Continuing its clinical win streak, AbbVie’s Skyrizi showed signs of superiority against Johnson & Johnson’s Stelara in topline data from a head-to-head Phase III Crohn’s disease study.
Pictured: AbbVie headquarters in California/iStock, Michael Vi
Topline data from the Phase III SEQUENCE trial showed that AbbVie’s Skyrizi (risankizumab) matched, and could potentially even outpace, Johnson & Johnson’s Stelara (ustekinumab) in patients with Crohn’s disease.
SEQUENCE was designed to establish the non-inferiority of Skyrizi compared to Stelara in terms of clinical remission. AbbVie’s IL-23 inhibitor not only met this bar, but also demonstrated signals of superiority: 59% of Skyrizi-treated patients achieved remission, as opposed to only 40% among Stelara comparators.
Remission, the study’s primary endpoint, was defined as scores lower than 150 in the Crohn’s Disease Activity Index, measured at week 24.
“These head-to-head data reinforce SKYRIZI is an effective treatment option for patients living with Crohn’s disease,” Roopal Thakkar, AbbVie’s chief medical officer and senior vice president of development and regulatory affairs, said in a statement.
SEQUENCE’s results also highlight the role Skyrizi can play in helping patients reach both clinical and endoscopic remission, Thakkar said.
Both AbbVie’s Skyrizi and J&J’s Stelara are approved by the FDA for Crohn’s disease, though the latter was ahead by some six years, earning its regulatory greenlight in September 2016. Skyrizi was authorized in June 2022. The two treatments share other indications, too, including plaque psoriasis and psoriatic arthritis.
The therapeutic antibodies also have similar mechanisms of action. By blocking the interaction between IL-23 and its corresponding receptor, Skyrizi disrupts the signaling cascade that culminates in an inflammatory response. In turn, this alleviates the inflammation-driven symptoms of Crohn’s disease and other similar conditions.
Stelara, in comparison, targets two players in this cascade: IL-12 and IL-23. This mechanism also dampens the inflammatory cascade and addresses key symptoms in related diseases.
First posted in August 2020, SEQUENCE is a multicenter, randomized and assessor-blinded study that directly compared Skyrizi against Stelara in 527 patients with moderate-to-severe Crohn’s disease who had failed a prior line of anti-tumor necrosis factor therapy. Aside from efficacy, SEQUENCE also looked at Skyrizi’s safety and found no new safety risks.
The most common side effects associated with AbbVie’s antibody were headache, COVID-19 and Crohn’s disease.
Tuesday’s data from SEQUENCE continues Skyrizi’s winning streak. In ulcerative colitis, another form of inflammatory bowel disease, the IL-23 blocker led to significant and clinically meaningful improvements in remission when used as either an induction or maintenance therapy. AbbVie used these data as the basis for its regulatory submissions last month.
In July 2023, Skyrizi also emerged superior in another head-to-head study, this time against Amgen’s Otezla (apremilast) in plaque psoriasis.
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.
