Division of Gastroenterology, Department of Internal Medicine, University of Kentucky College of Medicine, 800 Rose Street, MN649, Lexington, KY, 40536, USA.
Department of Internal Medicine, University of Kentucky College of Medicine, Lexington, KY, USA.
Dig Dis Sci. 2021 Jun;66(6):2051-2058. doi: 10.1007/s10620-020-06486-x. Epub 2020 Jul 24.
The Gemini trial failed to detect a significant difference in response rate for patients with ulcerative colitis (UC) randomized to standard (every 8 week) vedolizumab dosing vs escalated (every 4 week) dosing. Subsequent real-world data imply the Gemini trial design may have obscured a benefit of escalated dosing.
We investigated outcomes after vedolizumab dose escalation for patients with UC. We also explored potential clinical predictors of dose escalation requirement.
In this retrospective study, we included patients with UC who received vedolizumab between 1/2017-1/2019. We compared rates of clinical response (decrease in partial Mayo score by ≥ 2) and remission (partial Mayo < 2) for standard vs escalated dosing.
Among the 90 patients reviewed, 52 achieved and maintained remission on standard dosing. The average time to remission with standard dosing was 33.3 ± 6.6 weeks. After an average of 56.3 ± 7.4 weeks standard dosing, 24 patients (22 "partial responders" and 2 "non-responders") were dose-escalated. Of the 22 "partial responders" dose-escalated, 10 (45%) achieved remission, 10 (45%) achieved further improvement. Neither "non-responder" demonstrated further clinical benefit. Prior anti-tumor necrosis factor (anti-TNF) biologic exposure predicted dose escalation requirement (p = 0.008). Patients requiring dose escalation had more severe disease at baseline as measured by both full Mayo (p = 0.009) and partial Mayo scores (p = 0.01).
We show dose escalation benefited patients with UC who exhibit a "partial response" to standard dosing. Early vedolizumab dose escalation should be considered in both patients with severe disease and those with prior anti-TNF experience.
Gemini 试验未能检测到溃疡性结肠炎（UC）患者对标准（每 8 周）维多珠单抗剂量与升级（每 4 周）剂量随机分组的反应率有显著差异。随后的真实世界数据表明，Gemini 试验设计可能掩盖了升级剂量的益处。
我们调查了 UC 患者接受维多珠单抗剂量升级后的结局。我们还探讨了剂量升级需求的潜在临床预测因素。
在这项回顾性研究中，我们纳入了 2017 年 1 月至 2019 年 1 月期间接受维多珠单抗治疗的 UC 患者。我们比较了标准与升级剂量组的临床缓解率（部分 Mayo 评分下降≥2）和缓解率（部分 Mayo<2）。
在 90 例患者中，52 例患者在标准剂量组达到并维持缓解。标准剂量组缓解的平均时间为 33.3±6.6 周。在标准剂量治疗平均 56.3±7.4 周后，24 例患者（22 例“部分缓解者”和 2 例“无反应者”）进行了剂量升级。在 22 例升级的“部分缓解者”中，10 例（45%）达到缓解，10 例（45%）进一步改善。没有“无反应者”表现出进一步的临床获益。先前的抗肿瘤坏死因子（anti-TNF）生物制剂暴露预测了剂量升级的需求（p=0.008）。需要剂量升级的患者基线时疾病更严重，无论是全 Mayo（p=0.009）评分还是部分 Mayo 评分（p=0.01）。
我们发现剂量升级使对标准剂量有“部分反应”的 UC 患者受益。早期维多珠单抗剂量升级应考虑在严重疾病和有抗 TNF 经验的患者中进行。
