The Clinical Efficacy and Influence Factors of Individualized Treatment of Ustekinumab in Crohn's Disease

A Retrospective Analysis on the Clinical Efficacy and Influence Factors of Individualized Treatment of Ustekinumab in Patients With Crohn's Disease

The loss of response rate of ustekinumab(UST) is high, and the specific mechanism has not yet been elucidated. Our study aimed to retrospectively analyze the clinical efficacy and influence factors of individualized treatment of ustekinumab (UST) in patients with Crohn's disease (CD).

Study Overview

• Status: Completed
• Conditions: IBD (Inflammatory Bowel Disease)
• Intervention / Treatment: Drug: Optimized Treatment (OPT)

Detailed Description

Interleukin (IL-12) and interleukin (IL-23) co-contain the P40 subunit, and ustekinumab (UST) is a fully humanized IgG1 monoclonal antibody that targets the P40 subunit. The conventional regimen of UST in the treatment of Crohn's disease is that after the first sufficient dose (6 mg/kg) of intravenous infusion, 90 mg UST is injected subcutaneously at the 8th week according to the patient's response, and maintenance therapy is given every 8 or 12 weeks. However, data from real-world studies suggest that the clinical efficacy of treating CD with the conventional UST regimen is less than ideal.Our study aimed to retrospectively analyze the clinical efficacy and influence factors of individualized treatment of ustekinumab in patients with Crohn's disease .

• Study Type: Observational
• Enrollment (Actual): 122

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Wenzhou, Zhejiang, China
      • The Second Affiliated Hospital of Wenzhou Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Inflammatory bowel disease (IBD) is a chronic inflammatory disease involving the digestive tract, including two clinical phenotypes: Crohn's disease (CD) and ulcerative colitis (UC).

Description

Inclusion Criteria:

1. Diagnosed with moderate to severe Crohn's disease
2. Receiving treatment with ustekinumab

Exclusion Criteria:

1. Combined with other autoimmune diseases (such as systemic lupus erythematosus, Sjogren's syndrome, etc.), malignant tumors, or severe cardiovascular and cerebrovascular diseases
2. Merge active tuberculosis or severe infection
3. Liver and kidney dysfunction
4. Pregnancy or lactation period
5. Combination therapy with hormones, immunosuppressants, small molecule drugs, or other biological agents
6. Clinical data missing ≥ 30% or lost to follow-up during the follow-up period.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The endoscopic efficacy of ustekinumab treatment at week 36	Simplified Crohn's Disease Endoscopic Score (SES-CD) was employed to evaluate the degree of intestinal inflammation of CD patients.Intestinal inflammation was assessed as mild (3-6 points) , moderate (7-15 points) , and severe (≥16 points) .	at week 36
The clinical efficacy of ustekinumab treatment at week 36	Harvey-Bradshaw Index (HBI) was applied to assess the clinical activity of CD patients.HBI is divided into mild (5-7 points), moderate (8-16 points), and severe (≥ 17 points).	at week 36

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
influencing factors	At week 36, analyze the influencing factors of clinical remission rate(HBI≤ 4 points) .	at week 36
influencing factors	At week 36, analyze the influencing factors of endoscopic remission rate(SES-CD ≤ 2 points, or no ulcers).	at week 36

Collaborators and Investigators

• Sponsor: Second Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): July 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 20, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 20, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Crohn's disease; Ustekinumab; Individualized treatment; Clinical efficacy
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Crohn Disease; Inflammatory Bowel Diseases
• Other Study ID Numbers: SAHoWMU-CR2025-01-201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No