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RISS 인기검색어
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- 저자 : ( Tomoo Nakagawa ) (검색결과 2 건)
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Tomoo Nakagawa,Taku Kobayashi,Kiyohiro Nishikawa,Fumika Yamada,Satoshi Asai,Yukinori Sameshima,Yasuo Suzuki,Mamoru Watanabe,Toshifumi Hibi 대한장연구학회 2019 Intestinal Research Vol.17 No.4
Background/Aims: An interim analysis of post-marketing surveillance of CT-P13, an infliximab biosimilar, was performed to evaluate its safety and efficacy in Japanese patients with inflammatory bowel disease. Methods: Patients were prospectively enrolled between November 2014 and March 2017, after the launch of CT-P13 in Japan, and case report forms of patients followed for at least 4 months were analyzed as of July 2018. Results: Of 523 patients in the analysis set, 372 remained on CT-P13 therapy, while 54 (20.2%) of 267 patients with Crohn’s disease, and 97 (37.9%) of 256 patients with ulcerative colitis were withdrawn during follow-up. A total of 144 adverse drug reactions (ADRs) were reported in 106 patients (20.3%). Infusion reaction was the most frequent ADR observed in 49 patients (9.4%). Efficacy parameters decreased immediately after the start of treatment in naïve patients to anti-tumor necrosis factor-α antibody. In the patients switched from originator infliximab for nonmedical reasons, the decreased parameters due to proceeded treatment with the originator were maintained in low ranges, and the treatment continuation rate was high with low ADR incidence. In contrast, in patients switched for medical reasons such as adverse event or loss of response, the incidence of ADRs was high. However, the efficacy parameters were improved, and the treatment continuation rate was not significantly different from that of the naïve patient group. Conclusions: In this interim analysis, CT-P13 was comparable to the originator infliximab with respect to ADRs and efficacy, and is therefore considered to be a cost-efficient interchangeable biosimilar for Japanese patients with inflammatory bowel disease.
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( Kenichiro Okimoto ),( Makoto Arai ),( Hideaki Ishigami ),( Keiko Saito ),( Shoko Minemura ),( Daisuke Maruoka ),( Tomoaki Matsumura ),( Tomoo Nakagawa ),( Tatsuro Katsuno ),( Masaki Suzuki ),( Yukio 대한간학회 2018 Gut and Liver Vol.12 No.1
Background/Aims: Eosinophilic esophagitis (EoE) is of ten erroneously diagnosed as gastroesophageal reflux disease (GERD). The aim of this study is to investigate the prevalence of EoE and the expression of tight junction (TJ) proteins in patients with GERD symptoms. Methods: One hundred patients with GERD symptoms and 10 healthy controls were prospectively studied. Sixty-two patients had symptoms refractory to proton pump inhibitors (PPI). All patients underwent esophageal biopsy. Patients were diagnosed with EoE if the number of eosinophil granulo cytes per high-power field was ≥15. Immunohistochemical analysis of TJ proteins (claudin-1, claudin-4, occludin, and zonula occludin-1 [ZO-1]) was performed. Results: EoE was diagnosed in six of 100 patients (6%) with GERD symptoms and in six patients (9.7%) of 62 patients with PPI-refractory GERD. Only one had typical EoE endoscopic findings. The proportion of ZO-1-positive cells was significantly lower in the lower than in the middle esophagus (56.0%±14.0% vs 66.0%±11.5%, p<0.05). There were no significant correla tions between TJ protein expression and GERD symptoms. Conclusions: The prevalence of EoE among patients with PPI-refractory GERD is approximately 10%. Regardless of endoscopic findings, esophageal biopsy is crucial in diag nosing EoE. The disruption of ZO-1 expression in the lower esophagus is significantly associated with GERD symptoms. (Gut Liver 2018;12:30-37)
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