Efficacy and Safety of Guselkumab in Patients With Moderate-to-Severe Ulcerative Colitis:A Real-World Prospective Cohort Study.
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.
• 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) ≥ 2.
• 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.