Prolonged Exposure to Sublingual Immunotherapy Improves Safety of Oral Immunotherapy study, JACI

Interesting press release from the 2012 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI):

March 5, 2012 - Follow up story on CNN.com: Experimental treatment may help food allergies

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One step closer to treatment for food allergy

ORLANDO – Currently, there is no cure for food allergy and no medication to prevent reactions. The only way to avoid a reaction is strictly avoiding the trigger food. This can be tricky because you have to carefully read food labels and ask about ingredients when eating food prepared by another person.
Yet, thanks to research from the 2012 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI), more clues are falling into place regarding the prospects for safe treatments for food allergy.
 

Two potential treatments are sublingual immunotherapy and oral immunotherapy. The goal of immunotherapy is to build up your immune system. Your body responds to gradually increasing doses of the allergen by developing immunity or tolerance to it. The difference between sublingual and oral immunotherapy is that the allergen is held under the tongue with sublingual, where the allergen is simply swallowed with oral immunotherapy.

New research from the 2012 AAAAI Annual Meeting found that children with severe milk allergy who received a longer schedule of sublingual immunotherapy and then moved to oral immunotherapy had less respiratory reactions along with less frequent use of certain medications.


“While the overall result of the study, which was recently published in The Journal of Allergy and Clinical Immunology, found that oral was far more effective than sublingual immunotherapy, it was also clear that oral was associated with more significant allergic reactions to the treatment,” said senior study author Robert A. Wood, MD, FAAAAI, director of Allergy & Immunology at Johns Hopkins Children’s Center.
 

In their previous research, sublingual was compared to oral immunotherapy after a short period of increasing sublingual doses. To add another piece to the puzzle, the same researchers from Johns Hopkins and Duke University decided to see if a longer period on sublingual and then oral immunotherapy would improve the safety of the treatment.
 

Thirty children with cow’s milk allergy were randomly placed into two groups that received either a short or longer sublingual schedule followed by oral immunotherapy. Eight sublingual subjects 
moved over to oral immunotherapy. After comparing reactions across the doses, the study authors concluded that the longer sublingual schedule before moving to oral immunotherapy appeared to improve safety although it did not eliminate all symptoms. Symptoms occurred with approximately 25% of 2,251 doses.
 

While the overall rates of reaction between the two groups were similar, the longer sublingual immunotherapy group followed by oral immunotherapy had fewer lower and upper respiratory reactions and used antihistamines and inhaled beta-agonists less frequently.
 

“We continue to search for the best approach for the treatment of food allergy. This study shows that for at least some children, especially those with more frequent or severe reactions to oral immunotherapy, beginning treatment with sublingual might be beneficial,” emphasized Dr. Wood.
 

The AAAAI represents allergists, asthma specialists, clinical immunologists, allied health professionals and others with a special interest in the research and treatment of allergic and immunologic diseases. Established in 1943, the AAAAI has nearly 6,500 members in the United States, Canada and 60 other countries. The AAAAI’s Find an Allergist/Immunologist service is a trusted resource to help you find a specialist close to home.

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Editorial notes:
•    This study was presented during the 2012 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) on March 2-6 in Orlando. However, it does not necessarily reflect the policies or the opinions of the AAAAI.
 

•    A link to all abstracts presented at the Annual Meeting is available at www.annualmeeting.aaaai.org


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Abstract 478:

Prolonged Exposure to Sublingual Immunotherapy Improves Safety of Oral Immunotherapy 

S. Seopaul1, C. A. Keet1, P. A. Frischmeyer-Guerrerio1, A. Thyagarajan2,J. T. Schroeder1, R. Hamilton1, S. Boden2, P. Steele2, S. Driggers1, A. W.Burks2, R. A. Wood1;1Johns Hopkins University, Baltimore, MD,2DukeUniversity, Durham, NC.

RATIONALE: We recently compared sublingual (SLIT) to oral immunotherapy (OIT) following a short SLIT escalation for treatment of cow’s milk (CM)-allergy and found that while SLIT was safer than OIT, it was less efficacious. This analysis sought to determine if a more prolonged period on SLIT could improve safety of subsequent OIT.


METHODS: 30 children with IgE-mediated-CM-allergy were randomized to either SLIT (goal 7mg daily, N510) or 4 weekly SLITescalations to a dose of 3.7mg followed by OIT (goal 1000 or 2000mg daily, N520). 


After 60 weeks of maintenance, SLIT subjects who reacted to less than 4gm CM-protein on food challenge crossed-over to OIT. Dose escalation started at less than ¼ the tolerated food challenge dose and escalated to 2000mg daily for one year. The rates of adverse events across dosing regimens were compared using negative binomial analysis with generalized estimating equations.

RESULTS: 8 SLIT subjects crossed over to OIT. Symptoms occurred with 24.4% of 2251 doses (oral 23.1%, skin 0.84%, GI 0.89%, lower respiratory 0.27% and upper respiratory 0.13%). One subject withdrew due to persistent GI symptoms. Antihistamines and inhaled beta-agonists were given for 1.3% and 0.04% of doses. Although the overall rates of reactions with OIT following brief versus prolonged SLIT were similar (p50.976), lower and upper respiratory reactions were significantly less common (p50.02 and p50.006, respectively) and antihistamines and inhaled betaagonists used less frequently (p50.002 and p50.001, respectively) in the prolonged SLIT group.


CONCLUSION: Prolonged SLIT before OIT dosing appeared to improve safety, but did not eliminate all symptoms.

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