Petronio Lorenzo, Dal Buono Arianna, Gabbiadini Roberto, Migliorisi Giulia, Privitera Giuseppe, Ferraris Matteo, Loy Laura, Bezzio Cristina, Armuzzi Alessandro
IBD Center, Department of Gastroenterology, IRCCS Humanitas Research Hospital, via Manzoni 56, Rozzano, 20089 Milan, Italy.
Department of Biomedical Sciences, Humanitas University, via Rita Levi Montalcini 4, Pieve Emanuele, 20072 Milan, Italy.
Pharmaceuticals (Basel). 2025 Jan 30;18(2):190. doi: 10.3390/ph18020190.
: Inflammatory bowel diseases (IBDs), which include Crohn's disease (CD) and ulcerative colitis (UC), are chronic conditions requiring long-term therapy to maintain remission and improve quality of life. Despite the approval of numerous drugs, IBD continues to present treatment challenges. This review aims to summarize novel therapeutic target agents in phases II and III of development, including sphingosine-1-phosphate receptor modulators (S1P), anti-interleukin-23 (IL-23), and other small molecules and monoclonal antibodies currently under investigation (e.g., anti-TL1A, obefazimod, NX-13, RIPK-inhibitors). : A comprehensive literature search was conducted up to December 2024 to identify relevant articles published in English over the past three-five years, focusing on phase II/III studies for UC and CD. The search included databases such as PubMed, Google Scholar, and the ClinicalTrials.gov portal. : Clinical trials underline the potential of novel immunomodulators, including anti-TL1A, obefazimod, NX-13, RIPK inhibitors, and anti-IL-23p19 agents, as promising therapeutic options for IBD. Anti-IL23p19 therapies, such as risankizumab and mirikizumab, alongside guselkumab, exemplify this class's growing clinical relevance. While some are already in clinical use, others are nearing approval. : Ongoing research into long-term safety and the development of personalized treatment strategies remains pivotal to enhance outcomes. Patient stratification and the strategic positioning of these therapies within the expanding treatment landscape are critical for optimizing their clinical impact.
炎症性肠病(IBD)包括克罗恩病(CD)和溃疡性结肠炎(UC),是需要长期治疗以维持缓解和改善生活质量的慢性疾病。尽管有多种药物获批,但IBD的治疗仍面临挑战。本综述旨在总结处于研发II期和III期的新型治疗靶点药物,包括1-磷酸鞘氨醇受体调节剂(S1P)、抗白细胞介素-23(IL-23)以及目前正在研究的其他小分子和单克隆抗体(如抗TL1A、奥贝法莫德、NX-13、RIPK抑制剂)。截至2024年12月进行了全面的文献检索,以识别过去三到五年以英文发表的相关文章,重点关注UC和CD的II/III期研究。检索包括PubMed、谷歌学术和ClinicalTrials.gov等数据库。临床试验强调了新型免疫调节剂的潜力,包括抗TL1A、奥贝法莫德、NX-13、RIPK抑制剂和抗IL-23p19药物,作为IBD有前景的治疗选择。抗IL23p19疗法,如瑞莎珠单抗和mirikizumab,以及古塞库单抗,体现了这类药物日益增长的临床相关性。虽然有些已经在临床使用,但其他的也即将获批。对长期安全性的持续研究和个性化治疗策略的开发对于提高疗效仍然至关重要。患者分层以及这些疗法在不断扩大的治疗格局中的战略定位对于优化其临床影响至关重要。