Efficacy and Safety of Sublingual Immunotherapy for Two Seasons in Patients with Japanese Cedar Pollinosis

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 Received: November 6, 2014 Accepted after revision: February 18, 2015 Published online: April 18, 2015 Correspondence to: Dr. Yoshitaka Okamoto Department of Otolaryngology, Head and Neck Surgery Graduate School of Medicine, Chiba University 1-8-1 Inohana, Chuo-ku, Chiba 260-8670 (Japan) E-Mail yokamoto @ faculty.chiba-u.jp © 2015 S. Karger AG, Basel 1018–2438/15/1663–0177$39.50/0 www.karger.com/iaa Dr. Y. Okamoto and Dr. K. Okubo were the controllers of the study and equally contributed to this study. Dr. A. Konno was the medical advisor. D ow nl oa de d by : 54 .7 0. 40 .1 1 11 /2 0/ 20 17 4 :0 1: 25 A M