Comparison of histologic outcomes with Vedolizumab and Adalimumab in ulcerative colitis: VARSITY study

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Created On: 31/08/2021

Comparison of histologic outcomes with Vedolizumab and Adalimumab in ulcerative colitis: VARSITY study

To distinguish between the histologic outcomes linked with vedolizumab and adalimumab in moderate to severe ulcerative colitis (UC).

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Key take away

In ulcerative colitis patients, vedolizumab use leads to a more significant histologic remission and minimal histologic disease activity at weeks 14 and 52 compared to adalimumab usage in both anti-tumour necrosis factor (TNF)-naïve and anti-TNF-failure subgroups.

Background

To distinguish between the histologic outcomes linked with vedolizumab and adalimumab in moderate to severe ulcerative colitis (UC).

Method

Participants in the VARSITY (The Study of Vedolizumab Intravenous and Adalimumab Subcutaneous in UC patients) were randomized to maintenance with:

Vedolizumab intravenous (IV) 300 mg every eight weeks, or
Adalimumab subcutaneous (SC) 40 mg every two weeks (both after standard induction)

At weeks 14 and 52, the Robarts Histopathology Index (RHI) score and the Geboes Index score helped to evaluate the pre-defined histologic exploratory outcomes of histologic remission (Geboes <2 or RHI ≤2) and minimal histologic disease activity with Geboes score of ≤3.1 or RHI ≤4.

Result

Seven hundred and sixty-seven patients were given vedolizumab (383 patients) or adalimumab (386 patients). Mean baseline histologic disease activity was similar. Vedolizumab elicited higher histologic remission than adalimumab at week 14 and week 52 overall and in both anti–TNF-naïve and -failure subgroups (Table 1):

Minimal histologic disease activity had similar results in both groups. Anti–TNF-naive patients generally had better histologic outcomes compared to -failure patients. Histologic improvement was associated with endoscopic improvement. Patients in the vedolizumab group had a greater frequency of mucosal healing (the composite endpoint of histologic and endoscopic improvement) (Table 2):

Conclusion

Both the anti-TNF-naive and -failure subgroups had increased incidences of histologic remission, marginal histologic disease activity, and combined histologic + endoscopic findings in the vedolizumab group when compared to the adalimumab group.

Source:

Gastroenterology

Link:

https://www.gastrojournal.org/article/S0016-5085(21)03126-7/fulltext?referrer=https%3A%2F%2Fpubmed.ncbi.nlm.nih.gov%2F

Article:

Histologic Outcomes With Vedolizumab Versus Adalimumab in Ulcerative Colitis: Results From An Efficacy and Safety Study of Vedolizumab Intravenous Compared to Adalimumab Subcutaneous in Participants With Ulcerative Colitis (VARSITY)