AbbVie announced positive results from two Phase 3 induction studies, ADVANCE and MOTIVATE, showing both doses of risankizumab (600 mg and 1,200 mg) met both primary endpoints of clinical remission and endoscopic response at week 12 in adult patients with moderate to severe Crohn's disease. The ADVANCE study enrolled patients who had an inadequate response or were intolerant to conventional and/or biologic therapy. The MOTIVATE study evaluated patients who had responded inadequately or were intolerant to biologic therapy. In both studies, clinical remission was measured by CDAI (Crohn's Disease Activity Index) and PRO-2 (two-component patient-reported outcome). In the ADVANCE study, a significantly greater proportion of patients treated with risankizumab 600 mg or 1,200 mg achieved clinical remission per CDAI at week 12 (45 and 42% of patients, respectively, compared to 25% of patients receiving placebo; p<0.001). Similar results were seen with clinical remission per PRO-2 (43 and 41%, respectively, compared to 21% of patients receiving placebo; p<0.001). A significantly greater proportion of patients treated with either dose of risankizumab achieved endoscopic response at week 12 (40% and 32% of patients receiving risankizumab 600 mg or 1200 mg, respectively, versus 12% in the placebo group; p<0.001). In the MOTIVATE study, 42% and 41% of patients treated with risankizumab 600 mg or 1,200 mg achieved clinical remission (per CDAI) at week 12, respectively, versus 19% of patients receiving placebo (p<0.001). A significantly greater proportion of patients in MOTIVATE also achieved clinical remission (per PRO-2) (35% and 39% of risankizumab 600 mg or 1,200 mg-treated patients, respectively, compared to 19% of patients receiving placebo; p=0.001 for 600 mg; p<0.001 for 1,200 mg). In addition, 29% and 34% of patients receiving risankizumab 600 mg or 1,200 mg achieved endoscopic response, respectively, versus 11% in the placebo group (p<0.001). Additionally, multiplicity-adjusted key secondary endpoints showed significant clinical and endoscopic outcomes, with symptom improvement observed as early as week 4.1,2 After 4 weeks of treatment in both studies, a greater proportion of patients receiving either dose of risankizumab achieved clinical response (per CDAI) compared to placebo.1,2 Specifically, in ADVANCE, 41 and 37% of patients receiving risankizumab 600 mg or 1,200 mg achieved clinical response (per CDAI) compared to 25% in the placebo group (p<0.001 for 600 mg; p=0.008 for 1,200 mg). In MOTIVATE, 36 and 33% of patients receiving risankizumab 600 mg or 1,200 mg achieved clinical response (per CDAI), respectively, compared to 21% in the placebo group (p=0.002 for 600 mg; p=0.012 for 1,200 mg). During the 12-week induction period, the safety profile of risankizumab in both studies was generally consistent with the known safety profile of risankizumab.1-6 No new safety risks were observed. In ADVANCE, serious adverse events (SAEs) occurred in 7.2% of patients in the risankizumab 600 mg group and 3.8% of patients in the risankizumab 1,200 mg group compared to 15.1% of patients in the placebo group. The most common adverse events (AEs) observed in the risankizumab treatment groups were headache, nasopharyngitis and fatigue.1 Rates of serious infections were 0.8 and 0.5% in those treated with risankizumab 600 mg or 1,200 mg, respectively, and 3.8% in patients who received placebo.1 The rates of AEs leading to discontinuation of the study drug were 2.4 and 1.9% of patients treated with risankizumab 600 mg or 1,200 mg, respectively, compared with 7.5% on placebo.1 In ADVANCE, there were two deaths reported in the placebo group.1 There were no adjudicated major adverse cardiac events (MACE) or adjudicated anaphylactic reaction events reported. In MOTIVATE, SAEs occurred in 4.9% of patients in the risankizumab 600 mg group and 4.4% of patients in the risankizumab 1,200 mg group compared to 12.6% of patients in the placebo group.2 The most common AEs observed in the risankizumab treatment groups were headache, arthralgia and nasopharyngitis.2 Rates of serious infections were 0.5 and 1.0% in those treated with risankizumab 600 mg or 1,200 mg, respectively, and 2.4% in patients who received placebo.2 The rates of AEs leading to discontinuation of the study drug were 1.0 and 2.4% of patients treated with risankizumab 600 mg or 1,200 mg, respectively, compared with 8.2% on placebo.2 There was one death in the risankizumab 1,200 mg group due to squamous cell carcinoma of the lung diagnosed on study day 8, which was assessed as unrelated to the study drug by the investigator.2 There were no adjudicated MACE or adjudicated anaphylactic reaction events reported. Full results from the ADVANCE and MOTIVATE studies will be presented at upcoming medical conferences and published in a peer-reviewed medical journal. Use of risankizumab in Crohn's disease is not approved and its safety and efficacy have not been evaluated by regulatory authorities. The maintenance study for Crohn's disease is ongoing and once completed will be submitted to regulatory authorities with the induction studies. Risankizumab (SKYRIZI) is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialization globally.