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Ann Allergy Asthma Immunol. 2008 May;100(5):475-81. doi: 10.1016/S1081-1206(10)60474-7.

Sublingual-oral administration of standardized allergenic extracts: phase 1 safety and dosing results.

Author information

1
Research and Development, Greer Laboratories, Lenoir, North Carolina 28645, USA. esch@greerlabs.com

Abstract

BACKGROUND:

European studies provide a preponderance of evidence for sublingual allergen immunotherapy (SLIT) safety and efficacy, but they use allergen products that differ from those expected to be approved in the United States.

OBJECTIVE:

To determine the safety and tolerability of 4 US-licensed standardized SLIT allergenic extracts.

METHODS:

Adults 18 to 50 years old with allergic rhinitis with or without asthma due to timothy grass pollen, short ragweed pollen, house dust mite, or cat hair allergy completed a single-session dose escalation followed by an 8-week, open-label daily course of SLIT. Participants documented the presence and severity of adverse effects and adherence using a daily electronic diary.

RESULTS:

Ninety-one participants initiated treatment, and 77 completed the phase 1 testing. Maximum tolerable doses ranged from 50 to 2,090 BAU for cat hair and dust mite extract, 31 to 91 Amb a 1 Units for short ragweed pollen extract, and 50 to 21,090 BAU for timothy grass pollen extract. During the 8-week treatment course, 98.9% of participants reported at least 1 mild, 70.4% at least 1 moderate, and 13.6% at least 1 severe adverse effect. Most adverse effects (94.6%) were rated as mild, 5.2% as moderate, and 0.1% as severe; nasal and oral-mucosal adverse effects were most commonly reported. No life-threatening adverse reactions occurred in more than 4,500 administered doses.

CONCLUSIONS:

Daily sublingual-oral dosing of standardized allergenic extracts at maximum tolerable doses was generally well tolerated. These results are a first step toward establishing the safety of US-licensed SLIT extracts when appropriately self-administered and monitored.

PMID:
18517081
DOI:
10.1016/S1081-1206(10)60474-7
[Indexed for MEDLINE]

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