Agarwal Yashasvi, Bhatt Nehal K, Harikrishnan Samyuktha, Neelakantan Ramaswamy Sanathanan, Chand Shalvin, Bendagiri Matam Manvitha, Mohammed Lubna
Internal Medicine, Jawaharlal Nehru Medical College, Belagavi, IND.
Internal Medicine, PramukhSwami Medical College, Anand, IND.
Cureus. 2025 Jul 31;17(7):e89108. doi: 10.7759/cureus.89108. eCollection 2025 Jul.
Ulcerative colitis (UC) is a chronic, relapsing, and remitting immune-mediated condition requiring long-term therapy. Moderate to severe disease is managed using steroids, sulfasalazine, thiopurines, biologicals [anti-tumor necrosis factor, anti-integrins, and anti-interleukin (IL) 12/23], and small molecules (janus kinase inhibitors, sphingosine-1-receptor modulators). Ustekinumab (UST) is an IgG1 monoclonal antibody acting on IL 12/23 recently authorized to treat moderate to severe UC that is not responsive to other biologic medicines. There remains an unmet need in the management of UC despite the growing availability of therapeutic agents. Current treatment algorithms use a standard approach for all patients, but targeted therapies are required for better outcomes. This systematic review aims to evaluate the safety and efficacy of UST in patients with moderate to severe UC. We also noted the clinical and endoscopic improvement with maintenance of clinical and steroid-free remission across multiple databases to strengthen reproducibility. This systematic review followed the Preferred Reporting Items for Systematic Review and Meta Analysis (PRISMA) 2020 guidelines. Relevant literature was retrieved from PubMed, PubMed Central, Cochrane Library, Science Direct, and Google Scholar. Articles published in English within the last five years (2020 to 2025) were included. Quality assessment tools were applied to ensure the quality of evidence-based medicine that will be utilized to develop a conclusion and direct future review. The studies analysed showed a superiority of UST in the induction and maintenance of remission in active, difficult-to-treat UC. Our findings indicate that a reduction in Mayo score with improvement in c-reactive protein (CRP) and fecal calprotectin (fCal) can be used to assess a reduction in inflammatory burden and response to treatment. Histo-endoscopic mucosal healing also provides a long-term clinical assessment of the reduction in disease burden. All safety events that led to drug discontinuation and malignancy were similar for UST therapy and placebo. UST, as a treatment option for moderate to severe UC, can provide an alternative avenue in the development of patient-centric targeted therapies. Further research targets should include the formulation of a standard dosing regimen and the evaluation of the long-term safety profile of the drug. There is also limited literature available for comparative analysis of UST treatment with other available therapeutic options, especially biologic agents, and its effect on extra-intestinal manifestations.
溃疡性结肠炎（UC）是一种慢性、复发性、缓解性免疫介导疾病，需要长期治疗。中重度疾病的治疗使用类固醇、柳氮磺胺吡啶、硫唑嘌呤、生物制剂[抗肿瘤坏死因子、抗整合素和抗白细胞介素（IL）12/23]以及小分子药物（Janus激酶抑制剂、鞘氨醇-1-受体调节剂）。乌司奴单抗（UST）是一种作用于IL 12/23的IgG1单克隆抗体，最近被批准用于治疗对其他生物药物无反应的中重度UC。尽管治疗药物越来越多，但UC的治疗仍存在未满足的需求。目前的治疗方案对所有患者采用标准方法，但需要靶向治疗以获得更好的疗效。本系统评价旨在评估UST治疗中重度UC患者的安全性和有效性。我们还通过多个数据库记录了临床和内镜改善情况以及维持临床缓解和无类固醇缓解情况，以加强可重复性。本系统评价遵循系统评价和Meta分析的首选报告项目（PRISMA）2020指南。从PubMed、PubMed Central、Cochrane图书馆、Science Direct和谷歌学术搜索中检索相关文献。纳入过去五年（2020年至2025年）发表的英文文章。应用质量评估工具以确保用于得出结论和指导未来评价的循证医学质量。分析的研究表明，UST在诱导和维持活动性、难治性UC缓解方面具有优势。我们的研究结果表明，Mayo评分降低以及C反应蛋白（CRP）和粪便钙卫蛋白（fCal）改善可用于评估炎症负担减轻和对治疗的反应。组织内镜黏膜愈合也为疾病负担减轻提供了长期临床评估。导致停药和恶性肿瘤的所有安全事件在UST治疗组和安慰剂组中相似。UST作为中重度UC的一种治疗选择，可为以患者为中心的靶向治疗发展提供另一条途径。进一步的研究目标应包括制定标准给药方案以及评估该药物的长期安全性。关于UST治疗与其他可用治疗选择（尤其是生物制剂）的比较分析及其对肠外表现的影响的文献也有限。
