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Optimizing the dose and long-term efficacy of sublingual immunotherapy

Published online: December 8, 2018

Seasonal allergic rhinitis is a considerable health and economic burden worldwide, not only impairing the quality of life of sufferers of all age groups but also decreasing the productivity of the workforce. Japanese cedar (JC) pollen allergy (pollinosis) affects approximately 25% of the Japanese population; indeed, it has been termed the “national affliction”. Sublingual immunotherapy (SLIT) for JC pollinosis was introduced in 2014 in the form of standardized JC pollen extract drops, but the dose required to obtain an optimal response in JC pollinosis patients has not been determined. More recently, fast-dissolving tablets for SLIT have been developed that promise to allow more accurate dose optimization.

In an original article recently published in The Journal of Allergy and Clinical Immunology: In Practice, Gotoh and colleagues conducted a placebo-controlled multi-arm clinical trial that aimed to determine the optimal dose of standardized JC pollen SLIT tablets, their efficacy in relation to duration of treatment, including disease-modifying effects, and the safety of long-term administration.

The trial included JC pollinosis patients between 5 and 64 years of age who were allocated to four groups with three treatment doses. Efficacy was evaluated as a reduction in allergic rhinitis symptoms and medication use. In the first year, the optimal dose was determined based on statistically significant differences in efficacy between the treatment dose groups, with a favorable safety profile. Patients were then reassigned to receive optimal SLIT dose or placebo over the next 2 years. Over the course of the 3-year trial, the optimal SLIT dose resulted in significant improvements in rhinitis symptoms, medication use, and quality of life, and exhibited a benign safety profile.

The trial outcomes suggest that dose optimization is an important consideration in SLIT therapy to ensure maximal efficacy with continuous improvement. The results also revealed that the optimal SLIT dose had a disease-modifying effect, which is one of the major goals of allergen immunotherapy.

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