美国食品和药物管理局批准注射古塞尔库马布治疗性结肠炎,可自行使用,并提供快速,持续的缓解. FDA approves injectable guselkumab for ulcerative colitis, offering self-administration and rapid, sustained relief.

在2025年,性结肠炎治疗取得重大进展,FDA批准了皮下Guselkumab (Tremfya) 用于中度至重度UC的成人,使其成为第一个提供皮下和静脉注射的IL-23抑制剂,用于UC和克罗恩病. In 2025, ulcerative colitis treatment saw major advances with the FDA approval of subcutaneous guselkumab (Tremfya) for induction in adults with moderately to severe UC, making it the first IL-23 inhibitor offering both subcutaneous and intravenous options for UC and Crohn’s disease. 根据ASTRO试验,在0周、4周和8周的4 000毫克的亚皮质疗法显示,在排泄、内皮科反应和症状缓解方面有重大改进,第2周可看到效益,持续到第24周。 Based on the ASTRO trial, the subcutaneous regimen—400 mg at weeks 0, 4, and 8—showed significant improvements in remission, endoscopic response, and symptom relief, with benefits seen by week 2 and sustained through week 24. 该选项使自我管理成为可能,减少了诊所的就诊次数。 The option enables self-administration, reducing clinic visits. 欧洲药品署的CHMP建议采取类似的次皮诱导措施,支持更广泛的准入。 The European Medicines Agency’s CHMP recommended a similar subcutaneous induction, supporting broader access. 这些发展反映了向更方便、目标更明确和有效的疗法的转变,包括生物类、新生物学和基于微生物的治疗,改善了需求未得到满足的病人的疗效。 These developments reflect a shift toward more convenient, targeted, and effective therapies, including biosimilars, novel biologics, and microbiome-based treatments, improving outcomes for patients with unmet needs.