Vedolizumab tied to favourable treatment outcomes in IBD
Use of the gut-selective anti-integrin monoclonal antibody vedolizumab was associated with favourable treatment outcomes in patients with inflammatory bowel diseases (IBD) such as ulcerative colitis and Crohn’s disease, according to studies presented at the 2018 Crohn’s & Colitis Congress (CCC).
Potential first-line induction agent
In a study comparing vedolizumab with the TNF* antagonist infliximab as first-line induction agent, 59 patients with moderate-to-severe ulcerative colitis were evaluated (n=32 and 27 received vedolizumab and infliximab, respectively). More than half of the participants showed clinical response to the therapy (78.1 percent and 66.7 percent, respectively). [CCC 2018, abstract 138]
Despite the lack of significant difference between vedolizumab and infliximab recipients in overall response rates (5.21 and 5.38/100 person-weeks [PW], respectively, incident rate ratio [IRR], 0.97, 95 percent CI, 0.53–1.77) and among TNF-naïve patients (6.74 and 6.48/100 PW, IRR, 1.04, 95 percent CI, 0.47–2.29), the response rates were higher among TNF-experienced patients who received vedolizumab vs infliximab (4.52 vs 2.29/100 PW, IRR, 1.97, 95 percent CI, 0.45–8.63).
While these findings require further validation in a larger population, vedolizumab still demonstrated its potential over infliximab, the researchers pointed out. “Our findings strengthen [the] standing [of vedolizumab] as a potential first-line agent among TNF-naïve and -experienced patients with [ulcerative colitis].”
Another comparison comprising 420 biologic-naïve patients (n=105 and 315 for vedolizumab and infliximab, respectively) reflected a trend towards prolonged time to first IBD-related hospitalization (153 vs 98 days) and flare (111 vs 93 days) with vedolizumab vs infliximab. [CCC 2018, abstract 199]
Sustained clinical response
A separate study showed sustained clinical response with vedolizumab at 24 months in patients with Crohn’s disease or ulcerative colitis. The observational study involved 64 patients (median age 42 years, 56 percent females, median disease duration 9 years) who had achieved a 6-month sustained clinical response or remission with vedolizumab. [CCC 2018, abstract 189]
At 24 months, 63 percent of participants exhibited a sustained clinical response overall, with higher response rates among patients with Crohn’s disease vs ulcerative colitis (75 percent vs 50 percent; p=0.026).
Favourable safety profile
Furthermore, a meta-analysis (n=2,912, mean disease duration 8–16 years) revealed low adverse event (AE) rates associated with vedolizumab (10 percent, 8 percent, and 7 percent for infections, serious AEs, and serious infections, respectively), as well as low infusion-related reactions (2 percent). [CCC 2018, abstract 155]
“[These findings] support the safety profile … and favourable long-term benefit-risk profile of [vedolizumab] in … clinical practice,” said the researchers.
Overall, although these studies highlight the potential benefits of vedolizumab in IBD treatment, the researchers recommend that studies be done in larger populations or with longer follow-up times to further validate the safety and efficacy of vedolizumab.