AbbVie announced positive top-line results from INSPIRE, a Phase 3 induction study, showing risankizumab (SKYRIZI®,1200 mg intravenous [IV], at weeks 0, 4 and 8) met the primary endpoint of clinical remission (per Adapted Mayo Score) at week 12, as well as all secondary endpoints in adult patients with moderately to severely active ulcerative colitis.1 In the study, 20.3% of patients receiving risankizumab achieved clinical remission compared to 6.2% of patients receiving placebo. A significantly greater proportion of patients treated with risankizumab achieved endoscopic improvement at week 12 compared to placebo a Clinical remission per Adapted Mayo Score is defined as stool frequency subscore (SFS) =1 and not greater than baseline, rectal bleeding subscore (RBS) of 0 and endoscopic subscore =1 without friability. bClinical response per Adapted Mayo Score is defined as a 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. c Endoscopic improvement is defined as endoscopic subscore =1 without friability.

d Histologic-endoscopic mucosal improvement is defined as Geboes score =3.1 and endoscopic subscore =1 without friability. During the 12-week, double-blind, placebo-controlled period, the safety profile of risankizumab 1200 mg IV was consistent with the safety profile observed in previous studies across other indications, with no new safety risks observed.1 The most common adverse events observed in the risankizumab group were COVID-19, anemia and arthralgia. Serious adverse events occurred in 2.3% of patients in the risankizumab 1200 mg IV group compared to 10.2% of patients in the placebo group.1 Rates of serious infections were 0.6% in those treated with risankizumab 1200 mg IV and 1.2% in patients who received placebo.1 There was one death in the risankizumab 1200 mg group due to COVID-19 pneumonia on study day 33.

There were no adjudicated major adverse cardiac events (MACE), no adjudicated anaphylactic reaction events and no malignancy events reported in the risankizumab group. Use of risankizumab in ulcerative colitis is not approved and its safety and efficacy have not been evaluated by regulatory authorities. The maintenance study for ulcerative colitis is ongoing.

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