AbbVie Announces European Approval of SKYRIZI® for Ulcerative Colitis
AbbVie has received European Commission approval for SKYRIZI® (risankizumab) to treat adults with moderately to severely active ulcerative colitis (UC) who have not responded to or were intolerant of conventional or biologic therapies.
“Ulcerative colitis is a chronic, unpredictable condition that requires effective symptom management,” said Edouard Louis, M.D., Ph.D., professor and head of gastroenterology at Liège University Hospital. “In the INSPIRE and COMMAND trials, SKYRIZI demonstrated significant improvements in clinical remission and mucosal healing, which is crucial for long-term disease management.”
UC affects around 5 million people globally, with symptoms including diarrhea, abdominal pain, and rectal bleeding, often leading to substantial discomfort and limitations in daily life.
Roopal Thakkar, M.D., executive vice president of research & development at AbbVie, noted, “SKYRIZI provides a valuable new option for UC treatment, particularly benefiting patients who have not responded to other therapies. The positive results from the Phase 3 trials highlight its effectiveness in achieving mucosal healing.”
SKYRIZI’s recommended induction dose is 1,200 mg via intravenous infusion at weeks 0, 4, and 8. For maintenance, patients receive either 180 mg or 360 mg subcutaneously every 8 weeks starting at week 12, based on individual needs.
The approval is based on data from the INSPIRE and COMMAND trials, which showed:
- Clinical Remission: In INSPIRE, 20% of patients on SKYRIZI achieved clinical remission at week 12 compared to 6% on placebo. In COMMAND, 40% and 38% of patients on SKYRIZI achieved remission at week 52, respectively, versus 25% in the control group.
- Mucosal Healing: 37% of INSPIRE patients on SKYRIZI showed mucosal healing at week 12 compared to 12% on placebo. In COMMAND, 51% and 48% of patients achieved mucosal healing at week 52 with SKYRIZI, compared to 32% in the control group.
- Histologic Endoscopic Mucosal Healing (HEMH): 24% of patients in INSPIRE and 43% and 42% in COMMAND achieved HEMH with SKYRIZI, compared to lower percentages in the placebo and control groups.
The safety profile of SKYRIZI was consistent with prior findings, with common adverse events including COVID-19, anemia, and nasopharyngitis. The results of the trials were published in JAMA in July 2024.
SKYRIZI is a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading global development and commercialization.
About Ulcerative Colitis UC is a chronic inflammatory bowel disease affecting the large intestine, characterized by symptoms like rectal bleeding and abdominal pain. The disease can vary in severity and impact, leading to significant burden and disability.
INSPIRE and COMMAND Trials
- INSPIRE: Phase 3 trial evaluating the efficacy and safety of SKYRIZI 1,200 mg IV as induction therapy.
- COMMAND: Phase 3 trial assessing SKYRIZI 180 mg or 360 mg SC as maintenance therapy.
About SKYRIZI® SKYRIZI is an IL-23 inhibitor used to treat various immune-mediated diseases, including ulcerative colitis. It is approved by the FDA and EMA for multiple indications.
Important Safety Information SKYRIZI should not be used in patients with active infections or hypersensitivity to the drug. It may increase infection risk and should not be used with live vaccines during treatment. Full safety information is available in the Summary of Product Characteristics (SmPC) at EMA’s website.
