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AbbVie Secures European Commission Approval for Skyrizi in Treating Moderate to Severe Ulcerative Colitis

AbbVie announced today that the European Commission has granted approval for Skyrizi (risankizumab) as a treatment option for adults with moderate to severe ulcerative colitis (UC). This marks the fourth approved indication for Skyrizi in the European Union, highlighting its versatility in addressing various inflammatory conditions.




The approval is underpinned by robust data from two pivotal Phase 3 trials: the INSPIRE induction trial and the COMMAND maintenance trial. In these studies, Skyrizi demonstrated significant efficacy in achieving clinical remission and other key endpoints, such as mucosal healing and histologic endoscopic mucosal healing.


Clinical Trial Successes

In the INSPIRE induction trial, patients receiving 1,200 mg of risankizumab via intravenous (IV) infusion showed a significantly higher rate of clinical remission at week 12 compared to those on a placebo. Specifically, 20% of patients on risankizumab achieved clinical remission, compared to just 6% in the placebo group.

The COMMAND maintenance trial further supported these findings, with 40% and 38% of patients receiving 180 mg or 360 mg of risankizumab subcutaneously (SC) achieving clinical remission at week 52, respectively, compared to 25% in the induction-only control group.


Key Secondary Endpoints

  • Mucosal Healing: In the INSPIRE trial, 37% of patients treated with risankizumab achieved mucosal healing at week 12, compared to 12% in the placebo group (p<.00001). For patients without previous biologic or JAK inhibitor failure, this figure was even higher at 48% versus 14%.

  • Histologic Endoscopic Mucosal Healing (HEMH): At week 12, 24% of patients in the INSPIRE trial achieved HEMH with risankizumab, compared to 8% in the placebo group (p<.00001). In the COMMAND trial, 43% and 42% of patients receiving 180 mg and 360 mg of risankizumab, respectively, achieved HEMH at week 52, compared to 23% in the induction-only control group.


About the INSPIRE Induction Trial

The INSPIRE trial is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study that evaluates the efficacy and safety of risankizumab 1,200 mg IV as induction therapy in patients with moderately to severely active UC.


About the COMMAND Maintenance Trial

The COMMAND trial is a Phase 3, multicenter, randomized, double-blind, controlled, 52-week maintenance study. It examines the efficacy and safety of risankizumab 180 mg or 360 mg SC in adults with moderately to severely active UC. Patients who responded to risankizumab IV induction were rerandomized to receive maintenance doses of risankizumab or to withdraw from treatment, serving as a control group. The primary objective is to evaluate the long-term maintenance efficacy and safety of risankizumab in these patients.


With the European Commission's approval, Skyrizi offers a new therapeutic option for adults with moderately to severely active ulcerative colitis, particularly for those who have not responded to conventional or biologic therapies.

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