Background: 

The objective of our systematic review and meta-analysis was to evaluate the effectiveness and safety of tofacitinib in the treatment of moderate-severe ulcerative colitis (UC).

Methods: 

We searched Medline, Embase, Web of Science, and Cochrane Central to identify articles and abstracts reporting efficacy or safety data on tofacitinib use in UC. Primary outcome assessed was remission. Secondary outcomes included clinical response, steroid free remission, and adverse events (AEs).

Results: 

A total of 26 studies were included. The rates of remission were 29.81% [95% confidence interval (CI): 22.37%-37.25%, I²: 90%] at week 8, 32.27% (95% CI: 27.67%-36.88%, I²: 42%) at 6 months and 38.03% (95% CI: 33.59%-42.48%, I²: 0%) at 1-year. Clinical response rates were 59.41% (95% CI: 55.03%-63.94%, I²: 61%) at week 8, 48.99% (95% CI: 36.92%-61.06%, I²: 91%) at 6 months and 50.87% (95% CI: 42.16%-59.58%, I²: 67%) at 1-year. Odds ratio of clinical response at week 8 in biologic naive versus biologic experienced patients was 1.59 (95% CI: 0.54-4.63). Pooled incidence rate for serious infections, major adverse cardiovascular events, and nonmelanotic squamous cell malignancies across all doses was 4.41 per 100-patient years (PYs) (95% CI: 2.32-8.38 per 100-PY, I²: 78%), 0.91 per 100-PY (95% CI: 0.43-1.93 per 100-PY, I²: 37%) and 0.91 per 100-PY (95% CI: 0.61-1.34 per 100-PY, I²: 0%), respectively. Higher dose was associated with an increased frequency of AEs.

Conclusions: 

While the overall efficacy and safety of tofacitinib in moderate-severe UC is consistent with clinical trial data, the dose dependent increase in AEs highlights the significance of early dose de-escalation. Rate of clinical response after tofacitinb induction was similar in biologic naive and biologic experienced patients.

中文翻译：

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托法替布治疗溃疡性结肠炎的有效性和安全性：系统评价和荟萃分析

背景： 

我们的系统评价和荟萃分析的目的是评估托法替布治疗中重度溃疡性结肠炎（UC）的有效性和安全性。

方法： 

我们检索了 Medline、Embase、Web of Science 和 Cochrane Central，以查找报告托法替尼在 UC 中使用的疗效或安全性数据的文章和摘要。评估的主要结果是缓解。次要结局包括临床反应、无类固醇缓解和不良事件 (AE)。

结果： 

总共纳入 26 项研究。第 8 周缓解率为 29.81% [95% CI: 22.37%-37.25%, I ^{2 : 90%]、32.27% (95% CI: 27.67%-36.88%,} I ² : 42%) ) 在 6 个月时为 38.03% (95% CI: 33.59%-42.48%, I ² : 0%) 在 1 年时。第 8 周时的临床缓解率为 59.41% (95% CI: 55.03%-63.94%, I ^{2 : 61%)，第 6 个月时的临床缓解率为 48.99% (95% CI: 36.92%-61.06%,} I ² : 91%)，1 年时为50.87%（95% CI：42.16%-59.58%，I ^{2 ：67%）。}未接受过生物制剂治疗的患者与接受过生物制剂治疗的患者在第 8 周的临床反应比值比为 1.59 (95% CI: 0.54-4.63)。所有剂量下严重感染、主要不良心血管事件和非黑色素鳞状细胞恶性肿瘤的汇总发病率为每 100 名患者年 (PY) 4.41 例（95% CI：2.32-8.38 每 100-PY，I 2 ：78 % ^），每 100-PY 0.91（95% CI：每 100-PY 0.43-1.93，I ²：37%）和每 100-PY 0.91（95% CI：每 100-PY 0.61-1.34，I ²：0%），分别。较高剂量与 AE 频率增加相关。

结论： 

虽然托法替布治疗中重度 UC 的总体疗效和安全性与临床试验数据一致，但 AE 的剂量依赖性增加凸显了早期剂量递减的重要性。在未接受过生物制剂治疗的患者和经历过生物制剂治疗的患者中，托法替丁诱导后的临床反应率相似。