| Affiliation: | 1. Allergy Center, Mie National Hospital, Mie, Japan;2. Clinical Research Center, Fukuoka National Hospital, Fukuoka, Japan;3. Department of Otorhinolaryngology, Head and Neck Surgery, University of Yamanashi, Yamanashi, Japan;4. Department of Otorhinolaryngology, Nippon Medical School, Tokyo, Japan;5. Department of Otorhinolaryngology, Head and Neck Surgery, Akita Graduate School of Medicine, Akita, Japan;6. Department of Otolaryngology-Head and Neck Surgery, Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama, Japan;g. Department of Pediatrics, Jikei University Daisan Hospital, Tokyo, Japan;h. Department of Pediatrics, Fujita Health University, The Second Teaching Hospital, Nagoya, Japan;i. Department of Pediatrics, Fukuoka National Hospital, Fukuoka, Japan;j. Department of Allergy, Kanagawa Children''s Medical Center, Yokohama, Japan;k. Department of Respiratory Medicine, Saitama Medical University, Saitama, Japan;l. Department of Allergy, Sagamihara National Hospital, Kanagawa, Japan;m. Department of Pediatrics, Kansai Medical University Takii Hospital, Osaka, Japan;n. Department of Pediatrics, Osaka Prefectural Hospital Organization Osaka Habikino Medical Center, Osaka, Japan;o. Department of Allergy and Internal Medicine, Osaka Prefectural Hospital Organization Osaka Habikino Medical Center, Osaka, Japan;p. Division of Respiratory Medicine and Allergology, Department of Medicine, Showa University, School of Medicine, Tokyo, Japan;q. Department of Clinical Development, Torii Pharmaceutical Co., Ltd., Tokyo, Japan |
| Abstract: | ![]()
BackgroundTo evaluate the long-term safety of subcutaneous immunotherapy with TO-204, a standardized house dust mite (HDM) allergen extracts, we conducted a multicenter, open label clinical trial.MethodsJapanese patients aged 5–65 years were eligible for the study, if they had HDM-induced allergic rhinitis (AR), allergic bronchial asthma (BA), or both. TO-204 was administered in a dose titration scheme, and the maintenance dose was determined according to the predefined criteria. The treatment period was 52 weeks, and patients who were willing to continue the treatment received TO-204 beyond 52 weeks. This clinical trial is registered at the Japan Pharmaceutical Information Center (Japic CTI-121900).ResultsBetween July 2012 and May 2015, 44 patients (28 with AR and 16 with allergic BA) were enrolled into the study. All patients were included in the analysis. The duration of treatment ranged from 23 to 142 weeks and the median maintenance dose was 200 Japanese allergy units (JAU). Adverse events occurred in 22 patients (50%). The most common adverse event was local reactions related to the injection sites. Four patients experienced anaphylactic reactions when they were treated with the dose of 500 JAU. Two patients experienced anaphylactic shock with the doses of 1000 JAU at onset. These 6 patients could continue the study with dose reduction.ConclusionsSafety profile of TO-204 was acceptable in Japanese patients with HDM-induced AR or allergic BA. Higher doses should be administered carefully, because the risk of anaphylaxis increased at doses of 500 or 1000 JAU. |
