- 著者
- Yoshito MIYATA Shin OHTA Akihiko TANAKA Kaho AKIMOTO Hiroki SATO Tomoki UNO Haruna SATO Yoshitaka UCHIDA Megumi JINNO Kuniaki HIRAI Hideki INOUE Tetsuya HONMA Mayumi YAMAMOTO Shintaro SUZUKI Hironori SAGARA
- 出版者
- The Showa University Society
- 雑誌
- The Showa University Journal of Medical Sciences (ISSN:09156380)
- 巻号頁・発行日
- vol.32, no.4, pp.247-256, 2020 (Released:2021-01-28)
- 参考文献数
- 28
Mepolizumab is a monoclonal antibody against interleukin-5 used for the treatment of severe asthma. The effect of long-term mepolizumab administration and its persistence in clinical practice is poorly understood. Thus, this study aimed to investigate the effect of long-term administration of mepolizumab in patients with severe asthma. Mepolizumab was administered to 20 patients with severe asthma. We then prospectively followed the patients for 104 weeks to investigate the efficacy of long-term mepolizumab administration in clinical practice. Eleven patients were evaluated for 104 weeks. Mepolizumab administration reduced asthma exacerbations in a year from 52 to 104 weeks and improved asthma control in every period as assessed by questionnaires. Also, blood eosinophil counts decreased at every point, and blood basophil counts decreased at 104 weeks. We compared various parameters among the 11 patients who continued administration for more than 104 weeks and 7 patients who discontinued treatment due to ineffectiveness. Significant differences were observed in disease duration, maximum expiratory flow at 50%, and blood basophil count. Long-term mepolizumab administration improved asthma symptoms in patients with severe asthma and reduced the frequency of exacerbations.
- 著者
- Takao Fujisawa Terufumi Shimoda Keisuke Masuyama Kimihiro Okubo Kohei Honda Mitsuhiro Okano Toshio Katsunuma Atsuo Urisu Yasuto Kondo Hiroshi Odajima Kazuyuki Kurihara Makoto Nagata Masami Taniguchi Shoichiro Taniuchi Satoru Doi Tomoshige Matsumoto Shoji Hashimoto Akihiko Tanaka Kensuke Natsui Nahoko Abe Hideki Ozaki
- 出版者
- Japanese Society of Allergology
- 雑誌
- Allergology International (ISSN:13238930)
- 巻号頁・発行日
- vol.67, no.3, pp.347-356, 2018 (Released:2018-07-28)
- 参考文献数
- 49
- 被引用文献数
- 7
Background: To 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.Methods: Japanese 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).Results: Between 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.Conclusions: Safety 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.