Efficacy and Safety of Guselkumab in Patients With Moderate-to-Severe Ulcerative Colitis:A Real-World Prospective Cohort Study.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- 48-week endoscopic remission
研究概览
简要总结
In a real-world setting, this study systematically evaluates the clinical efficacy and safety of guselkumab (GUS) in the treatment of ulcerative colitis (UC), encompassing multi-dimensional outcomes including clinical remission, biochemical remission, endoscopic remission, histologic healing, and intestinal ultrasound changes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Diagnosis of ulcerative colitis is established based on clinical manifestations, laboratory findings, colonoscopy, radiological imaging (CT or ultrasound), and histopathological examination.
- •Presence of moderate-to-severe disease activity, defined as a modified Mayo score (MMS) ≥ 5 points, accompanied by a rectal bleeding subscore (RBS) ≥ 1 and a Mayo endoscopic subscore (MES) ≥
- •Inadequate response or intolerance to at least one conventional therapy (5-aminosalicylates, corticosteroids, or immunosuppressants), as assessed by the investigator according to clinical practice.
- •Based on the research cohort requirements, the GUS real-world cohort may include patients who are biologic-naive, have failed first-line therapy, or have failed multiple lines of therapy.
- •Availability of baseline data for disease activity assessment, including symptom scores (partial Mayo score or PRO2), endoscopic evaluation (MES), biochemical markers (C-reactive protein or fecal calprotectin), or imaging parameters (CT or intestinal ultrasonography).
- •Patients enrolled in the prospective GUS cohort are required to provide written informed consent voluntarily.
排除标准
- •Diagnosed with other intestinal diseases, such as Crohn's disease, intestinal tuberculosis, infectious colitis, ischemic colitis or other chronic intestinal inflammatory diseases;
- •If there is an active intestinal infection, and the fecal culture or pathogen test shows positive within 8 weeks before the study (including Clostridium difficile, cytomegalovirus, etc.), and the re-examination turns negative without any signs of persistent infection, a re-evaluation can be conducted.
- •Combined with severe infections, malignant tumors, severe liver and kidney dysfunction, or accompanied by active autoimmune diseases such as systemic lupus erythematosus, rheumatoid arthritis, sarcoidosis, and Graves' disease that may interfere with disease assessment
- •Those who have undergone total colorectal resection or stoma surgery in the past and whose disease activity cannot be evaluated, or are expected to undergo major intestinal surgery during the study period;
- •Has had a severe allergic reaction to monoclonal antibodies;
- •During pregnancy or lactation (can be recorded as an independent cohort but not included in the primary analysis);
- •Severe absence of baseline and follow-up data makes it impossible to determine efficacy or safety.
- •Currently participating in other interventional clinical trials that may interfere with the results of this study.
研究组 & 干预措施
Guselkumab treatment group
干预措施: Guselkumab (Drug)
结局指标
主要结局
48-week endoscopic remission
时间窗: 48 weeks
Assessment was performed using the Mayo endoscopic subscore: endoscopic response was defined as a decrease in the Mayo endoscopic subscore by at least 1 point from baseline or a score of ≤1; endoscopic remission was defined as a Mayo endoscopic subscore of 0. For patients who completed the 48-week treatment, endoscopic scores were evaluated, and the number/proportion of patients achieving endoscopic remission was calculated.
48-week histological remission
时间窗: 48 weeks
Investigators apply the Geboes score, and histological remission is defined as a Geboes score ≤ 2B.0. The Nancy Histological Index (NHI) is assessed concurrently, with histological remission defined as an NHI = 0 (indicating no active inflammation). Investigators performed histological scoring for patients who completed the 48-week treatment course and evaluated the number/proportion of patients achieving histological remission.
次要结局
- 12-week clinical remission(12 weeks)
- 12-week biochemical remission(12 weeks)
- 12-week intestinal ultrasound response(12 weeks)
- 24-week and 48-week intestinal ultrasound response(24 weeks; 48 weeks)
- 24-week endoscopic response and remission(24 weeks)
- 48-week drug persistence rate(48 weeks)
- Hospitalization and surgery rates at week 48(48 weeks)
- Inflammatory Bowel Disease Questionnaire (IBD-Q) scores at week 48(48 weeks)
- 24-week and 48-week Corticosteroid-free remission rate(24 weeks; 48 weeks)
- Impact of Prior Biologic Exposure on Efficacy(Efficacy comparisons were compared at all key study visits: baseline, week 12, week 24, and week 48.)
- Exploratory Study (Comparing the Efficacy of GUS and VDZ)(Efficacy comparisons were compared at all key study visits: baseline, week 12, week 24, and week 48)