39 - Clinical and Endoscopic Improvements With Risankizumab Induction and Maintenance Dosing versus Placebo Are Observed Irrespective of Number of Prior Failed Biologics

Marc Ferrante, MD, PhD¹, Laurent Peyrin-Biroulet, MD², Axel Dignass, MD, PhD³, David T. Rubin, MD, FACG⁴, Silvio Danese, MD, PhD⁵, Geert D’Haens, MD⁶, Kristina Kligys, PhD⁷, Sofie Berg, PhD⁸, Jasmina Kalabic, MD⁹, Javier Zambrano, MD⁷, Yafei Zhang, PhD⁷, Toshimitsu Fujii, MD¹⁰, Remo Panaccione, MD^11
1University Hospitals Leuven, Leuven, Brabant Wallon, Belgium; ²University Hospital of Nancy, Lorraine University, Vandoeuvre, Franche-Comte, France; ³Agaplesion Markus Hospital / Goethe University, Frankfurt, Hessen, Germany; ⁴University of Chicago Medicine Inflammatory Bowel Disease Center, Chicago, IL; ⁵IRCCS Ospedale San Raffaele and University Vita-Salute San Raffaele, Milan, Molise, Italy; ⁶Amsterdam University Medical Centres, Amsterdam, Zuid-Holland, Netherlands; ⁷AbbVie, Inc., North Chicago, IL; ⁸AbbVie Inc., Mettawa, IL; ⁹AbbVie Deutschland GmbH & Co. KG, Ludwigshafen, Hessen, Germany; ¹⁰Tokyo Medical and Dental University, Tokyo, Tokyo, Japan; ¹¹University of Calgary, Calgary, AB, Canada

Introduction: In phase 3 induction (ADVANCE, MOTIVATE) and maintenance (FORTIFY) studies, risankizumab (RZB), was well-tolerated and efficacious in patients with moderate to severe Crohn’s disease (CD) who failed/were intolerant to conventional or biologic therapy. This post-hoc analysis examined efficacy and safety of RZB induction and maintenance dosing based on number of prior biologics failed.

Methods: Clinical and endoscopic endpoints (see Table footnotes for endpoints, definitions) were assessed for RZB versus (vs) PBO following intravenous (IV) induction and subcutaneous (SC) maintenance dosing based on prior failure of 1, 2, or ≥3 biologics. Pooled induction data are reported for PBO and RZB 600 mg IV q4w groups at Week (Wk) 12. Data from withdrawal (PBO SC), RZB 180 mg, and RZB 360 mg SC q8w groups are reported at FORTIFY Wk 52.

Results: At induction baseline (BL), 48%, 25%, and 27% of patients failed 1, 2, and ≥3 prior biologics, respectively, with 6%, 27%, and 75% having prior vedolizumab exposure and 2%, 12%, and 59% having prior ustekinumab exposure. Most (90%) patients who failed 1 biologic and all who failed ≥2 biologics were anti-TNF refractory. BL characteristics were generally balanced across subgroups, although disease duration and steroid use were slightly higher in the ‘≥3 subgroup’. Across the subgroups, patients achieved greater rates of clinical remission and endoscopic response with RZB 600 mg IV vs PBO at induction Wk 12, with greater efficacy generally observed in patients failing fewer biologics. At FORTIFY Wk 52, patients achieved greater endoscopic remission and response rates with RZB 180 mg and RZB 360 mg SC vs withdrawal (PBO SC) across most subgroups, while the endpoints of ulcer-free endoscopy and deep remission were significant with RZB 360 mg SC. Patients who failed 2 and ≥3 prior biologics achieved higher clinical remission rates with RZB 360 mg SC vs withdrawal (PBO SC) at Wk52. There were no differences in treatment emergent adverse events among subgroups at induction Wk 12 or maintenance Wk 52.

Discussion: Induction and maintenance dosing of RZB was efficacious and well tolerated in patients with CD irrespective of number of prior biologics failed. Endoscopic response and remission rates were greater with both RZB SC doses vs PBO across all subgroups at induction Wk 12 and maintenance Wk 52. Rates of ulcer-free endoscopy and deep remission at maintenance Wk 52 were greater with RZB 360 mg SC across all subgroups.



Disclosures:


Marc Ferrante, MD, PhD¹, Laurent Peyrin-Biroulet, MD², Axel Dignass, MD, PhD³, David T. Rubin, MD, FACG⁴, Silvio Danese, MD, PhD⁵, Geert D’Haens, MD⁶, Kristina Kligys, PhD⁷, Sofie Berg, PhD⁸, Jasmina Kalabic, MD⁹, Javier Zambrano, MD⁷, Yafei Zhang, PhD⁷, Toshimitsu Fujii, MD¹⁰, Remo Panaccione, MD¹¹, 39, Clinical and Endoscopic Improvements With Risankizumab Induction and Maintenance Dosing versus Placebo Are Observed Irrespective of Number of Prior Failed Biologics, ACG 2022 Annual Scientific Meeting Abstracts. Charlotte, NC: American College of Gastroenterology.