Background

5-Aminosalicylates (5-ASA) are the key drugs in induction and maintenance therapy in ulcerative colitis (UC). Some UC patients are involved in 5-ASA intolerance after induction of oral 5-ASA compounds. There is no evidence of the prognosis including the risk of colectomy in 5-ASA intolerant UC patients.

Methods

The aim of this study is to establish the prognosis of 5-ASA intolerant UC patients in a multicenter cohort study. A retrospective review of a prospective multicenter database (2014–2018) of 1,574 UC patients was carried out and a total of 1,286 patients treated with oral 5-ASA compounds were enrolled. We compared the risk of colectomy and biologics induction between patients (i) tolerant to first 5-ASA compound (1079), (ii) intolerant to first 5-ASA compound but tolerant to other 5-ASA compound (107) and (iii) intolerant to 5-ASA compound and withdrawal of 5-ASA (100).

Results

We identified 1,286 patients with UC, of which 40 patients (3.1%) resulted in colectomy and 247 patients (19%) treated with biologics. Colectomy rate in patients (iii) intolerant to 5-ASA and withdrawal of 5-ASA were higher than (i) tolerant to first 5-ASA and (ii) intolerant to first 5-ASA but tolerant to other 5-ASA (9.0%, 2.7%, 1.9%, respectively). (iii) Patients withdrawal of 5-ASA showed higher risk of colectomy compared with (i) tolerant to first 5-ASA (Hazard ratio (HR) 4.71, 95% Confidence interval (CI): 2.04–10.8). The risk of colectomy among (ii) patients intolerant to first 5-ASA but tolerant to other 5-ASA showed no significant difference compared with (i) tolerant to first 5-ASA (HR 0.76, 95% CI: 0.43–1.35). The biologics induction rate in (iii) patients withdrawal of 5-ASA was significantly higher than (i) tolerant to first 5-ASA and (ii) intolerant to first 5-ASA but tolerant to other 5-ASA (37%, 18%, 16%, respectively). Also (iii) patients withdrawal of 5-ASA showed higher risk of induction with biologics compared with (i) tolerant to first 5-ASA (HR 2.35, 95% CI: 1.50–3.68). Those risk among (ii) patients intolerant to first 5-ASA but tolerant to other 5-ASA showed no significant difference compared with (i) tolerant to first 5-ASA (HR 0.76, 95% CI: 0.43–1.35).

Conclusion

Patients with UC who had 5-ASA intolerance and withdrew from 5-ASA showed poor prognosis. We should consider trying other 5-ASA compounds even if the patients had intolerance to one 5-ASA compound.

中文翻译：

---

P461对5-氨基水杨酸不耐受是溃疡性结肠炎患者预后不良的风险

背景

5-氨基水杨酸酯（5-ASA）是溃疡性结肠炎（UC）诱导和维持治疗中的关键药物。一些UC患者在口服5-ASA化合物诱导后参与5-ASA不耐受。没有证据表明5-ASA不耐受的UC患者包括结肠切除术的风险。

方法

这项研究的目的是在多中心队列研究中确定5-ASA不耐受的UC患者的预后。对前瞻性多中心数据库（2014-2018年）的1574名UC患者进行了回顾性研究，共纳入1286名接受口服5-ASA化合物治疗的患者。我们比较了患者（i）耐受第一种5-ASA化合物（1079），（ii）耐受第一种5-ASA化合物但耐受其他5-ASA化合物（107）和（iii）患者之间结肠切除术和生物制剂诱导的风险不耐受5-ASA化合物并退出5-ASA（100）。

结果

我们确定了1,286例UC患者，其中40例（3.1％）导致了结肠切除术，247例（19％）接受了生物制剂治疗。（iii）对5-ASA不耐受和5-ASA退出的患者的结肠切除率高于（i）对前5-ASA耐受的患者和（ii）对前5-ASA耐受但对其他5-ASA耐受的患者（9.0％ ，2.7％和1.9％）。（iii）与（i）耐受首批5-ASA的患者相比，退出5-ASA的患者发生结肠切除术的风险更高（危险比（HR）4.71，95％可信区间（CI）：2.04-10.8）。（ii）不耐受第一种5-ASA但又耐受其他5-ASA的患者与（i）耐受第一种5-ASA的患者进行结肠切除的风险没有显着差异（HR 0.76，95％CI：0.43-1.35）。（iii）停用5-ASA的患者的生物制剂诱导率显着高于（i）耐受前5-ASA的患者和（ii）耐受前5-ASA的患者但耐受其他5-ASA的患者（37％，18％ ，分别为16％）。同样（iii）退出5-ASA的患者与（i）耐受第一种5-ASA的患者相比，有较高的生物制剂诱导风险（HR 2.35，95％CI：1.50–3.68）。（ii）不耐受第一种5-ASA但又耐受其他5-ASA的患者与（i）耐受第一种5-ASA的患者相比，风险无显着差异（HR 0.76，95％CI：0.43-1.35）。

结论

患有5-ASA不耐受并退出5-ASA的UC患者预后较差。即使患者对一种5-ASA化合物不耐受，我们也应考虑尝试其他5-ASA化合物。