What is the efficacy and safety profile for long-term use of vedolizumab (VEDO) for ulcerative colitis (UC)?
Long-term treatment with VEDO maintains remission and response in UC and is well tolerated. Restarting VEDO after a gap in treatment, and increasing its dose in those already on treatment, can improve rates of response and remission.
Loftus EV Jr, Colombel JF, Feagan BG, et al. Long-term efficacy of vedolizumab for ulcerative colitis. J Crohns Colitis. 2017 Apr 1;11(4):400–11. http://www.ncbi.nlm.nih.gov/pubmed/27683800
The GEMINI long-term safety (GEMINI LTS) study enrolled patients who completed one of two placebo-controlled induction trials in addition to patients who had received VEDO induction in an open-label cohort. Regardless of their treatment in the lead-in protocol, all participants in GEMINI LTS received open-label VEDO every 4 weeks. The study cohort will be followed for up to 152 weeks. This interim analysis focused on treatment efficacy (partial Mayo score ≤2, pMayo), safety, health-related quality of life (HRQoL) measured with IBDQ, EQ-5D, and SF-36.
The efficacy analysis was restricted to 657 patients who had responded to VEDO induction therapy in GEMINI 1 or the open-label cohort. Patients previously exposed to anti-TNFs comprised 43% of the cohort; those who previously failed anti-TNFs and immunosuppressants comprised 32% of the cohort. After 100 weeks in GEMINI LTS, 90% (141/156) of patients maintained a pMayo ≤2. This proportion was 88% (42/48) among those with prior anti-TNF failure and 92% (97/106) among those who were anti-TNF naïve. No new safety events were noted. HRQoL improvements were durable with long-term VEDO therapy. Reintroduction of VEDO every 4 weeks among subjects to had responded to VEDO induction and then received placebo maintenance was well tolerated. In this subgroup, restarting VEDO increased rates of response from 69% to 84%, and increased rates of remission from 56% to 73%. Among subjects who withdrew from GEMINI 1 on VEDO every 8 weeks, clinical response and remission on VEDO every 4 weeks in GEMINI LTS increased to 41% and 28%, representing gains of 19% and 6%, respectively.
Study Design: Longitudinal cohort study-interim analysis
Funding: Millennium Pharmaceuticals, Inc. [d/b/a Takeda Pharmaceuticals International Co.]
Setting: >290 centres world-wide
Level of Evidence: 2b (Oxford Levels of Evidence)
The summary and conclusion in this issue of E-mentoring in IBD pertains to the manuscript(s) being reviewed, and should be considered in the context of what is already known surrounding the topic and incorporated into practice as deemed appropriate by the individual learner.