Department of Gastroenterology and Hepatology, Toyota Kosei Hospital, Toyota, Japan.
Department of Gastroenterology and Hepatology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Nagoya J Med Sci. 2023 Aug;85(3):402-427. doi: 10.18999/nagjms.85.3.402.
Ustekinumab has recently been approved for the treatment of ulcerative colitis (UC) based on data from clinical trials. However, the effectiveness of ustekinumab in patients with UC in a real-world setting remains unclear. Hence, in this meta-analysis, we aimed to evaluate the effectiveness of ustekinumab in a real-world setting and to investigate the predictors of its effectiveness. A comprehensive literature search was performed to examine the effectiveness of ustekinumab in UC patients admitted between January 2019 and December 2021. Data on clinical remission, response, and corticosteroid-free clinical remission rates were extracted, pooled, and analyzed. Meta-regression analysis was performed to investigate the source of heterogeneity and the impact of moderators on the outcomes of interest. A total of 14 eligible studies were identified. The pooled clinical remission rate was 55.0% at week 8, 36.1% at week 16, 46.6% at month 6, and 38.6% at month 12. The meta-regression analysis showed that prior use of anti-tumor necrosis factor (TNF) agents and vedolizumab and the publication style were significant moderators. Additionally, out of 258 patients, there were 28 adverse events (AEs) (10.9%). The effectiveness of ustekinumab in real-world patients with UC was consistent with the results clinical trials. Moreover, previous treatment with anti-TNF agents and vedolizumab might have affected the effectiveness of ustekinumab.
乌司奴单抗最近基于临床试验数据被批准用于治疗溃疡性结肠炎（UC）。然而，乌司奴单抗在真实世界环境中治疗 UC 患者的疗效仍不清楚。因此，在这项荟萃分析中，我们旨在评估乌司奴单抗在真实世界环境中的疗效，并探讨其疗效的预测因素。我们进行了全面的文献检索，以评估 2019 年 1 月至 2021 年 12 月期间接受乌司奴单抗治疗的 UC 患者的疗效。提取、汇总和分析了临床缓解、应答和无皮质类固醇临床缓解率的数据。进行了荟萃回归分析，以探讨异质性的来源以及调节因素对感兴趣结局的影响。确定了 14 项符合条件的研究。第 8 周时的临床缓解率为 55.0%，第 16 周时为 36.1%，第 6 个月时为 46.6%，第 12 个月时为 38.6%。荟萃回归分析表明，先前使用抗肿瘤坏死因子（TNF）药物和维得利珠单抗以及发表方式是显著的调节因素。此外，在 258 名患者中，有 28 例不良事件（AE）（10.9%）。乌司奴单抗在真实世界中治疗 UC 患者的疗效与临床试验结果一致。此外，先前使用抗 TNF 药物和维得利珠单抗可能影响了乌司奴单抗的疗效。
