PDF(Pubmed)
Abstract：
Dose escalation is one of the treatment approaches studied and suggested in advanced therapies for Crohn\'s disease (CD) and ulcerative colitis (UC). This study aimed to identify and characterize the dosing escalation patterns of advanced therapies in CD and UC.
Two systematic literature reviews (SLRs) were conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. MEDLINE®, Embase®, and Cochrane Library were searched for articles published between January 2011 and October 2021 and limited to non-interventional studies in English language. Congress and bibliographic searches were also conducted. Articles were screened by two independent researchers. Dose escalation patterns were described and summarized considering the regional regulatory label recommendation (in North America [NA] or outside of North America [ONA]).
Among 3190 CD and 2116 UC articles identified in the Ovid searches, 100 CD and 54 UC studies were included in the SLR, with more studies conducted ONA. Most studies reported an initial maintenance dose pattern aligned with the lower starting dose per local regulatory label; however, several ONA studies (n = 13 out of 14) reported ustekinumab every 8 weeks as starting maintenance pattern in CD. In ONA studies, the median within-guideline escalation rates in CD and UC were 43% in ustekinumab (CD only), 33% and 32% for vedolizumab; 29% and 39% for adalimumab; and 14% and 10% for infliximab. Evidence regarding dose escalation patterns for tofacitinib, certolizumab pegol, and golimumab was limited. Some dose escalation patterns outside of label recommendations were observed including ustekinumab every 8 weeks to every 4 weeks and vedolizumab every 8 weeks to every 6 weeks.
Dose escalation strategies are widely documented in the literature. The reported dose escalation patterns and escalation rates vary by region and by CD and UC. Most escalation patterns reported were aligned with regulatory recommendations while some reported more diverse or aggressive dose escalation.
CRD42021289251.
Two systematic literature reviews (SLRs) were conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. MEDLINE®, Embase®, and Cochrane Library were searched for articles published between January 2011 and October 2021 and limited to non-interventional studies in English language. Congress and bibliographic searches were also conducted. Articles were screened by two independent researchers. Dose escalation patterns were described and summarized considering the regional regulatory label recommendation (in North America [NA] or outside of North America [ONA]).
Among 3190 CD and 2116 UC articles identified in the Ovid searches, 100 CD and 54 UC studies were included in the SLR, with more studies conducted ONA. Most studies reported an initial maintenance dose pattern aligned with the lower starting dose per local regulatory label; however, several ONA studies (n = 13 out of 14) reported ustekinumab every 8 weeks as starting maintenance pattern in CD. In ONA studies, the median within-guideline escalation rates in CD and UC were 43% in ustekinumab (CD only), 33% and 32% for vedolizumab; 29% and 39% for adalimumab; and 14% and 10% for infliximab. Evidence regarding dose escalation patterns for tofacitinib, certolizumab pegol, and golimumab was limited. Some dose escalation patterns outside of label recommendations were observed including ustekinumab every 8 weeks to every 4 weeks and vedolizumab every 8 weeks to every 6 weeks.
Dose escalation strategies are widely documented in the literature. The reported dose escalation patterns and escalation rates vary by region and by CD and UC. Most escalation patterns reported were aligned with regulatory recommendations while some reported more diverse or aggressive dose escalation.
CRD42021289251.
摘要：
背景：剂量递增是克罗恩病（CD）和溃疡性结肠炎（UC）的高级疗法中研究和建议的治疗方法之一。本研究旨在确定和表征CD和UC中先进疗法的剂量递增模式。
方法：根据系统评价和荟萃分析（PRISMA）指南的首选报告项目进行了两个系统文献综述（SLR）。MEDLINE®,Embase®,搜索了Cochrane图书馆在2011年1月至2021年10月之间发表的文章，并且仅限于英语非干预研究。还进行了国会和书目搜索。文章由两名独立研究人员筛选。考虑到区域监管标签建议（在北美[NA]或北美[ONA]以外），描述并总结了剂量递增模式。
结果：在Ovid搜索中确定的3190CD和2116UC文章中，100CD和54UC研究包括在SLR中，进行了更多的ONA研究。大多数研究报告了初始维持剂量模式与每个当地监管标签的较低起始剂量一致;然而，多项ONA研究(14项研究中的n=13)报道每8周一次的ustekinumab作为CD的开始维持模式.在ONA研究中，在ustekinumab（仅CD）中，CD和UC的中位指南内升高率为43%，维多珠单抗分别为33%和32%；阿达木单抗分别为29%和39%；英夫利昔单抗分别为14%和10%。关于托法替尼剂量递增模式的证据，赛托珠单抗pegol，和戈利木单抗是有限的。观察到标签建议之外的一些剂量递增模式，包括每8周至每4周的ustekinumab和每8周至每6周的维多珠单抗。
结论：剂量递增策略在文献中有广泛记载。报告的剂量递增模式和递增率因地区以及CD和UC而异。大多数报告的升级模式与监管建议一致，而一些报告的剂量升级更多样化或激进。
UNASSIGNED：CRD42021289251。
方法：根据系统评价和荟萃分析（PRISMA）指南的首选报告项目进行了两个系统文献综述（SLR）。MEDLINE®,Embase®,搜索了Cochrane图书馆在2011年1月至2021年10月之间发表的文章，并且仅限于英语非干预研究。还进行了国会和书目搜索。文章由两名独立研究人员筛选。考虑到区域监管标签建议（在北美[NA]或北美[ONA]以外），描述并总结了剂量递增模式。
结果：在Ovid搜索中确定的3190CD和2116UC文章中，100CD和54UC研究包括在SLR中，进行了更多的ONA研究。大多数研究报告了初始维持剂量模式与每个当地监管标签的较低起始剂量一致;然而，多项ONA研究(14项研究中的n=13)报道每8周一次的ustekinumab作为CD的开始维持模式.在ONA研究中，在ustekinumab（仅CD）中，CD和UC的中位指南内升高率为43%，维多珠单抗分别为33%和32%；阿达木单抗分别为29%和39%；英夫利昔单抗分别为14%和10%。关于托法替尼剂量递增模式的证据，赛托珠单抗pegol，和戈利木单抗是有限的。观察到标签建议之外的一些剂量递增模式，包括每8周至每4周的ustekinumab和每8周至每6周的维多珠单抗。
结论：剂量递增策略在文献中有广泛记载。报告的剂量递增模式和递增率因地区以及CD和UC而异。大多数报告的升级模式与监管建议一致，而一些报告的剂量升级更多样化或激进。
UNASSIGNED：CRD42021289251。
