AbbVie announced that the European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the approval of risankizumab (SKYRIZI®) for the treatment of adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional or biologic therapy. The recommended induction dose is 1200 mg intravenous (IV), followed by a maintenance dose of 180 mg or 360 mg subcutaneous (SC), based on individual patient presentation. The final European Commission decision is expected in the third quarter of 2024.

The CHMP positive opinion is supported by data from two Phase 3 clinical trials: the INSPIRE induction trial and the COMMAND maintenance trial. The INSPIRE trial evaluated 1200 mg of IV risankizumab administered as an induction dose at 0, 4 and 8 weeks in patients with moderately to severely active UC. In the COMMAND trial, patients who responded to induction treatment in INSPIRE were rerandomized to receive 180 mg or 360 mg of SC risankizumab as maintenance doses for an additional 52 weeks.

The safety profile of risankizumab in both trials was consistent with the safety profile observed in previous trials across other indications, with no new safety risks observed. Use of risankizumab in UC is not approved in the European Union, and its safety and efficacy remain under evaluation. Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.

Adapted Mayo Score is based on stool frequency subscore (SFS), rectal bleeding subscore (RBS) and endoscopic subscore (ES). Endoscopic improvement is defined as ES =1 without evidence of friability. Histologic-endoscopic mucosal improvement (HEMI) is defined as an ES of =1 without evidence of friability and Geboes score =3.1. UC is a chronic, idiopathic, immune-mediated IBD of the large intestine that causes continuous mucosal inflammation extending, to a variable extent, from the rectum to the more proximal colon.

The hallmark signs and symptoms of UC include rectal bleeding, abdominal pain, bloody diarrhea, tenesmus (a sense of pressure), urgency and fecal incontinence. The disease course of UC varies between patients and can range from quiescent disease to chronic refractory disease, which in some cases can lead to surgery or life-threatening complications. The severity of symptoms and unpredictability of disease course can lead to substantial burden and often disability among those living with the disease.

INSPIRE is a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of IV risankizumab 1200 mg administered at 0, 4 and 8 weeks as induction therapy in patients with moderately to severely active UC. The primary endpoint of the trial is clinical remission (per Adapted Mayo Score, defined as SFS =1 and not greater than baseline, RBS of 0 and ES =1 without friability) at week 12. Key secondary endpoints include clinical response (decrease from baseline in the Adapted Mayo Score =2 points and =30% from baseline, plus a decrease in RBS =1 or an absolute RBS =1), endoscopic improvement (ES =1 without friability) and HEMI (ES of 0 or 1 without friability and Geboes score =3.1) at week 12.