What question did this study set out to answer?

To assess the short- and long-term effectiveness and safety of risankizumab therapy in Crohn's disease.

January 23, 2026

P1014Multicenter Real-World Outcomes of Risankizumab in Crohn’s Disease: The RESOLVE IG-IBD Study

Key Points

To assess the short- and long-term effectiveness and safety of risankizumab therapy in Crohn's disease.
Retrospective enrollment of Crohn's disease patients treated with risankizumab across 28 Italian centers.
Primary endpoints included steroid-free clinical remission and endoscopic remission at specified weeks.
Secondary outcomes assessed clinical response, biochemical remission, and imaging results.
At week 12, 60.8% achieved steroid-free clinical remission, and 76.5% had a clinical response.
Among 154 patients at week 52, 65.6% achieved steroid-free clinical remission.
Fecal calprotectin decreased significantly from 869.9 to 351.2 μg/g by week 52.

Abstract

Abstract The RESOLVE IG-IBD Study Group: Marina Aloi Mariangela Allocca Annalisa Aratari Marta Ascolani Paola Balestrieri Lorenzo Bertani Cristina Bezzio Giorgia Bodini Fabrizio Bossa Emma Calabrese Michele Campigotto Rosanna Cannatelli Flavio Caprioli Marica Cappello Pietro Capone Michele Cicala Giuseppe Cuccia Ferdinando D’Amico Silvio Danese Alice De Bernardi Francesca Romana De Filippo Elena Del Zanna Federico Desideri Dhanai Di Paolo Antonio Di Sario Massimo Claudio Fantini Concetta Ferracane Stefano Festa Gionata Fiorino Elisa Foscarini Federica Furfaro Roberto Gabbiadini Andrea Geccherle Viviana Gerardi Emiliano Giangreco Antonietta Gerarda Gravina Alfredo Greco Lucrezia Laterza Loris Riccardo Lopetuso Irene Marafini Mauro Mastronardi Marco Mendolaro Manuela Merli Giammarco Mocci Sara Onali Maria Francesca Onidi Alba Panarese Luca Pastorelli Raffaele Pellegrino Alessandra Piagnani Roberta Pica Maria Beatrice Principi Francesca Profeta Daniela Pugliese Davide Giuseppe Ribaldone Antonio Rispo Fernando Rizzello Ivan Salerno Fabrizio Santagata Simone Saibeni Edoardo Vincenzo Savarino Rocco Spagnuolo Enrico Tettoni Antonio Tursi Angela Variola Chiara Viganò. Background Risankizumab (RZB), a humanized IgG1 monoclonal antibody targeting the p19 subunit of IL-23, has recently been approved for the treatment of moderate-to-severe Crohn’s disease (CD). Given the limited real-world evidence available, this study aimed to evaluate the short- and long-term effectiveness and safety of RZB therapy in a large, real-life cohort of Italian CD patients. Methods From September 2023 to March 2025, all consecutive CD patients treated with RZB across 28 Italian centers were retrospectively enrolled. All patients completing the induction phase with a minimum 12-weeks-follow-up were included. The primary endpoints were steroid-free clinical remission (SFCR) (HBI 5) at week 12 and endoscopic remission at week 52 (±8 weeks) (SES-CD 0–1 or Rutgeerts score i0-i1 for patients with only anastomotic/neoterminal ileum disease). Secondary outcomes included clinical response (≥3-point decrease in HBI), clinical and biochemical remission (CRP ≤5 mg/L), radiologic remission ((BWT≤4mm without increased enhancement), resolution of extra-intestinal manifestations (EIMs), and adverse events at 12, 26 and 52 weeks. Results Of 520 patients completing the 12-week follow-up, 264 (50.8%) had failed ≥3 biologics, 285 (54.8%) had prior ustekinumab (UST) exposure, and 313 (60.4%) had previous intestinal resection. Table 1 contains additional demographics and clinical data. At week 12, SFCR and clinical response were achieved in 60.8% and 76.5% of patients, respectively. Among UST-exposed patients, rates were 53.3% and 71.6%; among multi-failure patients, 55.7% and 73.5%, respectively. Biochemical remission occurred in 36.7% at week 12. Among 154 patients who completed the 52-weeks follow-up, 65.6% achieved SFCR, and 49.4% combined clinical and biochemical remission. Of 72 patients undergoing colonoscopy 37.5% achieved endoscopic remission. Among 61 patients with available imaging, average BWT decreased from 7.16 mm to 5.62 mm (p = 0.003) at week 52, and inflamed segment length from 24.9cm to 7.5 cm (p = 0.018). Notably, 25.7% of patients achieved radiologic remission. Average fecal calprotectin decreased from 869.9 μg/g to 351.2 μg/g (p = 0.002), and CRP from 9.2 to 3.2 mg/L (p 0.001). Rheumatologic and dermatologic EIMs activity decreased from 17.1% to 11.7% (p = 0.039) and 6.7% to 1.3% (p = 0.039), respectively. RZB was well-tolerated, with no new safety signals. Conclusion In this large, real-world cohort of CD patients with extensive prior biologic exposure, RZB therapy was associated with high rates of SFCR and significant improvements in clinical, biochemical, radiological and endoscopic outcomes. RZB also demonstrated effectiveness in managing rheumatologic and dermatologic EIMs. The safety profile was consistent with previous data. Conflict of interest: Scaldaferri, Franco: No conflict of interest Dr. Di Vincenzo, Federica: No conflict of interest Armuzzi, Alessandro: Consulting fees from AbbVie, Abivax, Alfa Sigma, Astra Zeneca, Biogen, Boehringer Ingelheim, Bristol-Myers Squibb, Celltrion, Eli-Lilly, Enthera, Ferring, Galapagos, Gilead, Giuliani, Janssen, Lionhealth, MSD, Nestlé, Pfizer, Protagonist Therapeutics, Roche, Samsung Bioepis, Sanofi, Sandoz, Takeda, Teva Pharmaceuticals, Tillots Pharma Speaker’s fees from AbbVie, Abivax, AG Pharma, Alfa Sigma, Biogen, Bristol-Myers Squibb, Celltrion, Eli-Lilly, Ferring, Galapagos, Gilead, Janssen, Lionhealth, MSD, Novartis, Pfizer, Roche, Samsung Bioepis, Sandoz, Takeda, Teva Pharmaceuticals Research support from Biogen, MSD, Takeda, and Pfizer Non-financial support from Abbvie, Janssen, MSD, Pfizer, Takeda

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Cite This Study

Scaldaferri et al. (Thu,) studied this question.

synapsesocial.com/papers/69730ef2c8125b09b0d1ebb0 https://doi.org/https://doi.org/10.1093/ecco-jcc/jjaf231.1195

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