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溃疡性结肠炎患者使用戈利木单抗 4 年的真实临床经验。

Real-life experience with 4 years of golimumab persistence in ulcerative colitis patients.

机构信息

Department of Gastroenterology, Hospital Universitario y Politécnico La Fe, Avinguda de Fernando Abril Martorell, 106, 46026, Valencia, Spain.

Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas (CIBERehd), Madrid, Spain.

出版信息

Sci Rep. 2020 Oct 20;10(1):17774. doi: 10.1038/s41598-020-73577-0.

Abstract

Golimumab has demonstrated its long-term efficacy and safety in ulcerative colitis in clinical trials, but no data of long-term persistence has been published from real world. To estimate long-term persistence of golimumab, as well as factors associated with longer persistence, in patients with ulcerative colitis in real life. Observational multicentre study including adult patients with ulcerative colitis treated with golimumab and with at least twelve months of follow-up. We included 190 patients, 105 (55.26%) naive to anti-TNF, with mean disease duration of 9.32 ± 8.09 years. Probability of persistence was 63%, 46%, 39% and 27% at 1, 2, 3 and 4 years, respectively. Persistence was lower in patients with primary failure to previous anti-TNF. Eighty-two (43.16%) patients needed dose intensification during follow-up, with a mean time until intensification of 8.03 ± 8.64 months. Dose intensification and lower disease duration predicted higher persistence with golimumab (p = 0.037 and p = 0.008, respectively). During a follow-up of 17.25 ± 15.83 months, 32 (16.5%) patients needed hospitalisation and 11 (6%) underwent colectomy. No unexpected adverse events were reported. Golimumab has demonstrated good persistence and safety profile for long treatment in ulcerative colitis patients.

摘要

戈利木单抗在溃疡性结肠炎的临床试验中已显示出其长期疗效和安全性,但尚未从真实世界中发布其长期持续存在的数据。为了评估溃疡性结肠炎患者在真实生活中使用戈利木单抗的长期持续存在情况,以及与更长持续时间相关的因素。这是一项观察性多中心研究,纳入了接受戈利木单抗治疗且随访时间至少 12 个月的成年溃疡性结肠炎患者。我们纳入了 190 名患者,其中 105 名(55.26%)患者之前未接受过抗 TNF 治疗,平均疾病持续时间为 9.32±8.09 年。1、2、3 和 4 年的持续率分别为 63%、46%、39%和 27%。在先前抗 TNF 治疗原发性失败的患者中,持续率较低。在随访期间,82 名(43.16%)患者需要进行剂量强化,剂量强化的平均时间为 8.03±8.64 个月。剂量强化和较短的疾病持续时间预测了戈利木单抗的更高持续率(p=0.037 和 p=0.008)。在 17.25±15.83 个月的随访期间,32 名(16.5%)患者需要住院治疗,11 名(6%)患者接受了结肠切除术。未报告任何意外的不良事件。在溃疡性结肠炎患者中,戈利木单抗显示出良好的持久性和安全性,可长期治疗。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/bd8d/7576126/01f20541dae9/41598_2020_73577_Fig1_HTML.jpg

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