Efficacy of Japanese cedar pollen sublingual immunotherapy tablets for Japanese cypress pollinosis

Tomoya Kurokawa; Syuji Yonekura; Minoru Gotoh; Mitsuhiro Okano; Yuriko Maekawa; Kimihiro Okubo; Yoshitaka Okamoto

doi:10.1016/j.jacig.2022.10.006

Efficacy of Japanese cedar pollen sublingual immunotherapy tablets for Japanese cypress pollinosis

J Allergy Clin Immunol Glob. 2022 Dec 26;2(2):100075. doi: 10.1016/j.jacig.2022.10.006. eCollection 2023 May.

Authors

Tomoya Kurokawa^{1

2}, Syuji Yonekura¹, Minoru Gotoh³, Mitsuhiro Okano⁴, Yuriko Maekawa⁵, Kimihiro Okubo³, Yoshitaka Okamoto^{1

6}

Affiliations

¹ Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan.
² Clinical Research Center, Chiba University Hospital, Chiba, Japan.
³ Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan.
⁴ Department of Otorhinolaryngology, International University of Health and Welfare, Chiba, Japan.
⁵ Department of Medical Affairs, Torii Pharmaceutical Co, Ltd, Tokyo, Japan.
⁶ Chiba Rousai Hospital, Chiba, Japan.

Abstract

Background: We previously demonstrated the efficacy of Japanese cedar (JC) pollen sublingual immunotherapy (SLIT) tablets for treating seasonal allergic rhinitis in a clinical trial (trial no. 206-2-1) that covered 5 pollen dispersal seasons from 2015 to 2019.

Objective: Our aim was to perform post hoc analysis of the 206-2-1 trial data to evaluate the efficacy of JC pollen SLIT tablets for patients with rhinitis induced by pollen from Japanese cypress (JCY), a related Cupressaceae species that has a pollen dispersal season overlapping with that of JC.

Methods: Data were analyzed for 240 patients who received placebo during the first pollen dispersal season in 2015, were then rerandomized to receive JC SLIT tablets (the PA group) or placebo (the PP group) for 18 months (the 2016 and 2017 dispersal seasons), and were observed untreated for 2 years (the 2018 and 2019 dispersal seasons). The PA and PP groups were assigned to "high" and "low" subgroups if their rhinitis symptoms were exacerbated/did not change or decreased, respectively, during the peak JCY pollen dispersal period in 2015. The mean total nasal symptom and medication scores and other outcomes were compared for the high-PP, high-PA, low-PP, and low-PA groups during the 2016 to 2019 peak JCY pollen dispersal periods.

Results: The mean total nasal symptom and medication scores were significantly lower for the high-PA and low-PA groups than for the corresponding PP groups over the 4 years of treatment and observation. JCY pollen-specific IgE levels increased in both PA groups.

Conclusion: JC pollen SLIT tablets effectively suppressed JCY pollinosis symptoms, supporting the clinical relevance of immunologic cross-reactivity between JC and JCY allergens.

Keywords: Allergy immunotherapy; Japanese cedar; Japanese cypress; allergic rhinitis; conjunctivitis; cross-reactivity; disease modification; homologous; sublingual immunotherapy; sustained efficacy.