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Sublingual immunotherapy: the U.S. experience.

Harold S Nelson1

  • 1National Jewish Health and University of Colorado Denver School of Medicine, Denver, Colorado, USA.

Current Opinion in Allergy and Clinical Immunology
|October 31, 2013
PubMed
Summary
This summary is machine-generated.

Sublingual immunotherapy (SLIT) is nearing US approval for allergen preparations. Large trials show efficacy for grass and ragweed, establishing safety and dosing for single allergens.

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Area of Science:

  • Allergy and Immunology
  • Immunotherapy
  • Pharmacology

Background:

  • Sublingual immunotherapy (SLIT) is an emerging treatment modality for allergic diseases.
  • US approval of SLIT allergen preparations is anticipated.
  • This review focuses on pivotal multicenter trials supporting SLIT approval.

Purpose of the Study:

  • To review the evidence from large, multicenter trials on the safety and efficacy of sublingual immunotherapy (SLIT).
  • To inform the anticipated approval of SLIT allergen preparations in the United States.

Main Methods:

  • Analysis of data from large, multicenter clinical trials evaluating SLIT.
  • Focus on studies involving grass and short ragweed allergen preparations.
  • Inclusion of trials assessing both tablet and aqueous extract formulations.

Main Results:

  • Five single-season studies demonstrated a 20-28% improvement in symptom-medication scores for grass SLIT compared to placebo.
  • Short ragweed SLIT (tablets and aqueous extract) showed a 24-26% reduction in symptom-medication scores.
  • Limited data exists for house dust mite and cat allergens; efficacy of multi-allergen SLIT remains unclear.

Conclusions:

  • Sublingual immunotherapy (SLIT) is poised for approval in the US with established safety and efficacy for specific allergen preparations.
  • The evidence supports the use of approved SLIT products at established dosages.
  • Off-label use of injectable allergen extracts for SLIT or sublingual administration of multi-allergen preparations is not supported by current data.