INSPECT: A Retrospective Study to Evaluate Long-term Effectiveness and Safety of Darvadstrocel in Patients With Perianal Fistulizing Crohn's Disease Treated in the ADMIRE-CD Trial.
INSPECT: A Retrospective Study to Evaluate Long-term Effectiveness and Safety of Darvadstrocel in Patients With Perianal Fistulizing Crohn's Disease Treated in the ADMIRE-CD Trial.
复制标题
DOI：
10.1093/ibd/izab361
复制
发表时间：
2022-11-02
影响因子：
4.9
通讯作者：
中科院分区：
文献类型：
--
作者：
在一项随机、双盲试验（ADMIRE-CD [脂肪来源间充质干细胞诱导肛周瘘管克罗恩病缓解]试验）中，证明了单次给予达瓦德塞（扩增的同种异体脂肪来源间充质干细胞）治疗克罗恩病患者复杂肛周瘘管的疗效。当前的病历审查研究（INSPECT [一项在完成ADMIRE-CD的患者中评价达伐他汀长期疗效的回顾性病历审查研究]）评价了达伐他汀的长期疗效和安全性。合格患者已完成ADMIRE-CD试验至少52周。在治疗后104周和156周回顾性收集临床缓解和瘘管复发结局的数据。在治疗后208周内收集特别关注的不良事件（致瘤性和异位组织形成）。89例患者入组（43例达伐他汀患者，46例对照受试者）。在治疗后52、104和156周，29例患者观察到临床缓解。（67.4%）43，23（53.5%）43和23（53.5%），而对照组分别为24/46（52.2%）、20/46（43.5%）和21/46（45.7%）。在第52周临床缓解的患者中，分别有19/29例（65.5%）和16/29例（55.2%）接受达伐他汀治疗的患者以及17/24例（70.8%）和13/24例（54.2%）对照受试者在治疗后104周和156周维持缓解。两组间至瘘管复发的时间和瘘管复发或新发瘘管的发生率无显著差异。对照组1例（2.2%）患者报告了致瘤性（恶性表皮样癌）。未报告异位组织形成。ADMIRE-CD试验患者的真实世界随访表明，无论是通过达伐施特给药还是维持治疗方案实现，复杂性肛周瘘的临床缓解都可以长期持续，并证实了达伐施特具有良好的长期安全性特征。
The efficacy of a single administration of darvadstrocel (expanded allogeneic adipose-derived mesenchymal stem cells) for treating complex perianal fistulas in patients with Crohn’s disease was demonstrated in a randomized, double-blind trial (ADMIRE-CD [Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn\'s Disease] trial). The current chart review study (INSPECT [A retrospectIve chart review study evaluatINg the longer-term effectiveneSs of darvadstrocel in PatiEnts who CompleTed ADMIRE-CD]) evaluated the longer-term effectiveness and safety of darvadstrocel. Eligible patients had completed at least 52 weeks in the ADMIRE-CD trial. Data on clinical remission and fistula relapse outcomes were collected retrospectively at 104 and 156 weeks after treatment. Adverse events of special interest (tumorigenicity and ectopic tissue formation) were collected up to 208 weeks after treatment. Eighty-nine patients were included (43 darvadstrocel patients, 46 control subjects). At 52, 104, and 156 weeks posttreatment, clinical remission was observed in 29 (67.4%) of 43, 23 (53.5%) of 43, and 23 (53.5%) of 43 darvadstrocel-treated patients, compared with 24 (52.2%) of 46, 20 (43.5%) of 46, and 21 (45.7%) of 46 control subjects, respectively. In patients with clinical remission at week 52, this remission was sustained at 104 and 156 weeks after treatment in 19 (65.5%) of 29 and 16 (55.2%) of 29 darvadstrocel-treated patients and in 17 (70.8%) of 24 and 13 (54.2%) of 24 control subjects, respectively. Time to fistula relapse and incidence of fistula relapse or new fistula occurrence were not significantly different between groups. Tumorigenicity was reported for 1 (2.2%) patient in the control group (malignant epidermoid carcinoma). No ectopic tissue formation was reported. Real-world follow-up of patients from the ADMIRE-CD trial indicates that clinical remission of complex perianal fistulas can be sustained in the long term irrespective of whether it is achieved through darvadstrocel administration or maintenance treatment regimens and confirms a favorable long-term safety profile of darvadstrocel.
登录
查看更多内容
影响因子：
2.2
作者：
Aguilera-Castro L;Ferre-Aracil C;Garcia-Garcia-de-Paredes A;Rodriguez-de-Santiago E;Lopez-Sanroman A
通讯作者：
Lopez-Sanroman A
影响因子：
168.9
作者：
Panes, Julian;Garcia-Olmo, Damian;Danese, Silvio
通讯作者：
Danese, Silvio
影响因子：
29.4
作者：
Schwartz, DA;Loftus, EV;Sandborn, WJ
通讯作者：
Sandborn, WJ
DOI：
10.1111/j.1749-6632.2012.06667.x
发表时间：
2012-01-01
期刊：
HEMATOPOIETIC STEM CELLS VIII
影响因子：
--
作者：
Bernardo, Maria Ester;Fibbe, Willem E.
通讯作者：
Fibbe, Willem E.
影响因子：
158.5
作者：
Present, DH;Rutgeerts, P;van Deventer, SJH
通讯作者：
van Deventer, SJH