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Takeda Announces Results From Phase 3b Head-to-head VARSITY Study

(RTTNews) - Takeda Pharmaceutical Company Limited announced results from the Phase 3b head-to-head VARSITY study which demonstrated that the gut-selective biologic vedolizumab (Entyvio) was superior to the anti-tumor necrosis factor-alpha (anti-TNFa) biologic adalimumab (Humira) in achieving clinical remission in patients with moderately to severely active ulcerative colitis at week 52. Data showed th

at 31.3% (n=120/383) of patients receiving vedolizumab intravenous (IV) achieved the primary endpoint of clinical remission compared to 22.5% (n=87/386) of patients treated with adalimumab subcutaneous (SC) at week 52, with the difference being statistically significant (p=0.0061).

Furthermore, treatment with vedolizumab was associated with significantly higher rates of mucosal healing at week 52, with 39.7% of patients receiving vedolizumab achieving mucosal healing compared to 27.7% treated with adalimumab (p=0.0005). A non-statistically significant difference in favor of adalimumab was seen in the percentage of patients using oral corticosteroids at baseline who discontinued corticosteroids and were in clinical remission at week 52.

While the study was not powered to compare the safety of the two biologics, patients treated with vedolizumab (62.7%) had a lower rate of overall adverse events over 52 weeks than patients treated with adalimumab (69.2%), with a lower rate of infections reported in patients treated with vedolizumab (33.5%) as compared to adalimumab (43.5%). The rate of serious adverse events was also lower in vedolizumab-treated patients than adalimumab (11.0% vs. 13.7% respectively).
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