AbbVie’s next-generation anti-inflammation drug Skyrizi has been acing clinical trials left and right.
The latest? The antibody drug is applying pressure on Johnson & Johnson’s Stelara with a successful head-to-head study in Crohn’s disease.
Skyrizi matched up to Stelara in terms of inducing clinical remission in patients with active, moderate to severe Crohn’s disease who have failed on traditional anti-TNF agents, AbbVie said Tuesday.
Although the phase 3 SEQUENCE trial was designed to measure noninferiority on that primary endpoint, Skyrizi additionally showed a large treatment effect against Stelara. Remission rates, as measured by the Crohn’s Disease Activity Index (CDAI), were 59% for Skyrizi and 40% for Stelara, respectively, at week 24, according to AbbVie.
On another primary endpoint called endoscopic remission, Skyrizi beat Stelara. On the simple endoscopic score for Crohn’s disease, 32% of patients taking Skyrizi experienced remission at week 48, significantly higher than the 16% rate in the Stelara group.
What’s more, Skyrizi also showed a statistically significant advantage over Stelara on all secondary endpoints, AbbVie said. This includes superiority against the J&J drug on the CDAI clinical remission scale at week 48.
Skyrizi won an FDA nod in Crohn’s disease in June 2022 based on two induction studies and one maintenance trials that compared the IL-23 inhibitor to a placebo or withdrawal of treatment. Now, the new head-to-head data again show that “Skyrizi is an effective treatment option for patients living with Crohn’s disease,” AbbVie’s chief medical officer, Roopal Thakkar, said in a statement Tuesday.
A year into the Crohn’s disease launch, Skyrizi has captured about 25% of the market share for new and switching patients in the U.S., almost at parity with Stelara, AbbVie’s chief commercial officer Jeff Stewart said on the company’s second-quarter call in July. In the second quarter, Skyrizi sales jumped 50% year over year to nearly $1.9 billion.
Skyrizi has been on a clinical winning streak lately. In another inflammatory bowel disease subtype, ulcerative colitis, the drug recently delivered positive readouts across the board on primary and secondary endpoints—both as an induction and maintenance therapy, respectively, in two phase 3 trials.
Two weeks ago, AbbVie announced its submissions to the FDA and the European Medicines Agency for Skyrizi in ulcerative colitis.
The Crohn’s disease win also comes weeks after Skyrizi beat Amgen’s Otezla in a head-to-head plaque psoriasis trial. By week 16, 55.9% of patients with moderate psoriasis who took Skyrizi experienced clear or almost clear skin, versus 5.1% of patients on Otezla.
Based on a strong performance so far this year, AbbVie in July dialed up its 2023 sales guidance for Skyrizi by $200 million to $7.6 billion.
AbbVie is trying hard to grow Skyrizi and JAK inhibitor Rinvoq in inflammatory diseases to compensate for the revenue loss from the anti-TNF drug Humira, which suffered a 25% sales decline in the second quarter to $4 billion thanks to an ongoing biosimilar attack in the U.S.
Similarly, J&J is also bracing for Stelara’s patent cliff. While the IL-12/23 antibody begins losing U.S. patent protections starting this year, J&J has reached settlements with Amgen, a partnership between Teva and Alvotech, and a collaboration between Fresenius Kabi and Formycon that will delay their Stelara biosimlar launches until 2025.
In the second quarter, Stelara’s worldwide sales rose 8% to $2.8 billion.