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Entyvio shows superiority over Humira in first head-to-head biologic study in ulcerative colitis

OSAKA, Japan–(BUSINESS WIRE)–Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) today announced further results from the VARSITY study, which demonstrated the superiority of the gut-selective biologic vedolizumab (Entyvio®) to the anti-tumor necrosis factor-alpha (anti-TNFα) biologic adalimumab (Humira®) in achieving the primary endpoint of clinical remission at week 52 in patients with moderately to severely active ulcerative colitis (UC), have been published in The New England Journal of Medicine (NEJM). Clinical remission rates at week 52 were superior with vedolizumab at 31.3% (n=120/383) versus 22.5% (n=87/386) with adalimumab (p=0.006).

Featured image, by pharmaceutical daily staff: illustration. Source: www.humira.com

New exploratory data published in the NEJM showed vedolizumab achieved higher percentages of clinical remission at week 52 compared to adalimumab in both anti-TNFα-naïve patients (34.2% [n=104/304] vedolizumab vs. 24.3% [n=74/305] adalimumab) and anti-TNFα-experienced patients with UC (20.3% [n=16/79] vedolizumab vs. 16.0% [n=13/81] adalimumab).1 Further exploratory data showed 26.6% (n=102/383) of vedolizumab-treated patients achieved clinical remission at week 14 as compared to 21.2% (n=82/386) treated with adalimumab.1 Durable clinical remission was achieved in 18.3% (n=70/383) of patients with vedolizumab and 11.9% (n=46/386) of patients with adalimumab respectively.1

In the secondary endpoints of the study, treatment with vedolizumab was associated with significantly higher percentages of mucosal healing at week 52 compared to patients treated with adalimumab (39.7% [n=152/383] vs. 27.7% [n=107/386]; p<0.001).1 Vedolizumab was not superior to adalimumab in the percentage of patients using oral corticosteroids at baseline who discontinued corticosteroids and were in clinical remission at week 52 (12.6% [n=14/111] vs. 21.8% [n=26/119]).1 Exploratory results for the median change in oral corticosteroid use from baseline to week 52 were -10.0 mg in the vedolizumab group compared to -7.0 mg in the adalimumab group.1

Further exploratory results published in the NEJM showed that treatment with vedolizumab was associated with improvements in quality of life, with 52.0% (n=199/383) of vedolizumab-treated versus 42.2% (n=163/386) of adalimumab-treated patients reporting a ≥16-point improvement in total Inflammatory Bowel Disease Questionnaire (IBDQ) scores from baseline to week 52.1 The IBDQ examines the impact of inflammatory bowel disease on four aspects of patients’ lives: symptoms directly related to the primary bowel disturbance, systemic symptoms, and emotional and social function.

“In a chronic, debilitating condition like ulcerative colitis, it is essential that patients gain relief from the many different aspects of the disease,” said Dr. Bruce E. Sands, primary investigator of the VARSITY study and Chief of the Dr. Henry D. Janowitz Division of Gastroenterology at The Mount Sinai Hospital and the Icahn School of Medicine at Mount Sinai in New York. “The VARSITY results provide physicians with valuable insights to support their treatment decisions when initiating biologic therapy in patients with ulcerative colitis.”

“The VARSITY study, a first-of-its-kind comparison of two biologics in ulcerative colitis, shows the benefits vedolizumab treatment provides to patients versus adalimumab across efficacy outcomes, in addition to improvements in overall quality of life,” said Jeff Bornstein, M.D., Executive Medical Director, Takeda. “These data further support the use of vedolizumab as a first-line biologic therapy in ulcerative colitis.”

While the study was not powered to compare the safety of the two biologics, patients treated with vedolizumab (62.7%; n=240/383) had a lower percentage of overall adverse events over 52 weeks than patients treated with adalimumab (69.2%; n=267/386). The percentage of serious adverse events was also lower in vedolizumab-treated patients than adalimumab (11.0% [n=42/383] vs. 13.7% [n=53/386] respectively). The proportion of patients who discontinued treatment because of adverse events was similar in both groups.

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