Does switching to subcutaneous vedolizumab affect remission rates for inflammatory bowel disease?

Background

Vedolizumab is an effective treatment option for inflammatory bowel diseases (IBD), usually administered intravenously (IV) every 8 weeks, requiring patients to attend the infusion units. Subcutaneous formulation is now available with efficacy and safety demonstrated in VISIBLE1 and VISIBLE2 randomised controlled trials.

There are studies assessing real-world outcomes, however, they lack data for longer than a 10-month period and do not have a control group. Subcutaneous biologic preparations offer patients flexibility to self-administer therapy and reduce hospital visits.

Objective

To assess drug persistence, remission rates and cost savings between subcutaneous and IV vedolizumab for up to 12 months.

Methods

This was a retrospective, single-centre cohort study. Patients previously on IV vedolizumab who switched to subcutaneous therapy between February 2021 and February 2023 formed the subcutaneous group (n=95). The IV-control group continued IV therapy (n=100).

Disease activity scores (HBI for Crohn’s disease (CD) and SCCAI for ulcerative colitis (UC)), C-reactive protein (CRP) and faecal calprotectin (FCP) concentrations were collected at baseline, 6 and 12 months. Results are expressed as rates and odds ratio (OR) and data was analysed using one-way ANOVA, mixed-effect analyses (q value) and chi-squared test. This study did not require ethics approval.

Results

In the subcutaneous switch group (n=95, 54%), the median age of patients was 54.5 years, 43% (n=41) were female, 63% (n=60) had UC, 37% (n=35) had CD. The most common CD phenotype was ileal disease (n=15/35).

At 12 months there was a statistical significance in maintenance of remission with subcutaneous vedolizumab (86%; q=0.002) compared to IV. The odds for remission with subcutaneous vedolizumab at 6 and 12 months were 1.1 [CI] (p=0.7) and 3.6 [CI] (p=0.006) at 12 months.

There were no statistically significant differences in CRP and FCP between baseline, 6 or 12 months for both IV and subcutaneous groups: for CRP, 80% and 75% of patients maintained biochemical remission at 6 and 12 months respectively, and for FCP, 78% at 6 months and 81% at 12 months in the subcutaneous group.

Drug persistence for subcutaneous vedolizumab at 6 and 12 months were 93% and 87%, respectively. 4 patients (4%) switched to a different drug due to loss of response, and 8 (8%) switched back to IV vedolizumab due to adverse events, issues with homecare or symptom control.

Based on this switch, an expected reduction of £72,010 per annum is likely to be achieved using inhouse drug price and bed costs.

Conclusion

The study reported up to 12 months of data on subcutaneous vedolizumab and included an IV-control group allowing for comparisons to be drawn. Nonetheless, potential biases like selection bias are introduced by the study design.

However, transitioning patients from IV to subcutaneous vedolizumab was associated with low drug discontinuation rate, and superior remission rates at 12 months for subcutaneous compared to IV. These findings should be used to encourage the uptake of switching strategies as it offers multiple advantages to healthcare systems, including reduced workload in infusion units and cost savings.

Additional authors: N. Fernandes, N. Kamperidis, F. Aslam, A. Chana, S. Radhakrishnan, L. Dyal, N. Arebi

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