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To distinguish between the histologic outcomes linked with vedolizumab and adalimumab in moderate to severe ulcerative colitis (UC).
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.
To distinguish between the histologic outcomes
linked with vedolizumab and adalimumab in moderate to severe ulcerative colitis (UC).
Participants in the VARSITY (The Study of
Vedolizumab Intravenous and Adalimumab Subcutaneous in UC patients) were
randomized to maintenance with:
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.
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):
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.
Gastroenterology
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)
Laurent Peyrin-Biroulet et al.
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