[Analysis of influencing factors on the efficacy of vedolizumab in the treatment of ulcerative colitis patients].

Abstract

Objectives: To explore the influencing factors of the efficacy of vedolizumab (VDZ) in the treatment of ulcerative colitis (UC) patients. Methods: The clinical data of patients with active UC, who underwent VDZ treatment from November 2020 to February 2024 in the Second Affiliated Hospital of Wenzhou Medical University were retrospectively collected. Each patient received intravenous injection of VDZ (300 mg per dose) at weeks 0, 2 and 6, and then received the same dose of intravenous injection of VDZ every 8 weeks. At week 16, the patients were divided into clinical remission group (who achieved clinical remission) and clinical non-remission group. At week 34, the patients were divided into mucosal healing group (who achieved mucosal healing) and mucosal non-healing group, as well as pathological remission group (who achieved pathological remission) and pathological non-remission group. The serum cytokines levels [interleukin (IL)-4, IL-6, IL-10, and tumor necrosis factor (TNF)-α] were detected at week 0, and 16, and the magnitude of cytokine changes (the difference between week 16 and week 0) was caculated. At week 16, the clinical remission of the patients was evaluated. At week 34, the patients underwent re-examination of colonoscopy to assess intestinal inflammation and histopathological activity. Multivariate logistic regression models were used to explore the influencing factors of clinical remission, mucosal healing, and pathological remission. Results: A total of 100 patients were included, 54 males and 46 females, aged (43.5±13.7) years. At week 16, there were 68 patients in clinical remission group and 32 patients in clinical non-remission group. In clinical remission group, the reductions of IL-6 [M (Q₁, Q₃), -0.85 (-1.23, -0.46) vs -0.26 (-1.04, 0.19) ng/L, P<0.001] and IL-6+TNF-α [-0.99 (-1.46, -0.52) vs -0.30 (-0.83, 0.47) ng/L,P<0.001] were higher than those in clinical non-remission group. IL-6 reduction≥0.40 ng/L (OR=15.33, 95%CI: 4.42-53.19), disease location limited to the rectum and left sided colon (OR=0.16, 95%CI: 0.05-0.51) and baseline partial Mayo score<5 scores (OR=0.25, 95%CI: 0.07-0.84) were favorable factors of clinical remission at week 16. At week 34, a total of 87 patients underwent re-examination of colonoscopy. There were 43 patients in mucosal healing group and 44 patients in mucosal non-healing group. In mucosal healing group, the reductions of IL-6 and IL-6+TNF-α were higher than those in mucosal non-healing group, and the increase in IL-10 was also higher than that in the mucosal non healing group (all P<0.05). IL-6 reduction≥0.45 ng/L (OR=13.53, 95%CI:2.67-68.45) and baseline Mayo endoscopic score (MES)<2 scores (OR=0.08, 95%CI: 0.01-0.65) were the favorable factors of mucosal healing at week 34. At week 34, there were 23 patients in pathological remission group and 64 patients in pathological non-remission group. The reductions of IL-6 and IL-6+TNF-α, as well as the increase of IL-10 were higher than those in pathological non-remission group (all P<0.05). IL-6 reduction≥0.45 ng/L (OR=18.23, 95%CI: 2.32-143.52) was a favorable factor of pathological remission at week 34. Conclusions: IL-6 reduction≥0.40 ng/L, disease location limited to the rectum and left sided colon, as well as baseline partial Mayo score<5 scores are favorable factors of clinical remission at week 16. IL-6 reduction≥0.45 ng/L and baseline MES<2 scores are favorable factors of mucosal healing at week 34. IL-6 reduction≥0.45 ng/L is a favorable factor of pathological remission at week 34.