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

Abstract

Background and Aims Subcutaneous (SC) vedolizumab presents the opportunity for inflammatory bowel disease (IBD) patients to manage their treatment at home. There is currently no data on the process of transitioning patients established on intravenous (IV) to SC 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 12 weeks following the transition. Methods 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 124 patients agreed to transition, of which 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 (31µg/g vs. 47µg/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.

Real‐world data on switching from intravenous to subcutaneous vedolizumab treatment in patients with inflammatory bowel disease

“…In our study, serum vedolizumab trough concentrations at steady state were approximately twice as high during SC as compared with IV treatment. These findings are in line with the VISIBLE studies 4,5 and the study Ventress et al 6 Our results suggest an inverse relationship between serum vedolizumab trough levels and faecal calprotectin levels with vedolizumab given IV. However, after 6 months with SC vedolizumab at standard dose, this correlation was not seen.…”

“…Nevertheless, the authors described a 52% increase (p < 0.01) in the patients' faecal calprotectin levels at the end of their study which was rather unexpected. 6 Thus, further studies are warranted.…”

“…To our knowledge, there is only one report on the topic, and in that study, the follow-up time after the switch was only 12 weeks. 6 Given that the half-life of the drug is approximately 26 days and that the wash-out period is several months, such a short follow-up time may not be adequate to examine the effectiveness of the SC formulation. Nevertheless, the authors described a 52% increase (p < 0.01) in the patients' faecal calprotectin levels at the end of their study which was rather unexpected.…”

Editorial: intravenous to subcutaneous vedolizumab—switch without glitch!

“…Although limited by a lack of endoscopic assessment, and no comparator IV group, the study indicates maintained therapeutic efficacy, high treatment persistence and patient acceptability rates for the SC formulation. The findings extend the previous observations by Ventress et al which reported reassuring outcomes albeit with a shorter follow‐up duration of 12 weeks 8 . Intriguingly, serum vedolizumab levels increased after switching to SC and this may simply reflect steady‐state drug distribution with the SC formulation as opposed to better bioavailability.…”

“…8 Intriguingly, serum vedolizumab levels increased after switching to SC and this may simply reflect steady-state drug distribution with the SC formulation as opposed to better bioavailability. Similar findings have been reported in previous cohort studies of switching from IV to SC vedolizumab 8 as well as IV to SC infliximab. 9 Interestingly, previous reports suggest near-complete occupancy of α4β7 integrin in peripheral blood memory T cells regardless of drug levels 10 and this explains why the increased serum levels with SC vedolizumab may not necessarily translate to better clinical outcomes.…”