Short-Term Effectiveness of Ustekinumab in Crohn's Disease: Results from a Real-World Retrospective Multicenter Study in China.

Background: There are few data on ustekinumab treatment for Crohn's disease (CD) in a Chinese population. Our study is a real-world retrospective multicenter study aimed at exploring the effectiveness of ustekinumab in CD patients and comparing the effectiveness of first line and second line treatments.

Methods: Laboratory indicators, CD activity index (CDAI) and simple endoscopic score for CD (SES-CD) scores of patients at the 8th, 16th and 24th weeks of treatment were collected, and the clinical remission rate, clinical response rate, endoscopic remission rate and endoscopic response rate were calculated, and the patients were divided into first line group and second line group for comparison.

Results: A total of 102 patients were treated with ustekinumab, and 56 patients with a clinical data integrity rate greater than 70% were ultimately included. The clinical remission rate of the patients gradually increased at the 8th, 16th and 24th weeks of treatment, which were 34 cases (60.7%), 37 cases (66.1%) and 49 cases (87.5%), respectively. The clinical response rates for 8th, 16th and 24th weeks were 38 (67.8%), 42 (0.75%) and 51 (91.1%), respectively, and the endoscopic remission rate was 4% (2/50) at the 24th week. The clinical response rates of the first line group were higher than those of the second line group at the 16th and 24th weeks, with statistically significant differences. The clinical response time of patients receiving first line or second line treatment with ustekinumab was different, and the first line treatment group achieved clinical response more quickly.

Conclusion: Ustekinumab is effective in the short-term treatment of CD patients in China, with first line treatment superior to second line treatment and faster than second line treatment.