P477 Italian real-life study evaluating the long-term effectiveness of vedolizumab for the treatment of inflammatory bowel disease: the elderly cohort

Abstract

Background Vedolizumab is the first biological therapy for Inflammatory Bowel Disease(IBD) tested, in pivotal trials, on patients over 65 and up to 80 years old: accordingly, ithas been presented as a safer choice in frail patients. However, data form either the GEMINIprogram or real-life work in this population is still scarce. The aim of this study is to explorethe effectiveness and safety of vedolizumab in a large real-life cohort of elderly IBD patients.Methods The Long-term Italian Vedolizumab Effectiveness (LIVE) study included CD andUC patients started on vedolizumab from April 2016 to June 2017 at 47 centers of theItalian Group for the study of Inflammatory Bowel Disease (IG-IBD). Patients were prospectivelyfollowed-up to June 2019. Elderly patients (≥ 65 years) were included in this analysis.The primary endpoint was vedolizumab persistence. Secondary endpoints included: steroidfreeclinical remission (SFCR), C-reactive protein (CRP) normalization, deep remission andrates of adverse events (AEs). Results Of 1111 patients, 198 (17.8%, 90 CD and 108 UC)≥ 65 years were included. Mean disease duration was 11.6 (±11) years and most of patients(111, 56.1%) was naïve to biological therapy. Thirty-one (15.7%) patients had a history ofprevious cancer. Cumulative vedolizumab persistence at 12 and 24 months was 72% and52.1%, respectively. A significantly higher persistence was observed in biologic-naïve CDpatients, compared to biologic-experienced (p=0.04); no difference was observed in UC.Vedolizumab interval escalation was necessary in 20 (19.8%) patients at 12 months and in22 (23.4%) at 24 months. SFCR (defined as clinical remission, according to Harvey-Bradshawindex or partial Mayo score + no steroid therapy in the previous 3 months) was reportedin 37 (40.4%) and 31 (35.6%) CD patients, and in 34 (31.5%) and 34 (32.4%) UC patients,at 12 and 24 months, respectively. Mean CRP levels dropped from 13.2 (±17.4) mg/L atbaseline to 7.9 (±9.5) mg/L at 12 months and 5.7 mg/L (±6.4) at 24 months. CRP normalizationoccurred in 91 (43.4%) and 64 (32.3%) patients, at 12 and 24 months. Among patientswith available follow-up endoscopy, deep remission (combined clinical and endoscopicremission, according to Simple Endoscopic Score for CD or endoscopic Mayo score) wasreported in 5/23 (21.7%) and 3/15 (20%) CD patients, and in 5/45 (11.1%) and 9/25 (36%)UC patients, at 12 and 24 months. A total of 51 AEs was reported, leading to vedolizumabwithdrawal in 18 (9.1%) patients. Infections were the most common ones; 11 (5.6%) patientsreceived cancer diagnosis during follow-up. Conclusion In this preliminary analysis of thelargest real-life cohort of elderly IBD patients treated with vedolizumab, more than 50% ofpatients persisted on therapy after two years; an acceptable safety profile was observedthroughout the entire follow-up period.