VARSITY was a phase 3b randomised, double-blind, double-dummy, multicentre, active-controlled trial. The 771 participants were randomised to: 1) active vedolizumab intravenous (IV) infusions (300 mg)/placebo subcutaneous injections; or 2) placebo IV infusions/active adalimumab subcutaneous injections (160 mg, 80 mg, 40 mg). The primary endpoint was clinical remission.
The results were presented by Dr Stefan Schreiber (University-Hospital Schleswig-Holstein, Germany), who showed that the percentage of patients who completed the study was 74.5% in the vedolizumab group vs 61.9% in the adalimumab group. Overall clinical remission rates at week 52 were 31.3% for vedolizumab and 22.5% for adalimumab (P=0.0061). Mucosal healing at week 52 was achieved in 39.7% and 27.7% of patients, respectively (P=0.0005). Overall, 62.7% and 69.2% of patients experienced an adverse event. Serious adverse events occurred in 11.0% and 13.7% of patients, respectively.
Dr Schreiber noted that the clinical superiority of vedolizumab was most pronounced in the anti-TNF naïve subpopulation in a subgroup analysis. Treatment differences in clinical response appeared to emerge between week 6 and week 14. Corticosteroid-free remission rates numerically favoured adalimumab, while the absolute reduction of corticosteroid use was greater with vedolizumab; however, treatment group differences were not significant. Both drugs were found to be generally safe and well-tolerated. Dr Schreiber concluded: “These results support the use of vedolizumab prior to adalimumab in patients with moderately tot severely active ulcerative colitis.”
- Schreiber S, et al. ECCO 2019, OP34.
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Table of Contents: ECCO 2019
Featured articles
Interview with Prof. Janneke van der Woude
New Compounds: Study Results
Short-term and Long-term Treatment Results
The right drug for the right patient
Vedolizumab superior to adalimumab in ulcerative colitis
Complementary and Alternative Medicine
Crohn’s disease exclusion diet + partial enteral nutrition in paediatric Crohn’s disease
Microbial composition and psychological wellbeing
Remission
Early remission of Crohn’s disease prevents progression
Proactive adalimumab trough measurements
Observational Studies
IBD risk of treatment with IL-17 antagonists
Basic and Preclinical Research
Immune cells and microbes: a happy marriage?
Genetics
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