What is the role of sublingual immunotherapy in the treatment of asthma?

Updated: Oct 07, 2019
  • Author: John J Oppenheimer, MD; Chief Editor: Michael A Kaliner, MD  more...
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Answer

Answer

Sublingual immunotherapy has been shown to improve allergic rhinitis symptoms (including in pediatric patients) and allergic asthma. While adverse reactions do occur, sublingual immunotherapy is safe enough for home administration. Based on limited data, sublingual therapy, at least in the short term, may be less effective compared to traditional subcutaneous injection. [39]

SL immunotherapy may not be appropriate for everyone. Those affected by multiple allergens may not obtain relief of all of their symptoms by taking immunotherapy for only a single or several allergens. SL immunotherapy is more convenient than weekly injections for individuals with limited, specific allergies that match the SL product.

In April 2014, the FDA approved an SL tablet consisting of 5 calibrated grass pollen extracts (Oralair). It is indicated as immunotherapy for grass pollen-induced allergic rhinitis confirmed by positive skin test or in vitro testing for grass pollen-specific IgE antibodies in patients aged 5–65 years. It contains Perennial Ryegrass (Lolium perenne), Kentucky bluegrass (Poa pratensis), Timothy grass (Phleum pratense), Orchard grass (Dactylis glomerata), and Sweet Vernal grass (Anthoxanthum odoratum). 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. 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. [40]

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. [41, 42]

A sublingual (SL) house dust mite immunotherapy (Odactra) was approved by the FDA in 2017. It is a standardized allergen extract indicated as daily SL immunotherapy for allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts.

The first dose must be given in a healthcare setting under the supervision of a physician with experience in diagnosis and treatment of allergic diseases. Patient monitoring for signs or symptoms of a severe systemic or local allergic reaction is required following administration. Life-threatening allergic reactions are described in a boxed warning within the prescribing information. The boxed warning also includes the need to prescribe autoinjectable epinephrine for the patient to have while using sublingual immunotherapy.

Approval was based on a double-blind, multicenter trial (n = 1482) in adolescents and adults with HDM allergic rhinitis with or without conjunctivitis (AR/C). Over a 52-week period, HDM immunotherapy improved rhinoconjunctivitis score and visual analog scale-assessed AR/C symptoms (P < 0.001). [43]


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