Piecuch Dawid, Hańczyk Edyta, Kopciał Szymon, Pawelec Natalia, Mazur Weronika, Kornatowska Karolina
Faculty of Medicine, Kazimierz Pułaski University of Radom, 26-601 Radom, Poland.
Pharmacy (Basel). 2025 May 21;13(3):73. doi: 10.3390/pharmacy13030073.
Crohn's disease (CD) is a chronic inflammatory disorder of the gastrointestinal tract that leads to significant deterioration in patients' quality of life. Biologic therapy, including the use of ustekinumab (UST), is a modern approach to treating the moderate to severe form of CD, especially in patients refractory to traditional treatments. UST, which acts as an interleukin IL-12 and IL-23 antagonist, has shown high efficacy in reducing inflammation, improving quality of life, and promoting mucosal regeneration and fistula healing. However, the use of biologic therapies, such as UST, has challenges related to the timing of treatment and patient response, including the problem of immunogenicity. To determine the clinical efficacy and safety profile of UST in the treatment of CD, a review of the literature published in the PubMed database over the last 5 years was conducted. After excluding articles that did not meet the inclusion criteria, we analyzed 42 clinical studies. The review discusses the available data on the efficacy and safety of UST, as well as its comparison with other biologic therapies, such as infliximab and adalimumab. UST, although not significantly greater to adalimumab, has lower immunogenicity and higher treatment retention. The therapeutic value of UST is also confirmed by biosimilars such as ABP 65 and FYB202, which show comparable efficacy and safety profile. The analysis of predictive biomarkers, such as serum drug levels and baseline eosinophil levels, could be an important element in the future personalization of CD treatment. The review's findings point to the importance of further research to improve the tailoring of therapies to individual patients and improve long-term treatment outcomes.
克罗恩病（CD）是一种胃肠道慢性炎症性疾病，会导致患者生活质量显著下降。生物疗法，包括使用优特克单抗（UST），是治疗中度至重度CD的现代方法，尤其是对传统治疗无效的患者。UST作为白细胞介素IL - 12和IL - 23拮抗剂，在减轻炎症、改善生活质量、促进黏膜再生和瘘管愈合方面已显示出高效性。然而，使用生物疗法，如UST，存在与治疗时机和患者反应相关的挑战，包括免疫原性问题。为了确定UST治疗CD的临床疗效和安全性，我们对过去5年在PubMed数据库中发表的文献进行了综述。在排除不符合纳入标准的文章后，我们分析了42项临床研究。该综述讨论了UST疗效和安全性的现有数据，以及它与其他生物疗法，如英夫利昔单抗和阿达木单抗的比较。UST虽然在疗效上不比阿达木单抗显著更优，但具有较低的免疫原性和较高的治疗保留率。ABP 65和FYB202等生物类似药也证实了UST的治疗价值，它们显示出相当的疗效和安全性。对血清药物水平和基线嗜酸性粒细胞水平等预测生物标志物的分析，可能是未来CD治疗个体化的重要因素。该综述的结果指出了进一步研究的重要性，以改善针对个体患者的治疗方案定制并提高长期治疗效果。
