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

Abstract

BACKGROUND:

We conducted 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 SLIT (JapicCTI-142579). Here, we report details of the effects of the JC pollen SLIT tablet on rhinitis and conjunctivitis symptoms over three pollen dispersal seasons.

METHODS:

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 quality of life (QOL) were assessed on quantitative scales.

RESULTS:

In the second and third seasons, the AA, AP, and PA groups exhibited significantly better improvements in nasal, ocular, and medication scores compared with the PP group in the order AA > AP > PA > PP during the second season and AA > PA > AP > PP during the third season. Rescue medication use and QOL scores were also significantly better in the AA, AP, and PA groups compared with the PP group.

CONCLUSIONS:

The JC pollen SLIT tablet relieved nasal and ocular symptoms and medication use and improved QOL in a treatment duration-dependent manner. Continuous dosing regimens appear to enhance the efficacy of the drug.

• Authors: Syuji Yonekura, Minoru Gotoh, Shinya Kaneko, Keishi Kanazawa, Yoshie Takeuji, Kimihiro Okubo, Yoshitaka Okamoto
• Journal: Allergology international : official journal of the Japanese Society of Allergology (Allergol Int) Vol. 68 Issue 4 Pg. 494-505 (Oct 2019) ISSN: 1440-1592 [Electronic] England
• PMID: 31257168 (Publication Type: Clinical Trial, Phase II, Clinical Trial, Phase III, Journal Article)
• Copyright: Copyright © 2019 Japanese Society of Allergology. Production and hosting by Elsevier B.V. All rights reserved.

Chemical References

• Allergens

Topics

• Adolescent
• Adult
• Allergens (administration & dosage, immunology)
• Child
• Child, Preschool
• Cryptomeria (adverse effects)
• Female
• Humans
• Male
• Middle Aged
• Pollen (immunology)
• Rhinitis, Allergic, Seasonal (immunology, therapy)
• Seasons
• Sublingual Immunotherapy
• Treatment Outcome
• Young Adult