Department of Gastroenterology and Hepatology, University Hospitals Leuven, Leuven, Belgium.
Department of Chronic Diseases, Metabolism and Ageing, KU Leuven, Leuven, Belgium.
United European Gastroenterol J. 2019 Nov;7(9):1215-1225. doi: 10.1177/2050640619871797. Epub 2019 Aug 20.
In limited retrospective series, infliximab, adalimumab and vedolizumab have demonstrated efficacy in chronic antibiotic-refractory pouchitis. Here, we report single-centre data of all biological therapies in refractory pouchitis.
We retrospectively assessed all records from patients with ulcerative colitis and ileal pouch -anal anastomosis who received infliximab, adalimumab or vedolizumab for pouchitis. Clinically relevant remission, defined as a modified Pouchitis Disease Activity Index <5 and a reduction of modified Pouchitis Disease Activity Index ≥2 points from baseline, was assessed at week 14.
Thirty-three unique patients were identified. Prior to colectomy, patients had been exposed to cyclosporine ( = 14), infliximab ( = 12), adalimumab ( = 3), and/or vedolizumab ( = 3). All developed chronic antibiotic-refractory pouchitis, for which they received infliximab ( = 23), adalimumab ( = 13) or vedolizumab ( = 15). Clinically relevant remission was observed in 43.5% of patients in the infliximab group, and in 38.5% and 60.0% in the adalimumab and vedolizumab group, respectively. In the long-term, significantly more patients continued vedolizumab compared to anti-tumour necrosis factor (anti-TNF) therapy (hazard ratio 3.0, = 0.04). Adverse events (mainly infusion reactions) explained 40.7% of the patients discontinuing anti-TNF therapy, whereas discontinuation of vedolizumab was only related to insufficient efficacy. Four patients eventually required a permanent ileostomy.
In this case series of chronic antibiotic-refractory pouchitis, biological therapy was effective in the majority of patients and only a minority eventually required a permanent ileostomy. The use of anti-TNF agents was hampered by a high rate of adverse events, partly related to immunogenicity as some patients had been exposed to anti-TNF prior to colectomy. Vedolizumab was also efficacious and may provide a safe alternative in these chronic antibiotic-refractory pouchitis patients.
在有限的回顾性系列研究中，英夫利昔单抗、阿达木单抗和维得利珠单抗已证明对慢性抗生素难治性 pouchitis 有效。在此，我们报告了难治性 pouchitis 中所有生物治疗的单中心数据。
我们回顾性评估了所有接受英夫利昔单抗、阿达木单抗或维得利珠单抗治疗 pouchitis 的溃疡性结肠炎和回肠袋-肛门吻合术患者的记录。临床相关缓解定义为改良 pouchitis 疾病活动指数 <5 且与基线相比改良 pouchitis 疾病活动指数降低 ≥2 分，在第 14 周进行评估。
确定了 33 名独特的患者。在结肠切除术之前，患者曾暴露于环孢素（n=14）、英夫利昔单抗（n=12）、阿达木单抗（n=3）和/或维得利珠单抗（n=3）。所有人均发展为慢性抗生素难治性 pouchitis，接受了英夫利昔单抗（n=23）、阿达木单抗（n=13）或维得利珠单抗（n=15）治疗。英夫利昔单抗组中有 43.5%的患者出现临床相关缓解，阿达木单抗组和维得利珠单抗组分别为 38.5%和 60.0%。在长期随访中，继续接受维得利珠单抗治疗的患者明显多于抗肿瘤坏死因子（anti-TNF）治疗（风险比 3.0，p=0.04）。抗 TNF 治疗中断的主要原因是不良事件（主要是输注反应）（40.7%），而维得利珠单抗的停药仅与疗效不足有关。有 4 名患者最终需要永久性回肠造口术。
在本慢性抗生素难治性 pouchitis 病例系列研究中，生物治疗对大多数患者有效，只有少数患者最终需要永久性回肠造口术。抗 TNF 药物的使用受到不良事件发生率高的阻碍，部分原因与免疫原性有关，因为一些患者在结肠切除术之前曾接受过抗 TNF 治疗。维得利珠单抗也是有效的，可能为这些慢性抗生素难治性 pouchitis 患者提供一种安全的替代方案。
