In a follow-up readout, data from the head-to-head SEQUENCE study showed that AbbVie’s Skyrizi induced better rates of steroid-free remission in Crohn’s disease than Johnson & Johnson’s Stelara.
Pictured: AbbVie building in California/iStock, vzphotos
AbbVie on Sunday unveiled new data from its Phase III SEQUENCE study, demonstrating that its Skyrizi (risankizumab) was either non-inferior or outright superior to Johnson & Johnson’s Stelara (ustekinumab) for treating patients with Crohn’s disease.
This readout follows a previous data drop from SEQUENCE, posted last month, which showed that Skyrizi met the study’s two primary endpoints. Compared to Stelara, Skyrizi was non-inferior at inducing clinical remission at 24 weeks and was superior at achieving endoscopic remission at 48 weeks.
Sunday’s findings, which were presented at the United European Gastroenterology Week 2023, included new secondary endpoint data. At 48 weeks, 31% of Skyrizi-treated patients achieved steroid-free endoscopic remission, compared to only 15% of Stelara counterparts. Steroid-free clinical remission was likewise higher in the Skyrizi group at 61% versus 40% in the Stelara arm.
Both endpoints met statistical significance, with a p-value less than 0.0001, according to AbbVie’s press release.
These data not only “differentiate Skyrizi as an option for managing Crohn’s Disease,” but also help advance the field “by further informing on therapeutic strategies for patients,” Roopal Thakkar, AbbVie’s senior vice president of development and regulatory affairs, said in a statement.
SEQUENCE is a Phase III head-to-head study that enrolled 527 patients with moderately to severely active Crohn’s disease (CD), as determined by a CD activity index score of 220 to 450 at baseline. All participants had to have also failed at least one previous line of anti-tumor necrosis factor therapy.
Besides efficacy, SEQUENCE also compared the two treatments in terms of safety and found that serious adverse events arose in 17% of patients treated with J&J’s Stelara, compared to only 10% in those who received AbbVie’s Skyrizi.
Skyrizi’s safety profile was also consistent with what had been previously established in prior studies. No new signals of concerns were observed, according to AbbVie.
Both Skyrizi and Stelara are monoclonal antibodies that suppress the inflammatory cascade by targeting the IL-23 cytokine and preventing its interaction with the corresponding receptor—while Stelara also binds to IL-12. Stelara was first to reach the market with its FDA approval in September 2016, while Skyrizi followed nearly six years later in June 2022.
Skyrizi has logged several clinical wins. In ulcerative colitis, another type of inflammatory bowel disease, the IL-23 inhibitor showed significant efficacy both as an induction or maintenance therapy. In plaque psoriasis, Skyrizi won another head-to-head study, showing better symptom improvement than Amgen’s Otezla (apremilast).
Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
