Phase III ADVANCE and MOTIVATE studies of Skyrizi show efficacy in Crohns disease.- AbbVie

AbbVie announced positive results from two Phase III induction studies, ADVANCE and MOTIVATE, showing both doses of Skyrizi (risankizumab) (600 mg and 1200 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 1200 mg achieved clinical remission per CDAI at week 12 (45 and 42 percent of patients, respectively, compared to 25 percent of patients receiving placebo; p<0.001).1 similar results were seen with clinical remission per pro-2 (43 and 41 percent, respectively, compared to 21 percent 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 percent of patients receiving risankizumab 600 mg or 1200 mg, respectively, versus 12 percent in the placebo group; p><0.001). in the motivate study, 42 and 41 percent of patients treated with risankizumab 600 mg or 1200 mg achieved clinical remission (per cdai) at week 12, respectively, versus 19 percent 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 percent of risankizumab 600 mg or 1200 mg-treated patients, respectively, compared to 19 percent of patients receiving placebo; p="0.001" for 600 mg; p><0.001 for 1200 mg). in addition, 29 and 34 percent of patients receiving risankizumab 600 mg or 1200 mg achieved endoscopic response, respectively, versus 11 percent 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. 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. specifically, in advance, 41 and 37 percent of patients receiving risankizumab 600 mg or 1200 mg achieved clinical response (per cdai) compared to 25 percent in the placebo group (p><0.001 for 600 mg; p="0.008" for 1200 mg). in motivate, 36 and 33 percent of patients receiving risankizumab 600 mg or 1200 mg achieved clinical response (per cdai), respectively, compared to 21 percent in the placebo group (p="0.002" for 600 mg; p="0.012" for 1200 mg).>