Efficacy and Safety of Guselkumab in Patients With Moderate-to-Severe Ulcerative Colitis
Efficacy and Safety of Guselkumab in Patients With Moderate-to-Severe Ulcerative Colitis:A Real-World Prospective Cohort Study.
Second Affiliated Hospital of Wenzhou Medical University
97 participants
Jul 31, 2026
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Plain Language Summary
Simplified for easier understanding
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Interventions
All the patients receive GUS (IV) 200 mg induction therapy at weeks 0, 4, and 8, and who met the criteria for clinical symptom remission, biochemical remission, and improvement in intestinal ultrasound based on the clinical assessment at week 12, proceeded to receive GUS (SC) 100 mg every 8 weeks as maintenance therapy. Patients who did not meet the above criteria received GUS (SC) 200 mg every 4 weeks as maintenance therapy. At week 24, based on clinical and endoscopic evaluations, patients who achieved endoscopic remission were switched to GUS (SC) 100 mg every 8 weeks for maintenance, while those who did not achieve endoscopic remission continued to receive GUS (SC) 200 mg every 4 weeks for maintenance treatment.
Locations(1)
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NCT07726888