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Safety and tolerability of sublingual immunotherapy in clinical trials and real life

Senna, Gianenrico; Caminati, Marco; Canonica, Giorgio Walter

Current Opinion in Allergy and Clinical Immunology: December 2013 - Volume 13 - Issue 6 - p 656–662
doi: 10.1097/ACI.0000000000000007
IMMUNOTHERAPY AND NEW TREATMENTS: Edited by Giovanni Passalacqua and Robert Bush

Purpose of review Sublingual immunotherapy (SLIT) is effective in allergic rhinitis and asthma. Apart from its efficacy, safety is crucial as this treatment is usually self-administered at home. Tolerability also plays a pivotal role, as mild local reactions, although not life-threatening, may represent a risk for treatment withdrawal and can therefore negatively affect clinical outcomes. The present study addresses this issue by reviewing double-blind, placebo-controlled, randomized trials and real-life studies.

Recent findings The number of life-threatening SLIT-related reactions is negligible. SLIT-related adverse events are not always consistently reported nor uniformly classified in published studies. However, systemic reactions are rare and side effects mostly consist of mild, self-limiting local reactions. No treatment-related risk factors for adverse events have been clearly defined, as far as type of allergen, dose or schedule.

Summary SLIT provides an optimal safety profile both in children and in adults. Apart from life-threatening reactions, the lack of standardization of adverse events reporting may account for the wide variability of the prevalence of side effects in clinical trials and in real-life setting. It can lead to a possible underestimation of adverse events, concerning, in particular, local reactions. Since poor tolerability may affect adherence and cause treatment discontinuation, adopting shared strategies in order to recognize, grade and manage adverse events is mandatory.

aAllergy Unit, Verona University Hospital, Verona

bAllergy and Respiratory Diseases, IRCCS San Martino Hospital-University of Genoa-IST, Genoa, Italy

Correspondence to Marco Caminati, Allergy Unit, Verona University Hospital, Piazzale Aristide Stefani 1, 37126 Verona, Italy. Tel: +39 045 8123525; fax: +39 045 8122048; e-mail:

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