AbbVie announced that the European Commission has approved SKYRIZI® (risankizumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

"Ulcerative colitis is a chronic, unpredictable and sometimes debilitating disease, and people living with the condition need sustained symptom relief," said Edouard Louis, M.D., Ph.D., professor and head of gastroenterology, Liège University Hospital, dean of faculty, Liège University, and INSPIRE trial investigator. "Patients treated with SKYRIZI in the INSPIRE and COMMAND clinical trials experienced significant improvements in clinical remission and mucosal healing. These are important findings as mucosal healing goes beyond symptom management to restoration of the intestinal lining and is associated with improved long-term outcomes. This approval introduces a new treatment option to help patients with UC reach their long-term treatment goals."

UC is estimated to affect 5 million people around the world, with an increasing incidence globally. Common signs and symptoms include diarrhea, abdominal pain, blood in the stool, urgency to defecate, passing mucus from the rectum, and rectal pain and bleeding. Due to these symptoms, patients often lack the ability or desire to pursue everyday activities.

"The approval of SKYRIZI for the treatment of UC provides physicians with a new treatment option that is proven to help a wide range of patients with varying degrees of prior therapy use, including conventional or biological therapy," said Roopal Thakkar, M.D., executive vice president, research & development, and chief scientific officer, AbbVie. "Notably, in the Phase 3 trials we observed positive results in mucosal healing, particularly in patients without previous biologic experience or JAK inhibitor failure. The EU approval of SKYRIZI for people living with UC strengthens our diversified IBD portfolio, providing healthcare professionals with more options to treat their IBD patients."

The recommended SKYRIZI induction dose is 1,200 mg administered by intravenous (IV) infusion at week 0, week 4, and week 8. Starting at week 12 and every 8 weeks thereafter, the recommended maintenance dose of either 180 mg or 360 mg administered by subcutaneous (SC) injection is based on individual patient presentation.

The approval of SKYRIZI was based on two Phase 3 clinical trials, INSPIRE and COMMAND. Primary and key secondary endpoint results from the Phase 3 trials include the following:

Primary Endpoint: Clinical Remission

• In the INSPIRE induction trial, a significantly higher proportion of patients treated with risankizumab 1,200 mg IV achieved the primary endpoint of clinical remission (per Adapted Mayo Score*) at week 12 than patients receiving placebo (20% vs 6%; p<.00001).
• In the COMMAND maintenance trial, a significantly higher proportion of patients who received risankizumab 180 mg or 360 mg SC achieved clinical remission at week 52 than patients in the induction-only control group: 40% and 38%, respectively, versus 25% (p≤.01).

Key Secondary Endpoint: Mucosal Healing

• In INSPIRE, mucosal healing** was observed at week 12 in 37% of patients treated with risankizumab 1,200 mg IV compared to 12% of those receiving placebo (p<.00001). Specifically, in patients without previous biologic or JAK inhibitor failure, 48% of patients treated with risankizumab 1,200 mg IV achieved mucosal healing at week 12 versus 14% of those receiving placebo.
• In COMMAND, 51% of patients treated with risankizumab 180 mg and 48% of patients treated with risankizumab 360 mg achieved mucosal healing at week 52 versus 32% of patients in the induction-only control group (p<.001). In patients without previous biologic or JAK inhibitor failure, 60% of patients who received risankizumab 180 mg and 76% who received risankizumab 360 mg achieved mucosal healing versus 36% of patients in the induction-only control group.

Key Secondary Endpoint: Histologic Endoscopic Mucosal Healing (HEMH)

• In INSPIRE, 24% of patients treated with risankizumab 1,200 mg IV achieved HEMH† at week 12 versus 8% of those receiving placebo (p<.00001).
• In COMMAND, significantly more patients treated with risankizumab 180 mg and 360 mg achieved HEMH at week 52 than those treated with the induction dose only: 43% and 42%, respectively, versus 23% (p≤0.01).

The safety profile of SKYRIZI in both trials was consistent with the safety profile observed in previous trials across other indications, with no new safety risks observed. The most common adverse events observed were COVID-19, anemia, nasopharyngitis, and arthralgia.

Results from the INSPIRE induction and COMMAND maintenance Phase 3 trials were published in The Journal of the American Medical Association (JAMA) in July 2024.

SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.