Entyvio safe, effective for UC in real-world study
Entyvio safely and effectively treated ulcerative colitis in a real-world cohort of patients, according to research published in the American Journal of Gastroenterology.
Parambir S. Dulai, MD, of the University of California San Diego, and colleagues analyzed retrospective data from the VICTORY consortium, allowing them to look at a larger group of patients. Previous studies have demonstrated efficacy and safety of on Entyvio (vedolizumab, Takeda Pharmaceuticals), but have been limited by the size of their study group, the investigators wrote.
“Although these cohorts help to confirm clinical trial findings, the small size makes it difficult to confidently estimate treatment effectiveness, particularly among sub-populations of interest,” they wrote. “Through the VICTORY consortium, we report on a large cohort of UC patients treated with [vedolizumab] in a real-world clinical setting.”
Dulai and colleagues included adult patients (n = 321) with follow-up after starting vedolizumab for clinically active UC. The primary effectiveness outcomes of the review were cumulative rates of clinical remission and endoscopic remission. Researchers also included secondary outcomes measures of cumulative rates of steroid-free remission and deep remission, as well as safety outcomes of serious infection, serious adverse events and colectomy in their analysis.
Overall, 71% of the patients had prior anti-TNF alpha exposure. Median follow-up was 10 months (interquartile range, 5.5-14). The 12-month cumulative rate of clinical remission was 51% and for endoscopic remission it was 41%. Also at 12 months, investigators found that 37% of patients experienced steroid-free remission, and 30% experienced deep remission.
In searching for independent predictors of treatment effectiveness, Dulai and colleagues found that previous exposure to anti-TNF was associated with a reduced chance of achieving clinical remission (HR = 0.53; 95% CI, 0.38–0.75) and endoscopic remission (HR = 0.51; 95% CI, 0.29–0.88).
Investigators found vedolizumab was well-tolerated by the patients with 6% experiencing serious adverse events and 4% experiencing serious infections. Cumulative rates for colectomy over 12 months were lower among anti-TNF naive patients (2%) compared with patients who had already been exposed (19%).
“These data will help to better guide the use of [vedolizumab], and further refine the optimal position of this biologic in current treatment algorithms,” the researchers wrote. - by Alex Young
Disclosures: Dulai reports financial ties to Takeda and Pfizer. Please see the full study for the other authors’ relevant financial disclosures.