Real-World Study on Vedolizumab Serum Concentration, Efficacy, and Safety after the Transition from Intravenous to Subcutaneous Vedolizumab in Inflammatory Bowel Disease Patients: Single-Center Experience

Abstract

Little is known about how the change from intravenous to subcutaneous vedolizumab in a real-life setting in inflammatory bowel disease patients on stable maintenance therapy affects clinical outcomes. We compared the data on vedolizumab serum trough concentration, efficacy, and safety prior to and six months after the switch from intravenous to subcutaneous vedolizumab. In total, 24 patients, 13 with ulcerative colitis (UC) and 11 with Crohn’s disease (CD), were included. Mean serum trough concentration of intravenous vedolizumab was significantly lower than mean serum trough concentration of subcutaneous vedolizumab (p = 0.002). There was no significant difference between C-reactive protein levels, fecal calprotectin levels or clinical scores (Harvey–Bradshaw index or Partial Mayo score) prior to transition to subcutaneous vedolizumab and after 6 months. In four (16.7%) patients, two CD and two UC, therapy was discontinued during the follow-up period with a median of 5 months (minimum–maximum: 4–6). In all patients, therapy was discontinued due to loss of response. In total, 13 adverse events were reported by 11 patients, and the most common adverse event was COVID-19. No serious adverse events were reported. In conclusion, subcutaneous vedolizumab has shown to be effective and safe in patients on previously established maintenance therapy with intravenous vedolizumab.

Take vedolizumab home: transition from intravenous to subcutaneous treatment

“…For patients with UC, Simple Clinical Colitis Activity Index (SCCAI) or PMS was used as the disease activity score in the studies, and clinical remission was defined as SCCAI ⩽2 25 , 26 or PMS ⩽1. 27 , 28 Changes in the SCCAI or PMS before and after the switch were reported in five studies, 24 – 28 with no observed significant differences except in one study that showed a decrease in the SCCAI. 25 Six studies 24 , 25 , 27 – 30 compared the proportion of patients in clinical remission before and after the switch, with no significant differences observed except in one study, which showed more patients in clinical remission at week 20 compared to the time of the switch.…”

“…In clinical evaluations, the Harvey Bradshaw Index (HBI) was used as the disease activity score in all CD patients, and an HBI score of ⩽4 25 , 26 was defined as clinical remission. Changes in the HBI before and after the switch were reported in five studies, 24 – 28 none of which showed significant differences. For patients with UC, Simple Clinical Colitis Activity Index (SCCAI) or PMS was used as the disease activity score in the studies, and clinical remission was defined as SCCAI ⩽2 25 , 26 or PMS ⩽1.…”

“…We searched for a combination of subject and free words, including ‘vedolizumab’ and ‘subcutaneous’, in the PubMed, Web of Science, and Embase databases. Finally, we included nine articles, five conference abstracts, and one letter, totaling 15 RWS, 24 – 38 with 14 reporting on the effectiveness of SC VDZ as maintenance therapy ( Table 2 ).…”

“…In terms of biochemical evaluations, eight studies 24 – 28 , 30 , 32 , 35 documented changes in FC before and after switching. Among them, six 25 – 28 , 30 , 32 did not show significant changes, one indicated a decrease in FC, 35 and one reported a dose increase from 31 to 47 g/g. 24 The clinical significance of the slight increase in FC was restricted owing to its small value.…”

“… 24 The clinical significance of the slight increase in FC was restricted owing to its small value. Eight studies reported changes in the CRP levels 24 – 28 , 30 , 32 , 35 before and after switching, with no significant alterations observed. Different studies have variably defined biochemical remission, commonly relying on CRP ⩽5 mg/l and/or FC ⩽250 g/g.…”