AbbVie announces positive results from head-to-head study of Skyrizi in Crohn's disease

17 Oct 2023
www.pmlive.com
Clinical ResultBiosimilar
AbbVie announces positive results from head-to-head study of Skyrizi in Crohn's disease
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Source: PMLiVE
AbbVie has shared detailed results from a head-to-head study comparing its IL-23 inhibitorIL-23 inhibitor Skyrizi (risankizumab) to Johnson & Johnson’s Stelara (ustekinumab) in Crohn's disease.
The late-stage SEQUENCE study has been evaluating the drugs, both given as a subcutaneous injection every eight weeks after a lead-in period of intravenous infusions, in patients with moderately to severely active disease who have failed one or more traditional anti-TNF agents.
Crohn’s disease is a chronic, progressive condition of the digestive system, causing symptoms such as persistent diarrhoea and abdominal pain.
Despite the availability of a range of treatments, not every patient achieves long-lasting remission, and the progressive damage from disease flare-ups can result in some patients requiring surgery.
The results from SEQUENCE, which were presented at the United European Gastroenterology Week, showed that Skyrizi was superior to J&J’s IL-12 and IL-23 inhibitorIL-23 inhibitor at achieving endoscopic remission after 48 weeks of treatment, with 32% and 16% of patients, respectively, reaching that goal.
Skyrizi was shown to match Stelara on the second primary endpoint of clinical remission at week 24, with remission rates of 59% in the Skyrizi group and 40% in the Stelara cohort.
All secondary endpoints achieved statistical significance for superiority versus Stelara, AbbVie said, and safety results were consistent with the overall safety profile of Skyrizi.
Skyrizi, which is part of a collaboration between AbbVie and Boehringer Ingelheim, is already approved in major markets to treat Crohn’s disease, as well as plaque psoriasis and psoriatic arthritis.
Roopal Thakkar, senior vice president, development and regulatory affairs and chief medical officer at AbbVie, said: "Results such as these not only help differentiate Skyrizi as an option for managing Crohn's disease, but also may help to evolve the field by further informing on therapeutic strategies for patients."
"These findings reaffirm Skyrizi as an efficacious IL-23 inhibitorIL-23 inhibitor that can support the achievement of stringent targets that contribute to improved care for patients," said Laurent Peyrin-Biroulet, director of the Infinity Institute, professor of gastroenterology and head of the inflammatory bowel disease group, gastroenterology department at the University Hospital of Nancy in France.
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