Efficacy and safety of sublingual immunotherapy for two seasons in patients with
Japanese cedar pollinosis.
Author(s): Okamoto Y(1), Okubo K, Yonekura S, Hashiguchi K, Goto M, Otsuka T, Murata T,
Nakao Y, Kanazawa C, Nagakura H, Okawa T, Nakano K, Hisamitsu M, Kaneko S, Konno
A.
Affiliation(s): Author information:
(1)Department of Otolaryngology, Head and Neck Surgery, Graduate School of
Medicine, Chiba University, Chiba, Japan.
Publication date & source: 2015, Int Arch Allergy Immunol. , 166(3):177-88
BACKGROUND: Japanese cedar (JC) pollinosis is the most common seasonal allergic
rhinitis in Japan. Standardized JC pollen extract is available for subcutaneous
immunotherapy, but this treatment is limited by potentially serious side effects.
The aim of this double-blind, randomized comparative study was to evaluate the
efficacy and safety of standardized JC pollen extract in a new oral formulation
(CEDARTOLEN®, Torii Pharmaceutical Co., Ltd., Tokyo, Japan) for sublingual
immunotherapy (SLIT) for JC pollinosis.
METHODS: A total of 531 subjects with JC pollinosis were randomized into 2 groups
at a ratio of 1:1 to receive daily sublingual administration of standardized JC
pollen extract with a maintenance dose of 2,000 Japanese allergy units (JAU) or
placebo for 2 consecutive pollen seasons. The efficacy was evaluated using the
total nasal symptom and medication score (TNSMS) as the primary end point.
Secondary end points included the total ocular symptom and medication score
(TOSMS) and scores for individual symptoms and medication.
RESULTS: The TNSMS was significantly lower (p < 0.0001) in the SLIT group than in
the placebo group in the peak symptom period by 18 and 30% in the first and
second seasons, respectively. All secondary end points were also significantly
lower in the SLIT group in both seasons. No systemic anaphylaxis occurred.
CONCLUSIONS: SLIT with daily administration of standardized JC pollen extract was
effective for improving nasal and ocular symptoms of JC pollinosis and reducing
the use of relief medication. The JC pollen extract was well tolerated with only
local adverse events.
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