Abstract Background Mirikizumab (MIRI), a monoclonal IgG4 antibody against the p19 subunit of Interleukin 23 was recently licensed for the treatment of ulcerative colitis (UC). Most data come from the pivotal trials but real-life data are scant. The purpose of the present study was to evaluate prospectively the effectiveness and safety of MIRI in patients with ulcerative colitis in a real-world setting. Methods UC patients from 12 centres of the SN-IBD were prospectively enrolled. The primary endpoints were clinical response, steroid-free remission (SFR), and reduction of urgency at week 12 and at week 24. 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 extended according to the drug registration characteristics (RCP). In case of full response, patients continued with subcutaneous MIRI (200 mg/every 4 weeks). Urgency was determined by means of the Urgency Numerical Rating Scale (UNRS). Results One hundred and five patients were included in the study and baseline characteristics were shown in table 1. Previous failures to at least 2 therapy-lines of advanced therapies were registered in 74% of patients. At week 12, clinical response was observed in 24% of patients, whereas SFR was achieved by 53% of patients (Figure 1). Data from 71 patients were available at week 24 with 20% and 68%, respectively. Median urgency score decreased from score 6 at baseline to score 2 (p 0.001) at week 12 and to 1 at 24 weeks (p = 0.001, both). An extended induction period was necessary in 54% of patients. There was no difference between Ustekinumab-experienced and Ustekinumab-naïve UC patients Adverse events were reported in 5% of patients leading to three treatment discontinuations. Treatment failure occurred in 8 patients during the whole observation period. Conclusion our prospective real-life study confirmed the short-term effectiveness and safety of MIRI in patients with UC, especially in relieving bowel urgency. Conflict of interest: Costantino, Giuseppe: Advisory board/Lectures for Johnson &Johnson, Galapagos, Abbvie Dr. Viola, Anna: Advisory board/Lectures for Pfizer, Johnson & Johnson, Galapagos, Takeda, Eli-Lilly 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 Scrivo, Barbara: Advisory board/Lectures for Takeda Cappello, Maria: None Ferracane, Concetta: nothing to declare 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 Vassallo, Roberto: No conflict of interest Minissale Maria, Giovanna: No conflict of interest Mocciaro, Filippo: Advisory board/Lectures for AbbVie, Alfasigma, Galapagos, Takeda, Eli-Lill, y, Johnson &Johnson, Sandoz, Ferring. Muscianisi, Marco: 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)
Cottone et al. (Thu,) studied this question.