P0843Effectiveness and safety of induction therapy with Mirikizumab in older patients with ulcerative colitis compared to younger adults - a prospective multicentre real-life study from the Sicilian Network for Inflammatory Bowel Disease (SN-IBD)

Abstract Background Subjects aged ≥60 years represent an increasing population of patients with ulcerative colitis (UC). Beyond the questions concerning effectiveness of new therapies in this population, the aspects of safety remain the primary concern. In this special population, the only data of effectiveness and safety of Mirikizumab (MIRI), a monoclonal IgG4 antibody against the p19 subunit of Interleukin 23 licensed recently for the treatment of UC, come from the pivotal trials but real-life data are lacking. The purpose of the present study was to evaluate prospectively the effectiveness with special emphasis on urgency, and safety of MIRI in older patients with ulcerative colitis in comparison with younger adults Methods UC patients from 12 centres of the SN-IBD were prospectively enrolled. The primary endpoints were reduction of urgency, clinical response, and steroid-free remission (SFR). As a secondary endpoint, the need for prolonged induction was considered. All patients received 3 infusions at monthly intervals of 300 mg MIRI; in case of incomplete response, the induction period was prolonged according to the drug registration characteristics (RCP). Urgency was determined by means of the urgency numerical response scale (UNRS) Results Thirty-three older UC patients and 60 younger adult UC patients were included in the study and baseline characteristics were shown in table 1. Older patients showed a high percentage of steroid dependency. At week 12, clinical response was observed in 30% of older patients and 31% of adults (p = 0.920), but a lower SFR was achieved in elderly patients at week 12 compared to adults (0.006). Urgency at baseline was comparable between the two groups and decreased significantly during the induction period, but at week 12, faecal urgency was still higher in the older group compared to adults (p 0.001). An additional induction period was necessary in 48% and 31% of elderly and adult patients, respectively. No differences were found in terms of safety (AEs 9% vs 3% of elderly and adults respectively; p = 0.211) leading in 1 young adult to therapy discontinuation. Conclusion our prospective real-life pilot study confirmed the short-term effectiveness and safety of MIRI in the older UC population with a benefit on bowel urgency although to an apparent lower extent compared to younger patients. This is in line with a lower rate of SFR in older patients compared to adults after the induction period. This finding has to be confirmed with a longer follow-up. No safety issues were detected. Conflict of interest: Dr. Viola, Anna: Advisory board/Lectures for Pfizer, Johnson & Johnson, Galapagos, Takeda, Eli-Lilly Costantino, Giuseppe: Advisory board/Lectures for Johnson &Johnson, Galapagos, Abbvie Iuculano, Andrea: No conflict of interest Li Voti, Raffaele: No conflict of interest Macaluso, Fabio Salvatore: Advisory board and/or lecture fees for: AbbVie, MSD Galapagos, Sandoz, Takeda, Janssen, Eli-Lilly, Pfizer, Alfasigma, Giuliani Ferracane, Concetta: nothing to declare Cappello, Maria: None Scrivo, Barbara: Advisory board/Lectures for Takeda Scalisi, Giuseppe: No conflict of interest Garufi, Serena: No conflict of interest Giangreco, Emiliano: No conflict of interest Sciuto, Morena: No conflict of interest Antoci, Chiara: No conflict of interest Tortorella, Vincenza: Nessuno Catarella, Domenico: No conflict of interest Parisi, Stefanie: No conflict of interest Rao, Sofia: No conflict of interest Muscarella, Stefano: No conflict of interest Distefano, Maria Emanuela: No conflict of interest Minissale Maria, Giovanna: No conflict of interest Vassallo, Roberto: No conflict of interest Mocciaro, Filippo: Advisory board/Lectures for AbbVie, Alfasigma, Galapagos, Takeda, Eli-Lill, y, Johnson &Johnson, Sandoz, Ferring Blando, Giuseppe: No conflict of interest Orlando, Ambrogio: Advisory board and/or lecture fees for: AbbVie, Galapagos, Celltrion, MAD, Sofar, Pfizer, Takeda, Cadigroup, Sandoz, Janssen, Eli-Lilly, Alfasigma Fries, Walter: research grant (Pfizer) speaker fees (Abbvie, Takeda) advisory board (Pfizer, Lilly) non finanvcal support (Ferring, Lilly, Pfizer, Janssen, Takeda, Alpha-Wassermann)