Loftus Edward V, Sands Bruce E, Colombel Jean-Frédéric, Dotan Iris, Khalid Javaria Mona, Tudor David, Geransar Parnia
Division of Gastroenterology and Hepatology, Mayo Clinic College of Medicine, Rochester, MN, USA.
The Dr. Henry D. Janowitz Division of Gastroenterology, Icahn School of Medicine at Mount Sinai Hospital, New York, NY, USA.
Clin Exp Gastroenterol. 2020 Jun 11;13:211-220. doi: 10.2147/CEG.S248597. eCollection 2020.
Corticosteroid-free clinical remission is important in ulcerative colitis.
This GEMINI 1 post hoc analysis evaluated vedolizumab efficacy in achieving sustained corticosteroid-free clinical remission in moderately to severely active ulcerative colitis.
GEMINI 1 included a 6-week induction period followed by a 46-week maintenance period. Patients received stable corticosteroid dosing at baseline/during induction and tapered dosing during maintenance. Analysis groups included vedolizumab (induction and maintenance); vedolizumab/placebo (vedolizumab induction, placebo maintenance); and placebo (induction and maintenance). The primary endpoint was sustained corticosteroid-free clinical remission (partial Mayo score ≤2, no individual subscore >1, for ≥32 weeks). Multivariate analyses identified covariates associated with the primary endpoint. Safety endpoints included adverse events.
Baseline demographics and concomitant corticosteroid use were similar across groups (n=454). A greater proportion (95% confidence interval) of the vedolizumab group achieved sustained corticosteroid-free clinical remission (10.2% [6.9 to 13.6]) vs the placebo group (1.4% [0.0 to 7.3]; difference 8.9% [-3.8 to 21.4]). Proportions were similar between the vedolizumab/placebo and placebo groups. Covariates associated with sustained corticosteroid-free clinical remission (odds ratio [95% confidence interval]) were treatment (vedolizumab vs placebo: 9.35 [1.25 to 71.43]; =0.0605), anti-tumor necrosis factor alpha exposure (yes vs no: 0.26 [0.12 to 0.57]; =0.0008), and disease duration (≤2 vs >2 years: 2.66 [0.99-7.19]; =0.0531). Adverse events were similar across groups.
A numerically greater proportion of vedolizumab-treated patients with ulcerative colitis achieved sustained corticosteroid-free clinical remission. Vedolizumab treatment, no previous anti-tumor necrosis factor alpha exposure, and shorter disease duration were associated with sustained corticosteroid-free clinical remission.
NCT00783718.
无皮质类固醇临床缓解在溃疡性结肠炎中很重要。
这项GEMINI 1事后分析评估了维多珠单抗在中度至重度活动性溃疡性结肠炎患者中实现持续无皮质类固醇临床缓解的疗效。
GEMINI 1包括一个为期6周的诱导期，随后是一个为期46周的维持期。患者在基线/诱导期接受稳定的皮质类固醇给药，并在维持期逐渐减少剂量。分析组包括维多珠单抗（诱导期和维持期）；维多珠单抗/安慰剂组（维多珠单抗诱导期，安慰剂维持期）；以及安慰剂组（诱导期和维持期）。主要终点是持续无皮质类固醇临床缓解（部分梅奥评分≤2，单个分项评分均不>1，持续≥32周）。多变量分析确定了与主要终点相关的协变量。安全性终点包括不良事件。
各治疗组的基线人口统计学特征和皮质类固醇的联合使用情况相似（n = 454）。与安慰剂组（1.4% [0.0至7.3]）相比，维多珠单抗组有更高比例（95%置信区间）的患者实现了持续无皮质类固醇临床缓解（10.2% [6.9至13.6]）；差异为8.9% [-3.8至21.4]）。维多珠单抗/安慰剂组和安慰剂组的比例相似。与持续无皮质类固醇临床缓解相关的协变量（比值比[95%置信区间]）包括治疗（维多珠单抗与安慰剂：9.35 [1.25至71.43]；P = 0.0605）、抗肿瘤坏死因子α暴露情况（是与否：0.26 [0.12至0.57]；P = 0.0008）和病程（≤2年与>2年：2.66 [0.99至7.19]；P = 0.0531）。各治疗组的不良事件相似。
在接受维多珠单抗治疗的溃疡性结肠炎患者中，在数值上有更高比例的患者实现了持续无皮质类固醇临床缓解。维多珠单抗治疗、既往未接受过抗肿瘤坏死因子α治疗以及病程较短与持续无皮质类固醇临床缓解相关。
NCT00783718。
