AbbVie’s Skyrizi helps more Crohn’s patients stay off steroids than J&J’s Stelara, PhIII data show
Ayisha Sharma
News Reporter
AbbVie’s Skyrizi has demonstrated significantly higher rates of steroid-free clinical and endoscopic remission versus rival Johnson & Johnson’s Stelara in a Phase III trial, helping set the Crohn’s disease drug apart in an increasingly competitive market.
Stelara won an FDA approval for Crohn’s disease in 2016, while Skyrizi was approved three years later in 2019. But the competition is heating up with Stelara biosimilars set to enter the market in 2025, government price negotiations in 2026, and a new rival emerging in the form of Pfizer’s oral S1P inhibitor Velsipity for ulcerative colitis.
The Phase III SEQUENCE trial set Skyrizi against Stelara in more than 500 people with moderate to severe Crohn’s disease who had failed at least one anti-TNF drug.
In September, AbbVie revealed Skyrizi had met all endpoints in the trial. This included achieving non-inferiority in the primary endpoint of clinical remission at 24 weeks and superiority in the secondary endpoint of endoscopic remission at 48 weeks. On Sunday, AbbVie unveiled new secondary endpoint data at the annual United European Gastroenterology Week meeting.
These showed that Skyrizi achieved a steroid-free endoscopic remission rate of 31% versus 15% for Stelara at 48 weeks. Abbvie’s drug also attained a 61% steroid-free clinical remission rate in the same timeframe versus 40% for J&J’s product. Both sets of results were statistically significant (p<0.0001), the company said.
These outcomes are important because steroid use, while common in the management of Crohn’s disease flare-ups, can lead to side effects including weight gain, high blood sugar and weak bones.
Skyrizi is key to AbbVie’s long-term outlook because, alongside its JAK inhibitor Rinvoq, the drug could help offset the expected biosimilar erosion of its blockbuster inflammatory franchise Humira.
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