AbbVie announced that the European Commission has approved SKYRIZI 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,” continued Professor Louis.
UC is estimated to affect 5 million people around the world, and the incidence is increasing worldwide. The common signs and symptoms of UC include diarrhea, abdominal pain, blood in the stool, urgency to defecate, passing mucus from the rectum and rectal pain and bleeding. Because of the pain and discomfort, patients commonly 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. Notably, in the Phase 3 trials we observed positive results in mucosal healing particularly in patients without previous biologic experience or JAK inhibitor failure,” said Roopal Thakkar, M.D., executive vice president, research & development, and chief scientific officer, AbbVie. “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.1,2 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).3
- 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).
SOURCE: PRNewswire