The following article is a part of conference coverage from the 2019 Advances in Inflammatory Bowel Diseases (AIBD) Meeting, being held in Orlando, Florida. The team at MPR will be reporting on the latest news and research conducted by leading experts gastroenterology. Check back for more from the 2019 AIBD Meeting.
ORLANDO – Vedolizumab demonstrated long-term effectiveness and favorable safety profile in patients with moderately to severely active ulcerative colitis (UC) and Crohn Disease (CD), according to data from the phase 3 GEMINI LTS study presented at the 2019 Advances in Inflammatory Bowel Diseases (AIBD) Annual Meeting, held December 12 to 14, 2019 in Orlando, FL.
GEMINI LTS was a multinational, multicenter, open-label study that evaluated the long-term safety and efficacy of vedolizumab for up to 5 years. This post hoc analysis included a total of 421 vedolizumab-naive patients with UC (n=190) or CD (n=231) who were treated with 300mg vedolizumab every 4 weeks. Treatment persistence was assessed using the Kaplan-Meier survival analyses, which was further stratified by Week 12 treatment response, prior anti-tumor necrosis factor (anti-TNF) treatment failure, type of anti-TNF failure, and concomitant therapy at baseline.
Results showed that the treatment persistence rates were 53% (95% CI, 45%-61%) for UC patients and 41% (95% CI, 32%-49%) for CD patients at 54 months. Treatment persistence at 54 months was also significantly higher for Week 12 responders vs nonresponders: 60% (95% CI, 50-68%) vs 26% (95% CI, 12-44%) for UC patients (P <.0001) and 42% vs 35% (95% CI, 21-50%) for CD patients (P =.001), respectively. Moreover, vedolizumab treatment persistence rates were higher in anti-TNF naive patients with UC (P =.046) or CD (P =.016) at 54 months vs those with prior anti-TNF failure. Concomitant therapy did not affect vedolizumab persistence rates.
With regard to safety, vedolizumab discontinuation rates due to adverse events were low and similar for patients with UC or CD. The most common adverse event leading to discontinuation was gastrointestinal inflammation/disease exacerbation.
Vedolizumab, an integrin receptor antagonist, is approved for the treatment of moderately to severely active UC or CD. The product is available in 20mL single-use vials containing 300mg vedolizumab.
Loftus Jr EV, Peyrin-Biroulet L, Vermeire S, et al. Vedolizumab Treatment Persistence up to 5 Years: Post Hoc Analysis in Vedolizumab-Naive Patients From the GEMINI Long-Term Safety Study. Presented at: 2019 AIBD Annual Meeting; December 12-14, 2019; Orlando, FL.