Clinical Outcomes of Golimumab as First, Second or Third Anti-TNF Agent in Patients with Moderate-to-Severe Ulcerative Colitis
Clinical Outcomes of Golimumab as First, Second or Third Anti-TNF Agent in Patients with Moderate-to-Severe Ulcerative Colitis
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DOI：
10.1097/mib.0000000000001144
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发表时间：
2017-08-01
影响因子：
4.9
通讯作者：
Alba, Cristina
中科院分区：
文献类型：
--
作者：
Taxonera, Carlos;Rodriguez, Cristina;Alba, Cristina
背景：戈利木单抗治疗溃疡性结肠炎 (UC) 的疗效数据仅限于未接受过抗肿瘤坏死因子 a (TNF) 治疗的患者。本研究的目的是评估戈利木单抗在现实临床环境中用作 UC 中第一、第二或第三抗 TNF 药物的短期和长期疗效。 方法：这项回顾性多中心队列研究包括接受戈利木单抗治疗的中重度 UC 患者。主要疗效终点是短期部分 Mayo 评分缓解、长期戈利木单抗无失败生存期和无结肠切除生存期。 结果：在 142 名 UC 患者中，戈利木单抗作为第一（40%）、第二（23%）或第三抗 TNF（37%）给药。 92 名患者（65%，95% 置信区间 56.6-73）实现了短期临床缓解。 45 名患者（32%，95% 置信区间 23.7-39.7）获得临床缓解。戈利木单抗作为第一种抗 TNF 药物的应答率为 75%，作为第二种抗 TNF 药物的应答率为 70%（ns 与第一种抗 TNF 药物相比），作为第三种抗 TNF 药物的应答率为 50%（与第一种抗 TNF 药物相比，P = 0.007）。中位随访 12 个月后（四分位数范围 6-18），60 名患者（42%，95% 置信区间 34-51）出现戈利木单抗失败，15 名患者（11%）需要结肠切除术。 31 名患者 (22%) 需要增加戈利木单抗剂量，其中 71% 在增加剂量后恢复了反应。开始以 100 mg 戈利木单抗剂量维持治疗和短期无反应是戈利木单抗失败的独立预测因素。结论：在这个现实生活中的 UC 患者队列中，戈利木单抗治疗可有效诱导和维持临床反应。尽管未接受过抗 TNF 治疗的患者预后较好，但戈利木单抗对于接受过抗 TNF 治疗的患者也有效。只有在先前使用 2 种抗 TNF 药物失败后接受戈利木单抗治疗的患者的预后明显较差。戈利木单抗剂量递增是有益且安全的。
Background: Golimumab efficacy data in ulcerative colitis (UC) are limited to anti-tumor necrosis factor a (TNF)-naive patients. The aim of this study was to assess the short-term and long-term efficacy of golimumab used as first, second, or third anti-TNF in UC in a real-life clinical setting.Methods: This retrospective multicenter cohort study included patients with moderate-to-severe UC treated with golimumab. The primary efficacy endpoints were short-term partial Mayo score response, long-term golimumab failure-free survival, and colectomy-free survival.Results: In 142 patients with UC, golimumab was administered as first (40%), second (23%), or third anti-TNF (37%). Ninety-two patients (65%, 95% confidence interval 56.6-73) achieved short-term clinical response. Forty-five patients (32%, 95% confidence interval 23.7-39.7) achieved clinical remission. Response rates for golimumab were 75% as first anti-TNF, 70% as second anti-TNF (ns versus first anti-TNF), and 50% as third anti-TNF (P = 0.007 versus first anti-TNF). After 12 months median follow-up (interquartile range 6-18), 60 patients (42%, 95% confidence interval 34-51) had golimumab failure, and 15 patients (11%) needed colectomy. Thirty-one patients (22%) needed golimumab dose escalation, and 71% of these regained response after escalation. Starting maintenance with 100 mg golimumab doses and short-term nonresponse were independent predictors of golimumab failure.Conclusions: In this real-life cohort of patients with UC, golimumab therapy was effective for inducing and maintaining clinical response. Although anti-TNF-naive patients had better outcomes, golimumab was also effective in anti-TNF-experienced patients. Only the patients given golimumab after previous failure of 2 anti-TNF agents had significantly worse outcomes. Golimumab dose escalation was beneficial and safe.