Induction and Maintenance Treatment with Risankizumab Leads to Symptomatic Relief in Patients With Moderate to Severe Crohn’s Disease

ABSTRACT

Here, the patient reported outcomes (PROs) of AP score (APS) and SF, and their correlation with endoscopic outcomes, were examined during induction and maintenance treatment. Methods: Pooled data from the ADVANCE/MOTIVATE induction studies (PBO, RZB 600 mg intravenous (IV) groups), and data from the FORTIFY maintenance study (180 mg, 360 mg and RZB withdrawal/PBO subcutaneous [SC] groups), were examined for AP and SF clinical outcomes. Patient Reported Outcomes of Abdominal Pain Score (APS) and Stool Frequency (SF) during Induction and Maintenance Dosing with RZB (ITT#) (NRI-NC&) Endpoint ADVANCE + MOTIVATE RZB 600 mg IV PBO RZB 600 mg IV PBO RZB 600 mg IV PBO Wk 4 Wk 8 Wk 12 Decrease in APS from BL 59.4 [54.3, 64.5] 71.7 [67.9, 75.6] P < 0.001 63.8 [58.9, 68.8] 75.9 [72.2, 79.6] P< 0.001 58.8 [53.8, 63.9] 76.9 [73.2, 80.5] P< 0.001 Decrease in SF from BL 65.7 [60.9, 70.6] 81.6 [78.3, 84.9] P< 0.001 63.5 [58.6, 68.5] 84.1 [80.9, 87.2] P< 0.001 58 [52.9, 63.1] 85.4 [82.4, 88.4] P< 0.001 AP =0 in patients with APS ≥1 at Baseline 2.6 [0.9, 4.3] 5.6 [3.6, 7.6] P= 0.052 3.2 [1.3, 5.0] 11.5 [8.7, 14.3] P< 0.001 6.4 [3.8, 8.9] 17.9 [14.5, 21.2] P<0.001 SF ≤1 in patients with SF >2.8 at Baseline 4.8 [2.5, 7.1] 9.8 [7.1, 12.5] P=0.004 6 [3.4, 8.5] 18.2 [14.7, 21.6] P<0.001 11.6 [8.2, 15.1] 26.1 [22.2, 30.0] P<0.001 Endpoint FORTIFY Withdrawal (PBO SC) RZB 180 mg SC RZB 360 mg SC Withdrawal (PBO SC) RZB 180 mg SC RZB 360 mg SC Withdrawal (PBO SC) RZB 180 mg SC RZB 360 mg SC Withdrawal (PBO SC) RZB 180 mg SC RZB 360 mg SC Withdrawal (PBO SC) RZB 180 mg SC RZB 360 mg SC Wk 8 Wk 16 Wk 24 Wk 32 Wk 52 APS Remission (APS ≤1) 67.7 [60.5, 74.8] 72.6 [65.6, 79.6] P=0.413 75.9 [68.8, 82.9] P= 0.033 70.1 [63.1, 77.1] 65.6 [58.2, 73.0] P= 0.311 70.2 [62.7, 77.8] P= 0.743 61 [53.5, 68.4] 66.2 [58.8, 73.6] P= 0.306 68.1 [60.4, 75.8] P= 0.052 54.3 [46.6, 61.9] 66.2 [58.8, 73.6] P = 0.027 63.1 [55.2, 71.1] P= 0.035 46.3 [38.7, 54.0] 57.3 [49.6, 65.1] P= 0.027 55.3 [47.1, 63.5] P= 0.028 SF Remission (SF ≤2.8) 66.5 [59.2, 73.7] 68.2 [60.9, 75.4] P= 0.807 67.4 [59.6, 75.1] P= 0.420 64.6 [57.3, 72.0] 66.2 [58.8, 73.6] P = 0.783 67.4 [59.6, 75.1] P = 0.266 59.8 [52.3, 67.3] 59.9 [52.2, 67.5] P = 0.990 63.8 [55.9, 71.8] P = 0.154 57.3 [49.7, 64.9] 58.6 [50.9, 66.3] P= 0.881 58.2 [50.0, 66.3] P= 0.437 44.5 [36.9, 52.1] 51.6 [43.8, 59.4] P= 0.113 56 [3.6, 24.3] P= 0.008 AP =0 18.3 [12.4, 24.2] 30.6 [23.4, 37.8] P= 0.009 30.6 [23.4, 37.8] P= 0.009 SF ≤1 28.7 [21.7, 35.6] 35.7 [28.2, 43.2] P=0.081 39.0 [31.0, 47.1] P=0.006 AP =0 and SF ≤1 14.6 [9.2, 20.0] 21.7 [15.2, 28.1] P=0.092 23.4 [16.4, 30.4] P=0.021 BL = baseline;Wk = Week;Endoscopic remission = SES-CD ≤4 and at least 2-point reduction from baseline;Ulcer-free endoscopy = SES-CD ulcerated surface subscore =0 in patients with subscore ≥1 at baseline;#Intent-to-treat (ITT) population Includes randomized patients who (ADVANCE/MOTIVATE) received at least one dose of study drug during the 12-Week Induction Period, and had an SES-CD of ≥6 (≥4 for isolated ileal disease) or who (FORTIFY) received IV risankizumab for 12 weeks in the induction study and at least one dose of study drug in FORTIFY sub-study 1 and had an SES-CD of ≥6 (≥ 4 for isolated ileal disease) at baseline of induction. &Calculations were based on non-responder imputation with no special data handling for missing data due to COVID-19 pandemic. 95% CI and p-value for adjusted response rate difference compared to PBO calculated according to the Cochran-Mantel-Haenszel test adjusted for strata.