Photo Credit: Irina Shpiller
Study results indicate that switching from intravenous to subcutaneous vedolizumab in patients with IBD appears to be safe and effective.
Inflammatory Bowel Disease (IBD) presents a significant challenge in healthcare due to its chronic nature and complex treatment requirements. However, the advent of monoclonal antibodies (MAbs) has revolutionized the management of IBD, offering targeted therapy options that can effectively control inflammation and improve patient outcomes. Among these MAbs, vedolizumab (VDZ) has emerged as a pivotal agent, particularly for patients with moderate to severe ulcerative colitis (UC) and Crohn’s disease (CD) who have failed conventional or anti-TNFα therapies.
Convenience of a Subcutaneous Formulation
VDZ operates by selectively targeting the α4β7 integrin, thereby inhibiting the interaction between immune cells and the gut endothelium, which is crucial in the pathogenesis of IBD. Traditionally administered intravenously (IV), VDZ has demonstrated efficacy in inducing and maintaining remission in patients with both UC and CD. However, the recent introduction of a subcutaneous (SC) formulation of VDV (SC-VDZ) has expanded treatment options, offering patients the convenience of at-home administration and potentially reducing the burden associated with frequent hospital visits for IV infusions.
Clinical trials, such as VISIBLE I and II, have provided robust evidence supporting the efficacy and safety of SC-VDZ, demonstrating its non-inferiority to IV-VDZ in terms of clinical response and safety profile. Real-world data have further corroborated these findings, showing comparable effectiveness, remission rates, and quality-of-life scores between the two formulations. Additionally, SC-VDZ has been shown to offer time-saving benefits, making it an attractive option for patients seeking more convenient treatment modalities.
Consensus Lacking on Transition Timing
Despite promising data supporting the use of SC-VDZ, there remains a lack of consensus among healthcare professionals regarding the optimal timing for transitioning patients from IV to SC formulations, particularly for those on long-term maintenance therapy. To address this gap, a prospective observational cohort study was conducted by Dr. Laura Parisio and colleagues to evaluate the effectiveness and safety of switching from IV to SC-VDZ in patients with IBD who were in clinical remission and stable on standard IV-VDZ therapy.
The study enrolled 93 patients (43 with CD, 50 with UC) who were in steroid-free clinical remission (SFCR) with IV-VDZ treatment for at least 3 months. “At baseline, 80 patients (86%) had a combined remission,” wrote Dr. Parisio and team in J Gastrointestin Liver Dis. Patients were then switched to SC-VDZ and followed for 24 weeks. The primary endpoint of the study combined SFCR plus biochemical remission (BR) at 24 weeks after switching to SC-VDZ, with secondary endpoints including SFCR plus BR at 12 weeks, persistence on SC-VDZ therapy, and factors influencing 24-week combined remission.
IBD Remission Maintained
Results from the study demonstrated that transitioning from IV to SC-VDZ was effective in maintaining remission in patients with IBD, with high rates of combined SFCR plus BR observed at both 12 and 24 weeks post-transition. “At 24-week, 89.2% (n=74) maintained combined steroid-free clinical remission plus biochemical remission,” wrote the study authors. Furthermore, UC diagnosis was identified as a predictor of a higher probability of combined remission at 24 weeks compared with CD. In J Gastrointestin Liver Dis, the study team wrote that “25 adverse events were reported, mostly SARS-CoV-2 infections and injection site reactions, with a further four recurrence episodes. Twelve patients (12.9%) discontinued subcutaneous administration and restarted intravenous vedolizumab.
Potential to Improve Outcomes & QOL
The findings of this study provide valuable insights into the effectiveness and safety of transitioning from IV to SC-VDZ in patients with IBD. “Switching from intravenous to subcutaneous vedolizumab can be considered effective and safe for maintaining remission in patients with inflammatory bowel disease,” wrote Dr. Parisio and team. “In addition, this might reduce healthcare costs.”
While the results are promising, further research with larger sample sizes and longer follow-up periods is warranted to validate these findings and explore patient satisfaction and healthcare costs associated with this transition, according to the study authors. Ultimately, optimizing the use of SC-VDZ in clinical practice has the potential to improve treatment outcomes and enhance the quality of life for patients with IBD, they added in J Gastrointestin Liver Dis.
