AbbVie (NYSE: ABBV) today announced top-line results from the Phase 3 SEQUENCE clinical trial evaluating risankizumab (SKYRIZI®, 600 mg intravenous [IV] induction at week 0, 4 and 8 and 360 mg subcutaneous injection [SC] starting at week 12 and every 8 weeks thereafter) versus ustekinumab (STELARA®, IV dose at week 0 and 90 mg SC every 8 weeks thereafter) through week 48 in patients with moderately to severely active Crohn’s disease who have failed one or more anti-TNFs.
Abbvie’s SKYRIZI (risankizumab)
SKYRIZI(risankizumab) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.
SKYRIZI is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency for the treatment of plaque psoriasis, psoriatic arthritis and Crohn’s disease.
Phase 3 trials of risankizumab in psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis are ongoing.
Primary endpoint comparison between AbbVie’s SKYRIZI and Stelara
The first primary endpoint, clinical remission (defined as CDAI 150) at week 24, demonstrated non-inferiority of risankizumab versus ustekinumab (non-inferiority margin of 10%); remission rates were 59% in the risankizumab group and 40% in the ustekinumab group.
The results of the second primary endpoint, endoscopic remission (SES-CD <=4 and at least a 2-point reduction versus baseline, with no sub-score greater than 1 in any individual component) at week 48 demonstrated that risankizumab was superior to ustekinumab; remission rates were 32% in the risankizumab group and 16% in the ustekinumab group (p 0.0001).
“We are encouraged by these results, which demonstrate the impact SKYRIZI can have in helping patients achieve both clinical and endoscopic remission,” said Roopal Thakkar, senior vice president, development and regulatory affairs and chief medical officer, AbbVie. “These head-to-head data reinforce SKYRIZI is an effective treatment option for patients living with Crohn’s disease.”
Safety profile comparison between AbbVie’s SKYRIZI and Stelara
Risankizumab’s safety profile in the SEQUENCE study was consistent with the known safety profile, with no additional safety hazards reported. COVID-19, headache, and Crohn’s disease were the most prevalent adverse events in the risankizumab group, and COVID-19, Crohn’s disease, and arthralgia in the ustekinumab group.
“Head-to-head studies like the SEQUENCE study are important in helping physicians understand differences in therapies and define treatment algorithms in clinical practice,” said Laurent Peyrin-Biroulet, M.D., Ph.D., director of the Infinity Institute, professor of gastroenterology and head of the Inflammatory Bowel Disease group at the Gastroenterology Department, University Hospital of Nancy, France. “These results add to our growing body of evidence for SKYRIZI in Crohn’s Disease. This study highlights the efficacy of SKYRIZI compared to ustekinumab in helping eligible patients achieve clinical and endoscopic treatment goals and also reinforces the safety profile observed in previous studies.”
About Crohn’s Disease:
Crohn’s disease is a chronic, systemic disease characterised by gastrointestinal inflammation that causes persistent diarrhoea and abdominal pain. It is a progressive condition, which means that it worsens over time in a significant proportion of individuals or may develop consequences that necessitate immediate medical attention, including surgery. Because Crohn’s disease’s indications and symptoms are unpredictable, it places a considerable burden on persons dealing with the disease—not only physically, but also emotionally and financially.
About the SEQUENCE Study:
The SEQUENCE study is a Phase 3, multicenter, randomised, head-to-head study (study drug open-label and efficacy assessment blinded) comparing risankizumab to ustekinumab for the treatment of adults with moderate to severe Crohn’s disease who have previously failed one or more anti-tumor necrosis factor (TNF) therapies. All participants had a confirmed Crohn’s disease diagnosis for at least 3 months, a Crohn’s Disease Activity Index (CDAI) score of 220 to 450 at baseline, a confirmed diagnosis of moderate to severe Crohn’s disease assessed by stool frequency, abdominal pain score, Simple Endoscopy Score for Crohn’s Disease (SES-CD), and demonstrated intolerance or inadequate response to one or more anti-TNF therapies.
