以特拉西莫德作为性结肠炎的诱导和维持疗法 (ELEVATE):两个随机,双盲,安慰剂控制的第三期研究
William J Sandborn1, Séverine Vermeire2, Laurent Peyrin-Biroulet3
1Division of Gastroenterology, University of California San Diego, La Jolla, CA, USA.
Lancet (London, England)
|March 5, 2023
概括
在第3期试验中,埃特拉西莫德在性结肠炎患者的临床缓解方面表现出显著的疗效. 这种素1-酸盐受体调节器为中度至重度疾病提供了有前途的新疗法.
科学领域:
- 免疫学
- 胃肠病学
- 药理学
背景情况:
- 埃特拉西莫德是一种针对S1P亚型1,4和5的口服sphingosine 1- phosphate (S1P) 受体调节剂.
- 它正在用于免疫媒介疾病,包括性结肠炎 (UC).
研究的目的:
- 评估埃特拉西莫德在中度至重度活跃性结肠炎的成年患者的安全性和有效性.
- 评估埃特拉西莫德作为诱导和维持治疗的有效性.
主要方法:
- 进行了两个独立的,随机的,双盲的,安慰剂对照的第3期试验 (ELEVATE UC 52和ELEVATE UC 12).
- 患有中度至重度UC的成年人每天接受口服乙胺 (2 mg) 或安慰剂.
- 主要终点包括12周和52周的临床缓解率.
主要成果:
- 在这两项试验中,与安慰剂相比,在12周内,埃特拉西莫德显著增加了临床缓解率 (ELEVATE UC 52: 27% vs 7%;ELEVATE UC 12: 25% vs 15%).
- 在ELEVATE UC 52中,在52周后观察到持续缓解 (32%对比7%).
- 埃特拉西莫德组的不良事件发生率较高,但没有报告死亡或恶性瘤.
结论:
- 埃特拉西莫德是适度至重度性结肠炎的诱导和维持疗法,有效且耐受良好.
- 它提供了一种新的治疗方案, 解决了UC管理中的未满足需求.
相关概念视频
Drugs for Treatment of Ulcerative Colitis in IBD
207
Ulcerative colitis is a chronic inflammatory condition primarily affecting the colon and rectum. The primary drugs used in the treatment of ulcerative colitis are aminosalicylates. They exhibit anti-inflammatory and immunosuppressive properties. They modulate inflammatory mediators and inhibit the activity of nuclear factor κB (NF-κB). Aminosalicylates also reduce inflammation by inhibiting prostaglandin and leukotriene production and decreasing neutrophil chemotaxis and superoxide...
207
Drugs for Treatment of Crohn's Disease in IBD Using Immunomodulatory Agents
225
Crohn's disease is an inflammatory bowel disorder marked by chronic inflammation of the GI tract. Various treatment strategies for Crohn's disease are employed, such as immunomodulatory agents, glucocorticoids, and biologics or anti-TNF therapy. Azathioprine (Imuran), a commonly used immunomodulatory drug for Crohn's disease, is converted in the body to mercaptopurine, which inhibits purine biosynthesis and cell proliferation. Both are utilized in severe cases of Inflammatory Bowel...
225
Drugs for Treatment of Diarrhea-Predominant IBS
252
Diarrhea-predominant irritable bowel syndrome (IBS-D) is a subtype of IBS characterized primarily by frequent, loose, or watery stools, abdominal pain, and abdominal discomfort. Therapeutic approaches to managing IBS-D include dietary changes, stress management techniques, and pharmaceutical interventions.
Two specific drugs used in the treatment are alosetron (Lotronex) and eluxadoline (Viberzi). Alosetron, a 5-HT3 antagonist, works by slowing the movement of stools in the gut, reducing bowel...
Two specific drugs used in the treatment are alosetron (Lotronex) and eluxadoline (Viberzi). Alosetron, a 5-HT3 antagonist, works by slowing the movement of stools in the gut, reducing bowel...
252
Drugs for Treatment of Crohn's Disease in IBD Using Glucocorticoids
180
Glucocorticoids, a class of anti-inflammatory drugs, are pivotal in treating moderate to severe Crohn's disease by inducing remission. They exhibit their anti-inflammatory action by inhibiting the production of inflammatory cytokines such as tumor necrosis factor (TNF)-α, interleukin (IL)-1, and chemokines like IL-8. In addition, they reduce the expression of inflammatory cell adhesion molecules and inhibit gene transcription of nitric oxide synthase, phospholipase A2, cyclooxygenase-2...
180
Inflammatory Bowel Disease IV: Pharmacological Management
167
Upon diagnosis, managing Inflammatory Bowel Disease (IBD) involves addressing several crucial aspects. The primary goals include resting the bowel, correcting malnutrition, and providing symptomatic relief. Resting the bowel may consist of medications to reduce inflammation and promote healing. Correcting malnutrition is essential, often requiring dietary adjustments and nutritional supplements. Symptomatic relief aims to ease pain, diarrhea, and other discomforts in IBD.
Pharmacologic...
Pharmacologic...
167
Drugs for Treatment of Constipation-Predominant IBS
266
Pharmacological therapies for IBS-C are designed to alleviate abdominal discomfort and enhance bowel function. In patients with IBS-C, fiber supplements may help soften stools and decrease straining, but may also lead to increased gas production and bloating. Osmotic laxatives like milk of magnesia are frequently used to soften stools and increase stool frequency in IBS-C patients. In addition, two drugs approved for use in severe IBS-C adult cases are linaclotide (Linzess) and lubiprostone...
266


