Probert Christopher Sj, Sebastian Shaji, Gaya Daniel R, Hamlin P John, Gillespie Gillian, Rose Anita, Tate Helen, Wheeler Colin, Irving Peter M
Department of Cellular and Molecular Physiology, University of Liverpool, Liverpool, UK.
IBD Unit, Hull and East Yorkshire Hospitals NHS Trust Hull, Hull, Kingston upon Hull, UK.
BMJ Open Gastroenterol. 2018 Jul 7;5(1):e000212. doi: 10.1136/bmjgast-2018-000212. eCollection 2018.
GO-COLITIS aimed to measure the effectiveness of subcutaneous golimumab in tumour necrosis factor-α antagonist-naive patients with moderate to severe ulcerative colitis (UC) despite conventional treatment.
GO-COLITIS was an open label, single arm, phase 4 study with a pragmatic design which reflected UK clinical practice. Adult patients were eligible if diagnosed with UC ≥3 months, partial Mayo score (PMS) 4-9. Patients received subcutaneous golimumab induction (200 mg initially and 100 mg at week 2) followed at week 6 by 50 mg or 100 mg (depending on weight) every 4 weeks until week 54 with a 12-week follow-up. Efficacy was measured by PMS at baseline, week 6, 30, 54 and 66. Health-related quality of life (HRQoL; Inflammatory Bowel Disease Questionnaire (IBDQ) and EuroQol Group 5 Dimensions Health Questionnaire (EQ-5D)) was assessed at baseline, week 6 and week 54. All safety adverse events (AEs) were recorded.
207 patients were enrolled and 205 received golimumab (full analysis set (FAS)205). At week 6, 68.8% (95% CI 62.0% to 75.1%) and 38.5% (95% CI 31.8% to 45.6%) of patients were in response and remission, respectively, using PMS. At the end of the induction phase, 140/141 patients in clinical response continued into the maintenance phase (Maintenance FAS). Sustained clinical response through week 54 was achieved in 51/205 (24.9%) of the FAS205 population and 51/140 (36.4%) of the Maintenance FAS population. Statistically significant improvements from baseline to week 6 were observed for the IBDQ total score and for each IBDQ domain score (bowel symptoms, emotional function, systemic symptoms and social function), as well as the EQ-5D index score and associated visual analogue scale score (p<0.0001). Improvement of HRQoL was sustained through week 54. Serious AEs leading to treatment discontinuation occurred in 8.8% of patients.
In this study measuring patient-reported outcomes in patients with moderate to severe UC, golimumab induced and maintained response as measured by PMS and significantly improved quality of life measures.
NCT02092285; 2013-004583-56.
GO-COLITIS旨在评估皮下注射戈利木单抗对尽管接受了传统治疗但仍患有中度至重度溃疡性结肠炎（UC）且未使用过肿瘤坏死因子-α拮抗剂的患者的有效性。
GO-COLITIS是一项开放标签、单臂、4期研究，采用反映英国临床实践的实用设计。成年患者若被诊断为UC≥3个月、部分梅奥评分（PMS）为4 - 9则符合入选条件。患者接受皮下注射戈利木单抗诱导治疗（初始剂量200mg，第2周100mg），在第6周后根据体重每4周注射50mg或100mg，直至第54周，并进行12周的随访。通过基线、第6周、30周、54周和66周时的PMS来衡量疗效。在基线、第6周和第54周评估健康相关生活质量（HRQoL；炎症性肠病问卷（IBDQ）和欧洲五维健康问卷（EQ-5D））。记录所有安全不良事件（AE）。
共纳入207例患者，205例接受了戈利木单抗治疗（全分析集（FAS）205例）。使用PMS评估，在第6周时，分别有68.8%（95%CI 62.0%至75.1%）和38.5%（95%CI 31.8%至45.6%）的患者有反应和缓解。在诱导期结束时，140/141例有临床反应的患者进入维持期（维持FAS）。在FAS205人群中，51/205（24.9%）和在维持FAS人群中51/140（36.4%）的患者在第54周时实现了持续的临床反应。从基线到第6周，IBDQ总分、每个IBDQ领域得分（肠道症状、情绪功能、全身症状和社会功能）以及EQ-5D指数得分和相关视觉模拟量表得分均有统计学意义的改善（p<0.0001）。HRQoL的改善持续到第54周。导致治疗中断的严重AE发生在8.8%的患者中。
在这项针对中度至重度UC患者测量患者报告结局的研究中，戈利木单抗通过PMS诱导并维持了反应，并显著改善了生活质量指标。
NCT02092285；2013 - 004583 - 56。
