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P373 Effect of risankizumab on improved and sustained quality of life in patients with moderate to severe Crohn’s disease: Phase 2 trial results

E. Louis*1, W. J. Sandborn2, G. D’Haens3, F. Baert4, J. Kalabic5, K. Wallace6, W-J. Lee6, B. G. Feagan7

1University Hospital CHU of Liège, Liège, Belgium, 2University of California San Diego, La Jolla, USA, 3Academic Medical Center, Amsterdam, The Netherlands, 4AZ Delta Roeselare-Menen, Menen, Belgium, 5AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Germany, 6AbbVie Inc., North Chicago, USA, 7University of Western Ontario, Robarts Research Institute, London, Canada

Background

Risankizumab (RZB), an anti-interleukin 23 antibody, is being investigated as a treatment for Crohn’s disease (CD). The impact of RZB on health-related quality of life, measured by Inflammatory Bowel Disease Questionnaire (IBDQ), was assessed in the Phase 2 trial of RZB in CD (NCT02031276).

Methods

Adults (18–75 years) with moderate to severe CD (CDAI 220–450 with mucosal ulcers and CDEIS ≥7 [or ≥4 in patients with isolated ileitis on ileocolonoscopy]) were enrolled. In the double-blind phase (weeks [weeks] 0–12, period 1), patients received RZB (200 mg or 600 mg) or placebo (PBO) IV Q4W for 12 weeks as induction therapy. In the extended induction/washout phase (Weeks 14–26, period 2), those not in deep remission at Week 12 received open-label RZB 600 mg IV Q4W for 12 weeks and those in deep remission at Week 12 entered a washout phase until Week 26. Pts in clinical remission at Week 26 entered the maintenance phase and received open-label RZB 180 mg SQ Q8W for 26 weeks (Weeks 26–52, period 3); those not in clinical remission discontinued. In period 2 and 3, only patients who received open-label RZB treatment were analysed. Percentages of patients with IBDQ response (increase in IBDQ total score ≥16); IBDQ remission (IBDQ total score ≥170); and mean change from baseline (BL) in IBDQ total, domain, and selected individual item scores were calculated at Weeks 12, 26, and 52.

Results

Data from 121 patients were analysed in period 1. At Week 12, the percentage of patients with IBDQ response was significantly greater (p < 0.05) in both RZB groups vs. PBO (Table 1). A potential dose–response was observed at Week 12 with greater improvements seen in RZB 600 mg and 200 mg vs. PBO in IBDQ total score, domain scores (Table 2), and item scores from BL including bowel movement frequency, abdominal pain, rectal bleeding, stomach sick, and fatigue (all p < 0.05). During period 2, patients receiving extended induction therapy gained additional improvement in IBDQ outcomes at Week 26 vs. Week 12, especially those receiving PBO in period 1. These improvements in IBDQ outcomes were maintained at Week 52 of RZB treatment.

Table 1. Patients with IBDQ response and remission at Weeks 12, 26, and 52 (NRI).

Table 2. Mean change from baseline in IBDQ total and domain scores (LOCF).

Conclusion

In patients with CD, induction treatment with RZB 200 mg or 600 mg IV Q4W led to significant and dose–response improvements in IBDQ outcomes at Week 12. Additional improvement in IBDQ outcomes was observed with extended induction therapy. The treatment benefit of RZB in IBDQ was maintained by Week 52.