Department of Internal Medicine III, Medical University of Vienna, Vienna, Austria.
Monash University and Alfred Hospital, Melbourne, VIC, Australia.
J Crohns Colitis. 2018 Aug 29;12(9):1053-1066. doi: 10.1093/ecco-jcc/jjy079.
To evaluate the safety and efficacy of 3 additional years of subcutaneous golimumab maintenance in patients with moderately to severely active ulcerative colitis.
The PURSUIT-maintenance long-term extension enrolled patients who had completed placebo or golimumab 50 mg or 100 mg treatment every 4 weeks [q4w] through Week 52 and evaluations at Week 54 [n = 666]; treatment continued through Week 212. Patients receiving placebo were discontinued after study unblinding. Efficacy endpoints, golimumab concentrations, and anti-drug antibodies were summarized as observed for golimumab-induction responders who continued golimumab therapy during the long-term extension. Observations relating to safety were summarized for all treated patients.
Overall, 63% of patients who were receiving golimumab at the beginning of the extension remained on treatment through the end of the study. Among all treated patients in the extension, rates of adverse events of special interest [e.g. tuberculosis, demyelination, and malignancy] were infrequent. Nine deaths occurred during the extension [1 placebo, 1 golimumab 50 mg, and 7 golimumab 100 mg]. Serum golimumab concentrations were dose-proportional and were maintained over time. During the extension through Week 228, anti-drug antibody rates with golimumab 50 mg and 100 mg were 4.4% and 3.7%, respectively. Among golimumab-induction responders, 99.3% had no disease or mild disease activity as per the Physician's Global Assessment, 92.5% were corticosteroid-free, and 76.1% had an Inflammatory Bowel Disease Questionnaire score of ≥170 at Week 216.
Subcutaneous golimumab treatment of moderately to severely active ulcerative colitis for up to 3 additional years during the extension maintained clinical benefit with no new safety signals observed.ClinicalTrials.gov number NCT00488631.
评估在中重度活动溃疡性结肠炎患者中额外 3 年皮下注射戈利木单抗维持治疗的安全性和疗效。
PURSUIT-maintenance 长期扩展研究纳入了完成安慰剂或戈利木单抗 50mg 或 100mg 每 4 周 1 次（q4w）治疗至第 52 周及第 54 周评估（n=666）的患者；治疗持续至第 212 周。研究揭盲后，安慰剂组患者停止治疗。总结在长期扩展研究中继续接受戈利木单抗治疗的戈利木单抗诱导应答者的疗效终点、戈利木单抗浓度和抗药物抗体。总结所有治疗患者的安全性观察结果。
总体而言，扩展研究开始时正在接受戈利木单抗治疗的患者中，有 63%的患者在研究结束时仍在接受治疗。在扩展研究的所有治疗患者中，特殊关注的不良事件[如结核病、脱髓鞘和恶性肿瘤]发生率较低。扩展研究期间共发生 9 例死亡[1 例安慰剂，1 例戈利木单抗 50mg，7 例戈利木单抗 100mg]。血清戈利木单抗浓度与剂量呈比例，且随时间保持稳定。在扩展研究至第 228 周时，戈利木单抗 50mg 和 100mg 的抗药物抗体发生率分别为 4.4%和 3.7%。在戈利木单抗诱导应答者中，99.3%的患者根据医生总体评估无疾病或轻度疾病活动，92.5%的患者无皮质类固醇治疗，76.1%的患者在第 216 周时炎症性肠病问卷评分≥170。
在扩展研究期间，中重度活动溃疡性结肠炎患者接受皮下戈利木单抗治疗长达 3 年以上，持续获得临床获益，未观察到新的安全性信号。临床试验注册号：NCT00488631。
