Experiences of using vedolizumab in the treatment of inflammatory bowel disease in the East Midlands UK – a retrospective observational study

Abstract

Purpose: Clinical trials have demonstrated efficacy of vedolizumab in ulcerative colitis (UC) and Crohn's disease (CD). Further real-world data is needed to inform clinical practice. The primary outcome was to assess corticosteroid-free and clinical remission after vedolizumab initiation. Secondary outcomes included effect on disease activity scores, biochemical markers, concomitant drug use, endoscopic remission, surgical intervention, hospital admissions and adverse events. Materials and methods: A multi-centre retrospective observational study was conducted with patients initiated on vedolizumab across seven UK hospitals 1/11/14-30/11/16. Clinical disease activity was assessed using the partial Mayo Scores (pMS) and Harvey Bradshaw Index (HBI). Clinical remission was defined as HBI 4 or pMS <2 with a combined stool frequency and rectal bleeding sub score of 1. Clinical response was defined as 2-point decrease from baseline in pMS and 3-point decrease from baseline in HBI. Results: One hundred ninety-two patients were included in the final analysis. 45% of UC and 10% of CD patients were anti-TNF naive. Over the observation period corticosteroid-free remission rates for UC and CD were 46% and 45%, while clinical remission rates were 52% and 44%, respectively. Time to corticosteroid free remission for UC and CD was 17.6 [IQR: 8.7-29.6] and 14.1 [QR: 6.0-21.7] weeks, respectively. Time to clinical response for UC was 9.4 [IQR: 5.7-15.4] and CD was 9.5 [IQR: 6.1-18.2] weeks. There was a substantial decrease in the concomitant use of immunomodulators and a similar decrease in concomitant corticosteroid use over the study period. Conclusions: Results in this predominately anti-TNF experienced population mirror other published real-world data, demonstrating good clinical effectiveness and a comparable safety profile.

Real-world outcomes of 54-week vedolizumab therapy and response durability after treatment discontinuation in ulcerative colitis: results from a multicenter prospective POLONEZ study

“…Our analysis showed that 90.3% of all patients who reached week 54 were without corticosteroids. This result was consistent with the reports by Kopylov et al (86.2% at week 52), 25 Stallmach et al (83% at week 54), 33 and White et al (85% at week 52), 46 which similarly observed a significant decrease in concomitant corticosteroid use compared with baseline. Steroid-free clinical remission at week 54 was the primary endpoint in the study conducted by Amiot et al (40.5% of all patients) 39 and a secondary endpoint of the pivotal GEMINI-1 trial (41.8% of patients who continued to receive vedolizumab every 8 weeks and 44.8% of patients who continued to receive vedolizumab every 4 weeks), 10 which is similar to our study (47% of all patients).…”

Early recapture of response with tofacitinib 10 mg twice daily in patients with ulcerative colitis in OCTAVE Open following dose reduction or treatment interruption in OCTAVE Sustain

“…Like the RBS and SFS, the PMS is often used in clinical trials and observational studies in patients with UC 18,19 . Data reported here show that PMS is improved as early as month 1 in both the retreatment and dose escalation subpopulations and therefore may be another suitable endpoint for non‐invasive assessment of response following treatment interruption in patients with UC treated with tofacitinib 10 mg BID.…”

Analysis of colectomy rates for ulcerative colitis in pre‐ and postbiological eras in Lothian, Scotland

“…It would appear that this increase in vedolizumab prescription is in keeping with national trends. A retrospective cohort study conducted in the East Midlands showed that 45% of patients were prescribed vedolizumab as first‐line therapy [22] and 79% in another UK multicentre cohort of patients over 60 [23].…”