Subcutaneous administration of the gut-selective treatment was notably well-tolerated, safe, and cost-effective.
New real-world data showed that subcutaneous vedolizumab for inflammatory bowel disease (IBD) is comparable to intravenous administration across measures for efficacy, safety, and patient satisfaction.
The humanized monoclonal IgG1 antibody is currently approved for the management of moderate-to-severe ulcerative colitis (UC) and Crohn’s diseases in cases where conventional therapy or anti-TNF agents are inadequate. Recently, a formulation for subcutaneous administration of the gut-selective treatment was approved for this patient population. This approval was based on findings from the VISIBLE 1 and VISIBLE 2 trials.
The current prospective observational cohort study, led by Viktoria Bergqvist, MD, Department of Gastroenterology, Skane University Hospital, assessed patients who switched from intravenous to subcutaneous vedolizumab following at least 3 IV infusions. All patients involved in the study had official diagnoses of Crohn’s disease or ulcerative colitis.
Overall, 89 patients were included in the study (48 with CD, 41 UC). Subcutaneous treatment of 108 mg every 2 weeks proceeded for 6 months in a majority of the population. As such, the study’s primary endpoint was change in disease activity as defined by fecal calprotectin levels at month 6.
Secondary endpoints included clinical disease activity, remission rates, plasma CRP, drug persistence, adverse events, local injection reactions, serum drug concentrations, patient satisfaction, quality-of-life, and treatment costs.
The investigators observed that fecal calprotectin decreased significantly in patients with Crohn’s disease but not in ulcerative colitis.
“A subgroup analysis of faecal calprotectin levels in patients with limited ileal CD showed a median of 145 μg/g (IQR 48–281) at baseline and 94 μg/g (IQR 50.0–175.5) at follow-up,” they wrote.
Furthermore, there were no observed changes in clinical disease activity – measured according to average patient-based HBI and PRO2-CD scores -- among patients with Crohn’s disease. In those with ulcerative colitis, there was a statistically significant improvement in clinical symptoms measured by the UC Simple Clinical Colitis Activity Index (SCCAI) – although, median score remained unchanged.
The switch to subcutaneous administration had no observable effect on clinical indices, remission rates, plasma CRP levels and quality-of-life scores; in fact, patients experienced similar outcomes from subcutaneous vedolizumab compared to previous intravenous treatment. As many as 95.5% of patients continued treatment at 6 months – while 88.5% continued treatment at 12-month follow-up.
The safety profile for subcutaneous vedolizumab was deemed similar to intravenous infusion. Adverse events occurred in 15 (31.3%) patients with Crohn’s disease and 10 (24.4%) with ulcerative colitis – for intravenous vedolizumab, the noted rates were 27.1% and 22.0%, respectively.
The most reported adverse events were fatigue, headache, nausea, and rash. A significant majority of patients (88.0% - 94.0%) experienced none or mild local injection reactionism. Further, the investigators observed no serious adverse effects – only one patient discontinued drug administration due to local injection reactions at 12 months.
Additionally, the team noted severe local symptoms in 1.2% of patients; although, patient satisfaction with treatment was considered generally very high.
“This study shows that a switch from IV to SC vedolizumab maintenance treatment can be done with maintained efficacy, safety and tolerability, including in patients on optimized IV vedolizumab dosing,” the investigators wrote.
The considerable cost-effectiveness against IV treatment was 15.0% lower compared to IV.
“The appropriate window for serum vedolizumab concentration to target for combined optimal efficacy, patient convenience and cost-effectiveness during SC maintenance treatment, is still unclear and should be addressed in future studies,” they noted.
The study "Real-world data on switching from intravenous to subcutaneous vedolizumab treatment in patients with inflammatory bowel disease" was published in Alimentary Pharmacology & Therapeutics.