Treatment duration-dependent efficacy of Japanese cedar pollen sublingual immunotherapy: Evaluation of phase II/III trial over three pollen dispersal seasons

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Main idea: The JC pollen sublingual immunotherapy tablet relieved nasal and ocular symptoms, lowered the medication use and improved the quality of life in a treatment duration-dependent manner. Continuous dosing regimens appear to enhance the efficacy of the drug.

Abstract

A randomized, placebo-controlled, double-blind clinical trial to investigate the optimal dose and long-term efficacy and safety of Japanese cedar (JC) pollen tablets for sublingual immunotherapy (JapicCTI-142579) was conducted. Here there is data on the effects of the JC pollen sublingual immunotherapy tablet on rhinitis and conjunctivitis symptoms over three pollen dispersal seasons.

A total of 1042 JC pollinosis patients (aged 5-64 years) were randomized to receive tablets containing placebo (P), 2000, 5000, or 10,000 Japanese allergy units (JAU) of JC pollen for 15 months to identify an optimal dose. Patients receiving P (n = 240) and the optimal dose (5000 JAU; A, n = 236) were then randomized to receive P or A for an additional 18 months (AA, AP, PA, and PP groups, allocation ratio 2:1:1:2). Nasal and ocular symptoms, rescue medication use and the quality of life (QOL) were assessed on quantitative scales.

Results: In the second and the third seasons, the groups of patients who received immunotherapy tablets exhibited significantly better improvements in nasal and ocular symptoms. Rescue medication use and quality of life were also significantly better in the groups who received treatment in comparison to the placebo group.

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