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戈利木单抗改善中重度溃疡性结肠炎患者的健康相关生活质量:go-care 研究结果。

Golimumab improves health-related quality of life of patients with moderate-to-severe ulcerative colitis: Results of the go-care study.

机构信息

Gastroenterology Unit, Rho Hospital, ASST Rhodense, Milan, Italy.

IBD Unit, Gastroenterology IBD Unit, Rho Hospital, ASST Rhodense, Milan, Italy.

出版信息

Dig Liver Dis. 2024 Jan;56(1):83-91. doi: 10.1016/j.dld.2023.07.031. Epub 2023 Aug 12.

Abstract

BACKGROUND

In recent years, improvement of Health-Related Quality of Life (HRQoL) in Ulcerative colitis (UC) has become a relevant measure for treatment efficacy.

METHODS

We report results from a multicenter prospective study in Italy investigating HRQoL in adult patients with UC treated with golimumab (GLM). Patients who had shown clinical response after a 6-week induction phase (w0), were followed for an additional 48 weeks (w48) (total 54-week treatment).

RESULTS

Of the 159 patients enrolled 90 completed the study. Compared to values at the beginning of treatment (n = 137), significant improvements were observed for mean total Inflammatory Bowel Disease Questionnaire (IBDQ) scores at w0 (168.5) and w48 (181.7). Patients with baseline PMS above the median tended to have greater improvements in IBDQ at w0 (OR 2.037, p = 0.033) and w48 (OR 3.292, p = 0.027). Compared to beginning of GLM treatment, the mean Full Mayo Score (FMS) decreased by 5.9 points at w48, while mean Partial Mayo Score (PMS) decreased by 3.9 points at w0 and by 4.9 points at w48.

CONCLUSIONS

GLM improved HRQoL, disease activity and inflammatory biomarkers in UC patients with moderate-to-severely active disease. The greater the burden of disease activity at baseline, the greater the improvement of HRQoL after 24 and 48 weeks of treatment.

摘要

背景

近年来,溃疡性结肠炎(UC)患者健康相关生活质量(HRQoL)的改善已成为评估治疗效果的重要指标。

方法

我们报告了一项意大利多中心前瞻性研究的结果,该研究调查了接受戈利木单抗(GLM)治疗的成年 UC 患者的 HRQoL。在 6 周诱导期(w0)后表现出临床应答的患者,在另外的 48 周(w48)(总治疗 54 周)期间接受随访。

结果

在纳入的 159 名患者中,有 90 名完成了研究。与治疗开始时的数值(n=137)相比,在 w0(168.5)和 w48(181.7)时观察到平均总炎症性肠病问卷(IBDQ)评分显著改善。基线时 PMS 值高于中位数的患者在 w0(OR 2.037,p=0.033)和 w48(OR 3.292,p=0.027)时 IBDQ 改善更为显著。与开始 GLM 治疗相比,在 w48 时平均完全 Mayo 评分(FMS)降低了 5.9 分,而在 w0 时平均部分 Mayo 评分(PMS)降低了 3.9 分,在 w48 时降低了 4.9 分。

结论

GLM 改善了中重度活动期 UC 患者的 HRQoL、疾病活动度和炎症生物标志物。基线时疾病活动度负担越大,治疗 24 和 48 周后 HRQoL 的改善越大。

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