P0633Prescribing Patterns and Persistence of Advanced Therapies in people with Crohn’s disease with prior advanced therapy: Crohn’s Colitis Cure Data Insights Program

Abstract Background Optimal sequencing of advanced therapies (ADV) in inflammatory bowel disease (IBD) remains uncertain, (1) with limited real world (RW) data on the effectiveness of second or subsequent ADV lines. This study examined factors influencing ADV choice in bioexperienced Crohn’s disease (CD) and assessed treatment persistence, a pragmatic surrogate marker of efficacy. Methods Prospectively collected routine-care data from the Crohn’s Colitis Care (CCCare) registry across Australian centres for bio-experienced adults with CD maintained on standard or dose escalated adalimumab (ADA), infliximab (IFX), ustekinumab (UST) or vedolizumab (VDZ) between September 2017 and October 2025, with a clinical assessment within 14 months of data extraction (30 October 2025) were included. Baseline characteristics were compared and persistence assessed using Cox regression analysis and Kaplan-Meier curves. Results Among 531 maintenance courses of second or subsequent ADV in 402 individuals UST was used most 263 (49.5%), followed by IFX 103 (19.4%), ADA 84 (15.8%) and VDZ 81 (15.2%). Anti-TNF was the most prescribed initial ADV (265/402, 66.2%). Median duration of follow up was 5.3 years (IQR: 4.3–6.1). Median age at initiation was 37.0 years (IQR: 28.3–49.9) with no significant difference between treatment groups (p = 0.08), and gender balance (males 277/531 52.2%, p = 0.89). Concomitant immunomodulator use was highest in IFX (52/103, 50.5%) and ADA (37/84. 44.0%), and less in VDZ (30/81, 37.0%) and UST (75/263, 28.5%; p 0.01). Disease location differed (p = 0.01), with more ileal disease (L1) in those on ADA (37/78, 47.4%) compared with IFX (22.5%) and UST (27.6%), p 0.01. Persistence was lowest for VDZ (log-rank p = 0.002; Figure 1). In adjusted Cox regression analysis (ref VDZ), the risk of discontinuation was lower for IFX HR 0.53 (95% CI 0.34–0.83; p = 0.03) and UST HR 0.55 (0.39–0.78; p = 0.01), but not ADA HR 0.83 (0.55–1.27; p = 0.78). On multivariate analysis, the risk of discontinuation was higher with ADA versus IFX HR 2.21 (95% CI 1.20–4.06, p = 0.01), VDZ versus IFX HR 2.13 (1.19–3.80, p = 0.01), use of third line or later therapy HR 2.03 (1.20–3.43, p = 0.01) and with dose escalated ADV HR 1.46 (1.07–2.00, p = 0.02). Conclusion UST is favoured in bioexperienced individuals, with anti-TNF the favoured initial ADV. UST and IFX maintain greatest persistence compared to ADA and VDZ, with dose escalation and later line therapy associated with lower persistence. These results show that systems capturing RW data at scale on therapy use and efficacy are vital, providing a potential sustainable way to inform care. Large, live RW data systems are ideal for phase 4 studies with genuine propensity matching as cohorts achieve sufficient size. Reference: 1. Kapizioni C, Desoki R, Lam D, Balendran K, Al-Sulais E, Subramanian S, et al. Biologic Therapy for Inflammatory Bowel Disease: Real-World Comparative Effectiveness and Impact of Drug Sequencing in 13 222 Patients within the UK IBD BioResource. J Crohns Colitis. 2024 June 3;18(6):790–800. Conflict of interest: Dr. Ghali, Mark: No conflict of interest Wu, Rodger: No conflict of interest Haifer, Craig: Grant: Grants from St Vincent’s Clinic Foundation, Gastroenterological Society of Australia, Gutsy Group, Royal Australasian College of Physicians and Ferring. Personal Fees: CH has received speaker fees and educational support from Janssen, Pfizer, Takeda, Ferring and Abbvie. Lynch, Kate: Kate Lynch has received speaker honoraria, advisory board fees, and/or conferencetravel/registration support from AbbVie, Bristol-Myers Squibb (BMS), Chiesi, Dr. Falk,Ferring, Gilead, Guidepoint, Intercept Pharmaceuticals, Janssen-Cilag, Merck Sharp &Dohme (MSD), Norgine, Pfizer, Pliant, Sandoz, Takeda, and the Royal Adelaide Hospital(RAH) Research Fund. Ng, Wa Sang: Educational and research funding from Jansen, Abbvie, Ferring, Takeda, Pfizer Begun, Jakob: I have received honoraria or consulting fees from Abbvie, Janssen, Takeda, Pfizer, Ferring, Bristol Myers Squibb, Gilead, Tillott’s, Sandoz, Celltrion, Chiesi, Dr Falk, Microba, Glaxo Smith Klein, Antara, Suono, Therpeutic Guidelines, Research Review,Grants: NHMRC, US Department of Defence, The Gutsy Foundation, The Gastroenterological Society of Australia, The University of Queensland, The Viertel Foundation, and The Mater Foundation Lawrance, Ian Craig: No conflict of interest Radford-Smith, Graham Lindsay: None. Walker, Gareth: In the last 24 months, Dr Walker has received investigator grants or served as a speaker, a consultant or an advisory board member for: Janssen AbbVie Takeda Ferring Dr Falk Pharma Georgiamune Shahzad, Asif: No conflict of interest Boyapati, Ray Kiran: No conflict of interest Rivas, Consuelo: No conflict of interest Caquilpan, Victor: No conflict of interest Wilson, William: No conflict of interest Connor, Susan Jane: Grant: Research Support: Abbvie, Agency for Clinical Innovation, Amgen, BMS, Chiesi, Celltrion, DrFalk, Ferring, Janssen, Medical Research Future Fund, Pfizer, South Western Sydney Local Health District, Sydney Partnership for Health, Research and Enterprise, Takeda and The Leona M and Harry B Helmsley Charitable Trust Personal Fees: Ad Boards: Abbvie, Amgen, BMS, Celltrion, Eli Lilly, Ferring, GSK, Janssen, Organon, Pfizer, Takeda Speaker Fees: Abbvie, Cornerstones Health, Dr Falk, Ferring, Janssen, Pfizer, Sandoz, Sydney IBD School, Takeda Educational Support: DrFalk, Sandoz, Takeda Andrews, Jane Mary: Grant: The work I will present was funded via CCCure. CCCure’s funding sources include grants for research and payments for data reports from Pharma including AbbVie, J & J, Takeda, Celltrion, Falk, Ferring, BMS, Janssen, Pfizer, Sandoz Ghaly, Simon: Speaker fees, research grants and travel grants from Dr. Falk pharma, Janssen, Pfizer, AbbVie, Sandoz and Ferring and served on advisory boards for Pfizer and AbbVie.