Dive Brief:

• Takeda’s Entyvio outperformed AbbVie’s Humira as an ulcerative colitis therapy, according a topline readout of a Phase 3b study by the Japanese pharma.
• The trial randomly assigned to each biologic 769 patients who had an inadequate response to previous treatment. After a year, the Entyvio arm posted a clinical remission rate of 31% compared to Humira’s 23%, hitting statistical significance on the trial’s primary goal.
• On two secondary endpoints, Entyvio showed a higher rate of mucosal healing but AbbVie’s therapy showed a numerical edge in the percentage of patients who achieved corticosteroid-free clinical remission, Takeda conceded. Data were presented Saturday in Denmark at the 14th Congress of the European Crohn’s and Colitis Organization.

Dive Insight:

Earning an industry-leading $19.9 billion in sales last year, AbbVie’s Humira(adalimumab) has long been a target. Competitors have targeted the drug clinically through head-to-head studies, but legal and politically as well. So far, the company has staved off U.S. biosimilar entry until 2023, but has been less successful in dodging scrutiny of its pricing and patent practices. 

In the clinic, Humira has been pitted in head-to-head studies against other drugs before. While Pfizer’s Xeljanz (tofacitinib) failed to achieve non-inferiority to the drug in rheumatoid arthritis two years ago, Eli Lilly’s Taltz (ixekizumab) beat the anti-TNF biologic in active psoriatic arthritis last December.

Now, Takeda’s trial is the first clinical study to directly compare two biologics in ulcerative colitis, or UC, said Jeff Bornstein, the company’s executive medical director, in a March 9 statement.

“This is also the first time we have seen a direct comparison between two medicines with distinct modes of action in ulcerative colitis, the gut-selective anti-alpha4beta7 integrin vedolizumab and the anti-TNFα adalimumab,” Bornstein said.

While the study was powered to measure efficacy, Entyvio (vedolizumab) showed lower rates for adverse events (63% to Humira’s 69%) and infections (34% to 44%), Takeda noted. The pharma’s execs framed the study as demonstrating Entyvio’s efficacy and safety compared to the market leader in inflammatory disease. 

For Takeda, gastroenterology has been a key therapeutic area along with oncology, neuroscience and rare diseases. Entyvio is its top-selling gastro drug, posting roughly $1.8 billion in sales for the last nine months of 2018. (The Japanese pharma’s current fiscal year began last April and runs through May 2019.)

Entyvio, an integrin receptor antagonist, is approved in the U.S. as a treatment for adults with UC or Crohn’s disease. Humira’s wide-ranging labels cover both those conditions, as well as rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis among others.