What is the role of sublingual (SL) immunotherapy in the treatment of allergic rhinitis?

Updated: Jan 02, 2020
  • Author: Quoc A Nguyen, MD; Chief Editor: Arlen D Meyers, MD, MBA  more...
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A Cochrane Database of Systematic Reviews article concluded that the sublingual (SL) route is a safe and effective method of immunotherapy; [7]  SL immunotherapy is more convenient than weekly injections for individuals with limited, specific allergies that match the SL product. However, SL immunotherapy may not be appropriate for everyone. Those affected by multiple allergens may not obtain relief from all of their symptoms by taking immunotherapy for only a single or several allergens.

In April 2014, the FDA approved an SL tablet consisting of 5 calibrated grass pollen extracts (Oralair). It contains Perennial Ryegrass (Lolium perenne), Kentucky bluegrass (Poa pratensis), Timothy grass (Phleum pratense), Orchard grass (Dactylis glomerata), and Sweet Vernal grass (Anthoxanthum odoratum). [8]

The Oralair SL tablet needs to be initiated 4 months prior to the season for the specific allergen.

A second SL immunotherapy for Timothy grass (Grastek) was also approved in April 2014 for adults and children aged 5 years or older. It should be initiated at least 12 weeks before the start of the grass pollen season. [9] Efficacy and safety in North America was established in a large study (n=1500) of adults and children aged 5-65 years. Results showed a 23% improvement of symptoms in the entire grass pollen season. [10]

A third SL immunotherapy for ragweed (Ragwitek) was also approved in April 2014 for adults aged 18 years or older. Effectiveness studies included about 760 patients. Phase 3 clinical trials showed reduced rhinoconjunctivitis symptoms over the entire season by 27-43% compared with placebo. It is approved for adults aged 18 years or older. [11, 12]

A study by Devillier et al indicated that in patients with allergic rhinitis, administration of prescription SL immunotherapy with grass pollen tablets reduces the need for allergic rhinitis and asthma medications. The investigators found, for example, that asthma therapy was initiated in 1.8% of patients treated with SL immunotherapy, compared with 5.3% of control patients. [13]

An SL immunotherapeutic agent (Odactra) for house dust mites was approved by the FDA in 2017 for adults aged 18 through 65 years. It is a standardized allergen extract indicated as daily SL immunotherapy for allergic rhinitis, with or without conjunctivitis, confirmed using in vitro testing for IgE antibodies to the house dust mite D farinae or D pteronyssinus, or through skin testing using licensed house dust mite allergen extracts. [14]

The first dose must be administered in a healthcare setting and supervised by a doctor experienced in allergic disease diagnosis and treatment. After this initial dose is given, the patient must be monitored for signs or symptoms of a severe systemic or local allergic reaction. Within the prescribing information, a boxed warning describes life-threatening allergic reactions. The boxed warning also specifies that the patient must be prescribed autoinjectable epinephrine to have while using house dust mite immunotherapy.

Approval was based on a double-blind, multicenter trial (n = 1482) in adolescents and adults with house dust mite allergic rhinitis with or without conjunctivitis (AR/C). Over a 52-week period, house dust mite immunotherapy improved the rhinoconjunctivitis score and visual analog scale–assessed AR/C symptoms. [15]

A study by Soh et al indicated that sublingual immunotherapy with extracts from the dust mite Blomia tropicalis is effective in treating allergic rhinitis sensitized to this species. The study, which included 39 children and adults, found patients’ Total Nasal Symptom Scores and Mini Rhinoconjunctivitis Quality of Life Questionnaire scores improved after 3 months of treatment and continued to approve thereafter. [16]

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