2nd Department of internal Medicine, University General Hospital of Alexandroupoli, Alexandroupoli, W. Thrace.
Department of Gastroenterology, Medical School and University Hospital of Ioannina, Ioannina, Epirus.
Eur J Gastroenterol Hepatol. 2021 Dec 1;33(1S Suppl 1):e615-e624. doi: 10.1097/MEG.0000000000002182.
This real-world study assessed the impact of golimumab on health-related quality of life (HRQoL) and other patient-reported outcomes (PROs) in patients with ulcerative colitis over 12 months in Greece.
GO-LIFE was a noninterventional, prospective, multicenter, 12-month study. Patients who had moderately-to-severely active ulcerative colitis were naïve to antitumor necrosis factor (anti-TNFα) therapy and had failed previous conventional therapy. Patients received golimumab as per label. The primary endpoint was patients achieving inflammatory bowel disease questionnaire 32-item (IBDQ-32) remission at 12 months. Secondary endpoints, at 6 and 12 months, included patients achieving IBDQ-32 response; the mean change in the treatment satisfaction questionnaire for medication (TSQM) and the work productivity and activity impairment in ulcerative colitis (WPAI:UC) questionnaires; changes in healthcare utilization; patients achieving clinical response and remission; adherence rates and the percentage of patients who discontinued golimumab.
IBDQ-32 remission was achieved by 76.9% of patients at 12 months. Mean changes in all TSQM and WPAI:UC domain scores at 12 months were statistically significant. Clinical remission was achieved by 49.4 and 50.6% of patients at 6 and 12 months, and clinical response by 59.3 and 56.8%, respectively. All patients but one (80/81) had high adherence (≥80%) to golimumab treatment over 12 months. Ulcerative colitis-related health care resource utilization was reduced during the follow-up period.
In real-world settings, treatment with golimumab resulted in meaningful improvements in HRQoL and other PROs, and in disease activity at 6 and 12 months in patients with moderately-to-severely active ulcerative colitis who were naïve to anti-TNFa therapy.
这项真实世界研究评估了戈利木单抗对希腊中重度活动性溃疡性结肠炎患者 12 个月的健康相关生活质量（HRQoL）和其他患者报告结局（PROs）的影响。
GO-LIFE 是一项非干预性、前瞻性、多中心、12 个月的研究。患者既往未接受过抗肿瘤坏死因子（anti-TNFα）治疗，且对之前的常规治疗失败，患有中重度活动性溃疡性结肠炎。患者按说明书接受戈利木单抗治疗。主要终点是患者在 12 个月时达到炎症性肠病问卷 32 项（IBDQ-32）缓解。次要终点包括患者在 6 个月和 12 个月时达到 IBDQ-32 应答；治疗满意度问卷（TSQM）和工作生产力和活动障碍在溃疡性结肠炎（WPAI：UC）问卷中的平均变化；医疗保健利用的变化；达到临床应答和缓解的患者；依从率和停止使用戈利木单抗的患者比例。
12 个月时，76.9%的患者达到 IBDQ-32 缓解。12 个月时所有 TSQM 和 WPAI：UC 域评分的平均变化均具有统计学意义。6 个月和 12 个月时，分别有 49.4%和 50.6%的患者达到临床缓解，分别有 59.3%和 56.8%的患者达到临床应答。所有患者（81 例中有 80 例）在 12 个月内对戈利木单抗治疗的依从性均较高（≥80%）。在随访期间，溃疡性结肠炎相关医疗资源的利用减少。
在真实环境中，戈利木单抗治疗可显著改善中重度活动性溃疡性结肠炎患者的 HRQoL 和其他 PROs，并在抗 TNFa 治疗初治患者中改善疾病活动度，6 个月和 12 个月时。
