Gastroenterology Section, Perugia General Hospital, Perugia, Italy.
Department of Medicine and Surgery, Section of Anatomic Pathology and Histology, Medical School, University of Perugia, Perugia, Italy.
Drugs Today (Barc). 2022 Jul;58(7):351-367. doi: 10.1358/dot.2022.58.7.3408818.
Treating moderate to severe ulcerative colitis (UC) has been enriched by the increasing number of drugs available for this disease. However, failure of conventional therapies, an incomplete response, or loss of response to biologics is experienced in many UC patients. Thus, there is still a growing need for new drugs in the therapeutic arsenal for UC. Ozanimod is a sphingosine-1-phosphate (S1P) receptor modulator which has been recently approved for UC therapy. In this review, we focus on the mechanism of action of ozanimod hydrochloride in preclinical studies of intestinal inflammation as well as its clinical effectiveness and safety in moderate to severe UC patients. In this population, ozanimod was shown to be significantly more effective than placebo to induce clinical remission. Additionally, in terms of clinical response, corticosteroid-free remission, endoscopic improvement and mucosal healing, ozanimod performed significantly better than placebo in this population. No significant safety concerns about ozanimod emerged from clinical trials in UC.
治疗中重度溃疡性结肠炎（UC）的药物选择日益丰富。然而，许多 UC 患者经传统治疗失败、应答不完全或对生物制剂失去应答。因此，UC 的治疗方案仍需要新药。奥扎莫德是一种鞘氨醇-1-磷酸（S1P）受体调节剂，最近已被批准用于 UC 治疗。本文重点介绍奥扎莫德盐酸盐在肠道炎症的临床前研究中的作用机制，及其在中重度 UC 患者中的临床疗效和安全性。在该人群中，奥扎莫德诱导临床缓解的疗效显著优于安慰剂。此外，在临床应答、无皮质激素缓解、内镜改善和黏膜愈合方面，奥扎莫德也显著优于安慰剂。UC 临床试验中未发现奥扎莫德的安全性问题。
