GEMINI: Entyvio in IBD safe, effective through 5 years
Long-term use of Entyvio was shown to be safe and effective in patients with moderate-to-severe ulcerative colitis and Crohn’s disease through 5 years, according to interim results from the ongoing GEMINI open-label long-term safety study presented at the 12th Congress of the European Crohn’s and Colitis Organization.
“These latest findings underscore the consistent safety profile and effectiveness of vedolizumab [Entyvio, Takeda] as a long-term treatment option for adults with moderate to severely active ulcerative colitis and Crohn’s disease,” Séverine Vermeire, MD, of the University Hospitals Leuven, Belgium, said in a press release. “It is encouraging that the data continue to show the potential benefit of vedolizumab use for people impacted by one of these two chronic diseases.”
Overall, 154 UC patients from the GEMINI 1 study and 146 Crohn’s patients from the GEMINI II study responded to vedolizumab induction at week 6, continued with maintenance therapy every 4 or 8 weeks up to 1 year, and continued treatment with vedolizumab every 4 weeks in the GEMINI long-term safety study.
Among them, 54 UC patients and 58 Crohn’s patients stopped therapy by the cut-off for the 5-year interim analysis, and 37 UC patients and 27 Crohn’s patients had yet to reach 5 years of assessment.This interim analysis included 63 UC patients and 61 Crohn’s patients .
After 5 years of treatment with vedolizumab, 98% of the UC patients experienced clinical response and 90% were in clinical remission, while 95% of the Crohn’s patients experienced clinical response and 89% were in clinical remission.
The investigators also associated long-term vedolizumab treatment with improvements in health-related quality of life, and found that the safety profile was consistent with data from the previously reported 3-year interim analysis.
In the UC safety population, 137 patients had adverse events and 17 stopped therapy due to adverse events; 44 had serious adverse events, seven of which were drug-related, and eight patients stopped therapy due to serious adverse events.
In the Crohn’s disease safety population, 134 patients had adverse events and 15 stopped therapy due to adverse events; 41 had serious adverse events, three of which were drug-related, and eight patients stopped therapy due to serious adverse events.
“The most impressive aspect of these two 5-year long term extension studies is the durability of response,” Edward V. Loftus, Jr., MD, professor of medicine in the division of gastroenterology and hepatology at the Mayo Clinic, Rochester, Minn., told Healio Gastroenterology. “In the ‘as observed’ analysis, about 90% of patients were still in response/remission at last follow-up. Even if you assume the most conservative ‘worst case scenario,’ that the patients without available data were non-responders, about two-thirds of the UC patients were still in clinical response/remission at 4 years of cumulative treatment, while the majority of Crohn’s patients were still in response/remission at 4 years. The ‘truth’ is somewhere between these 2 analyses.”
Edward V. Loftus, Jr.
Post-hoc analysis, real-world data
Investigators also presented data from a post-hoc analysis of GEMINI I at the congress, which showed that a significantly greater proportion of 620 vedolizumab-treated UC patients who achieved remission at week 14 achieved sustained clinical remission at weeks 26, 38 and 52 compared with placebo (60% vs. 37%).
In addition, investigators shared real-world vedolizumab data from a systematic review and meta-analysis of 98 studies published through October 2016. These studies reported on 704 UC patients and 1,010 Crohn’s patients who were treated for 1 year, about 70% of whom were previously treated with at least one anti-TNF therapy.
The pooled clinical remission rates among UC patients were 32% at week 14, 31% at 6 months and 51% at 1 year, while the pooled clinical remission rates among Crohn’s patients were 30%, 23% and 30%, respectively.
Further, the pooled steroid-free remission rates among UC patients were 31% at 6 months and 48% at 1 year, and 23% and 25% in Crohn’s patients, respectively
Fatigue, arthralgia, fever and upper respiratory tract infections were the most common adverse events, and serious adverse events occurred in 7% to 8% of patients.
The investigators concluded that these real-world data support the positive benefit-risk profile of vedolizumab, and serve as “an important supplement” to randomized controlled trial results. – by Adam Leitenberger
Vermeire S, et al. Abstract DOP021. Presented at: ECCO Congress; February 15-18, 2017. Barcelona.
Loftus EV, et al. Abstract P209. Presented at: ECCO Congress; February 15-18, 2017. Barcelona.
Schreiber S, et al. Abstract P466. Presented at: ECCO Congress; February 15-18, 2017. Barcelona.
Stallmach A, et al. Abstract DOP026. Presented at: ECCO Congress; February 15-18, 2017. Barcelona.
Disclosures: Vermeire, Loftus, and other researchers report financial relationships with Takeda and numerous other relevant financial disclosures. Please see the ECCO disclosure database for a full list of all other researchers’ relevant financial disclosures.
Editor's note: This article was updated on February 28 with additional comments from a study author.