Vedolizumab serum trough concentrations with and without thiopurines in ulcerative colitis: The prospective VIEWS pharmacokinetics study

Vedolizumab Study in Ulcerative Colitis

Background

Ulcerative colitis (UC) is a long-term inflammatory disease that needs ongoing treatment and monitoring. There is not much information about how vedolizumab works during maintenance therapy and how thiopurines affect its levels.

Aim

This study aimed to understand how vedolizumab levels relate to treatment outcomes and what happens when thiopurines are stopped in UC patients who are doing well on maintenance therapy.

Methods

This analysis comes from the VIEWS clinical trial, which included UC patients from 8 centers in Australia between 2018 and 2022. Patients in remission were either kept on thiopurines or taken off them while continuing vedolizumab. We measured vedolizumab levels, checked for antibodies against it, and looked at clinical outcomes over 48 weeks.

Results

We studied 62 UC patients with an average age of 43.4 years, 42% of whom were female. All received vedolizumab, and 67.7% stopped thiopurines. Vedolizumab levels stayed stable over 48 weeks, regardless of thiopurine use, and no antibodies were found. Patients in remission had higher drug levels at week 48. A level above 11.3 μg/mL was linked to sustained remission, with a sensitivity of 82.4% and specificity of 60.0%. Patients who stopped thiopurines needed higher vedolizumab levels to stay in remission.

Conclusion

There is a positive link between vedolizumab levels and UC outcomes, suggesting that monitoring these levels could be helpful. Stopping thiopurines does not change vedolizumab levels, but it may require higher levels of vedolizumab to maintain remission.

Clinical Trial Importance

Clinical trials are essential for developing safe and effective treatments. It’s crucial to integrate their findings into everyday medical practice. Our AI-driven platform, DocSym, helps by bringing together ICD-11 standards, clinical protocols, and research into one easy-to-use resource for healthcare providers.

Streamlining Healthcare

In today’s healthcare landscape, improving efficiency is vital. Our mobile apps assist with scheduling, treatment monitoring, and telemedicine, simplifying patient care and expanding digital services.