Singh Arshdeep, Bhardwaj Arshia, Jain Devanshi, Sharma Riya, Singh Dharmatma, Mahajan Ramit, Kaur Kirandeep, Singh Aminder, Narang Vikram, Kaur Harpreet, Singh Manavjot, Gupta Pritish, Sehgal Tanisha, Midha Vandana, Sood Ajit
Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, 141 001, India.
Research and Development Centre, Dayanand Medical College and Hospital, Ludhiana, 141 001, India.
Indian J Gastroenterol. 2025 Jun 24. doi: 10.1007/s12664-025-01779-3.
The therapeutic target for ulcerative colitis (UC) has shifted towards deeper disease control. The real-world data on efficacy of tofacitinib in inducing histologic remission (HR) remains limited. We evaluated the real-world efficacy of tofacitinib in achieving endoscopic remission (ER) and HR.
A prospective observational cohort study was conducted from January 2022 to June 2024. Adult patients with moderate-to-severe UC (Mayo score ≥ 6, endoscopic subscore ≥ 2) who responded to tofacitinib induction by week 16 were included. Paired endoscopic and histologic assessments were performed at baseline and week 48. Endoscopic disease activity was graded using the Mayo endoscopic score (MES), while histologic activity was evaluated using the Nancy index (NI). The primary outcome was combined endoscopic-histologic remission (EHR), defined as MES of 0 and a NI of 0, at week 48. The key secondary outcomes included ER, HR, histologic endoscopic mucosal improvement (HEMI) and endoscopic improvement histologic remission (EIHR).
Total 86 patients who received tofacitinib induction therapy were evaluated. Nine non-responders at 16 weeks were excluded and 77 patients (median age 37 years, 38 [49%] females) were analyzed. At week eight, clinical response and remission were achieved in 66 (85.7%) and 37 (48.1%) patients, respectively. At week 48, 57 (74.02%) patients maintained clinical response. Median MES and NI were 1 (IQR 0-3) and 3 (IQR 0-3), respectively. Combined EHR was achieved in 22 (28.6%) patients, while ER and HR were observed in 30 (38.9%) and 29 (37.6%) patients, respectively. HEMI was noted in 32 (41.6%) patients, while EIHR was seen in 27 (35.1%) patients. No significant predictors of ER, HR or combined EHR were identified. No serious adverse effects were reported.
Tofacitinib is effective in achieving combined EHR, ER and HR. These findings support the potential for histologic healing as a therapeutic target for UC in real world.
溃疡性结肠炎（UC）的治疗目标已转向更深度的疾病控制。托法替布诱导组织学缓解（HR）疗效的真实世界数据仍然有限。我们评估了托法替布实现内镜缓解（ER）和HR的真实世界疗效。
于2022年1月至2024年6月进行了一项前瞻性观察队列研究。纳入在第16周对托法替布诱导治疗有反应的中度至重度UC成年患者（梅奥评分≥6，内镜亚评分≥2）。在基线和第48周进行配对的内镜和组织学评估。内镜疾病活动度采用梅奥内镜评分（MES）分级，组织学活动度采用南希指数（NI）评估。主要结局是第48周时的内镜-组织学联合缓解（EHR），定义为MES为0且NI为0。关键次要结局包括ER、HR、组织学内镜黏膜改善（HEMI）和内镜改善组织学缓解（EIHR）。
共评估了86例接受托法替布诱导治疗的患者。排除16周时9例无反应者，分析了77例患者（中位年龄37岁，38例[49%]为女性）。在第8周时，分别有66例（85.7%）和37例（48.1%）患者实现了临床反应和缓解。在第48周时，57例（74.02%）患者维持了临床反应。MES和NI的中位数分别为1（四分位间距0 - 3）和3（四分位间距0 - 3）。22例（28.6%）患者实现了联合EHR，30例（38.9%）和29例（37.6%）患者分别观察到ER和HR。32例（41.6%）患者出现HEMI，27例（35.1%）患者出现EIHR。未发现ER、HR或联合EHR的显著预测因素。未报告严重不良反应。
托法替布在实现联合EHR、ER和HR方面有效。这些发现支持组织学愈合作为UC在现实世界中治疗目标的潜力。
