Epinephrine use is uncommon in sublingual immunotherapy tablet trials


Published Online: November 9, 2016

Allergy immunotherapy can result in systemic allergic reactions and even life-threatening anaphylaxis. This analysis published by Nolte and colleagues in The Journal of Allergy and Clinical Immunology: In Practice described overall epinephrine use in multiple international clinical trials of 3 sublingual immunotherapy (SLIT)-tablet products.

Epinephrine administrations in 13 timothy grass, 5 ragweed, and 11 SQ house dust mite (HDM) SLIT-tablet trials were evaluated for doses up to and including the approved doses. Epinephrine auto-injectors were supplied to subjects in most of the trials conducted in North America, but not in the European or Japanese trials. Investigators and subjects were clearly instructed that epinephrine use was intended for treatment of severe systemic allergic reactions only.

The epinephrine administration rate for SLIT-tablet-related events was 0.2% administrations/subject (1.80 administrations per 100,000 SLIT-tablets). In grass SLIT-tablet trials, epinephrine was used eight times for grass SLIT-tablet–related adverse events (AEs): 4 for systemic allergic reactions and 4 for local mouth and/or throat swelling. In ragweed SLIT-tablet trials, epinephrine was used four times for ragweed SLIT-tablet–related AEs: 1 for systemic allergic reaction and 3 for local mouth and/or pharynx/throat swelling. In HDM SLIT-tablet trials, epinephrine was administered four times for HDM SLIT-tablet–related AEs: 1 for systemic allergic reaction and 3 for local events. Of the 16 epinephrine administrations for events related to SLIT-tablet treatment, 11 occurred within the first week of treatment and 5 were subject self-administered. All of the SLIT-tablet-related events requiring epinephrine were treated successfully with no further complications.

Epinephrine administrations in response to SLIT-tablet reactions during the clinical trials were uncommon, were for non-serious events, typically occurred within the first week of treatment, and were rarely self-administered. These data indicate that systemic and severe local adverse events may occur with SLIT-tablet treatment, but are manageable with conventional treatment, including epinephrine. Given the results of the current analysis, the need to prescribe epinephrine auto-injectors to all patients prescribed SLIT-tablets in the United States should be revisited.

The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.

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