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).
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
122
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.
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China
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) .
Time frame: 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).
Time frame: at week 36
influencing factors
At week 36, analyze the influencing factors of clinical remission rate(HBI≤ 4 points) .
Time frame: at week 36
influencing factors
At week 36, analyze the influencing factors of endoscopic remission rate(SES-CD ≤ 2 points, or no ulcers).
Time frame: at week 36
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