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首页> 外文期刊>Alimentary pharmacology & therapeutics. >Meta-analysis using individual patient data: Efficacy and durability of topical alicaforsen for the treatment of active ulcerative colitis
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Meta-analysis using individual patient data: Efficacy and durability of topical alicaforsen for the treatment of active ulcerative colitis

机译：使用个体患者数据进行荟萃分析：局部阿卡普生治疗活动性溃疡性结肠炎的疗效和持久性

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Background The antisense ICAM-1 inhibitor alicaforsen has been studied in four phase 2 studies in ulcerative colitis (UC). Recruited patients varied as to the extent of their colitis and in the severity of disease at entry. Aim To investigate the efficacy of alicaforsen enema in specific UC populations. Efficacy was analysed for short-term (week 6-10) and long-term (week 30) outcomes compared with either placebo or a high-dose mesalazine (mesalamine) enema in patients with disease extent up to 40 cm from the anal verge in patients with moderate or severe disease, and in patients with both of these features. Methods Individual patient data meta-analyses of 200 patients from four phase 2 studies evaluating nightly alicaforsen 240 mg enema and comparators. Patient data were pooled and analysed in a single data set. Continuous outcomes were evaluated using anova; dichotomous outcomes were evaluated using Pearson chi-square or Fisher's exact tests. Results Alicaforsen showed superior efficacy vs. placebo in: patients with disease extent up to 40 cm, patients with moderate and severe disease and especially when both those conditions were satisfied. In these patient groups, mesalazine also showed short-term efficacy. At week 30, however, the efficacy of mesalazine waned and alicaforsen became significantly more efficacious. Conclusions This post hoc meta-analysis showed that alicaforsen is effective in patients with active UC, especially in patients with distal disease, which is of moderate/severe activity. The efficacy of alicaforsen was durable in these sub-groups, suggesting a disease-modifying effect. This analysis suggests that alicaforsen enema may offer an effective, potentially durable response in moderate/severe distal active UC.
机译：背景技术在溃疡性结肠炎（UC）的四个2期研究中已经研究了反义ICAM-1抑制剂alicaforsen。被招募的患者的结肠炎程度和入院时的疾病严重程度各不相同。目的探讨alicaforsen灌肠在特定UC人群中的疗效。在距肛门近40 cm的患者中，与安慰剂或大剂量美沙拉嗪（美沙拉敏）灌肠相比，分析了短期（第6-10周）和长期（第30周）结局的疗效具有中度或重度疾病的患者，以及具有这两种特征的患者。方法来自四项2期研究的200例患者的个人患者荟萃分析，评估了每晚240毫克的阿立克福灌肠剂和比较剂。合并患者数据并在单个数据集中进行分析。使用方差分析评估连续结果;使用Pearson卡方或Fisher精确检验评估二分结果。结果Alicaforsen在以下方面表现出优于安慰剂的功效：疾病范围最大40 cm的患者，中度和重度疾病的患者，尤其是当这两个条件都满足时。在这些患者组中，美沙拉嗪也显示出短期疗效。然而，在第30周，美沙拉嗪的功效逐渐减弱，alicaforsen的功效明显提高。结论这项事后荟萃分析表明，alicaforsen对活动性UC患者有效，特别是对于中度/重度活动性远端疾病患者。 alicaforsen在这些亚组中的疗效持久，表明具有改善疾病的作用。这项分析表明，在中度/重度远端活动性UC中，alicaforsen灌肠可以提供有效，潜在的持久性应答。

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