Emerging drugs for the treatment of moderately to severely active ulcerative colitis: review of phase II and III clinical trials.

IF 2.7 3区医学 Q2 PHARMACOLOGY & PHARMACY

Expert Opinion on Emerging Drugs Pub Date : 2023-03-01 DOI:10.1080/14728214.2023.2186399

Laura Neurath, Ferdinando D'Amico, Silvio Danese

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引用次数: 3

Abstract

Introduction: Current therapeutic options for patients with ulcerative colitis comprise monoclonal antibodies against tumor necrosis factor (TNF), alpha4/beta7 integrin, and interleukin (IL)12/23 as well as small molecules such as tofacitinib, upadacitinib, ozanimod, and filgotinib. However, many patients fail to respond to these agents or have loss of response over time. Therefore, there is a large unmet clinical need for new therapeutic agents.

Areas covered: Here, we review recent phase 2/3 studies in active ulcerative colitis and discuss preliminary data on the efficacy (clinical, endoscopic, and histologic remission) and safety of novel drugs including Janus kinase (JAK) inhibitors, IL23 blockers, integrin inhibitors, and S1P1R modulators.

Expert opinion: We highlight the potential impact of these agents for the future therapeutic landscape of this disease with special emphasis on clinical impact, unmet needs, safety aspects, and advanced combination therapy.

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用于治疗中度至重度活动性溃疡性结肠炎的新兴药物:II期和III期临床试验回顾

目前溃疡性结肠炎患者的治疗选择包括针对肿瘤坏死因子(TNF)、α 4/ β 7整合素和白细胞介素(IL)12/23的单克隆抗体，以及小分子如托法替尼、upadacitinib、ozanimod和filgotinib。然而，随着时间的推移，许多患者对这些药物没有反应或失去反应。因此，对新的治疗药物有很大的未满足的临床需求。涵盖领域:在这里，我们回顾了最近在活动性溃疡性结肠炎的2/3期研究，并讨论了包括Janus激酶(JAK)抑制剂、il - 23阻滞剂、整合素抑制剂和S1P1R调节剂在内的新药的疗效(临床、内窥镜和组织学缓解)和安全性的初步数据。专家意见:我们强调这些药物对该疾病未来治疗前景的潜在影响，特别强调临床影响、未满足的需求、安全性方面和先进的联合治疗。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Expert Opinion on Emerging Drugs 医学-药学

CiteScore

5.90

自引率

0.00%

发文量

审稿时长

>12 weeks

期刊介绍： Expert Opinion on Emerging Drugs (ISSN 1472-8214 [print], 1744-7623 [electronic]) is a MEDLINE-indexed, peer-reviewed, international journal publishing structured reviews on Phase II and Phase III drugs/drug classes emerging onto the market across all therapy areas, providing expert opinion on their potential impact on the current management of specific diseases.