关键词: Crohn's disease IL‐23 inhibitor Mirikizumab gastrointestinal disorders inflammatory bowel disease monoclonal antibody

来  源:   DOI:10.1002/hsr2.2294   PDF(Pubmed)

Abstract:
UNASSIGNED: Crohn\'s disease (CD) is a chronic, progressive inflammatory bowel disorder characterized by persistent inflammation and noncontiguous \"skip lesions\" throughout the gastrointestinal tract. With a prevalence of 100-300 cases per 100,000 individuals, CD is most common in Western Europe and North America. Symptoms include abdominal pain, diarrhea, fever, weight loss, and anemia, with severe cases leading to complications such as perianal abscesses and cutaneous fistulas. Treatment involves pharmaceutical interventions, bowel rest, and sometimes surgery, with biological therapies like ustekinumab and mirikizumab gaining prominence.
UNASSIGNED: The VIVID-1 trial assessed mirikizumab in patients with moderately to severely active CD. By Week 12, mirikizumab significantly outperformed placebo in clinical response (45.4% vs. 19.6%, p < 0.000001). By Week 52, it showed higher clinical remission rates (54.1% vs. 19.6%) and demonstrated non-inferiority to ustekinumab in clinical remission (p = 0.51). The SEQUENCE study compared risankizumab to ustekinumab, with risankizumab showing superior reductions in inflammatory markers and higher biologic remission rates at Weeks 8, 24, and 48. Both treatments had similar safety profiles, with common adverse events including COVID-19, anemia, and headache.
UNASSIGNED: Mirikizumab, based on the VIVID-1 trial outcomes, is a promising addition to CD therapy. It demonstrated significant clinical responses and remission rates, warranting further research on its long-term efficacy and safety. Updating professional guidelines and addressing affordability will ensure broader access and improved management of CD.
摘要:
克罗恩病(CD)是一种慢性疾病,进行性炎症性肠病,其特征是持续的炎症和整个胃肠道不连续的“跳跃病变”。每10万人中有100-300例,CD在西欧和北美最常见。症状包括腹痛,腹泻,发烧,减肥,贫血,严重病例会导致肛周脓肿和皮肤瘘等并发症。治疗涉及药物干预,肠道休息,有时是手术,随着ustekinumab和mirikizumab等生物疗法的日益突出。
VIVID-1试验评估了中度至重度活动性CD患者的米利珠单抗。到第12周,mirikizumab的临床反应显着优于安慰剂(45.4%vs.19.6%,p<0.000001)。到第52周,它显示出更高的临床缓解率(54.1%vs.19.6%),并在临床缓解中证明了对ustekinumab的非劣效性(p=0.51)。SEQUENCE研究将risankizumab与ustekinumab进行了比较,在第8,24和48周时,利沙珠单抗显示出较好的炎症标志物降低和较高的生物学缓解率.两种治疗方法的安全性相似,常见的不良事件包括COVID-19,贫血,和头痛。
Mirikizumab,基于VIVID-1试验结果,是CD疗法的一个有希望的补充。它显示了显著的临床反应和缓解率,保证对其长期疗效和安全性的进一步研究。更新专业准则和解决可负担性问题将确保更广泛的访问和改进CD的管理。
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