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Efficacy of Tumor Necrosis Factor Antagonist Treatment in Patients With Refractory Ulcerative Proctitis.
Clinical Gastroenterology and Hepatology ( IF 11.6 ) Pub Date : 2019-06-13 , DOI: 10.1016/j.cgh.2019.05.060
Guillaume Pineton de Chambrun 1 , Aurélien Amiot 2 , Guillaume Bouguen 3 , Stéphanie Viennot 4 , Romain Altwegg 1 , Edouard Louis 5 , Michael Collins 6 , Mathurin Fumery 7 , Florian Poullenot 8 , Laura Armengol 9 , Anthony Buisson 10 , Vered Abitbol 11 , David Laharie 8 , Philippe Seksik 12 , Stéphane Nancey 13 , Pierre Blanc 1 , Yoram Bouhnik 14 , Benjamin Pariente 15 , Laurent Peyrin-Biroulet 16 ,
Affiliation  

BACKGROUND & AIMS It is a challenge to manage patients with ulcerative proctitis (UP) refractory to standard therapy. We investigated the effectiveness of tumor necrosis factor (TNF) antagonists in a large cohort of patients with refractory UP. METHODS We conducted a nationwide retrospective cohort study of 104 consecutive patients with active UP refractory to conventional therapies, treated at 1 of 15 centers in France or 1 center in Belgium (the GETAID cohort). Patients received at least 1 injection of anti-TNF (infliximab, adalimumab, golimumab) from October 2006 through February 2017. Clinical response was defined as significant improvement in UC-related symptoms, and remission as complete disappearance of UC-related symptoms, each determined by treating physicians. We collected demographic, clinical, and treatment data. The median duration of follow-up was 24 months (interquartile range, 13-51 months). The primary outcome was clinical response of UP to anti-TNF treatment. RESULTS Overall, 80 patients (77%) had a clinical response to anti-TNF therapy and 52 patients (50%) achieved clinical remission. Extra-intestinal manifestations (odds ratio OR, 0.24; 95% CI, 0.08-0.7), ongoing treatment with topical steroids (OR, 0.14; 95% CI, 0.03-0.73), and ongoing treatment with topical 5-aminosalycilates (OR, 0.21; 95% CI, 0.07-0.62) were significantly associated with the absence of clinical remission. Sixty percent (38/63) of the patients who had endoscopic assessment during follow up had mucosal healing. Among the overall population (n = 104), the cumulative probabilities of sustained clinical remission were 87.6% ± 3.4% at 1 year and 74.7% ± 4.8% at 2 years. CONCLUSIONS In a retrospective study of 104 patients with refractory UP, anti-TNF therapy induced clinical remission in 50% and mucosal healing in 60%. About two thirds of the patients were still receiving anti-TNF therapy at 2 years.

中文翻译:

肿瘤坏死因子拮抗剂治疗难治性溃疡性直肠炎患者的疗效。

背景和目的 管理对标准治疗无效的溃疡性直肠炎 (UP) 患者是一项挑战。我们在一大群难治性 UP 患者中研究了肿瘤坏死因子 (TNF) 拮抗剂的有效性。方法 我们对 104 名在法国 15 个中心中的 1 个中心或比利时的 1 个中心(GETAID 队列)接受治疗的传统疗法难治性活动性 UP 连续患者进行了一项全国性回顾性队列研究。从 2006 年 10 月到 2017 年 2 月,患者至少接受了 1 次抗 TNF(英夫利昔单抗、阿达木单抗、戈利木单抗)注射。 临床反应定义为 UC 相关症状的显着改善,缓解定义为 UC 相关症状完全消失,每个通过治疗医生。我们收集了人口统计学、临床和治疗数据。中位随访时间为 24 个月(四分位距,13-51 个月)。主要结果是 UP 对抗 TNF 治疗的临床反应。结果 总体而言,80 名患者 (77%) 对抗 TNF 治疗有临床反应,52 名患者 (50%) 达到临床缓解。肠外表现(比值比 OR,0.24;95% CI,0.08-0.7),外用类固醇持续治疗(OR,0.14;95% CI,0.03-0.73),以及外用 5-氨基水杨酸酯持续治疗(OR, 0.21;95% CI,0.07-0.62)与临床缓解的缺失显着相关。在随访期间进行内窥镜评估的患者中有 60% (38/63) 有粘膜愈合。在总人群(n = 104)中,持续临床缓解的累积概率在 1 年时为 87.6% ± 3.4%,在 2 年时为 74.7% ± 4.8%。结论 在一项对 104 名难治性 UP 患者的回顾性研究中,抗 TNF 治疗诱导了 50% 的临床缓解和 60% 的粘膜愈合。大约三分之二的患者在 2 年时仍在接受抗 TNF 治疗。
更新日期:2020-02-20
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