Assessment on the Deep Remission Rate and Its Influencing Factors of Individualized Ustekinumab Therapy in Patients With Crohn's Disease

Second Affiliated Hospital of Wenzhou Medical University156 enrolled

Overview

In alignment with the STRIDE-II consensus, the therapeutic goal for Crohn's disease (CD) has shifted towards "deep remission," which necessitates both mucosal and transmural healing. Recognizing the limitations of relying solely on endoscopic evaluation, this study aims to comprehensively assess the week-44 deep remission status in CD patients undergoing ustekinumab (UST) therapy. By systematically investigating baseline clinical, serological, and sonographic parameters, this research seeks to identify key predictive factors for deep remission, thereby providing robust clinical evidence to guide proactive and personalized UST optimization strategies.

Study Type

OBSERVATIONAL

Enrollment

156

Conditions

Crohn's Diseases

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1: Diagnosed with moderate to severe Crohn's disease 2.UST monotherapy 3.Follow-up time ≥44 weeks Exclusion Criteria: 1. UST combined with glucocorticoids, immunosuppressants, other biological agents or small molecule drugs 2. complicated with infectious diseases (active tuberculosis, septicemia, etc.), cardiovascular and cerebrovascular diseases, hepatic and renal insufficiency, malignant tumors 3. combined with systemic lupus erythematosus, rheumatoid arthritis and other autoimmune diseases 4. pregnancy or lactation 5. Clinical data missing \> 30%

Locations (1)

Outcomes

Primary Outcomes

deep remission rate at 44 week

At week 44 of UST therapy, the clinical remission rate (HBI ≤ 4), mucosal healing rate (SES-CD ≤ 2 or absence of ulcers), and transmural healing rate (bowel wall thickness ≤ 3 mm, normalized blood flow signal, preserved bowel wall stratification, and absence of mesenteric fat hypertrophy), and deep remission rate (simultaneous achievement of clinical remission, mucosal healing, and transmural healing) were evaluated.

Time frame: at 44 week