Minoru Gotoh1, Kimihiro Okubo1, Atsushi Yuta2, Yukiko Ogawa2, Hitoshi Nagakura3, Shigehiro Ueyama4, Tomoyo Ueyama4, Kayoko Kawashima5, Masashi Yamamoto5, Shigeharu Fujieda6, Masafumi Sakashita6, Hirokazu Sakamoto7, Naruhito Iwasaki7, Eri Mori8, Tomonori Endo8, Nobuo Ohta9, Hiroshi Kitazawa10, Mitsuhiro Okano11, Mikiya Asako12, Masami Takada12, Tetsuya Terada13, Yuko Inaka13, Syuji Yonekura14, Tomokazu Matsuoka15, Shinya Kaneko16, Hiroki Hata16, Nagisa Hijikata17, Hisataka Tanaka16, Keisuke Masuyama15, Yoshitaka Okamoto14. 1. Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Nippon Medical School, Tokyo, Japan. 2. Yuta Clinic, Mie, Japan. 3. Nagakura Ear, Nose and Throat Allergy Clinic, Tokyo, Japan. 4. Funai ENT Clinic, Oita, Japan. 5. Osaka Prefectural Hospital Organization, Osaka Habikino Medical Center, Osaka, Japan. 6. Division of Otorhinolaryngology, Head & Neck Surgery, Department of Sensory and Locomotor Medicine, Faculty of Medical Science, University of Fukui, Fukui, Japan. 7. Department of Otolaryngology, Head and Neck Surgery, Osaka City University, Graduate School of Medicine, Osaka, Japan. 8. Department of Otorhinolaryngology, Jikei University School of Medicine, Tokyo, Japan. 9. Division of Otolaryngology, Tohoku Medical and Pharmaceutical University Hospital, Miyagi, Japan. 10. Division of Pediatrics, Tohoku Medical and Pharmaceutical University Hospital, Miyagi, Japan. 11. Department of Otorhinolaryngology, International University of Health and Welfare (IUHW), School of Medicine, Tochigi, Japan. 12. Division of Otolaryngology, Head and Neck Surgery, Kansai Medical University Medical Center, Osaka, Japan. 13. Department of Otolaryngology, Osaka Medical College, Osaka, Japan. 14. Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University, Chiba, Japan. 15. Department of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Yamanashi University, Yamanashi, Japan. 16. Torii Pharmaceutical Co., Ltd., Tokyo, Japan. 17. Torii Pharmaceutical Co., Ltd., Tokyo, Japan. Electronic address: nagisa.hijikata@torii.co.jp.
Abstract
BACKGROUND: There have been no studies of dual administration of sublingual immunotherapy (SLIT) tablets for perennial and seasonal allergic rhinitis. This trial (JapicCTI-184014) was conducted to investigate the safety profile and immunological response during dual therapy with SQ house dust mite (HDM) and Japanese cedar pollen (JCP) SLIT tablets. METHODS: This was a multicenter, open-label, randomized trial of 109 Japanese patients with coexisting HDM and JCP allergic rhinitis who had positive tests for HDM- and JCP specific IgE (≥0.7 kU/L). Patients were allocated to receive HDM (N = 54) or JCP (N = 55) SLIT tablets alone for 4 weeks followed by 8 weeks of dual therapy with both SLIT tablets administered within 5 min of each other. Adverse events (AEs), adverse drug reactions (ADRs), and serum IgE and IgG4 specific for HDM (Dermatophagoides farinae, Dermatophagoides pteronyssinus) and JCP were recorded. RESULTS: The percentage of subjects with AEs and ADRs was similar between the two groups and between the two periods of monotherapy and dual therapy. Most AEs and ADRs were mild in severity, and no serious events were observed. The most common ADRs were local events in the oral cavity. Levels of IgE and IgG4 specific for HDM (D. farinae, D. pteronyssinus) and JCP were increased after treatment with HDM and JCP SLIT tablets, respectively. CONCLUSIONS: Dual therapy with both SLIT tablets administered within 5 min after 4 weeks of monotherapy with HDM or JCP tablet was well tolerated and induced the expected immunological responses.
RCT Entities:
BACKGROUND: There have been no studies of dual administration of sublingual immunotherapy (SLIT) tablets for perennial and seasonal allergic rhinitis. This trial (JapicCTI-184014) was conducted to investigate the safety profile and immunological response during dual therapy with SQ house dust mite (HDM) and Japanese cedar pollen (JCP) SLIT tablets. METHODS: This was a multicenter, open-label, randomized trial of 109 Japanesepatients with coexisting HDM and JCP allergic rhinitis who had positive tests for HDM- and JCP specific IgE (≥0.7 kU/L). Patients were allocated to receive HDM (N = 54) or JCP (N = 55) SLIT tablets alone for 4 weeks followed by 8 weeks of dual therapy with both SLIT tablets administered within 5 min of each other. Adverse events (AEs), adverse drug reactions (ADRs), and serum IgE and IgG4 specific for HDM (Dermatophagoides farinae, Dermatophagoides pteronyssinus) and JCP were recorded. RESULTS: The percentage of subjects with AEs and ADRs was similar between the two groups and between the two periods of monotherapy and dual therapy. Most AEs and ADRs were mild in severity, and no serious events were observed. The most common ADRs were local events in the oral cavity. Levels of IgE and IgG4 specific for HDM (D. farinae, D. pteronyssinus) and JCP were increased after treatment with HDM and JCP SLIT tablets, respectively. CONCLUSIONS: Dual therapy with both SLIT tablets administered within 5 min after 4 weeks of monotherapy with HDM or JCP tablet was well tolerated and induced the expected immunological responses.