P416 Real world data on the effectiveness and safety of vedolizumab in the treatment of Crohn's disease and ulcerative colitis: the Edinburgh experience

Abstract

Results: Of the 55 included children, 33 (60%) had UC/IBDU, and 22 (40%) had Crohn's Disease (CD); [28 (51%) male, mean age at first VDZ dose 14.5±2.8 years, and median disease duration 3.5 years (IQR 1.8-5.1)]. All were previously treated with anti-TNF (27% primary failure, 49% secondary failure, 15% adverse reaction and 9% for other reasons) and 8 (15%) had prior surgical intervention. Success rates at week 14 were 21% in UC, and only 9% in CD (p=0.24). Median follow-up period was 22 weeks (IQR 14-22) from VDZ initiation (range 6-76). Success rates by last follow-up were 39% in UC and 27% in CD (p=0.36). By the last follow-up 8 (15%) new children required surgery, of whom 6 had colectomy for UC (18% of the entire UC cohort). There were three mild adverse events to VDZ, including pruritis, transient dyspnea and mild periorbital oedema; there were no serious drug-related adverse events. Median fecal calprotectin decreased from 1168mcg/gm (IQR 609-1409) prior to treatment to 412mcg/gm (IQR 54-745) following treatment when available (p=0.013). Conclusions: In this largest real-life cohort of VDZ use in pediatric refractory IBD to date, VDZ was safe and effective in 21% and 39% of UC at 14 weeks and last follow-up whereas in CD the rates were 9% and 27%. These data thus support previous findings of slow induction rate of VDZ, particularly in CD. Background: Prior to the availability of biologic therapies, corticosteroids and narcotics were frequently used in inflammatory bowel disease (IBD) patients due to a paucity of disease modifying therapies. The increased accessibility to effective biologics for IBD over the last decade should be leading to less use of corticosteroids and narcotic medications. Methods: Data from the National Ambulatory Medical Care Survey (NAMCS) and National Hospital Ambulatory Medical Care Survey (NHAMCS) were used to examine visits of patients with IBD. Trends in corticosteroid and narcotic prescriptions were explored, and predictors of use were assessed using survey-weighted chi-square tests. Here, we present the short and medium term outcomes from a single centre cohort of IBD patients treated with vedolizumab. Methods: A vedolizumab treatment pathway was agreed. The following were prospectively collected for all patients at each infusion: observations, routine haematology, biochemistry and inflammatory markers, clinical disease activity score, faecal calprotectin (FC) and adverse events. Clinical effectiveness was evaluated by assessing changes in HBI and SCCAI at 12-14 weeks and 26 weeks. Clinical remission was defined as a HBI <5 and SCCAI <3. Response was defined as a change in disease activity ≥3. Changes in CRP/ FC were also analysed. Results: By the end of November 2016, 94 patients had received vedolizumab treatment. 63/94 (27 CD, 33 UC, 3 IBDU) had completed 12-14 week follow-up and are included in the primary analysis of clinical efficacy. Median disease duration was 7.9 years (IQR 4-15) with 36/63 (57%) patients previously exposed to anti-TNF therapy. Median HBI and SCCAI a...

Real‐world evidence for vedolizumab: Understanding the landscape

“…From the Netherlands, endoscopic response to vedolizumab therapy was observed in 8/15 (47%) patients with CD and 9/11 (82%) patients with UC, but the clinical remission rates were < 50% in both CD and UC . In Scotland, 340 patients (203 CD and 137 UC) experienced lower hospitalization rates and steroid usage associated with vedolizumab treatment . In Spain, a study of 274 patients (144 CD and 130 UC) identified that vedolizumab was more likely to be effective in UC than CD, if the patients were anti‐tumor necrosis factor naïve and if they had mild or moderate disease, instead of severe disease .…”