Efficacy and Safety of Guselkumab in Patients With Moderate-to-Severe Ulcerative Colitis

Second Affiliated Hospital of Wenzhou Medical University97 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Ulcerative Colitis (Disorder)Guselkumab

Interventions

GuselkumabDRUG

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age ≥ 18 years. 2. Diagnosis of ulcerative colitis is established based on clinical manifestations, laboratory findings, colonoscopy, radiological imaging (CT or ultrasound), and histopathological examination. 3. 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. 4. Inadequate response or intolerance to at least one conventional therapy (5-aminosalicylates, corticosteroids, or immunosuppressants), as assessed by the investigator according to clinical practice. 5. 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. 6. 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). 7. Patients enrolled in the prospective GUS cohort are required to provide written informed consent voluntarily. Exclusion Criteria: 1. Diagnosed with other intestinal diseases, such as Crohn's disease, intestinal tuberculosis, infectious colitis, ischemic colitis or other chronic intestinal inflammatory diseases; 2. 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. 3. 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 4. 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; 5. Has had a severe allergic reaction to monoclonal antibodies; 6. During pregnancy or lactation (can be recorded as an independent cohort but not included in the primary analysis); 7. Severe absence of baseline and follow-up data makes it impossible to determine efficacy or safety. 8. Currently participating in other interventional clinical trials that may interfere with the results of this study.

Locations (1)

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, China

RECRUITING

Outcomes

Primary Outcomes

48-week endoscopic remission

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.

Time frame: 48 weeks

48-week histological remission

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.

Time frame: 48 weeks

Secondary Outcomes

12-week clinical remission

Clinical remission in UC is assessed using the partial Mayo score (pMayo) or PRO2. It's defined as either a pMayo score ≤ 2 with no individual subscore \> 1, or meeting the symptomatic remission criteria of PRO2 (indicating improvement in both stool frequency and rectal bleeding scores to the mild or normal range).

Time frame: 12 weeks

12-week biochemical remission

1. CRP normalization (≤5 mg/L) or reduction by ≥50% from baseline. 2. Fecal calprotectin (FC) reduction to \<250 μg/g or reduction by ≥50% from baseline.

Time frame: 12 weeks

12-week intestinal ultrasound response

Response to intestinal ultrasound (IUS) was defined as meeting both of the following criteria: 1) a decrease in bowel wall thickness (BWT) by ≥25% or a reduction of ≥1 mm from baseline; and 2) a reduction in blood flow signal (Limberg score) by ≥1 grade.

Central Contacts

Yi Jiang, Doctor of Medicine

CONTACT

+8613676715542 wzjiangyi@yeah.net

guolong Ma, Master of Medicine

CONTACT

15868508303 maguolong2014@163.com

Data from ClinicalTrials.gov

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