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Safety of ragweed sublingual allergy immunotherapy tablets in adults with allergic rhinoconjunctivitis

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Abstract:

A sublingually administered allergy immunotherapy tablet (AIT) is under development to treat ragweed (Ambrosia artemisiifolia)-induced allergic rhinoconjunctivitis (ARC). This study investigates the optimal tolerable dose of once-daily ragweed pollen AIT. Subjects 18‐50 years old with ragweed-induced ARC were enrolled at two U.S. centers in a double-blind, placebo-controlled, dose-escalation study outside ragweed season. Groups (12 subjects each) were to be randomized 3:1 to 28 days of active treatment (groups assigned in sequence to 3, 6, 12, 24, 50, or 100 Amb a 1 U, without dose buildup at any level) or matching placebo. Recruitment to 50 Amb a 1-U was discontinued because of adverse events (AEs) after four AIT subjects were enrolled; 100 1 unit of ambrosia artemislifolia major allergen 1 was not initiated. Fifty-three subjects were randomized (AIT, n = 40; placebo, n = 13); four discontinued, all because of AEs (AIT, n = 3; placebo, n = 1). Treatment-related AEs (TRAEs) were more frequent with AIT (73%) than placebo (31%), increasing with dose level. AIT TRAEs were mostly mild (94%) or moderate (5%). No serious TRAEs or anaphylactic shock occurred. The most common TRAEs with AIT were localized pruritus, nasal irritation, and throat irritation. Median onset for common AIT application site reactions was ≤24 hours after first treatment (median duration, 15‐50 minutes). AIT increased immunoglobulin (Ig) significantly more than placebo (ragweed-specific IgE [6, 12, and 24 Amb a 1-U]; IgG4 [all doses]; p < 0.05). Three subjects in dose groups ≥24 Amb a 1-U experienced symptoms suggestive of systemic reaction. Of tested doses, ragweed AIT <24 Amb a 1-U once-daily was well tolerated in subjects with ragweed-induced ARC. Clinical trial registration URL and registration number: www.clinicaltrials.gov/ct2/show/NCT01134705.

Keywords: Adult; allergic rhinitis; allergy immunotherapy tablet; ambrosia artemisiifolia; clinical trial; immunoglobulin G; ragweed pollen; safety; specific immunotherapy; sublingual immunotherapy

Document Type: Research Article

DOI: http://dx.doi.org/10.2500/aap.2012.33.3605

Affiliations: Sneeze, Wheeze & Itch Associates, LLC, Normal, Illinois, USA

Publication date: September 1, 2012

More about this publication?
  • Allergy and Asthma Proceedings is a peer reviewed publication dedicated to distributing timely scientific research regarding advancements in the knowledge and practice of allergy, asthma and immunology. Its primary readership consists of allergists and pulmonologists.

    The goal of the Proceedings is to publish articles with a predominantly clinical focus which directly impact quality of care for patients with allergic disease and asthma.

    Featured topics include asthma, rhinitis, sinusitis, food allergies, allergic skin diseases, diagnostic techniques, allergens, and treatment modalities. Published material includes peer-reviewed original research, clinical trials and review articles.

    Articles marked "F" offer free full text for personal noncommercial use only.

    The journal is indexed in Thomson Reuters Web of Science and Science Citation Index Expanded, plus the National Library of Medicine's PubMed service.
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