DOP055Efficacy and Safety Up to 3 Years of Risankizumab Maintenance Treatment in Patients With Moderately to Severely Active Ulcerative Colitis: Interim Results from Phase 3 COMMAND Open-Label Extension Study

Abstract Background Risankizumab (RZB), a high-affinity humanised IgG1 monoclonal antibody targeting interleukin-23 p19, has demonstrated sustained efficacy, with a consistent safety profile supporting long-term use for patients (pts) with ulcerative colitis (UC).1-3 This interim analysis reports efficacy and safety through open-label extension (OLE) week (wks) 96 (3 years yrs of total maintenance) from the COMMAND OLE. Methods The OLE enrolled RZB-treated pts who completed the 52-wk maintenance substudies and/or responded to 12/24-wk induction therapy.1 All pts received subcutaneous RZB 180 mg (RZB180) starting at OLE wk 0, except those who received prior OLE RZB rescue therapy (1 RZB 1200 mg intravenous dose then RZB 360 mg RZB360 every 8 wk) and continued RZB360 for 96 wks. Efficacy endpoints (clinical remission CR per Adapted Mayo Score AMS, CR per Partial AMS PAMS, corticosteroid-free CR per PAMS, clinical response per AMS, clinical response per PAMS, endoscopic improvement, and endoscopic remission) were assessed at OLE wks 0 and 96 and reported as observed (AO) prior to OLE RZB rescue therapy and nonresponder imputation (NRI), among the overall population and by inadequate response to advanced therapy (AT-IR vs non-AT-IR; data cutoff: 25Aug2025). The safety analysis included pts who received at least 1 dose of OLE RZB, with data presented as events/100 pt-yrs. Results At OLE wk 0, approximately 90% pts (N = 1003) completed the study visit; some differences were observed in the clinical characteristics of RZB180 and RZB360-treated pts, including mean AMS (2.0, 3.4); a numerically higher proportion of RZB360-pts were AT-IR (63.1%, 76.8%), and had an endoscopic score of ≥ 3 (12.1%, 31.1%). A lower proportion of RZB360-treated pts achieved CR per AMS (54.8%, 25.2%) at OLE wk 0, while a higher proportion of RZB360-treated pts received OLE rescue therapy (RZB180, 22.1%; RZB360, 34.5%). Efficacy rates remained stable at OLE wks 0 and 96 for CR per AMS; similar results were observed within each subgroup, AT-IR and non-AT-IR (Table 1). Numerically lower efficacy rates were observed in the AT-IR vs non-AT-IR pts at wk 96; efficacy was sustained through OLE wk 96 for all endpoints (AO, NRI; Table 1). Similar rates were observed for any adverse event (AE), severe AE, and serious AE in RZB180 and RZB360-treated pts. No new safety risks were identified in either treatment group (Table 2). Conclusion In the ongoing COMMAND OLE, sustained clinical and endoscopic benefit was observed in pts receiving up to 3 yrs of long-term RZB maintenance therapy, with numerically lower efficacy rates observed for AT-IR vs non-AT-IR vs pts. The long-term safety of RZB remains consistent with a favorable benefit-risk profile, supporting its long-term use in UC. References: 1.Louis E et al. JAMA. 2024;332:881-97. 2.Atreya R et al. J Crohn’s Colitis. 2025;19(S1):i108-i110. Abstract. 3.Panaccione R et. al. J Crohn’s and Colitis. 2025, 19(1):jjaf005. Conflict of interest: Atreya, Raja: RA has served as a speaker, or consultant, or received research grants from AbbVie, Abivax, AlfaSigma, Arena Pharmaceuticals, Astra-Zeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion Healthcare, Dr Falk Pharma, Galapagos, Gilead, GlaxoSmithKline, InDex Pharmaceuticals, Johnson & Johnson, Lilly, Materia Prima, Merck Sharpe & Dohme, Pfizer, Roche Pharma, Takeda Pharma, Viatris. Louis, Edouard: Education and Reserach Grants for my department: Abbvie, Takeda, Johnson and Johnson, Pfizer, Fresenius-Kabi, Celltrion, EG pharma, Sandoz, Falk Personal Fees for conferences, advisory boards and consultancy: Abbvie, Takeda, Ferring, Pfizer, Johnson and Johnson, Lilly, Galapagos, Celltrion, Arena, BMS, Falk, Biokuris, Fresenius-Kabi, Thabor Loftus, Jr, Edward: Grant: AbbVie, Amgen, Bristol-Myers Squibb, Celgene, Genentech, Gilead, Janssen, Pfizer, Receptos, Robarts Clinical Trials, Takeda, Theravance, UCB. Personal Fees: AbbVie, Allergan, Amgen, Arena, Boehringer Ingelheim, Bristol-Myers Squibb, Calibr, Celgene, Celltrion, Eli Lilly, Genentech, Gilead, Iterative Scopes, Janssen, Ono Pharma, Pfizer, Sun Pharma, Takeda, UCB. Rubin, David T.: Grant support: Takeda Pharmaceuticals Consultant: Abbvie, Abivax SA, Altrubio, Athos Therapeutics, Inc, Bristol-Myers Squibb, Celltrion, Connect BioPharma, Eli Lilly & Co., Genentech (Roche) Inc., Iterative Health, Janssen Pharmaceuticals, Johnson & Johnson, Merck & Co., Mirador, Odyssey Therapeutics, Pfizer, Sanofi, Spyre, Takeda Pharmaceuticals, Vedanta Biosciences, and Ventyx. Dubinsky, Marla C: Personal Fees: Consultant or Advisory Board: Abbvie, Abivax, Astra Zeneca, BMS, Celltrion, Gilead, Genentech, Janssen, Johnson and Johnson, Lilly, Merck, Pfizer, Prometheus Biosciences, Sanofi, Spyre, Target RWE, Takeda Other: Shareholder, Co-founder, Board of Directors of Trellus Health Co-Founder Mi Test Health Hisamatsu, Tadakazu: Grant support: Mitsubishi Tanabe Pharma Corporation, EA pharma Co. Ltd., AbbVie, JIMRO Co. Ltd., Zeria Pharmaceutical Co. Ltd., Kyorin Pharmaceutical Co. Ltd., Takeda, Pfizer., Mochida, Boston Scientific Corporation, Kissei Pharmaceutical Co. Ltd. Consulting: Mitsubishi Tanabe Pharma Corporation, EA pharma Co. Ltd., AbbVie GK, Janssen Pharmaceutical K.K., Pfizer, Eli Lilly, Gilead Sciences, Bristol Myers Squibb, Abivax, MSD, Chugai. Lecture fee: Mitsubishi Tanabe Pharma Corporation, AbbVie GK, EA pharma Co. Ltd., Kyorin Pharmaceutical Co. Ltd., JIMRO Co., Janssen Pharmaceutical K.K., Mochida Pharmaceutical Co., Ltd., Takeda, Pfizer, Kissei Mambetsariev, Nurbek: Employee of AbbVie and may own stock and/or stock options. Kalabic, Jasmina: Employee of AbbVie and may own stock and/or stock options. Cheng, Peiyao: Employee of AbbVie and may own stock and/or stock options. Chen, Su: Employee of AbbVie and may own stock and/or stock options. O’Brien, Dan: Employee of AbbVie and may own stock and/or options. Morisset, Pierre: Employee of AbbVie and may own stock and/or stock options. Duan, W. Rachel: Employee of AbbVie and may own stock and/or stock options. Panaccione, Remo: Grant: Abbvie, Janssen, Pfizer, Takeda. Other: Consultant for: Abbott, AbbVie, Abbivax, Alimentiv (formerly Robarts), Amgen, AnaptysBio, Arena Pharmaceuticals, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Celltrion, Cosmos Pharmaceuticals, Eisai, Elan, Eli Lilly, Ferring, Galapagos, Fresenius Kabi, Genentech, Gilead Sciences, Glaxo-Smith Kline, JAMP Bio, Janssen, Merck, Mylan, Novartis, Oppilan Pharma, Organon, Pandion Pharma, Pendopharm, Pfizer, Progenity, Prometheus Biosciences, Protagonist Therapeutics, Roche, Sandoz, Satisfai Health, Shire, Sublimity Therapeutics, Spyre Therapeutics, Takeda Pharmaceuticals, Theravance Biopharma, Trellus, Union Biopharma, Viatris, Ventyx, UCB Speaker’s Fees for: AbbVie, Amgen, Arena Pharmaceuticals, Bristol-Myers Squibb, Celgene, Eli Lilly, Ferring, Fresenius Kabi, Gilead Sciences, Janssen, Merck, Organon, Pfizer, Roche, Sandoz, Shire, Takeda Pharmaceuticals Advisory Boards for: AbbVie, Alimentiv (formerly Robarts), Amgen, Arena Pharmaceuticals, AstraZeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Eli Lilly, Ferring, Fresenius Kabi, Genentech, Gilead Sciences, Glaxo-Smith Kline, JAMP Bio, Janssen, Merck, Mylan, Novartis, Oppilan Pharma, Organon, Pandion Pharma, Pfizer, Progenity, Protagonist Therapeutics, Roche, SandozShire, Sublimity Therapeutics, Takeda Pharmaceuticals, Ventyx.