戈利木单抗治疗门诊溃疡性结肠炎的长期、真实生活、观察性研究。

Long-term, Real-life, Observational Study in Treating Outpatient Ulcerative Colitis with Golimumab.

作者信息

Tursi Antonio, Mocci Giammarco, Elisei Walter, Allegretta Leonardo, Colucci Raffaele, Della Valle Nicola, De Medici Antonio, Faggiani Roberto, Ferronato Antonio, Forti Giacomo, Larussa Tiziana, Lorenzetti Roberto, Luzza Francesco, Penna Antonio, Pranzo Giuseppe, Rodinò Stefano, Sacco Rodolfo, Sebkova Ladislava, Zampaletta Costantino, Graziosi Camilla, Picchio Marcello, Bergna Irene Maria Bambina, Maconi Giovanni

机构信息

Territorial Gastroenterology Service, ASL BAT, Andria; Department of Medical and Surgical Sciences, Post- graduate School of Digestive Diseases, Catholic University, Rome, Italy.

Division of Gastroenterology, Brotzu Hospital, Cagliari, Italy.

出版信息

J Gastrointestin Liver Dis. 2021 Dec 21;30(4):456-461. doi: 10.15403/jgld-3992.

DOI:10.15403/jgld-3992

PMID:34812437

Abstract

BACKGROUND AND AIMS

Several studies have found Golimumab (GOL) effective and safe in the short-term treatment of ulcerative colitis (UC), but few long-term data are currently available from real world. Our aim was to assess the long-term real-life efficacy and safety of GOL in managing UC outpatients in Italy.

METHODS

A retrospective multicenter study assessing consecutive UC outpatients treated with GOL for at least 3-month of follow-up was made. Primary endpoints were the induction and maintenance of remission in UC, defined as Mayo score ≤2. Several secondary endpoints, including clinical response, colectomy rate, steroid free remission and mucosal healing, were also assessed during the follow-up.

RESULTS

One hundred and seventy-eight patients were enrolled and followed up for a median (IQR) time of 9 (3-18) months (mean time follow-up: 33.1±13 months). Clinical remission was achieved in 57 (32.1%) patients: these patients continued with GOL, but only 6 patients (3.4%) were still under clinical remission with GOL at the 42nd month of follow-up. Clinical response occurred in 64 (36.4%) patients; colectomy was performed in 8 (7.8%) patients, all of them having primary failure. Steroid-free remission occurred in 23 (12.9%) patients, and mucosal healing was achieved in 29/89 (32.6%) patients. Adverse events occurred in 14 (7.9%) patients.

CONCLUSIONS

Golimumab does not seem able to maintain long-term remission in UC in real life. The safety profile was good.

摘要

背景与目的

多项研究发现戈利木单抗（GOL）在溃疡性结肠炎（UC）的短期治疗中有效且安全，但目前来自现实世界的长期数据较少。我们的目的是评估GOL在意大利UC门诊患者管理中的长期实际疗效和安全性。

方法

进行了一项回顾性多中心研究，评估连续接受GOL治疗至少3个月随访的UC门诊患者。主要终点是UC缓解的诱导和维持，定义为梅奥评分≤2。在随访期间还评估了几个次要终点，包括临床反应、结肠切除术率、无类固醇缓解和黏膜愈合。

结果

共纳入178例患者，中位（IQR）随访时间为9（3 - 18）个月（平均随访时间：33.1±13个月）。57例（32.1%）患者实现了临床缓解：这些患者继续使用GOL，但在随访的第42个月时，只有6例（3.4%）患者仍处于GOL治疗下的临床缓解状态。64例（36.4%）患者出现临床反应；8例（7.8%）患者接受了结肠切除术，所有这些患者均为原发性治疗失败。23例（12.9%）患者实现了无类固醇缓解，29/89例（32.6%）患者实现了黏膜愈合。14例（7.9%）患者发生了不良事件。