P0609 Real-world short and long-term effectiveness of risankizumab in refractory Crohn’s disease: RISANCROHN study from the ENEIDA Registry
M Barreiro-de Acosta, L Nieto-Garcia, M Poncela, M Aguas, C Martinez Cuevas, F Argüelles-Arias, M Calvo, C J Gargallo-Puyuelo, L Zabalza, P Varela Trastoy, M M Bosca-Watts, D Ceballos, C Martinez-Pascual, F Rodríguez-Moranta, M L de Castro Parga, P Suárez, B Camps, V Royo, I Bastón-Rey, R de Francisco, S Garcia-Lopez, M D Martín-Arranz, I Alonso-Abreu, J P Gisbert, M Rivero, B Sicilia, I Nicolás, M Teller, Á Ponferrada, E Ricart, M Algara, P Fradejas, P Robledo, L Madero, A Elorza, M Piqueras, Y Zabana, S Porto-Silva, E Domènech, R Ferreiro-IglesiasAbstract
Background
Phase III trials have demonstrated the efficacy of risankizumab (RZB), this being the first humanized monoclonal IgG1 antibody which targets the interleukin 23 p19 subunit, in Crohn’s disease (CD). However, real-world data with this drug is limited. The aim of our study was to assess the real-world effectiveness of RZB in patients with CD.
Methods
Adult CD patients that had received treatment with RZB in the ENEIDA registry —a large prospectively maintained Spanish database promoted by the Spanish Working Group of Crohn’s and Colitis (GETECCU)— were included. Clinical and demographical data including number of previous biologics and advanced therapies were included. The primary endpoints were steroid-free clinical remission (SFCR) after induction period (Harvey-Bradshaw score <5) and long-term SFCR at the end of follow-up. Influence of previous use of ustekinumab (UST) and number of previous advanced therapies in short- and long-term efficacy was also evaluated. Statistical analysis was performed using the Chi-square/Student-t test and multivariate analysis with logistic regression.
Results
857 CD patients (60% male) were included: median age 50 (18-84) years, median disease duration 14 years, 27% smokers. 50% were L1, 8% L2, 38% L3, and 4% exclusively L4. B1 phenotype was present in 42%, 37% B2, 21% B3. Perianal disease was present in 28%, 46% had previously CD-related surgery and 39% extraintestinal manifestations. Only 3% were biological naïve, 50% had been exposed to 1-2 advanced therapies, and 47% to 3 or more. Following induction 56% of the patients achieved SFCR. Remission was more frequent in patients who had not previously been treated with UST (64% vs. 53% in those previously exposed to UST, p<0.01). In the multivariate analysis, a higher number of prior advanced therapies was associated with lower remission rates (p<0.01). Long-term efficacy was evaluated in 652 patients (median follow-up 7 months). At the end of the follow-up 61.2% of patients maintained SFCR. Long-term remission rate in patients non-exposed to UST was 72%, and 55% exposed to UST (p<0.01). In the multivariate analysis, younger age was associated with higher long-term remission rates (p<0.01). 11% needed dose optimization/reinduction during follow-up. 68 patients (7.9%) presented adverse events but only 18 (2%) needed to give up the treatment.
Conclusion
This study represents the largest cohort of real-world data on RZB in CD, including highly refractory patients with multiple prior drug failures. RZB induced SFCR in 56% of patients after induction and 61% in the long term. Higher remission rates were observed in patients who had never been exposed to UST. Younger age and fewer previous advanced therapies were associated with better outcomes.