New real-world data has shown that subcutaneous vedolizumab for inflammatory bowel disease (IBD) is comparable to intravenous administration across measures of 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 disease in cases where conventional therapy or anti-TNF agents are inadequate. Recently, a formulation for subcutaneous administration of the selective bowel treatment has been approved for this patient population. This approval was based on the results of the VISIBLE 1 and VISIBLE 2 trials.
The current prospective observational cohort study, led by Viktoria Bergqvist, MD, Department of Gastroenterology, Skane University Hospital, evaluated patients who switched from intravenous vedolizumab to subcutaneous vedolizumab after at least 3 IV infusions. All patients involved in the study had official diagnoses of Crohn’s disease or ulcerative colitis.
A total of 89 patients were included in the study (48 with MC, 41 CU). Subcutaneous treatment of 108 mg every 2 weeks took place for 6 months in a majority of the population. As such, the primary endpoint of the study 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, patient, quality of life and treatment costs.
The researchers observed that fecal calprotectin decreased significantly in patients with Crohn’s disease, but not in ulcerative colitis.
“A subgroup analysis of fecal 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) when tracking,” they wrote.
Additionally, no changes were observed in clinical disease activity – measured by mean patient-based HBI and PRO2-CD scores – in patients with Crohn’s disease. In people with ulcerative colitis, there was a statistically significant improvement in clinical symptoms as measured by the UC Simple Clinical Colitis Activity Index (SCCAI) – although the median score remained unchanged.
Switching to subcutaneous administration had no observable effect on clinical indices, remission rates, plasma CRP levels and quality of life scores; in fact, patients achieved similar results with subcutaneous vedolizumab compared to previous intravenous therapy. No less than 95.5% of patients continued treatment at 6 months, while 88.5% continued treatment at 12 months of follow-up.
The safety profile of subcutaneous vedolizumab was found to be similar to that of 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 rates noted 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%) had no or mild local reaction to the injection. Moreover, the investigators did not observe any serious adverse effects – only one patient discontinued the administration of the drug due to local injection reactions at 12 months.
Additionally, the team noted severe local symptoms in 1.2% of patients; however, patient satisfaction with treatment was generally rated as very high.
“This study demonstrates that a switch from IV maintenance therapy to SC vedolizumab can be made with maintained efficacy, safety, and tolerability, including in patients receiving an optimized dose of IV vedolizumab,” the researchers wrote.
Significant cost-effectiveness compared to IV treatment was 15.0% lower than IV treatment.
“The appropriate window for vedolizumab serum concentration to target optimal combined efficacy, patient convenience, and cost-effectiveness during SC maintenance therapy is still unclear and should be addressed in future studies.” they noted.
The study “Real-world data on switching from intravenous to subcutaneous vedolizumab therapy in patients with inflammatory bowel disease” was published in Food & Therapeutic Pharmacology.