subcutaneous birch pollen allergen-specific immunotherapy: a randomized, placebo-controlled, double-blind, double dummy study. Allergy. 2004;59 (1):45–53.
32.   Lin SY, Erekosima N, Suarez-Cuervo C, et al. Allergen-Specific Immunotherapy for the Treatment of Allergic Rhinoconjunctivitis and/or Asthma: Comparative Effectiveness Review (Internet). Rockville (MD): Agency for Healthcare Research and Quality (US); 2013 Mar. Report No.: 13-EHC061-EF.
33.   Radulovic S, Wilson D, Calderon M, Durham S. Systematic reviews of sublingual immunotherapy (SLIT). Allergy. 2011 Jun;66(6):740–52. doi:10.1111/j.1398-9995.2011.02583.x. Epub 2011 Mar 28.
34.   Saporta D. Sublingual immunotherapy and asthma. Townsend Lett. October 2010:44–48.
35.   Dunsky EH, Goldstein MF, Dvorin DJ, Belecanech GA. Anaphylaxis to sublingual immunotherapy. Allergy. 2006 Oct;61(10):1235.               
36.   Eifan AO, Keles S, Bahceciler NN, Barlan IB. Anaphylaxis to multiple pollen allergen sublingual immunotherapy. Allergy. 2007 May;62(5):567–568. Epub 2007 Feb 20.
37.   Blazowski L. Anaphylactic shock because of sublingual immunotherapy overdose during third year of maintenance dose. Allergy. 2008 Mar;63(3):374. Epub 2007 Dec 8.
38.   De Groot H, Bijl A. Anaphylactic reaction after the first dose of sublingual immunotherapy with grass pollen tablet. Allergy. 2009 Jun;64(6):963–964. doi:10.1111/ j.1398-9995.2009.01998.x. Epub 2009 Feb 16.
39.   Saporta D, McDaniel AB. Efficacy comparison of multiple-antigen subcutaneous injection immunotherapy and multiple-antigen sublingual immunotherapy. Ear Nose Throat J. 2007;86(8):493–497.
40.   Saporta D. Reactions to sublingual immunotherapy: an analysis of a group of patients who developed adverse events over a period of 5 years. Townsend Lett. August/September 2014:78–79.
41.   Cox L, Compalati E, Kundig T, Larche M. New directions in immunotherapy. Curr Allergy Asthma Rep. 2013 Apr;13(2):178–195. doi:10.1007/s11882-012-0335-7.
42.   Linkov G, Toskala E. Sublingual immunotherapy: what we can learn from the European experience. Curr Opin Otolaryngol Head Neck Surg. 2014 Jun;22(3):208–210. doi:10.1097/MOO.0000000000000042.
43.   Sub-lingual immunotherapy: World Allergy Organization Position Paper. World Allergy Organ J. November 2009. Available at http://www.waojournal.org/content/pdf/1939-4551-2-11-233.pdf.
44.   Saporta D. Sublingual immunotherapy: an alternative to allergy shots. Townsend Lett. 2012;345:64–68.
45.   Saporta D. Sublingual immunotherapy: a novel, albeit not so new, immunotherapy treatment modality. Am J Rhinol. 2008;22:253–257.doi:10.2500/ajr.2008.22.3131.
46.   Shaikh WA, Shaikh SW. A prospective study on the safety of sublingual immunotherapy in pregnancy. Allergy. 2012 Jun;67(6):741–743. doi:10.1111/j.1398-9995.2012.02815.x. Epub 2012 Apr 5.
47.   US Food and Drug Administration. FDA approves first sublingual allergen extract for the treatment of certain grass pollen allergies [online press release]. April 2, 2014. http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm391458.htm
48.   US Food and Drug Administration. FDA approves Ragwitek for short ragweed pollen allergies [online press release]. April 17, 2014. http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm393820.htm
49.   ALK announces FDA approval for Merck's grass sublingual allergy immunotherapy tablet GRASTEK® (GRAZAX®) [online press release]. ALK. Ir.alk-abello.com/releasedetail.cfm?releaseid=840112.
50.   Allergy tablet approval warrants caution for some [online article]. American College of Allergy, Asthma & Immunology. April 2, 2014. http://acaai.org/news/allergy-tablet-approval-warrants-caution-some.
51.   Ragwitek [package insert]. Merck & Co. Inc.; 2014 http://www.merck.com/product/usa/pi_circulars/r/ragwitek/ragwitek_pi.pdf
52.   Santa Fe Center for Allergy & Environmental Medicine [website]. www.drshrader.com
53.   College Pharmacy. 3505 Austin Bluffs Pkwy #101. Colorado Springs, CO 80918.
54.   Umetsu DT, Rachid R, Schneider LC. Oral immunotherapy and anti-IgE antibody treatment for food allergy. World Allergy Organ J. 2015;8(1): 20. doi:10.1186/s40413-015-0070-3
55.   Yepes-Nuñez JJ, Zhang Y, Roqué I, et al. Immunotherapy (oral and sublingual) for food allergy to fruits. Cochrane Database Syst Rev. Epub 2015 Nov 9;11:CD010522. Saporta D. Low-dose allergen immunotherapy (LDA) vs. subcutaneous injection immunotherapy: a comparative study. Townsend Lett. June 2015:62–66.

Dr SaportaDr. Saporta completed his training in 1990 at Columbia Presbyterian Hospital in New York City. He is board certified in otolaryngology and has been a fellow of the American Academy of Otolaryngic Allergy (AAOA) since 2001. His private practice in Elizabeth, New Jersey, is heavily oriented to the management of allergic conditions. Interested in the use of oral vaccines since early in his practice, Dr. Saporta presented a protocol for sublingual immunotherapy at the 64th annual meeting of the AAOA that since then has been successfully used for the management of allergic rhinitis with or without asthma.

 

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