Characterizing unmet medical need and the potential role of new biologic treatment options in patients with ulcerative colitis and Crohn's disease: a systematic review and clinician surveys
Characterizing unmet medical need and the potential role of new biologic treatment options in patients with ulcerative colitis and Crohn's disease: a systematic review and clinician surveys
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DOI：
10.1097/meg.0000000000000378
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发表时间：
2015-07-01
影响因子：
2.1
通讯作者：
Puelles, Jorge
中科院分区：
文献类型：
--
作者：
Gordon, Jason P.;McEwan, Phil C.;Puelles, Jorge
目的 溃疡性结肠炎 (UC) 和克罗恩病 (CD) 患者接受生物治疗的结果比较尚无定论。本研究的目的是描述 UC 或 CD 患者未满足的医疗需求的程度，并确定新疗法的潜在作用。方法对报告 UC 或 CD 患者使用现有生物疗法相关结果的研究进行了系统的文献综述，重点关注治疗失败的性质和发生率。为了补充系统评价，从英国和法国执业胃肠病学家的调查中获得了同期数据。将数据定性地合并在一个叙述框架中，以评估 UC 或 CD 患者未满足的医疗需求的程度。 结果 系统评价 (n=120) 中确定的研究存在异质性，特别是在治疗失败的定义方面；治疗失败的估计很高但不确定。根据标准化定义，临床医生（n=102）提供的治疗失败估计较高，其中二线治疗失败（主要：37%；次要：41%）高于一线治疗失败（主要：26%；次要：28%）。大多数系统评价和调查数据反映了英夫利昔单抗和阿达木单抗的结果。 结论 通过审查和临床医生调查发现，与现有生物制剂相关的高治疗失败率表明需要其他生物治疗方案来改善 UC 和 CD 患者的治疗和结果。与现有和新的生物治疗相关的结果应在头对头随机试验中根据其在临床实践中可能的用途进行研究。
ObjectivesComparative outcomes of patients with ulcerative colitis (UC) and Crohn's disease (CD) prescribed a biologic therapy are inconclusive. The aim of this research was to characterize the degree of unmet medical need in patients with UC or CD and to identify the potential role for new therapies.MethodsA systematic literature review was undertaken of studies reporting outcomes associated with the use of existing biologic therapies in patients with UC or CD, focusing on the nature and rate of treatment failure. To complement the systematic review, contemporaneous data were obtained from a survey of practising gastroenterologists in the UK and France. Data were qualitatively combined in a narrative framework to evaluate the degree of unmet medical need among patients with UC or CD.ResultsStudies identified in the systematic review (n=120) were heterogeneous, particularly with respect to the definitions of treatment failure; estimates of treatment failure were high but uncertain. On the basis of standardized definitions, estimates of treatment failure provided by clinicians (n=102) were high, and they were higher for second-line treatment failure (primary: 37%; secondary: 41%) compared with first-line treatment failure (primary: 26%; secondary: 28%). The majority of the systematic review and survey data were reflective of outcomes with infliximab and adalimumab.ConclusionHigh treatment failure rates associated with existing biologics, identified by the review and clinician surveys, indicate a need for other biologic treatment options to improve the management and outcomes for people with UC and CD. Outcomes associated with existing and new biologic treatments should be investigated in head-to-head randomized trials in the context of their likely uses in clinical practice.