P386 尽管诱导治疗后临床症状有所缓解,但肠紧迫感仍持续存在,这与溃疡性结肠炎患者不利的长期预后有关:多中心 UC-RGENCY 研究的结果

A Buisson, A Amiot, M Nachury, R Altwegg, M Serrero, T Guilmoteau, X Treton, L Caillo, L Vuitton, G Bouguen, B Pereira, M Fumery
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BU was defined as a binary criterion based on the SCCAI definition. The primary endpoint was the time to drug discontinuation due to active UC. Secondary endpoints were time to relapse, time to colectomy as well as steroid-free clinical remission (pMS ≤ 2) (CFREM), endoscopic remission (CFREM + Mayo endoscopic score (MES) ≤ 1), and mucosal healing (CFREM + MES ≤ 1 + histological remission i.e. Nancy index ≤ 1) at last follow-up. Results Among 473 patients with UC, 270 were assessed for BU after induction therapy (week 16) (mean age 43.0±17.0 years-old, median UC duration 6 [3-11] years, female gender=54.0%, pancolitis=45.9%). The median follow-up was 14 [8-22] months. The rate of CFREM after induction therapy was 54.4% (147/270) while 21.5% (58/270) had remaining bowel urgencies after induction therapy. Among the 147 patients achieving remission after induction therapy, 12 had persistent BU (8.2%), while 62.6% (77/123) of patients with no CFREM after induction therapy did not have any BU. The agreements between BU and rectal bleeding (75.2%, κ-coefficient = 0.33±0.06) or normalization of stools frequency (67.9%,κ-coefficient = 0.35±0.05) were mild. Among the patients with persistent BU after induction therapy, only 3.7% had no endoscopic activity (MES = 0). In multivariable analyses including CFREM at week 16, persistence of BU after induction therapy was independently associated with the time to drug discontinuation (HR=2.0[1.1-3.5], p=0.016) and colectomy (HR=4.4[2.3-8.4], p<0.001), and absence of mucosal healing (OR = 5.0[1.1-24.8], p=0.046) at last follow-up. A trend was also observed regarding the association between remaining BU after induction therapy and no CFREM (OR=6.1[0.8-48.0], p=0.085) or absence of endoscopic remission (OR=2.4[0.9-6.1], p=0.077) at last follow-up. Conclusion Persistence of BU despite clinical remission is associated with higher risk of drug discontinuation due to active UC, colectomy and lower likelihood of mucosal healing. 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引用次数: 0

摘要

背景 STRIDE 2 建议将溃疡性结肠炎(UC)患者的临床缓解定义为无直肠出血和大便次数正常,但不包括肠紧迫感(BU),尽管它对生活质量有负面影响。在这一大型多中心队列中,我们旨在评估诱导治疗后肠紧迫感的持续存在是否与溃疡性结肠炎患者不良的长期预后独立相关。方法 从一项多中心回顾性研究中,我们纳入了曾接触过至少一种抗肿瘤坏死因子药物、部分梅奥评分(pMS)> 2、在 2019 年 1 月至 2022 年 6 月期间开始使用生物制剂或小分子药物的连续 UC 成人患者。根据 SCCAI 的定义,BU 被定义为二元标准。主要终点是因活动性 UC 而停药的时间。次要终点是复发时间、结肠切除时间以及最后一次随访时的无类固醇临床缓解(pMS ≤ 2)(CFREM)、内镜缓解(CFREM + 梅奥内镜评分(MES)≤ 1)和粘膜愈合(CFREM + MES ≤ 1 + 组织学缓解,即南希指数≤ 1)。结果 在473名UC患者中,有270人在诱导治疗后(第16周)接受了BU评估(平均年龄为43.0±17.0岁,中位UC病程为6 [3-11]年,女性=54.0%,胰腺炎=45.9%)。中位随访时间为 14 [8-22] 个月。诱导治疗后出现 CFREM 的比例为 54.4%(147/270),而 21.5%(58/270)的患者在诱导治疗后仍有肠道紧迫感。在诱导治疗后获得缓解的 147 名患者中,12 人(8.2%)有持续的 BU,而在诱导治疗后没有 CFREM 的患者中,62.6%(77/123)没有任何 BU。BU与直肠出血(75.2%,κ系数=0.33±0.06)或大便次数正常化(67.9%,κ系数=0.35±0.05)之间的吻合度较低。在诱导治疗后出现持续性 BU 的患者中,只有 3.7% 没有内镜活动(MES = 0)。在包括第16周CFREM的多变量分析中,诱导治疗后BU持续存在与停药时间(HR=2.0[1.1-3.5],p=0.016)和结肠切除术(HR=4.4[2.3-8.4],p<0.001)以及最后一次随访时粘膜未愈合(OR=5.0[1.1-24.8],p=0.046)独立相关。在诱导治疗后仍存在 BU 与最后一次随访时无 CFREM(OR=6.1[0.8-48.0],p=0.085)或无内镜缓解(OR=2.4[0.9-6.1],p=0.077)之间的关联方面,也观察到一种趋势。结论 尽管临床缓解,但 BU 的持续存在与活动性 UC、结肠切除术和粘膜愈合可能性较低导致的停药风险较高有关。肠道紧迫性应纳入国际指南,以界定 UC 患者的临床缓解。
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P386 Persistence of bowel urgency despite clinical remission after induction therapy is associated with unfavorable long-term outcomes in patients with ulcerative colitis: results from the multicenter UC-RGENCY study
Background STRIDE 2 recommendations define clinical remission as no rectal bleeding and normalization of stool frequency in patients with ulcerative colitis (UC), without including bowel urgency (BU) despite its negative impact on quality of life. In this large multicenter cohort, we aimed to assess whether the persistence of BU after induction therapy is independently associated with poor long-term outcomes in patients with UC. Methods From a multicenter retrospective study, we included consecutive UC adult patients previously exposed to at least one anti-TNF agent, with partial Mayo score (pMS) > 2, who started biologics or small molecules between Jan2019 and June2022. BU was defined as a binary criterion based on the SCCAI definition. The primary endpoint was the time to drug discontinuation due to active UC. Secondary endpoints were time to relapse, time to colectomy as well as steroid-free clinical remission (pMS ≤ 2) (CFREM), endoscopic remission (CFREM + Mayo endoscopic score (MES) ≤ 1), and mucosal healing (CFREM + MES ≤ 1 + histological remission i.e. Nancy index ≤ 1) at last follow-up. Results Among 473 patients with UC, 270 were assessed for BU after induction therapy (week 16) (mean age 43.0±17.0 years-old, median UC duration 6 [3-11] years, female gender=54.0%, pancolitis=45.9%). The median follow-up was 14 [8-22] months. The rate of CFREM after induction therapy was 54.4% (147/270) while 21.5% (58/270) had remaining bowel urgencies after induction therapy. Among the 147 patients achieving remission after induction therapy, 12 had persistent BU (8.2%), while 62.6% (77/123) of patients with no CFREM after induction therapy did not have any BU. The agreements between BU and rectal bleeding (75.2%, κ-coefficient = 0.33±0.06) or normalization of stools frequency (67.9%,κ-coefficient = 0.35±0.05) were mild. Among the patients with persistent BU after induction therapy, only 3.7% had no endoscopic activity (MES = 0). In multivariable analyses including CFREM at week 16, persistence of BU after induction therapy was independently associated with the time to drug discontinuation (HR=2.0[1.1-3.5], p=0.016) and colectomy (HR=4.4[2.3-8.4], p<0.001), and absence of mucosal healing (OR = 5.0[1.1-24.8], p=0.046) at last follow-up. A trend was also observed regarding the association between remaining BU after induction therapy and no CFREM (OR=6.1[0.8-48.0], p=0.085) or absence of endoscopic remission (OR=2.4[0.9-6.1], p=0.077) at last follow-up. Conclusion Persistence of BU despite clinical remission is associated with higher risk of drug discontinuation due to active UC, colectomy and lower likelihood of mucosal healing. Bowel urgency should be implemented into international guidelines to define clinical remission in patients with UC.
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