AbbVie has shared positive top-line results from a head-to-head study of its interleukin-23 inhibitor Skyrizi (risankizumab) in Crohn’s disease.
The late-stage study, SEQUENCE, has been evaluating the drug against Johnson & Johnson’s Stelara (ustekinumab) in patients with moderately to severely active disease who have failed one or more traditional anti-TNF agents.
Skyrizi was shown to match Stelara in terms of clinical remission at week 24, with remission rates of 59% in the Skyrizi group and 40% in the Stelara cohort.
On the second primary endpoint of endoscopic remission at week 48, Skyrizi demonstrated superiority to Stelara, with remission rates of 32% and 16%, respectively.
All secondary endpoints achieved statistical significance for superiority versus Stelara, AbbVie said, and safety results were consistent with the overall safety profile of Skyrizi.
Crohn’s disease is a chronic, progressive condition of the digestive system, causing symptoms such as persistent diarrhoea and abdominal pain. It is estimated that over 155,000 adults are living with Crohn’s disease in the UK, almost half of which have moderate or severe cases.
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.
Skyrizi, which is part of a collaboration between AbbVie and Boehringer Ingelheim, is already approved by the US Food and Drug Administration and the European Medicines Agency 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: “We are encouraged by these results, which demonstrate the impact Skyrizi can have in helping patients achieve both clinical and endoscopic remission.”
Laurent Peyrin-Biroulet, director of the Infinity Institute, professor of gastroenterology and head of the Inflammatory Bowel Disease group at the Gastroenterology Department at the University Hospital of Nancy, added: “Head-to-head studies like the SEQUENCE study are important in helping physicians understand differences in therapies and define treatment algorithms in clinical practice.
“These results add to our growing body of evidence for Skyrizi in Crohn’s disease. This study highlights the efficacy of Skyrizi compared to Stelara in helping eligible patients achieve clinical and endoscopic treatment goals and also reinforces the safety profile observed in previous studies.”