The Use Of Vedolizumab In A Secondary Care Dgh Setting; Real World Experience And Outcomes

Introduction To evaluate the clinical and biochemical outcomes of patients with inflammatory bowel disease to Vedolizumab- at a District General Hospital Methodology Retrospective cohort study assessing 55 patients administered Vedolizumab between 2015 and 2019. Demographics and clinical information were recorded. Response was determined using Harvey Bradshaw (HB) and partial Mayo score (pMS). Baseline indices and serum CRP were recorded at (i) prior to commencement, (ii) 6 months, and (iii) 12 months. A clinical response was determined by a decrease in pMS and HB of at least 3 points for UC and CD respectively or to a score below 5. Results A total of 55 patients (33 CD, 22 UC) were found on our electronic records. A total of 44(18 UC, 26 CD) were included with 11 patients excluded as they had started within 6 months of study commencement. Mean age for UC was 45.2 years and CD was 42.8 years, 15/18(83.3%) UC patients and 20/26 (76.9%) CD patients had prior anti TNF exposure. 56% (5/9) of all those TNF naive were found to have a response at 6 months. UC group Mean CRP reduction at 6 and 12 months was -7.1 and -6.3 respectively. Mean pMS prior to treatment 5.8 and at 6 months was 4.8. At 6 months, 6% (n=1/18) were responders, 61% (11/18) were partial responders and 33% (n=6/18) were non responders. 67% (n=12/18) completed 12 months treatment when 8%(n=1/12) were responders, 58% (n=7/12) partial responders and 33% (n=4/12) were non responders. CD group Mean CRP reduction at 6 and 12 months were -7.7 and -7.2 respectively. Mean HB prior to treatment 7.7 and at 6 months was 5.7. At 6 months, 19%( n=5/26) were in clinical remission, 15% (n=4/26) were responders, 46% (n=12/26) were partial responders and 19% (n=5/26) non responders. 65% (n=17/26) completed 12 months treatment, of those 23.5% (n=4/17) were in clinical remission, 17.6%( n=3/17) were responders, 41% (n=7/17) were partial responders and 17.6% (n= 3/17) were non responders. Reasons for stopping treatment in all patients: treatment was stopped prior to completion of 12 months in 15/44(34%) patients. This included need for surgery 4.5% (2/44), abnormal liver function tests 9%(n=4/44), intolerance 18% (8/44), and pregnancy 2.2% (1/44). Conclusion Our results reflect similar safety and efficacy of Vedolizumab to published data. Vedolizumab was generally well tolerated with no serious adverse effects.