Abdominal Center, Gastroenterology, University of Helsinki and Helsinki University Hospital, Helsinki, Finland.
Pfizer Oy, Helsinki, Finland.
Scand J Gastroenterol. 2024 Apr;59(4):425-432. doi: 10.1080/00365521.2023.2298361. Epub 2023 Dec 29.
The aim was to define the effectiveness of tofacitinib and to characterize the patient population receiving tofacitinib in a real-world cohort clinical setting for ulcerative colitis (UC) in Finland.
This is a retrospective non-interventional multicenter patient chart data study conducted in 23 Finnish Inflammatory Bowel Disease (IBD) centers. Baseline demographic and clinical data, clinical remission, steroid-free remission rate and time to tofacitinib discontinuation, colectomy or UC-related hospitalization were studied.
The study included 252 UC patients of which 69% were male. Most patients had extensive disease (71%) and were bio-experienced (81%). Tofacitinib demonstrated positive treatment outcomes with clinical response, clinical remission, and steroid-free clinical remission at one year in 33%, 34% and 31% of patients, respectively. Moreover, 64% of patients in pMayo remission at week 16 from the start of tofacitinib were still in remission at one year. Only no or mild disease activity compared to moderate activity at baseline was associated with a higher probability of achieving remission according to pMayo at six months, = .008. Hospitalizations and/or colectomies during the study period (before treatment discontinuation/end of follow-up) were low ( = 24), with less than 5 colectomies.
In this real-world cohort, including a majority of bio-experienced UC patients, tofacitinib was effective in achieving steroid-free clinical remission in a third of the population at one year. A majority of patients in remission at week 16 were also in remission at one year. Results are in line with earlier published real-world studies. Registration: ClinicalTrials.gov NCT05082428.
旨在确定托法替布的疗效,并在芬兰的溃疡性结肠炎(UC)真实世界队列临床环境中对接受托法替布治疗的患者人群进行特征描述。
这是一项在 23 家芬兰炎症性肠病(IBD)中心进行的回顾性非干预性多中心患者图表数据研究。研究了基线人口统计学和临床数据、临床缓解、无类固醇缓解率以及托法替布停药、结肠切除术或与 UC 相关的住院时间。
该研究纳入了 252 例 UC 患者,其中 69%为男性。大多数患者患有广泛性疾病(71%),并且具有生物治疗经验(81%)。托法替布在一年时显示出积极的治疗结果,分别有 33%、34%和 31%的患者达到临床应答、临床缓解和无类固醇临床缓解。此外,在开始托法替布治疗后 16 周达到 pMayo 缓解的 64%的患者在一年时仍处于缓解状态。只有与基线时中度活动相比,无或轻度疾病活动与达到缓解的可能性更高相关(pMayo,=0.008)。研究期间(在治疗停药/随访结束之前)的住院和/或结肠切除术数量较低(=24),不到 5 例结肠切除术。
在这项真实世界队列研究中,包括大多数具有生物治疗经验的 UC 患者,托法替布在一年时使三分之一的人群达到了无类固醇的临床缓解。在 16 周达到缓解的大多数患者在一年时也处于缓解状态。结果与之前发表的真实世界研究一致。注册:ClinicalTrials.gov NCT05082428。