Abstract
Background: Vedolizumab (VDZ) and ustekinumab (UST) have become available for the treatment of Crohn's disease (CD), however, due to limited clinical experience, the optimal treatment strategy after a failure of anti-tumor necrosis factor (anti-TNF) has yet to be elucidated. In our study, we aim to evaluate the efciency and safety of VDZ and UST as second-line classes of biological therapy in a head-to-head manner in comparable populations of CD patients.
Methods: Consecutive patients with CD who have previously been treated with anti-TNF therapy were included. Patients were followed at regular intervals coincident with drug applications and clinical activity (HBI - Harvey-Bradshaw Index), inflammatory markers (C-reactive protein, fecal calprotectin) and adverse events were recorded.
The primary outcome was the proportion of patients in clinical remission in weeks 30-32 (HBI <= 4), the clinical response in terms of HBI decrease, and the withdrawal rate. Results: Forty-five patients with VDZ and 50 with UST were included.
Both groups were comparable in all the evaluated parameters with the exception of the male-to-female ratio and the proportion of patients with penetrating disease phenotype. The proportion of patients in clinical remission increased from 44.4% at baseline to 58.1% in weeks 30-32 in the VDZ group and from 55.1% to 63.2% in the UST group; however, the increase was not statistically significant.
The mean paired HBI diference between weeks 30-32 and baseline reached -1.94 +- 5.14 (p = 0.05) in the VDZ cohort and -2.94 +- 5.91 (p = 0.01) in the UST cohort. The proportion of patients in steroid-free clinical remission increased from 38.8% to 62.5% in the UST cohort (p = 0.04), and from 33.3% to 45.2% in the VDZ (p = 0.67).
Six patients on VDZ and none on UST discontinued the treatment. Conclusion: Our study demonstrated a comparable efcacy of VDZ and UST with respect to the rate of clinical remission and biomarker response; however, the steroid-sparing efect of UST was more prominent.
There is a need for prospective randomized head-to-head trials to assess the optimal position of new biological agents in the treatment of patients with CD.