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Toshifumi Hibi,Satoshi Motoya,Toshifumi Ashida,Souken Sai,Yukinori Sameshima,Shiro Nakamura,Atsuo Maemoto,Masahiro Nii,Barbara A Sullivan,Robert A. Gasser Jr,Yasuo Suzuki 대한장연구학회 2019 Intestinal Research Vol.17 No.3
Background/Aims: Inhibition of α4β7 integrin has been shown to be effective for induction and maintenance therapy in patients with ulcerative colitis (UC). We investigated the effects of varying doses of the α4β7 inhibitor abrilumab in Japanese patients with moderate-to-severe UC despite conventional treatments. Methods: In this randomized, double-blind, placebo-controlled study, 45 UC patients were randomized to abrilumab 21 mg (n=11), 70 mg (n=12), 210 mg (n=9), or placebo (n=13) via subcutaneous (SC) injection for 12 weeks. The double-blind period was followed by a 36-week open-label period, in which all patients received abrilumab 210 mg SC every 12 weeks, and a 28-week safety follow-up period. The primary efficacy variable was clinical remission at week 8 (total Mayo score ≤2 points with no individual subscore >1 point). Results: Clinical remission at week 8 was 4 out of 31 (12.9%) overall in the abrilumab groups versus 0 out of 13 in the placebo group (abrilumab 21 mg, 1/10 [10.0%]; 70 mg, 2/12 [16.7%]; 210 mg, 1/9 [11.1%]). In both the double-blind and open-label periods, fewer patients in the abrilumab groups experienced ≥1 adverse event compared with those in the placebo group. There were no cases of progressive multifocal leukoencephalopathy and no deaths. Conclusions: Abrilumab 70 mg and 210 mg yielded numerically better results in terms of clinical remission rate at Week 8 than placebo, with the 210 mg dose showing more consistent treatment effects. Abrilumab was well tolerated in Japanese patients with UC.
( Taku Kobayashi ),( Hiroaki Ito ),( Toshifumi Ashida ),( Tadashi Yokoyama ),( Masakazu Nagahori ),( Tomoki Inaba ),( Mitsuhiro Shikamura ),( Takayoshi Yamaguchi ),( Tetsuharu Hori ),( Philippe Pinton 대한장연구학회 2021 Intestinal Research Vol.19 No.4
Background/Aims: A subgroup analysis was conducted in Japanese patients with moderate to severe ulcerative colitis (UC) enrolled in the phase 3 VISIBLE 1 study, which evaluated the safety and efficacy of a new vedolizumab subcutaneous (SC) for-mulation. Methods: Eligible patients received open-label infusions of vedolizumab 300 mg intravenous (IV) at weeks 0 and 2 in the induction phase. Patients with clinical response by complete Mayo score at week 6 entered the double-blind maintenance phase and were randomized to vedolizumab 108 mg SC every 2 weeks, placebo, or vedolizumab 300 mg IV every 8 weeks. The primary endpoint was clinical remission (complete Mayo score ≤2 points; no individual subscore >1 point) at week 52. Results: Of 49 patients who entered the induction phase, 22 out of 49 patients (45%) had clinical response at week 6 and were randomized to vedolizumab 108 mg SC (n=10), placebo (n=10), or vedolizumab 300 mg IV (n=2). At week 52, 4 out of 10 pa-tients (40%) who received vedolizumab SC had clinical remission versus 2 out of 10 patients (20%) who received placebo (dif-ference: 20% [95% confidence interval, ±27.9 to 61.8]). Two patients (2/10, 20%) who received vedolizumab SC experienced an injection-site reaction versus none who received placebo. Conclusions: Our results indicate that the efficacy of vedolizumab SC in a subgroup of Japanese patients with UC are similar with those in the overall VISIBLE 1 study population, and with those established with vedolizumab IV. The safety and tolerability of vedolizumab SC were generally similar to that established for vedolizumab IV. (ClinicalTrials.gov ID NCT02611830; EudraCT 2015-000480-14) (Intest Res 2021;19:448-460)
Discrete element simulations of continental collision in Asia
Tanaka Atsushi,Sanada Yoshinori,Yamada Yasuhiro,Matsuoka Toshifumi,Ashida Yuzuru Korean Society of Earth and Exploration Geophysici 2005 지구물리와 물리탐사 Vol.8 No.1
조립질 물질을 이용한 축소모형실험(예를 들어 모래상자실험)을 다양한 크기의 많은 지질학적 문제에 성공적으로 적용되어왔다. 이러한 물리적 실험은 개별요소법(DEM)을 이용하여 수치적으로도 수행될수 있다. 이연구에서는 현재 지구상에서 가장 중요한 지구조적 과정 중의 하나인 인도판과 유라시아판의 충돌문제를 시뮬레이션하기 위해 개별요소법을 적용하였다. 개별요소 시뮬레이션은 구조지질학뿐만 아니라 토질역학, 암석역학 등의 다양한 동역학적 분야에 적용되어왔다. 조사대상이 많은 작은 입자들의 조합으로 가정되기 때문에 개별요소 시뮬레이션은 거대하고 불연속적인 변형이 일어나는 대상을 다룰 수 있다. 그러나 DEM 시뮬레이션에서는 개개 입자에 대한 입력변수들과 전체 물성의 관계에 대해 거의 알려져 있지 않기 때문에 입력 변수들의 타당성을 검증하기 어려운 경우가 자주 있다. 그러므로 이전의 연구들에서는 시행착오에 의해 입력변수를 조정하여만 하였다. 이러한 어려움을 극복하기 위하여, 이 연구에서는 개별요소 시뮬레이션에 수치적인 이축 시험을 도입하였으며, 이러한 수치 시험 결과를 이용하여 충돌 모델에 사용되는 입력변수의 타당성을 검토하였다. 결과적인 층돌 모델은 동 아시아에서 관측되는 실제 변형과 매우 비슷하며, GPS 자료 및 동 아시아의 원위치 응력자료와 잘 대비된다.