Safety profile and immunological response of dual sublingual immunotherapy with house dust mite tablet and Japanese cedar pollen tablet
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 (...
| Main Authors: | , , , , , , , , , , , , , , , , , , , , , , , , , , , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2020-01-01
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| Series: | Allergology International |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S132389301930108X |
| _version_ | 1818150950032900096 |
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| author | Minoru Gotoh Kimihiro Okubo Atsushi Yuta Yukiko Ogawa Hitoshi Nagakura Shigehiro Ueyama Tomoyo Ueyama Kayoko Kawashima Masashi Yamamoto Shigeharu Fujieda Masafumi Sakashita Hirokazu Sakamoto Naruhito Iwasaki Eri Mori Tomonori Endo Nobuo Ohta Hiroshi Kitazawa Mitsuhiro Okano Mikiya Asako Masami Takada Tetsuya Terada Yuko Inaka Syuji Yonekura Tomokazu Matsuoka Shinya Kaneko Hiroki Hata Nagisa Hijikata Hisataka Tanaka Keisuke Masuyama Yoshitaka Okamoto |
| author_facet | Minoru Gotoh Kimihiro Okubo Atsushi Yuta Yukiko Ogawa Hitoshi Nagakura Shigehiro Ueyama Tomoyo Ueyama Kayoko Kawashima Masashi Yamamoto Shigeharu Fujieda Masafumi Sakashita Hirokazu Sakamoto Naruhito Iwasaki Eri Mori Tomonori Endo Nobuo Ohta Hiroshi Kitazawa Mitsuhiro Okano Mikiya Asako Masami Takada Tetsuya Terada Yuko Inaka Syuji Yonekura Tomokazu Matsuoka Shinya Kaneko Hiroki Hata Nagisa Hijikata Hisataka Tanaka Keisuke Masuyama Yoshitaka Okamoto |
| author_sort | Minoru Gotoh |
| collection | DOAJ |
| description | 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. Keywords: Allergic rhinitis, Dual therapy, Immunological response, Safety, Sublingual immunotherapy |
| first_indexed | 2024-12-11T13:31:04Z |
| format | Article |
| id | doaj.art-25922d3900614ec9956cee71f76e2ec8 |
| institution | Directory Open Access Journal |
| issn | 1323-8930 |
| language | English |
| last_indexed | 2024-12-11T13:31:04Z |
| publishDate | 2020-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Allergology International |
| spelling | doaj.art-25922d3900614ec9956cee71f76e2ec82022-12-22T01:05:15ZengElsevierAllergology International1323-89302020-01-01691104110Safety profile and immunological response of dual sublingual immunotherapy with house dust mite tablet and Japanese cedar pollen tabletMinoru Gotoh0Kimihiro Okubo1Atsushi Yuta2Yukiko Ogawa3Hitoshi Nagakura4Shigehiro Ueyama5Tomoyo Ueyama6Kayoko Kawashima7Masashi Yamamoto8Shigeharu Fujieda9Masafumi Sakashita10Hirokazu Sakamoto11Naruhito Iwasaki12Eri Mori13Tomonori Endo14Nobuo Ohta15Hiroshi Kitazawa16Mitsuhiro Okano17Mikiya Asako18Masami Takada19Tetsuya Terada20Yuko Inaka21Syuji Yonekura22Tomokazu Matsuoka23Shinya Kaneko24Hiroki Hata25Nagisa Hijikata26Hisataka Tanaka27Keisuke Masuyama28Yoshitaka Okamoto29Department of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Nippon Medical School, Tokyo, JapanDepartment of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Nippon Medical School, Tokyo, JapanYuta Clinic, Mie, JapanYuta Clinic, Mie, JapanNagakura Ear, Nose and Throat Allergy Clinic, Tokyo, JapanFunai ENT Clinic, Oita, JapanFunai ENT Clinic, Oita, JapanOsaka Prefectural Hospital Organization, Osaka Habikino Medical Center, Osaka, JapanOsaka Prefectural Hospital Organization, Osaka Habikino Medical Center, Osaka, JapanDivision of Otorhinolaryngology, Head & Neck Surgery, Department of Sensory and Locomotor Medicine, Faculty of Medical Science, University of Fukui, Fukui, JapanDivision of Otorhinolaryngology, Head & Neck Surgery, Department of Sensory and Locomotor Medicine, Faculty of Medical Science, University of Fukui, Fukui, JapanDepartment of Otolaryngology, Head and Neck Surgery, Osaka City University, Graduate School of Medicine, Osaka, JapanDepartment of Otolaryngology, Head and Neck Surgery, Osaka City University, Graduate School of Medicine, Osaka, JapanDepartment of Otorhinolaryngology, Jikei University School of Medicine, Tokyo, JapanDepartment of Otorhinolaryngology, Jikei University School of Medicine, Tokyo, JapanDivision of Otolaryngology, Tohoku Medical and Pharmaceutical University Hospital, Miyagi, JapanDivision of Pediatrics, Tohoku Medical and Pharmaceutical University Hospital, Miyagi, JapanDepartment of Otorhinolaryngology, International University of Health and Welfare (IUHW), School of Medicine, Tochigi, JapanDivision of Otolaryngology, Head and Neck Surgery, Kansai Medical University Medical Center, Osaka, JapanDivision of Otolaryngology, Head and Neck Surgery, Kansai Medical University Medical Center, Osaka, JapanDepartment of Otolaryngology, Osaka Medical College, Osaka, JapanDepartment of Otolaryngology, Osaka Medical College, Osaka, JapanDepartment of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University, Chiba, JapanDepartment of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Yamanashi University, Yamanashi, JapanTorii Pharmaceutical Co., Ltd., Tokyo, JapanTorii Pharmaceutical Co., Ltd., Tokyo, JapanTorii Pharmaceutical Co., Ltd., Tokyo, Japan; Corresponding author. Clinical Development Department, Torii Pharmaceutical Co., Ltd., 3-4-1 Nihonbashi-honcho, Chuo-ku, Tokyo, 103-8439, Japan.Torii Pharmaceutical Co., Ltd., Tokyo, JapanDepartment of Otorhinolaryngology, Head and Neck Surgery, Graduate School of Medicine, Yamanashi University, Yamanashi, JapanDepartment of Otolaryngology, Head and Neck Surgery, Graduate School of Medicine, Chiba University, Chiba, JapanBackground: 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. Keywords: Allergic rhinitis, Dual therapy, Immunological response, Safety, Sublingual immunotherapyhttp://www.sciencedirect.com/science/article/pii/S132389301930108X |
| spellingShingle | Minoru Gotoh Kimihiro Okubo Atsushi Yuta Yukiko Ogawa Hitoshi Nagakura Shigehiro Ueyama Tomoyo Ueyama Kayoko Kawashima Masashi Yamamoto Shigeharu Fujieda Masafumi Sakashita Hirokazu Sakamoto Naruhito Iwasaki Eri Mori Tomonori Endo Nobuo Ohta Hiroshi Kitazawa Mitsuhiro Okano Mikiya Asako Masami Takada Tetsuya Terada Yuko Inaka Syuji Yonekura Tomokazu Matsuoka Shinya Kaneko Hiroki Hata Nagisa Hijikata Hisataka Tanaka Keisuke Masuyama Yoshitaka Okamoto Safety profile and immunological response of dual sublingual immunotherapy with house dust mite tablet and Japanese cedar pollen tablet Allergology International |
| title | Safety profile and immunological response of dual sublingual immunotherapy with house dust mite tablet and Japanese cedar pollen tablet |
| title_full | Safety profile and immunological response of dual sublingual immunotherapy with house dust mite tablet and Japanese cedar pollen tablet |
| title_fullStr | Safety profile and immunological response of dual sublingual immunotherapy with house dust mite tablet and Japanese cedar pollen tablet |
| title_full_unstemmed | Safety profile and immunological response of dual sublingual immunotherapy with house dust mite tablet and Japanese cedar pollen tablet |
| title_short | Safety profile and immunological response of dual sublingual immunotherapy with house dust mite tablet and Japanese cedar pollen tablet |
| title_sort | safety profile and immunological response of dual sublingual immunotherapy with house dust mite tablet and japanese cedar pollen tablet |
| url | http://www.sciencedirect.com/science/article/pii/S132389301930108X |
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