P1012Real-world comparative effectiveness of risankizumab versus other biologics in perianal Crohn’s disease: a multicentre retrospective cohort study

Abstract Background Perianal Crohn’s disease (pCD) represents a challenging disease phenotype. While risankizumab (RZB) is effective for luminal Crohn’s disease, evidence in pCD remains limited. We aimed to evaluate the real-world effectiveness of RZB versus tumour necrosis factor inhibitors (anti-TNF), ustekinumab (UST), and vedolizumab (VDZ) in patients with pCD. Methods This multicentre retrospective cohort included patients from ten IBD centres (2020–2025). Adults with pCD initiating RZB as second-line or later were compared with historical controls treated with anti-TNF, UST, or VDZ. The primary outcome was perianal clinical remission, defined as absence of drainage from all perianal fistula openings and no perianal interventions during follow-up. Secondary outcomes were: clinical response (physician-assessed improvement in fistula activity or healing); in inactive pCD, clinical relapse (recurrence of drainage from a previously closed opening, new draining fistula, or need for perianal re-intervention); and radiological response/healing on MRI or TRUS. Associations were estimated using multivariable logistic regression. Unless otherwise stated, percentages are reported in the order RZB, UST, anti-TNF, VDZ. Results A total of 497 patients were included: 247 with active pCD (RZB 69, UST 80, anti-TNF 56, VDZ 42) and 250 with inactive pCD (RZB 123, UST 38, anti-TNF 51, VDZ 38). In active pCD, clinical response rates were comparable between RZB, UST, and anti-TNF but lower with VDZ (79.7%, 80.0%, 78.6%, 50.0%; p = 0.001). Clinical remission rates were higher with RZB compared to other therapies (53.6%, 41.8%, 23.8%, 37.5%; p = 0.023), and RZB remained independently associated with greater odds of achieving perianal clinical remission (OR 2.79; 95% CI 1.29–6.28; p = 0.011). Time to response was shortest for RZB (median 3 IQR 2-4 months vs 4-7 months; p 0.001). New fistula formation occurred least often with RZB (2.9%, 8.8%, 14.3%, 35.7%; p 0.001). Radiological healing was more frequent with UST and anti-TNF than with RZB or VDZ (UST 41.9%, anti-TNF 39.5%, RZB 18.8%, VDZ 14.3%, p = 0.019). In inactive pCD, clinical relapse occurred least often with RZB (8.1%, 21%, 31%, 29%; p = 0.001), and RZB remained independently associated with lower odds of perianal clinical relapse (OR 0.11; 95% CI 0.03–0.33; p 0.001). Conclusion In this multicentre real-world cohort, RZB as second-line or later therapy achieved comparable clinical response to UST and anti-TNF, higher rates of clinical remission in active pCD, and the lowest relapse rate in inactive pCD. These findings support RZB as a promising and effective therapeutic option for both induction and maintenance in this difficult-to-treat phenotype. Conflict of interest: Dr. Dakka, Amer: No conflict of interest Van Lierop, Lisa: Nothing to disclose Hoentjen, Frank: Frank Hoentjen has served on advisory boards or as speaker for Abbvie, CCRN, Janssen, Takeda, Pfizer, Celltrion, Teva, Amgen and Pendopharm, and has received independent research funding from Celltrion, Janssen, Abbvie, and Takeda. Shelemey, Paige: N/A Plevris, Nikolas: Speaker fees / travel support from Abbvie, Pfizer, Janssen, Lilly, Ferring Toskas, Alexandros: No conflict of interest Kamperidis, Nikolaos: No conflict of interest Manti, Magdalini: Nothing to declare Savarino, Edoardo Vincenzo: Personal Fees: Takeda, Abbvie, MSD, Janssen, Sofar Castellet-Farrús, Sílvia: No conflict of interest Barreiro-de Acosta, Manuel: MBA has been speaker, consultant and advisory member for or has received research funding from MSD, AbbVie, Janssen, Kern Pharma, Celltrion, Takeda, Alphasigma, Lilly, Pfizer, Sandoz, Biocon, Abivax, Fresenius, Faes Farma, Ferring, Tillots, Chiesi, Adacyte, Diasorin, Oncostellae and SunRock. Cuccia, Giuseppe: No conflict of interest Pugliese, Daniela: Consultant/Lectures fees from: AbbVie, Takeda, Johnson, Pfizer, Alfasigma, MSD, Lilly, Celltrion. Imperatore, Nicola: None to declare Eder, Piotr Michał: Travel and educational grants: Takeda, Ferring, Abbvie, Janssen (J&J), Eli Lilly. Lecture and/or consultancy fees: Takeda, Abbvie, Ferring, Janssen (J&J), Eli Lilly, Bristol Myers Squibb, Pfizer, Recordati, Ibsen, Sandoz. Goldman, Adam: No conflict of interest Shani, Uria: No conflict of interest Ben-Horin, Shomron: Grant: Abbvie, Takeda, Janssen, Celltrion, Pfizer, Medtronic, Galmed, OutSense Personal Fees: Advisory board and/or consulting and/or Speaker fees from Abbvie, Takeda, Janssen, Celltrion, Pfizer, GSK, Ferring, Novartis, Roche, Gilead, NeoPharm, EviNature, Galmed, Medial Earlysign, BMS, Pfizer, Falk, Medtronic and Eli Lilly. Options/stocks in Predicta Med, Evinature, Galmed, Alma Therpeautics. Kopylov, Uri: Grant: Takeda, Janssen,Abbvie, Medtronic, Ely Lilly Other: Takeda, Janssen, ,Ely Lilly, Roche, Celtrion, Abbvie, Medtronic, CTS, Pfizer, BMS- speaker and advisory fees Albshesh, Ahmad: received speaking and lecturing fees from Takeda, Janssen and abbvie