Introduction Vedolizumab is a gut selective α4β7 integrin antibody licenced for treatment of moderate to severe inflammatory bowel disease (IBD) in patients not responding or intolerant to immunomodulators or TNF-alpha antagonists. It has been shown to be effective at induction and maintenance of remission, with a good safety profile. As it is increasingly used in clinical practice we wanted to confirm its effectiveness and safety in our cohort of patients.
Method IBD patients receiving Vedolizumab at Norfolk & Norwich University Hospital from March 2015 to January 2017 were identified. Details of IBD diagnosis, previous treatments, therapy duration, clinical response and remission were obtained by case notes review.
Results 53 IBD patients (26 male, 27 female) were identified; 27 with Crohn’s, 26 with ulcerative colitis (UC). 18 have since stopped Vedolizumab, while 35 continue. 16 patients received a concomitant immunomodulator. 9 patients were anti-TNF naïve, 44 previously failed anti-TNF therapy.
41 patients (77%) showed initial response to treatment (20 Crohn’s, 21 UC). 7 patients (13%) were primary non-responders and stopped therapy. 2 patients stopped therapy within 1 month due to side effects. 3 patients have been treated for less than 2 months and it is too early to assess response. Of the 41 initial responders, 5 subsequently stopped due to loss of response, and 1 had to stop due to side effects. A further 3 received treatment during a clinical trial and stopped therapy when funding was withdrawn despite maintained remission.
32 patients remain in clinical response on Vedolizumab since initiation (60%). 12 of these patients are in clinical remission. 3 additional patients are on treatment but yet to show response, pending further assessment. Longest treatment period is currently 20 months, with mean duration of 7 months.
While response rates are broadly similar between UC and CD, 21 (81%) and 20 (74%) respectively, in this panel Crohn’s patients have a higher remission rate; with 10 patients currently maintaining remission (36%) compared to 2 UC patients (8%). This is probably related to treatment duration (mean duration of 10 months in Crohn’s compared to 5 months for UC).
Vedolizumab has been well tolerated in our cohort, with only 3 patients (6%) developing side effects (listeria infection, perianal sepsis, and chronic cough).
Conclusion These results confirm that Vedolizumab is a safe and effective treatment for IBD patients intolerant of or unresponsive to immunomodulators/anti-TNF therapy, or where these are contra-indicated. A majority of our patients have shown response to treatment and 12 (23%) achieved sustained remission with a very low incidence of side effects.
. Sandborn WJet al. Vedolizumab as induction and maintenance therapy for Crohn’s disease. N Engl J Med 2013;369:711–721.
Disclosure of Interest None Declared
- Crohn’s disease
- Inflammatory Bowel Disease
- Ulcerative colitis