Vedolizumab Reports Consistent Safety Profile

Dr Stefan Schreiber

Stefan Schreiber, MD, PhD

Vedolizumab (Entyvio) has been shown to remain consistent in its safety profile, according to a recent meta-analysis of real-world data on the ulcerative colitis (UC) and Crohn disease (CD) treatment option.

The analysis of the Takeda Pharmaceuticals product also included the real-world use of immunosuppressive (IM) therapies in patients with inflammatory bowel disease (IBD) that initiated treatment with vedolizumab in the United States. Data was presented at the 25th United European Gastroenterology (UEG) Week in Barcelona, Spain.

"Real-world data furthers our understanding of the efficacy and safety signals we see in placebo-controlled registration trials, which have strict selection criteria and may not be illustrative of the patient population seen in clinical practice,” Stefan Schreiber, MD, PhD, a professor of medicine and gastroenterology at Christian Albrechts University in Kiel, Germany, said in a statement. “A meta-analysis adds stability to such real-world observations, especially when based on very large patient numbers. In this case, vedolizumab real-world data were systematically collected and analyzed with the rates of serious infections, infusion-related reactions and malignancies consistent with data previously reported in clinical trials in patients with moderate to severe UC or CD.”

The review included 33 studies involving 2857 patients with UC (n = 829) or CD (n = 1532) being treated with vedolizumab with an average follow-up ranging from 0.5 to 18 months. Rates of infections, adverse events (AE), and serious AEs and infections were analyzed and shown to be consistent with previous data on the drug’s safety profile.

The most common non-infection AEs were were acne or acne-like lesions (7%; 95% confidence interval [CI] 5-11%), fatigue (6%; 95% CI, 3-15%) and arthralgia (5%; 95% CI, 3-10%). The most common infectious AEs were upper respiratory tract infections (6%; 95% CI, 3-11%) and sinusitis (4%; 95% CI, <1-19%). Infusion-related reactions occurred in 2% (95% CI, <1-4%) of patients (n = 811), and malignancies were reported in less than 1% of patients (<1-4%; 2 studies). Overall, the total AE rate reported in patients treated with vedolizumab was 21% (95% CI, 14-32%).

The total AE rate was 10% for infections (95% CI 6-16%), 8% for serious AEs (95% CI 6-10%), and 7% for serious infections (95% CI 3-13%).

The US-based IM data was also examined, assessing 567 patients with CD (68.4%) or UC (31.6%). Of the total patient population being treated with vedolizumab, 45.4% did not have a history of IM therapy. After analysis, it was shown that 87% of the patients without IM therapy history being treated with vedolizumab were no longer on IM therapy during follow-up.

On the other hand, in the remaining 54.6% of patients (those with a history of IM therapy), 61% were no longer on IM during follow-up. Lower rates of resource utilization were shown in patients without IM therapy history.

"These data provide additional insight on the usage patterns, long-term safety profile and outcomes of Entyvio use in real-world clinical practice," Mona Khalid, the senior director and head of Evidence and Value Generation at Takeda Pharmaceuticals, said. "We look forward to the continued expansion of our body of knowledge on the safety profile of Entyvio treatment in ulcerative colitis and Crohn's disease, and are pleased to present these real-world results at the UEG Week in Barcelona."