AbbVie trumpets Skyrizi's resounding win against J&J's Stelara in Crohn's disease

AbbVie already shared last month that its Skyrizi had trounced Johnson & Johnson’s rival biologic drug Stelara in Crohn’s disease. Now, detailed trial results show just how decisive Skyrizi’s win is.

Skyrizi helped significantly more patients with moderate to severe Crohn’s disease achieve clinical remission than Stelara did at Week 48 in the phase 3 SEQUENCE trial. The remission rates, as measured by the Crohn’s Disease Activity Index, were 61% and 41% for Skyrizi and Stelara, respectively.

The difference in treatment effects at Week 48 was similar to that at Week 24, when 59% patients who took Skyrizi reached remission, versus 40% for Stelara, as AbbVie previously announced. The trial was only designed for Skyrizi to show noninferiority to Stelara at Week 24, one of the trial’s primary endpoints.

The data were presented at the United European Gastroenterology Week 2023.

Skyrizi’s advantage over Stelara covers other aspects. Compared with Stelara, Skyrizi doubled the remission rate as observed under an endoscope to 32% at Week 48. Almost all patients who achieved endoscopic remission or clinical remission while on Skyrizi or Stelara went without steroid.

On a less stringent measurement called endoscopic response, which is defined as a decrease of at least 50% on the Simple Endoscopic Score for Crohn's Disease, Skyrizi also performed better. The AbbVie drug delivered a 45% response rate at both Week 24 and Week 48, while the J&J med’s rate slightly dropped from 26% at Week 24 to 22% at Week 48.

“The results from the SEQUENCE study provide physicians with important data to help inform therapy options that can help patients reach treatment goals,” the study’s lead investigator, Laurent Peyrin-Biroulet, M.D., Ph.D., from the University Hospital of Nancy, France, said in a statement.

AbbVie has its eyes on Stelara from the get-go. Both Skyrizi and Stelara target IL-23, while Stelara also inhibits IL-12.

Skyrizi got its FDA approval in Crohn’s disease in June 2022, and, by the second quarter this year, the drug has already captured a quarter of the market share from new and switching patients in the U.S.

In August, AbbVie filed applications with the FDA and the European Medicines Agency, seeking approvals for Skyrizi in the other type of inflammatory bowel disease, ulcerative colitis. The drug previously aced two phase 3 trials as an induction and maintenance treatment in patients with moderate to severe active ulcerative colitis.

Both Skyrizi and Stelara could face some competition from Pfizer’s oral S1P receptor modulator Velsipity, also known as etrasimod, which just snagged an FDA nod in ulcerative colitis last week.

Pfizer has argued that Velsipity should be used as a front-line treatment following 5-ASA therapies or steroids because it has shown a remission rate that’s on par with biologics.

Skyrizi is billed as a successor to Humira in AbbVie’s inflammatory disease portfolio. At the beginning of the year, AbbVie raised its sales projections for Skyrizi and JAK inhibitor Rinvoq to a combined $17.5 billion in 2025, up from the company’s previous estimate of $15 billion. By 2027, AbbVie hopes the two drugs can more than offset Humira’s patent cliff with sales of $21 billion.

AbbVie has also been spending big on the marketing side for Skyrizi and Rinvoq, with both seeing some of the highest levels of TV drug ad spend over the year so far.