Zezos Petros, Kabakchiev Boyko, Weizman Adam V, Nguyen Geoffrey C, Narula Neeraj, Croitoru Kenneth, Steinhart A Hillary, Silverberg Mark S
Division of Gastroenterology, Mount Sinai Hospital, University of Toronto, Toronto, Canada.
Zane Cohen Centre for Digestive Diseases, Mount Sinai Hospital, Toronto, Canada.
J Can Assoc Gastroenterol. 2020 Apr;3(2):74-82. doi: 10.1093/jcag/gwy065. Epub 2018 Nov 22.
Vedolizumab (VDZ) is a humanized monoclonal IgG1 antibody which inhibits leukocyte vascular adhesion and migration into the gastrointestinal tract through α4β7 integrin blockade.
We retrospectively assessed the 12-month, real-world efficacy and safety of VDZ as induction and maintenance therapy in adult patients with ulcerative colitis (UC).
The rates of clinical remission (CR, partial Mayo score < 2), steroid-free clinical remission (SFCR), and mucosal healing were assessed with nonresponder imputation analysis. Baseline independent predictors of clinical remission were investigated, and adverse events were recorded.
We analyzed outcomes in 74 patients; 32% were anti-TNF naïve, 68% had pancolitis, and 46% were on systemic steroids at baseline. At week six, week 14, six months and one year, the CR rates were 26%, 34%, 39% and 39% respectively, and the SFCR rates were 24%, 31%, 38% and 39%, respectively. Among patients not in CR after induction, the probability of remission at six months was 20%. Sustained SFCR between weeks 14 and 52 and between weeks 22 and 52 was found in 69% and 86% of the patients, respectively. Steroid-free clinical remission at 12 months was significantly associated with remission after the induction phase (OR = 30.4; 95% CI, 6 to 150; < 0.001). Mucosal healing rate at one year was 39%. The most common side effect was headache (7%).
Increasing remission rates were observed over the first six months of VDZ treatment. One-fifth of patients not in remission post-induction achieved remission by six months of continued therapy. Mucosal healing was associated with higher rates of one-year steroid-free remission and VDZ treatment continuation.
维多珠单抗（VDZ）是一种人源化单克隆IgG1抗体，通过阻断α4β7整合素抑制白细胞血管黏附及向胃肠道的迁移。
我们回顾性评估了VDZ作为成人溃疡性结肠炎（UC）诱导和维持治疗的12个月真实世界疗效及安全性。
采用无反应者填补分析评估临床缓解率（CR，部分梅奥评分<2）、无类固醇临床缓解率（SFCR）和黏膜愈合率。研究临床缓解的基线独立预测因素，并记录不良事件。
我们分析了74例患者的结局；32%既往未使用过抗TNF药物，68%为全结肠炎，46%在基线时使用全身类固醇。在第6周、第14周、6个月和1年时，CR率分别为26%、34%、39%和39%，SFCR率分别为24%、31%、38%和39%。在诱导治疗后未达到CR的患者中，6个月时缓解的概率为20%。分别有69%和86%的患者在第14周和第52周之间以及第22周和第52周之间维持SFCR。12个月时的无类固醇临床缓解与诱导期后的缓解显著相关（OR = 30.4；95%CI，6至150；<0.001）。1年时的黏膜愈合率为39%。最常见的副作用是头痛（7%）。
在VDZ治疗的前6个月观察到缓解率不断提高。诱导治疗后未缓解的患者中有五分之一通过持续治疗6个月实现缓解。黏膜愈合与1年无类固醇缓解率及VDZ治疗持续率较高相关。
