Retrospective analysis of ustekinumab in Crohn's disease between biologic-naïve and biologic-experienced

This thesis investigates the differences in clinical efficacy of ustekinumab (UST) as a biologic-naïve or biologic-experienced for Crohn's Disease (CD) patients in terms of clinical manifestations and laboratory test indicators. It also explores the correlation between clinical response status and patients' quality of life, as well as their anxiety and depression levels.

This study involved 61 CD patients treated with UST. We gathered clinical data, laboratory results, CDAI scores and SES-CD scores at 0, 8, and 32 week, and assessed quality of life and psychological state at baseline and week 32. Initially, patients were divided into biologic-naïve and biologic-experienced groups based on their previous biologic history. By analyzing the changes in laboratory indicators at weeks 0, 8, and 32, as well as the differences in the degree of these changes, the effectiveness of different treatment regimens was evaluated. At the end of the treatment (week 32), 61 patients were reclassified into the clinical response group and the non-response group based on the decrease in CDAI score. Subsequently, statistical methods were used to assess the differences in quality of life and psychological status between these two response groups.

There was no statistically significant difference in the baseline data between the biologic-naïve and biologic-experienced groups (P > 0.05). After treatment, the inflammatory and nutritional indicators in both groups improved. The inflammation decreased more significantly in the biologic-naïve group. At 32 week, the reduction in CDAI and SES-CD in the biologic-naïve group was better than that in the treated group (all P = 0.03), but there was no difference in clinical response and remission rate between the two groups. Regardless of whether there was clinical response, the IBDQ score of patients increased compared to the baseline. The improvement in IBDQ in the clinical response group was higher than that in the clinical non-response group (P = 0.001). Only the anxiety subscale (HADS-A) of the response group, significantly decreased (P = 0.02), while the depression score of HADS-D showed no significant improvement. There were no statistically significant differences in the anxiety subscale (HADS-A) and depression subscale (HADS-D) of the rnon-esponse group (P > 0.05).

UST can improve the inflammation and nutritional status of patients with CD who are biologic-naïve or biologic-experienced. The clinical and endoscopic improvement benefits for the biologic-naïve are more prominent. The quality of life of patients who achieved a clinical response has improved more significantly. Anxiety symptoms can be somewhat alleviated, while the depressive state has not shown any significant change.