It is likely that approval of allergen preparations for sublingual immunotherapy (SLIT) will soon occur in the United States. This article reviews experience with SLIT in this country, concentrating on the large, multicenter trials that will provide the evidence of safety and efficacy necessary to obtain that approval.
Large multicenter trials have been conducted with both grass and short ragweed. In five single-season studies with sublingual grass tablets, usually starting 4 months prior to and continuing through the pollen season, the combined symptom medication score was improved 20–28% relative to placebo-treated individuals. Short ragweed tablets, initiated 4 months prior to and continued through the pollen season, reduced symptom/medication scores by 24–26%. Similar results have been reported with short ragweed aqueous extract administered sublingually. To date, there has been only one small study each with house dust mite and cat allergen extracts. All of these studies were conducted with a single allergen. One small study, comparing timothy alone to the same dose of timothy combined with nine other pollen extracts, raised still unanswered questions regarding the efficacy of SLIT with multiple allergen mixes.
SLIT is coming to the United States. There will be approved allergen preparations for which the appropriate dosing for efficacy and safety has been established. It would be inappropriate to use the evidence generated by these large studies to justify off-label use of allergen extracts approved for injection or the administration of multiple allergen preparations sublingually.
National Jewish Health and University of Colorado Denver School of Medicine, Denver, Colorado, USA
Correspondence to Harold S. Nelson, MD, National Jewish Health, 1400 Jackson St, Denver, Colorado, USA. Tel: +1 303 398 1562; fax: +1 303 398 1476; e-mail: email@example.com