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

Edouard Louis, MD¹, Joana Torres, MD, PhD², James Lindsay, DO³, Stefan Schreiber, MD⁴, Ryan Ungaro, MD, MS⁵, Laimas Jonaitis, MD, PhD⁶, Kristina Kligys, PhD⁷, Stijn Van Haaren, MsC⁷, Ezequiel Neimark, MD⁷, Javier Zambrano, MD⁷, Yafei Zhang, PhD⁷, Geert D’Haens, MD^8
1University Hospital CHU of Liège, Liège, Liege, Belgium; ²Hospital Beatriz Ângelo, Loures, Portugal and Hospital da Luz, Lisbon, Lisboa, Portugal; ³The Royal London Hospital, Barts Health NHS Trust, London, England, United Kingdom; ⁴University Hospital Schleswig-Holstein, Kiel University, Kiel, Schleswig-Holstein, Germany; ⁵Icahn School of Medicine at Mount Sinai, New York, NY; ⁶Lithuanian University of Health Sciences, Kaunas, Kauno Apskritis, Lithuania; ⁷AbbVie, Inc., North Chicago, IL; ⁸Amsterdam University Medical Centres, Amsterdam, Zuid-Holland, Netherlands

Introduction: Burdensome symptoms of Crohn’s disease (CD) include abdominal pain (AP) and increased stool frequency (SF), and STRIDE II guidelines identify symptom relief as an important treatment goal. Risankizumab (RZB) was shown to be well-tolerated and superior to placebo (PBO) for inducing and maintaining clinical remission and endoscopic response in patients with moderate to severe CD. 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. Tetrachoric correlations were applied to determine the relationship between AP and SF and achievement of endoscopic endpoints (see Table footnotes for endpoint definitions) at Weeks (Wks) 12 and 52.

Results: Significantly more patients receiving 600 mg RZB IV versus (vs) PBO reported improvements from baseline (BL) in SF and APS at Wks 4, 8, and 12. Of patients reporting AP ≥1 at Induction BL, significantly more patients achieved APS =0 at Wks 8 and 12 with RZB vs PBO. Of patients reporting SF >2.8 at BL, a significantly greater proportion of patients achieved SF ≤1 at Wks 4, 8 and 12 with RZB vs PBO. During maintenance, AP remission rates at Wks 32 and 52 with were significantly greater with RZB SC (180 mg and 360 mg) vs withdrawal/PBO SC, while SF remission rates were significantly greater with 360 mg RZB SC vs RZB withdrawal/PBO SC at Wk 52. A significant difference in the complete resolution of symptoms, as measured by AP=0, SF≤1, and AP=0 plus SF≤1, was observed for patients receiving RZB 360 mg SC vs withdrawal (PBO SC). AP remission at Wk 12 was weakly correlated with endoscopic remission and ulcer-free endoscopy at Wk 12. Weak/moderate correlations of SF remission with endoscopic outcomes were observed at Wk 12. At Wk 52, moderate correlations were observed with endoscopic outcomes and AP and SF remission.

Discussion: CD-related PROs improved with RZB induction therapy, and 360 mg SC RZB maintenance dosing was most effective for symptomatic remission and complete resolution of symptoms. Symptom improvements and endoscopic outcomes were moderately correlated, underscoring the importance of an objective measure to assess disease activity.



Disclosures:


Edouard Louis, MD¹, Joana Torres, MD, PhD², James Lindsay, DO³, Stefan Schreiber, MD⁴, Ryan Ungaro, MD, MS⁵, Laimas Jonaitis, MD, PhD⁶, Kristina Kligys, PhD⁷, Stijn Van Haaren, MsC⁷, Ezequiel Neimark, MD⁷, Javier Zambrano, MD⁷, Yafei Zhang, PhD⁷, Geert D’Haens, MD⁸, 37, Induction and Maintenance Treatment with Risankizumab Leads to Symptomatic Relief in Patients With Moderate to Severe Crohn’s Disease, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.