More (statistically significant) patients achieved clinical remission with Takeda’s Entyvio (vedolizumab).
Entyvio (vedolizumab) is the first drug shown to outperform AbbVie’s Humira (adalimumab) in ulcerative colitis (UC) in a clinical trial. Pfizer's Xeljanz (tofacitinib) did not achieve noninferiority to Humira in rheumatoid arthritis. Eli Lilly's Taltz (ixekizumab), however, did better than Humira in active psoriatic arthritis.
What is different in this latest trial is that vedolizumab operates by a different mechanism of action in UC. It is a gut-selective anti-α4β7 integrin, while Humira is an anti-TNF-α drug.
In the phase IIIb study, 769 patients who had an inadequate response to previous treatment were randomly assigned one of the biologics. After one year, nearly one-third of the patients receiving Entyvio experienced clinical remission compared with less than one-quarter of the patients receiving Humira. In addition, Entyvio showed a higher rate of mucosal healing. Humira, on the other hand, was better at providing corticosteroid-free clinical remission. It is also interesting that Entyvio showed lower rates for adverse events (63% to Humira's 69%) and infections (34% to 44%).
Entyvio is already approved in the United States for UC and Crohn's disease, while Humira has U.S. approvals for those two ailments, as well as for rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis, among others.