Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, 141001, India.
Department of Internal Medicine, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.
Dig Dis Sci. 2024 Apr;69(4):1389-1402. doi: 10.1007/s10620-024-08276-1. Epub 2024 Feb 15.
Ulcerative proctitis (UP), though associated with high symptom burden and poor quality of life, is excluded from most of the randomized controlled trials in UC, including the OCTAVE trials. We aimed to analyse the effectiveness of tofacitinib in UP, and compare it to that in left sided colitis (LSC) and pancolitis (PC).
This was a prospective cohort study. Patients with either steroid-dependent or refractory ulcerative colitis, who received tofacitinib, were divided into three groups based on the disease extent [UP, LSC and PC]. The primary outcome was comparison of proportion of patients in clinical remission in the three groups, at weeks 8, 16 and 48. Safety outcomes were reported using incidence rate per patient year of exposure.
Clinical remission was achieved in 47%(15/32), 24%(23/94), and 43%(23/54) of patients at week 8, 56%(18/32), 37%(35/94), and 56%(30/54) of patients at week 16, and 59%(19/32), 38%(36/94), and 24%(13/54) of patients at week 48 in groups UP, LSC and PC, respectively. Corticosteroid-free clinical remission rates were significantly higher in patients in groups UP at week 48. Five (15%) patients with UP were primary non-responders to tofacitinib at week 16, while three (9%) patients had secondary loss of response at week 48. The probability of sustained clinical response was highest in patients with UP. Patients with UP had the lowest incidence of adverse effects.
The effectiveness of tofacitinib in inducing and maintaining clinical remission is greater in patients with UP compared to LSC and PC.
溃疡性直肠炎（UP）尽管与高症状负担和生活质量差有关，但在包括 OCTAVE 试验在内的大多数 UC 随机对照试验中都被排除在外。我们旨在分析托法替尼治疗 UP 的疗效，并将其与左半结肠炎（LSC）和全结肠炎（PC）进行比较。
这是一项前瞻性队列研究。接受托法替尼治疗的类固醇依赖性或难治性溃疡性结肠炎患者根据疾病范围分为三组[UP、LSC 和 PC]。主要结局是比较三组患者在第 8、16 和 48 周时达到临床缓解的比例。使用每患者年暴露的发生率报告安全性结局。
第 8 周时，32%（15/32）、24%（23/94）和 43%（23/54）的患者达到临床缓解，第 16 周时，56%（18/32）、37%（35/94）和 56%（30/54）的患者达到临床缓解，第 48 周时，59%（19/32）、38%（36/94）和 24%（13/54）的患者达到临床缓解。第 48 周时，UP 组患者达到无皮质类固醇的临床缓解率明显更高。第 16 周时，有 5 名（15%）UP 患者对托法替尼原发性无应答，第 48 周时有 3 名（9%）患者出现继发性应答丧失。UP 患者持续临床应答的概率最高。UP 患者不良反应发生率最低。
与 LSC 和 PC 相比，托法替尼诱导和维持 UP 患者临床缓解的疗效更大。
