Effectiveness and safety of vedolizumab in inflammatory bowel disease patients aged 60 and over: an observational multicenter UK experience

Hajir Ibraheim; Mark A. Samaan; Ashish Srinivasan; Oliver Brain; Jonathan Digby-Bell; Peter Irving; Irena Norman; Issrah Jawad; Julia Biedermann; Ana Ibarra; Klaartje Bel Kok; Gareth Parkes; Joanna Rimmer; Elisabeta Compot; Miles Parkes; Jonathan Segal; Philip Oppong; Ailsa Hart; Bu'Hussain Hayee; Nick Powell

Authors Hajir Ibraheim, Mark A. Samaan, Ashish Srinivasan, Oliver Brain, Jonathan Digby-Bell, Peter Irving, Irena Norman, Issrah Jawad, Julia Biedermann, Ana Ibarra, Klaartje Bel Kok, Gareth Parkes, Joanna Rimmer, Elisabeta Compot, Miles Parkes, Jonathan Segal, Philip Oppong, Ailsa Hart, Bu'Hussain Hayee, Nick Powell.

Abstract

Background The GEMINI trials established the efficacy of vedolizumab in moderate-to-severe inflammatory bowel disease (IBD) and demonstrated a favorable safety profile, suggesting it may be advantageous in older patients at greater risk of treatment-related complications. However, there is a paucity of data exploring the outcomes of vedolizumab in this group. Our objective was to determine the clinical effectiveness and safety of vedolizumab in older IBD patients within a real-world multicenter UK cohort.

Methods A retrospective review of electronic records across 6 UK hospitals was undertaken to evaluate the clinical effectiveness and safety outcomes of vedolizumab in IBD patients aged ≥60 at start of therapy. Rates of clinical response, remission and corticosteroid-free remission were assessed at weeks 14 and 52, using validated clinical indices, and were compared to historical controls from real-world vedolizumab-treated cohorts unstratified by age.

Results Of 74 patients aged 60 years or above (median 66 years), 48 were included in our effectiveness analysis (29 ulcerative colitis, 19 Crohn’s disease). Rates of clinical response, remission and corticosteroid-free remission at week 14 were 64%, 48% and 30%, respectively. By week 52, the rates of clinical response, remission, and corticosteroid-free remission were 52%, 38%, and 32%, respectively. Six (8%) patients experienced adverse effects. Effectiveness and safety outcomes were comparable to those of age-unstratified vedolizumab-treated cohorts.

Conclusion Our 1-year outcome data suggests that vedolizumab is safe and effective in older IBD patients and broadly comparable to cohorts unselected by age.

Keywords Inflammatory bowel disease, ulcerative colitis, Crohn’s disease, vedolizumab, older
onset IBD

Ann Gastroenterol 2020; 33 (2): 170-177