Amiot A, Serrero M, Peyrin-Biroulet L, Filippi J, Pariente B, Roblin X, Buisson A, Stefanescu C, Trang-Poisson C, Altwegg R, Marteau P, Vaysse T, Bourrier A, Nancey S, Laharie D, Allez M, Savoye G, Moreau J, Vuitton L, Viennot S, Aubourg A, Pelletier A-L, Bouguen G, Abitbol V, Gagniere C, Bouhnik Y
Creteil, France.
Marseille, France.
Aliment Pharmacol Ther. 2017 Aug;46(3):310-321. doi: 10.1111/apt.14167. Epub 2017 Jun 8.
We recently showed that vedolizumab is effective in patients with Crohn's disease (CD) and ulcerative colitis (UC) with prior anti-TNF failure in a multicentre compassionate early-access programme before marketing authorisation was granted to vedolizumab.
To assess effectiveness and safety of vedolizumab at week 54 in patients UC and CD.
Between June and December 2014, 173 patients with Crohn's disease (CD) and 121 with ulcerative colitis (UC) were treated with vedolizumab induction therapy. Among those 294 patients, 272 completed the induction period and were evaluated at the week 14 visit (161 patients with CD and 111 with UC). Disease activity was assessed using the Harvey-Bradshaw Index for CD and the partial Mayo Clinic score for UC. The primary outcome was steroid-free clinical remission at week 54.
At week 54, steroid-free clinical remission rates at week 54 were 27.2% and 40.5% in patients with CD and UC respectively. In addition, the sustained steroid-free clinical remission (from week 14 to week 54) rates were 8.1% and 19.0% respectively. No deaths were observed. Severe adverse events occurred in 17 (7.2%) patients, including six (2.5%) leading to vedolizumab discontinuation.
Vedolizumab is able to maintain steroid-free clinical remission in up to one-third of patients with UC and CD at week 54 with a reasonable safety profile. A significant number of patients experienced loss of response during the first year of treatment, particularly in patients with CD.
我们最近表明，在维多珠单抗获得上市许可之前的一项多中心同情性早期准入项目中，维多珠单抗对先前抗TNF治疗失败的克罗恩病（CD）和溃疡性结肠炎（UC）患者有效。
评估维多珠单抗在第54周时对UC和CD患者的有效性和安全性。
2014年6月至12月期间，173例克罗恩病（CD）患者和121例溃疡性结肠炎（UC）患者接受了维多珠单抗诱导治疗。在这294例患者中，272例完成了诱导期，并在第14周就诊时进行了评估（161例CD患者和111例UC患者）。使用哈维-布拉德肖指数评估CD患者的疾病活动度，使用梅奥诊所部分评分评估UC患者的疾病活动度。主要结局是第54周时无类固醇临床缓解。
在第54周时，CD患者和UC患者的无类固醇临床缓解率分别为27.2%和40.5%。此外，持续无类固醇临床缓解（从第14周到第54周）率分别为8.1%和19.0%。未观察到死亡病例。17例（7.2%）患者发生严重不良事件，其中6例（2.5%）导致维多珠单抗停药。
维多珠单抗能够在第54周时使多达三分之一的UC和CD患者维持无类固醇临床缓解，安全性良好。相当数量的患者在治疗的第一年出现反应丧失，尤其是CD患者。
