IBD (Inflammatory Bowel Disease)
Conditions
Keywords
Ustekinumab, Individualized treatment, Clinical efficacy, Crohn's disease
Brief summary
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).
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 .
Interventions
After the first sufficient intravenous infusion of UST (6 mg/kg), the patient's response was assessed based on PRO2 at week 8, and an individualized treatment plan was developed. At week 8, the patients with incomplete response of PRO2 (a decline of PRO2 was less than 50% from baseline or still in moderate to severe active phase of PRO2) were given one or more UST intravenous re-induction (6 mg/kg) every 4 or 6 weeks.
Sponsors
Second Affiliated Hospital of Wenzhou Medical University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The endoscopic efficacy of ustekinumab treatment at week 36 | 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) . |
| The clinical efficacy of ustekinumab treatment at week 36 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| influencing factors | at week 36 | At week 36, analyze the influencing factors of clinical remission rate(HBI≤ 4 points) . |
Countries
China
Outcome results
None listed