Transitioning from Intravenous to Subcutaneous Vedolizumab in Patients with Inflammatory Bowel Disease [TRAVELESS].

BACKGROUND AND AIMS: Subcutaneous [SC] vedolizumab presents the opportunity for inflammatory bowel disease [IBD] patients to manage their treatment at home. There are currently no data on the process of transitioning patients established on intravenous [IV] to SC vedolizumab as part of routine clinical care. The aim of this programme is to evaluate the clinical and biochemical outcomes of switching a cohort of IBD patients established on IV vedolizumab to SC, at 12 weeks following the transition. METHODS: In all, 178 adult patients were offered the opportunity to transition to SC vedolizumab. Patients who agreed were reviewed prior to switching and at Week 12 [W12] after their first SC dose. Evaluation outcomes included disease activity scores, the IBD-Control Patient-Reported Outcome Measures [PROMs], and faecal calprotectin [FCP]. Reasons for patients declining or accepting transitioning, pharmacokinetics, adverse drug reactions, and risk factors for a poor outcome in SARS-CoV-2 infection were also assessed. RESULTS: A total of 124 patients agreed to transition, of whom 106 patients had been on IV vedolizumab for at least 4 months. There were no statistically significant differences in disease activity scores or IBD-Control PROMs between baseline and W12. A statistically significant increase in FCP was observed [31 µg/g vs. 47 µg/g; p = 0.008], although this was unlikely to be clinically relevant. The most common adverse drug reaction reported was injection site reactions [15%]. Based on this cohort of patients, an expected reduction of £572,000 per annum is likely to be achieved. CONCLUSIONS: Transitioning patients established on IV vedolizumab to SC appears to be safe and effective, with high patient satisfaction and multiple benefits for the health service.

Transitioning from intravenous to subcutaneous vedolizumab in patients with inflammatory bowel disease (TRAVELESS)

IntroductionIn May 2020, subcutaneous (SC) vedolizumab was approved for use in Inflammatory Bowel Disease (IBD). Patients with IBD have a number of risk factors for a poor outcome from SARS-CoV-2 infection and managing this risk by reducing hospital visits is crucial. Currently there is no information on the process or outcomes of transitioning patients established on intravenous (IV) vedolizumab to SC.MethodsThis is a prospective service evaluation of adult patients who are either stable on IV vedolizumab or have been newly started and opted for SC administration. Between October and December 2020, all suitable patients attending our infusion centre for vedolizumab were offered the option to switch to SC. Initially, the aim was to offer a SC dose to patients in place of their IV infusion with injection training by IBD specialists. This proved to be a challenge as it left a narrow window of time for homecare deliveries to be arranged for subsequent doses. Therefore, the remaining patients who agreed to the switch received an IV infusion at their baseline review, with the aim of administering the first SC dose in place of the next scheduled IV dose.Outcomes include reasons for consenting or declining to switch, patient experience with using SC injections and time saved by not needing to travel to the infusion centre. Data on factors associated with poor outcomes from SARS-CoV-2 infection were collected, including co-morbidities, smoking status, concomitant medication and age.Clinical baseline data collected as part of routine care included disease activity (modified Harvey-Bradshaw Index or Simple Clinical Colitis Activity Index), biochemical results including C-reactive protein, albumin, haemoglobin and platelet count, faecal calprotectin and quality of life using IBD-Control. Trough vedolizumab levels were measured in patients who had had at least 3 IV doses previously. Patients will be reviewed after 12 weeks as part of the switching programme.Results179 patients were offered the opportunity to change to SC vedolizumab (54.2% CD, 44.1% UC, 1.7% IBDU), of which 125 (70%) (64 (51.2%) CD, 58 (46.4%) UC and 3 (2.4%) IBDU) agreed to the switch. The mean age (SD) was 55 (19.4). 11 patients were new to vedolizumab or reloading. The median time taken by patients (leaving home to returning home) to receive their infusions was 180 minutes (IQR 45 to 360).The main reasons for agreeing to switch were patient preference to manage their treatment at home (70.4%), concerns about contracting an infection at the infusion centre (15.7%) and difficulty attending the infusion centre (15.7%). Reasons for patients declining included not wanting to self-inject (28.3%), needle phobia (15.2%), and current instability of symptoms (15.2%). There have been no major adverse events to date.ConclusionsThis is a description of a service evaluation design to monitor outcomes in patients who have consented to transition from IV to SC vedolizumab at one IBD tertiary referral centre.

Management of Crohn's disease in an immunosuppressed COVID-19-positive patient: safety-driven prioritisation of nutritional therapy as a bridge to restarting immunosuppression.

Active inflammatory bowel disease (IBD), combined immunosuppression and corticosteroid therapy have all been identified as risk factors for a poor outcome in COVID-19 infection. The management of patients with both COVID-19 infection and active IBD is therefore complex. We present the case of a 31-year-old patient with Crohn's disease, on dual immunosuppression with infliximab and mercaptopurine presenting with inflammatory small bowel obstruction and COVID-19 infection. The case highlights the use of nutritional therapy, which remains underused in the management of adults with IBD, to manage his flare acutely. Following negative SARS-CoV-2 PCR testing and SARS-CoV-2 IgG testing confirming an antibody response, ustekinumab (anti-interleukin 12/23) was prescribed for long-term maintenance.