Department of Biomedical Sciences, Humanitas Clinical and Research Center, IRCCS, Humanitas University, Milan, Italy.
Gastroeneterology and Hepatology Unit, Canberra Hospital, Canberra, ACT, Australia.
Aliment Pharmacol Ther. 2021 Jan;53(2):265-272. doi: 10.1111/apt.16160. Epub 2020 Nov 18.
Vedolizumab was shown to be effective and safe for patients with ulcerative colitis (UC) or Crohn's disease (CD) in the GEMINI phase 3 and long-term safety (LTS) studies.
To report treatment persistence and safety results up to 2 years after enrolment in the vedolizumab extended access programme (XAP) METHODS: Vedolizumab XAP is a phase 3b/4, prospective, open-label, multinational, interventional study. At rollover from GEMINI LTS, patients who were experiencing continued clinical benefit with vedolizumab received reduced dosing frequency from every 4 weeks (Q4W) to every 8 weeks (Q8W). Patient persistence on Q8W dosing, incidence of relapse, and safety 2 years after enrolment were investigated.
We enrolled 311 patients (142 UC and 169 CD). At baseline, 93.7% (UC) and 89.3% (CD) of patients were in clinical remission; 93.0% (UC) and 84.6% (CD) reduced dosing frequency to Q8W at enrolment. Of those who reduced dosing frequency to Q8W at enrolment, 93.9% (UC) and 91.6% (CD) remained on Q8W dosing; 6.1% (UC) and 8.4% (CD) re-escalated to Q4W dosing. Relapse was reported in 9.1% (UC) and 14.0% (CD) of patients who reduced dosing to Q8W. Adverse events related to vedolizumab were infrequent; no new events were reported.
We observed high patient persistence on vedolizumab Q8W in the first 2 years after the reduction of dosing frequency in the XAP along with low rates of Q4W dose re-escalation and relapse. The safety profile was consistent with previous reports. ClinicalTrials.gov: NCT02743806.
在 GEMINI 三期和长期安全性（LTS）研究中，维得利珠单抗已被证明对溃疡性结肠炎（UC）或克罗恩病（CD）患者有效且安全。
报告在参加维得利珠单抗扩展准入计划（XAP）后 2 年内的治疗持续性和安全性结果。
维得利珠单抗 XAP 是一项三期 b/四期、前瞻性、开放标签、多国、干预性研究。在从 GEMINI LTS 翻班时，继续从维得利珠单抗中获益的患者将剂量频率从每 4 周（Q4W）减少至每 8 周（Q8W）。研究了 2 年后患者 Q8W 给药的持久性、复发率和安全性。
我们纳入了 311 名患者（UC 142 例，CD 169 例）。基线时，93.7%（UC）和 89.3%（CD）的患者处于临床缓解状态；93.0%（UC）和 84.6%（CD）在入组时减少了剂量频率至 Q8W。在入组时减少至 Q8W 剂量频率的患者中，93.9%（UC）和 91.6%（CD）继续接受 Q8W 剂量；6.1%（UC）和 8.4%（CD）重新增加至 Q4W 剂量。减少剂量至 Q8W 的患者中，9.1%（UC）和 14.0%（CD）报告复发。与维得利珠单抗相关的不良事件并不常见；未报告新的事件。
在 XAP 减少剂量频率后的前 2 年内，我们观察到患者对 Q8W 维得利珠单抗的高持久性，同时 Q4W 剂量重新增加和复发的发生率较低。安全性概况与先前的报告一致。临床试验.gov：NCT02743806。
