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Poster presentations: Clinical: Therapy and Observation 2020

P717 Ustekinumab in Crohn’s disease: Real-world outcomes from the Sicilian Network for inflammatory bowel diseases (SN-IBD):–Preliminary results

A. Viola1, G. Fiocco1, A. Alibrandi2, F.S. Macaluso3, M. Cappello4, A.C. Privitera5, G. Magrì6, S. Garufi7, A. Centritto1, M. Ventimiglia3, E. Giuffrida4, C. Ferracane6, G. Costantino1, S. Renna3, A. Orlando3, W. Fries1

1Inflammatory Bowel Disease Unit, Department of Clinical and Experimental Medicine, University of Messina, A.O.U. Policlinico ‘G. Martino’, Messina, Italy, 2Department of Economics, Unit of Statistical and Mathematical Sciences, University of Messina, Italy, 3A.O.O.R. ‘Villa Sofia-Cervello’, Inflammatory Bowel Disease Unit, Palermo, Italy, 4Gastroenterology and Hepatology Unit, A.O.U. Policlinico ‘G. Giaccone’,, University of Palermo, , Palermo, Italy, 5A.O Cannizzaro, Inflammatory Bowel Disease Unit, Catania, Italy, 6A.O. ‘Santa Marta e S. Venera’, Gastroenterology Unit, Acireale, Italy, 7A.O.O.R. ‘S. Elia- M. Raimondi’, Gastroenterology Unit, Caltanissetta, Italy

Background

Ustekinumab is approved in Europe for the treatment of moderate-to-severe Crohn’s disease (CD) since 2016. Italian real-life data on efficacy and safety are scarce. The aim of this study was to assess effectiveness, safety and usage of Ustekinumab in an Italian cohort of patients.

Methods

Data of patients with moderate-to-severe CD who started Ustekinumab in Sicily were extracted from the database of the SN-IBD. Demographic data, disease-related data (disease duration, location, clinical activity) and previous therapies with biologics were collected. The primary study endpoints were steroid-free clinical remission and steroid-free clinical response at week 12, 24 and 52 on Ustekinumab therapy. Secondary study endpoints were: treatment persistence at 24 weeks, safety, and biochemical response (reduction of CRP).

Results

One hundred thirteen patients started Ustekinumab in Sicily. We performed a preliminary analysis only on patients who reached at least 24 weeks of follow-up. Ninety-three patients (M = 53%; mean age 45 ± 14.9 years) were included. At week 24, 38 patients (41%) achieved steroid-free clinical remission, 56 patients (60%) clinical response. From baseline to the end of follow-up there was a significant reduction of steroid use (41% vs. 21%, p = 0.038) and of mean HBI score (6.5 ± 4.4 vs. 4.8 ± 4.1; p < 0.001). No significant CRP changes were recorded during follow-up. Twelve patients (11%) discontinued therapy due to primary failure (3 patients), secondary failure (5 patients), adverse events (3 patients) and 1 patient was lost to follow-up. Kaplan–Meier survival analysis showed a persistence on therapy with Ustekinumab of 89% of patients after 24 weeks (Figure 1).

Conclusion

Preliminary data from our real-life cohort of treatment-refractory CD patients suggest a satisfactory effectiveness and a good safety profile of Ustekinumab.